48156 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 63 

[EPA–HQ–OAR–2015–0730; FRL–9969–08– 

OAR] 

RIN 2060–AS93 

National Emission Standards for 

Hazardous Air Pollutants: Nutritional 

Yeast Manufacturing Residual Risk 

and Technology Review 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This action finalizes the 

residual risk and technology review 

(RTR) conducted for the Manufacturing 

of Nutritional Yeast source category 

regulated under national emission 

standards for hazardous air pollutants 

(NESHAP). In addition, we are 

finalizing other amendments, including 

revisions to the form of the volatile 

organic compounds (VOC) standards for 

fermenters, removal of the option to 

monitor brew ethanol, inclusion of 

ongoing relative accuracy test audit 

(RATA), and revisions to other 

monitoring, reporting, and 

recordkeeping requirements. 

DATES: This final rule is effective on 

October 16, 2017. The incorporation by 

reference of certain publications listed 

in the rule is approved by the Director 

of the Federal Register as of October 16, 

2017. 

ADDRESSES: The Environmental 

Protection Agency (EPA) has established 

a docket for this action under Docket ID 

No. EPA–HQ–OAR–2015–0730. All 

documents in the docket are listed on 

the https://www.regulations.gov Web 

site. Although listed in the index, some 

information is not publicly available, 

e.g., confidential business information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically through 

https://www.regulations.gov, or in hard 

copy at the EPA Docket Center, EPA 

WJC West Building, Room Number 

3334, 1301 Constitution Ave. NW., 

Washington, DC. The Public Reading 

Room hours of operation are 8:30 a.m. 

to 4:30 p.m. Eastern Standard Time, 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the EPA 

Docket Center is (202) 566–1742. 

FOR FURTHER INFORMATION CONTACT: For 

questions about this final action, contact 

Allison Costa, Sector Policies and 

Programs Division (Mail Code E143–03), 

Office of Air Quality Planning and 

Standards, U.S. Environmental 

Protection Agency, Research Triangle 

Park, North Carolina 27711; telephone 

number: (919) 541–1322; fax number: 

(919) 541–0516; and email address: 

costa.allison@epa.gov. For specific 

information regarding the risk modeling 

methodology, contact Chris Sarsony, 

Health and Environmental Impacts 

Division (C539–02), Office of Air 

Quality Planning and Standards, U.S. 

Environmental Protection Agency, 

Research Triangle Park, North Carolina 

27711; telephone number: (919) 541– 

4843; and email address: sarsony.chris@

epa.gov. For information about the 

applicability of the NESHAP to a 

particular entity, contact John Cox, 

Office of Enforcement and Compliance 

Assurance, U.S. Environmental 

Protection Agency, EPA WJC South 

Building (Mail Code 2227A), 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460; telephone number: (919) 

564–1395; and email address: cox.john@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

Preamble acronyms and 

abbreviations. We use multiple 

acronyms and terms in this preamble. 

While this list may not be exhaustive, to 

ease the reading of this preamble and for 

reference purposes, the EPA defines the 

following terms and acronyms here: 

BAE Batch-average concentration of brew 

ethanol in fermenter liquid 

BAVOC Batch-average concentration of 

volatile organic compounds in fermenter 

exhaust 

CAA Clean Air Act 

CDX Central Data Exchange 

CEDRI Compliance and Emissions Data 

Reporting Interface 

CEMS Continuous emission monitoring 

system 

CFR Code of Federal Regulations 

CPMS Continuous parameter monitoring 

system 

CRA Congressional Review Act 

EPA Environmental Protection Agency 

ERT Electronic Reporting Tool 

FID Flame ionization detector 

GC Gas chromatograph 

HAP Hazardous air pollutant(s) 

HQ Hazard quotient 

ICR Information Collection Request 

MACT Maximum achievable control 

technology 

NEI National Emissions Inventory 

NESHAP National emission standards for 

hazardous air pollutants 

NTTAA National Technology Transfer and 

Advancement Act 

OMB Office of Management and Budget 

ppmv Parts per million by volume 

PRA Paperwork Reduction Act 

RATA Relative accuracy test audit 

REL Recommended exposure limit 

RFA Regulatory Flexibility Act 

RfC Reference concentration 

RIN Regulatory Information Number 

RTO Regenerative thermal oxidizer 

RTR Risk and technology review 

SSM Startup, shutdown, and malfunction 

THC Total hydrocarbons 

TOSHI Target organ-specific hazard index 

UMRA Unfunded Mandates Reform Act 

URE Unit risk estimate 

VOC Volatile organic compound 

Background information. On 

December 28, 2016, the EPA issued a 

proposed rulemaking presenting the 

results of the RTR of the Manufacturing 

of Nutritional Yeast NESHAP, as well as 

proposing additional revisions to the 

NESHAP. In this action, we are 

finalizing decisions and revisions for 

the rule. We summarize some of the 

more significant comments we received 

regarding the proposed rule and provide 

our responses in this preamble. A 

summary of all other public comments 

on the proposal and the EPA’s responses 

to those comments is available in the 

document titled, ‘‘Nutritional Yeast 

Manufacturing Risk and Technology 

Review: Summary of Public Comments 

and Responses,’’ which is in the docket 

for this action (Docket ID No. EPA–HQ– 

OAR–2015–0730). A ‘‘track changes’’ 

version of the regulatory language that 

incorporates the changes in this action 

is also available in the docket. 

Organization of this document. The 

information in this preamble is 

organized as follows: 

I. General Information 

A. Does this action apply to me? 

B. Where can I get a copy of this document 

and other related information? 

C. Judicial Review and Administrative 

Reconsideration 

II. Background 

A. What is the statutory authority for this 

action? 

B. What is the Manufacturing of 

Nutritional Yeast source category and 

how does the NESHAP regulate HAP 

emissions from this source category? 

C. What changes did we propose for the 

Manufacturing of Nutritional Yeast 

source category in our December 28, 

2016, proposal? 

III. What is included in this final rule? 

A. What are the final rule amendments 

based on the risk review for the 

Manufacturing of Nutritional Yeast 

source category? 

B. What are the final rule amendments 

based on the technology review for the 

Manufacturing of Nutritional Yeast 

source category? 

C. What are the final rule amendments 

addressing emissions during periods of 

startup, shutdown, and malfunction? 

D. What other changes have been made to 

the NESHAP? 

E. What are the effective and compliance 

dates of the standards? 


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F. What are the requirements for 

submission of performance test data to 

the EPA? 

IV. What is the rationale for our final 

decisions and amendments for the 

Manufacturing of Nutritional Yeast 

source category? 

A. Residual Risk Review for the 

Manufacturing of Nutritional Yeast 

Source Category 

B. Technology Review for the 

Manufacturing of Nutritional Yeast 

Source Category 

C. Revised Form of the Fermenter VOC 

Standard 

D. Removal of the Option To Monitor Brew 

Ethanol 

E. Requirement To Conduct RATA 

F. Requirement To Collect All Valid CEMS 

Data 

G. Compliance Dates for the Amendments 

V. Summary of Cost, Environmental, and 

Economic Impacts and Additional 

Analyses Conducted 

A. What are the affected facilities? 

B. What are the air quality impacts? 

C. What are the cost impacts? 

D. What are the economic impacts? 

E. What are the benefits? 

F. What analysis of environmental justice 

did we conduct? 

G. What analysis of children’s 

environmental health did we conduct? 

VI. Statutory and Executive Order Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

B. Executive Order 13771: Reducing 

Regulations and Controlling Regulatory 

Costs 

C. Paperwork Reduction Act (PRA) 

D. Regulatory Flexibility Act (RFA) 

E. Unfunded Mandates Reform Act 

(UMRA) 

F. Executive Order 13132: Federalism 

G. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

H. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

I. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

J. National Technology Transfer and 

Advancement Act (NTTAA) and 1 CFR 

Part 51 

K. Executive Order 12898: Federal Actions 

To Address Environmental Justice in 

Minority Populations and Low-Income 

Populations 

L. Congressional Review Act (CRA) 

I. General Information 

A. Does this action apply to me? 

Regulated entities. Categories and 

entities potentially regulated by this 

action are shown in Table 1 of this 

preamble. 

TABLE 1—NESHAP AND INDUSTRIAL

SOURCE CATEGORIES AFFECTED BY

THIS FINAL ACTION

NESHAP and Source Category NAICS1

Code 

Manufacturing of Nutritional Yeast 311999 

1 North American Industry Classification 

System. 

Table 1 of this preamble is not 

intended to be exhaustive, but rather to 

provide a guide for readers regarding 

entities likely to be affected by the final 

action for the source category listed. To 

determine whether your facility is 

affected, you should examine the 

applicability criteria in the final 

Manufacturing of Nutritional Yeast 

NESHAP (40 CFR part 63, subpart 

CCCC). If you have any questions 

regarding the applicability of any aspect 

of this NESHAP, which we refer to as 

‘‘subpart CCCC’’ in this preamble, 

please contact the appropriate person 

listed in the preceding FOR FURTHER

INFORMATION CONTACT section of this 

preamble. 

B. Where can I get a copy of this 

document and other related 

information? 

In addition to being available in the 

docket, an electronic copy of this final 

action will also be available on the 

Internet. Following signature by the 

EPA Administrator, the EPA will post a 

copy of this final action at: https://

www.epa.gov/stationary-sources-airpollution/manufacturing-nutritionalyeast-national-emission-standards. 

Following publication in the Federal 

Register, the EPA will post the Federal 

Register version and key technical 

documents at this same Web site. 

Additional information is available on 

the RTR Web site at https://

www3.epa.gov/ttn/atw/rrisk/rtrpg.html. 

This information includes an overview 

of the RTR program, links to project 

Web sites for the RTR source categories, 

and detailed emissions and other data 

we used as inputs to the risk 

assessments. 

C. Judicial Review and Administrative 

Reconsideration 

Under Clean Air Act (CAA) section 

307(b)(1), judicial review of this final 

action is available only by filing a 

petition for review in the United States 

Court of Appeals for the District of 

Columbia by December 15, 2017. Under 

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

established by this final rule may not be 

challenged separately in any civil or 

criminal proceedings brought by the 

EPA to enforce the requirements. 

Section 307(d)(7)(B) of the CAA 

further provides that only an objection 

to a rule or procedure which was raised 

with reasonable specificity during the 

period for public comment (including 

any public hearing) may be raised 

during judicial review. This section also 

provides a mechanism for the EPA to 

reconsider the rule if the person raising 

an objection can demonstrate to the 

Administrator that it was impracticable 

to raise such objection within the period 

for public comment or if the grounds for 

such objection arose after the period for 

public comment (but within the time 

specified for judicial review) and if such 

objection is of central relevance to the 

outcome of the rule. Any person seeking 

to make such a demonstration should 

submit a Petition for Reconsideration to 

the Office of the Administrator, U.S. 

EPA, Room 3000, EPA WJC South 

Building, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460, with a copy to 

both the person(s) listed in the 

preceding FOR FURTHER INFORMATION

CONTACT section, and the Associate 

General Counsel for the Air and 

Radiation Law Office, Office of General 

Counsel (Mail Code 2344A), U.S. EPA, 

1200 Pennsylvania Ave. NW., 

Washington, DC 20460. 

II. Background 

A. What is the statutory authority for 

this action? 

Section 112 of the CAA establishes a 

two-stage regulatory process to address 

emissions of hazardous air pollutants 

(HAP) from stationary sources. In the 

first stage, we must identify categories 

of sources emitting one or more of the 

HAP listed in CAA section 112(b) and 

then promulgate technology-based 

NESHAP for those sources. ‘‘Major 

sources’’ are those that emit, or have the 

potential to emit, any single HAP at a 

rate of 10 tons per year (tpy) or more, 

or 25 tpy or more of any combination of 

HAP. For major sources, these standards 

are commonly referred to as maximum 

achievable control technology (MACT) 

standards and must reflect the 

maximum degree of emission reductions 

of HAP achievable (after considering 

cost, energy requirements, and non-air 

quality health and environmental 

impacts). In developing MACT 

standards, CAA section 112(d)(2) directs 

the EPA to consider the application of 

measures, processes, methods, systems, 

or techniques, including but not limited 

to those that reduce the volume of or 

eliminate HAP emissions through 

process changes, substitution of 

materials, or other modifications; 

enclose systems or processes to 

eliminate emissions; collect, capture, or 


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1The U.S. Court of Appeals for the District of 

Columbia Circuit has affirmed this approach of 

implementing CAA section 112(f)(2)(A): NRDC v. 

EPA, 529 F.3d 1077, 1083 (D.C. Cir. 2008) (‘‘If EPA 

determines that the existing technology-based 

standards provide an ’ample margin of safety,’ then 

the Agency is free to readopt those standards during 

the residual risk rulemaking.’’). 

treat HAP when released from a process, 

stack, storage, or fugitive emissions 

point; are design, equipment, work 

practice, or operational standards; or 

any combination of the above. 

For these MACT standards, the statute 

specifies certain minimum stringency 

requirements, which are referred to as 

MACT floor requirements, and which 

may not be based on cost 

considerations. See CAA section 

112(d)(3). For new sources, the MACT 

floor cannot be less stringent than the 

emission control achieved in practice by 

the best-controlled similar source. The 

MACT standards for existing sources 

can be less stringent than floors for new 

sources, but they cannot be less 

stringent than the average emission 

limitation achieved by the bestperforming 12 percent of existing 

sources in the category or subcategory 

(or the best-performing five sources for 

categories or subcategories with fewer 

than 30 sources). In developing MACT 

standards, we must also consider 

control options that are more stringent 

than the floor under CAA section 

112(d)(2). We may establish standards 

more stringent than the floor, based on 

the consideration of the cost of 

achieving the emissions reductions, any 

non-air quality health and 

environmental impacts, and energy 

requirements. 

In the second stage of the regulatory 

process, the CAA requires the EPA to 

undertake two different analyses, which 

we refer to as the technology review and 

the residual risk review. Under the 

technology review, we must review the 

technology-based standards and revise 

them ‘‘as necessary (taking into account 

developments in practices, processes, 

and control technologies)’’ no less 

frequently than every 8 years, pursuant 

to CAA section 112(d)(6). Under the 

residual risk review, we must evaluate 

the risk to public health remaining after 

application of the technology-based 

standards and revise the standards, if 

necessary, to provide an ample margin 

of safety to protect public health or to 

prevent, taking into consideration costs, 

energy, safety, and other relevant 

factors, an adverse environmental effect. 

The residual risk review is required 

within 8 years after promulgation of the 

technology-based standards, pursuant to 

CAA section 112(f). In conducting the 

residual risk review, if the EPA 

determines that the current standards 

provide an ample margin of safety to 

protect public health, it is not necessary 

to revise the MACT standards pursuant 

to CAA section 112(f).1 For more 

information on the statutory authority 

for this rule, see the proposal published 

on December 28, 2016 (81 FR 95810). 

B. What is the Manufacturing of 

Nutritional Yeast source category and 

how does the NESHAP regulate HAP 

emissions from this source category? 

The EPA promulgated the 

Manufacturing of Nutritional Yeast 

NESHAP on May 21, 2001 (66 FR 

27876). The standards are codified at 40 

CFR part 63, subpart CCCC. The 

manufacturing of nutritional yeast 

industry consists of facilities that 

manufacture 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. Facilities that manufacture 

nutritional yeast intended for 

consumption by animals, such as an 

additive for livestock feed, are not 

included in the description of sources 

covered by this subpart in 40 CFR 

63.2131. In addition, subpart CCCC 

clarifies that fermenters are not subject 

to emission limitations during the 

production of specialty yeast (e.g., yeast 

for use in wine, champagne, whiskey, or 

beer) in 40 CFR 63.2132. The source 

category was originally defined as 

Baker’s Yeast Manufacturing in 1992, 

but was renamed Manufacturing of 

Nutritional Yeast in 1998 to clarify the 

scope of the source category. See the 

preamble for the proposed rule for 

additional background (81 FR 95814, 

December 28, 2016). The source 

category covered by subpart CCCC 

currently includes four facilities. 

The affected sources at nutritional 

yeast manufacturing facilities are the 

collection of equipment used to 

manufacture Saccharomyces cerevisiae 

yeast, including fermenters. The subpart 

CCCC emission limitations apply to the 

final three stages of the fermentation 

process, which are often referred to as 

stock (third-to-last stage), first 

generation (second-to-last stage), and 

trade (last stage) fermentation. 

Currently, the fermenters are subject 

to batch-average VOC (BAVOC) 

emission limitations that differ for each 

fermentation stage, and which must be 

met for 98 percent of all batches in each 

fermentation stage on a rolling 12- 

month basis. The measurement of VOC 

is used as a surrogate for the HAP of 

interest, acetaldehyde. The BAVOC 

limits are 300 parts per million by 

volume (ppmv) for stock fermenters 

(third-to-last stage), 200 ppmv for first 

generation fermenters (second-to-last 

stage), and 100 ppmv for trade 

fermenters (last stage). 

In the original subpart CCCC 

requirements, facilities can 

continuously monitor either the VOC 

concentration in the fermenter exhaust 

or the brew ethanol concentration in the 

fermenter liquid to determine 

compliance with the emission 

limitations. If a facility monitors brew 

ethanol concentration, it must conduct 

an annual performance test to determine 

the correlation between the brew 

ethanol concentration in the fermenter 

liquid and the VOC concentration in the 

fermenter exhaust gas. 

C. What changes did we propose for the 

Manufacturing of Nutritional Yeast 

source category in our December 28, 

2016, proposal? 

On December 28, 2016, the EPA 

published a proposed rule in the 

Federal Register for subpart CCCC, that 

address the results of the RTR analyses 

and proposed other amendments. In the 

action, we proposed finding that the 

risks from the Manufacturing of 

Nutritional Yeast source category are 

acceptable; that additional emissions 

controls for the source category are not 

necessary to provide an ample margin of 

safety; and that there have been no 

developments in practices, processes, 

and control technologies that warrant 

changes to the fermenter emission 

limitations. Additionally, we proposed 

several changes to the existing rule 

(apart from the RTR process) that were 

intended to promote consistency with 

relevant statutory requirements and 

goals. These changes included revising 

the form of the VOC standards for 

fermenters; removing the option to 

monitor brew ethanol; including 

requirements to conduct annual RATA; 

removing gas chromatograph (GC) 

continuous emission monitoring system 

(CEMS) as an option to monitor VOC 

concentration; collecting CEMS data at 

all times during the batch monitoring 

period; using Procedure 1 of Appendix 

F to part 60 for VOC CEMS; requiring 

electronic reporting; and revising 

startup, shutdown, and malfunction 

(SSM) provisions. 

III. What is included in this final rule? 

This action finalizes the EPA’s 

determinations pursuant to the RTR 

provisions of CAA section 112 for the 

Manufacturing of Nutritional Yeast 

source category. This action also 

finalizes other changes to subpart CCCC, 

including: Revising the form of the VOC 

standards for fermenters; removing the 


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option to monitor brew ethanol; 

including requirements to conduct 

ongoing RATA; using Procedure 1 of 

Appendix F to part 60 for VOC CEMS; 

removing GC CEMS as an option to 

monitor VOC concentration; collecting 

CEMS data at all times during the batch 

monitoring period; requiring electronic 

reporting; and revising SSM provisions. 

A. What are the final rule amendments 

based on the risk review for the 

Manufacturing of Nutritional Yeast 

source category? 

The EPA proposed no changes to 

subpart CCCC based on the risk review 

conducted pursuant to CAA section 

112(f). Specifically, as we proposed, we 

are finalizing our determination that 

risks from the nutritional yeast 

manufacturing facilities are acceptable, 

and that the standards provide an ample 

margin of safety to protect public health. 

The EPA received no new data or other 

information during the public comment 

period that changed that determination. 

Therefore, we are not requiring 

additional controls under CAA section 

112(f)(2). 

B. What are the final rule amendments 

based on the technology review for the 

Manufacturing of Nutritional Yeast 

source category? 

We determined that there are no 

developments in practices, processes, 

and control technologies that warrant 

revisions to the MACT standards for this 

source category. The EPA proposed no 

changes to subpart CCCC based on the 

technology review conducted pursuant 

to CAA section 112(d)(6). The EPA 

received no new data or other 

information during the public comment 

period that affected the technology 

review determination. Therefore, we are 

not finalizing revisions to the MACT 

standards under CAA section 112(d)(6). 

C. What are the final rule amendments 

addressing emissions during periods of 

startup, shutdown, and malfunction? 

In its 2008 decision in Sierra Club v. 

EPA, 551 F.3d 1019 (D.C. Cir. 2008), the 

United States Court of Appeals for the 

District of Columbia Circuit vacated 

portions of two provisions in the EPA’s 

CAA section 112 regulations governing 

the emissions of HAP during periods of 

SSM. Specifically, the Court vacated the 

SSM exemptions contained in 40 CFR 

63.6(f)(1) and 40 CFR 63.6(h)(1), holding 

that under section 302(k) of the CAA, 

emissions standards or limitations must 

be continuous in nature and that the 

SSM exemption violates the CAA’s 

requirement that some CAA section 112 

standard apply continuously. 

Consistent with Sierra Club v. EPA, 

the EPA has established standards in 

this rule that apply at all times. We have 

eliminated the malfunction exemption 

in this rule, in addition to making other 

changes to ensure that the rule’s 

emission limitations apply continuously 

(the latter changes are addressed in 

sections III.D and IV.C of this preamble). 

While, for simplicity, we refer 

throughout this section to the SSM 

exemption and the associated SSM plan 

requirements, only the malfunction 

exemption and its removal are relevant 

to this action because periods of startup 

and shutdown were never exempt from 

emissions standards in this subpart. We 

have revised Table 6 to subpart CCCC 

(the General Provisions applicability 

table) in several respects as is explained 

in more detail below. For example, we 

have eliminated the incorporation of the 

General Provisions’ requirement that the 

source develops an SSM plan. We have 

also eliminated and revised certain 

recordkeeping and reporting that is 

related to the SSM exemption as 

described in detail in the proposed rule 

and summarized again here. 

In establishing the standards in this 

rule, the EPA has taken into account 

startup and shutdown periods and, for 

the reasons explained below, has not 

established alternate standards for those 

periods. Periods of startup, normal 

operations, and shutdown are all 

predictable and routine aspects of a 

source’s operations. In this NESHAP, 

owners or operators of nutritional yeast 

manufacturing facilities employ process 

controls to limit emissions. These 

process controls are employed from the 

time a fermenter starts production of a 

batch of yeast and continue until the 

fermenter is emptied of yeast. 

Additionally, emissions are averaged 

over the entire duration of each batch in 

order to determine compliance with 

emission limitations, so there was no 

need to set separate limits for periods of 

startup and shutdown in this rule. 

Malfunctions, in contrast, are neither 

predictable nor routine. Instead they are 

by definition sudden, infrequent, and 

not reasonably preventable failures of 

emissions control, process, or 

monitoring equipment. 40 CFR 63.2 

(definition of malfunction). The EPA 

interprets CAA section 112 as not 

requiring emissions that occur during 

periods of malfunction to be factored 

into development of CAA section 112 

standards and this reading has been 

upheld as reasonable by the D.C. 

Circuit. U.S. Sugar Corp. v. EPA, 830 

F.3d 579, 606–610 (2016). Instead, 

under CAA section 112, emissions 

standards for new sources must be no 

less stringent than the level ‘‘achieved’’ 

by the best controlled similar source 

and for existing sources generally must 

be no less stringent than the average 

emission limitation ‘‘achieved’’ by the 

best performing 12 percent of sources in 

the category. There is nothing in CAA 

section 112 that directs the Agency to 

consider malfunctions in determining 

the level ‘‘achieved’’ by the best 

performing sources when setting 

emission standards. As the D.C. Circuit 

has recognized, the phrase ‘‘average 

emissions limitation achieved by the 

best performing 12 percent of ’’ sources 

‘‘says nothing about how the 

performance of the best units is to be 

calculated.’’ Nat’l Ass’n of Clean Water 

Agencies v. EPA, 734 F.3d 1115, 1141 

(D.C. Cir. 2013). While the EPA 

accounts for variability in setting 

emissions standards, nothing in CAA 

section 112 requires the Agency to 

consider malfunctions as part of that 

analysis. A malfunction should not be 

treated in the same manner as the type 

of variation in performance that occurs 

during routine operations of a source. A 

malfunction is a failure of the source to 

perform in a ‘‘normal or usual manner’’ 

and no statutory language compels the 

EPA to consider such events in setting 

CAA section 112 standards. As the D.C. 

Circuit recognized in U.S. Sugar Corp, 

accounting for malfunctions in setting 

emission standards would be difficult, if 

not impossible, given the myriad 

different types of malfunctions that can 

occur across all sources in the category 

and given the difficulties associated 

with predicting or accounting for the 

frequency, degree, and duration of 

various malfunctions that might occur. 

Id. at 608 (‘‘the EPA would have to 

conceive of a standard that could apply 

equally to the wide range of possible 

boiler malfunctions, ranging from an 

explosion to minor mechanical defects. 

Any possible standard is likely to be 

hopelessly generic to govern such a 

wide array of circumstances.’’) As such, 

the performance of units that are 

malfunctioning is not ‘‘reasonably’’ 

foreseeable. See, e.g., Sierra Club v. 

EPA, 167 F.3d 658, 662 (D.C. Cir. 1999) 

(‘‘The EPA typically has wide latitude 

in determining the extent of datagathering necessary to solve a problem. 

We generally defer to an agency’s 

decision to proceed on the basis of 

imperfect scientific information, rather 

than to ‘invest the resources to conduct 

the perfect study.’ ’’) See also, 

Weyerhaeuser v. Costle, 590 F.2d 1011, 

1058 (D.C. Cir. 1978) (‘‘In the nature of 

things, no general limit, individual 

permit, or even any upset provision can 

anticipate all upset situations. After a 

certain point, the transgression of 


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regulatory limits caused by 

‘uncontrollable acts of third parties,’ 

such as strikes, sabotage, operator 

intoxication or insanity, and a variety of 

other eventualities, must be a matter for 

the administrative exercise of case-bycase enforcement discretion, not for 

specification in advance by 

regulation.’’). In addition, emissions 

during a malfunction event can be 

significantly higher than emissions at 

any other time of source operation. For 

example, if an air pollution control 

device with 99-percent removal goes offline as a result of a malfunction (as 

might happen if, for example, the bags 

in a baghouse catch fire) and the 

emission unit is a steady state type unit 

that would take days to shut down, the 

source would go from 99-percent 

control to zero control until the control 

device was repaired. The source’s 

emissions during the malfunction 

would be 100 times higher than during 

normal operations. As such, the 

emissions over a 4-day malfunction 

period would exceed the annual 

emissions of the source during normal 

operations. As this example illustrates, 

accounting for malfunctions could lead 

to standards that are not reflective of 

(and significantly less stringent than) 

levels that are achieved by a wellperforming non-malfunctioning source. 

It is reasonable to interpret CAA section 

112 to avoid such a result. The EPA’s 

approach to malfunctions is consistent 

with CAA section 112 and is a 

reasonable interpretation of the statute. 

In subpart CCCC, it is unlikely that a 

malfunction would result in a violation 

of the standards for fermenters. The rule 

provides an option for owners or 

operators to determine the average VOC 

concentration for all batches within 

each fermentation stage using data from 

12-month periods. This option limits 

the effect of malfunctions on the ability 

of a facility to meet the emission 

limitations because the averaging 

effectively minimizes ‘‘spikes’’ in 

emissions. Additionally, many of the 

common malfunctions reported during 

EPA site visits by owners or operators 

of nutritional yeast manufacturing 

facilities were malfunctions of the 

emissions monitoring equipment. While 

the equipment is unable to record 

accurate data during periods of 

malfunction, it does not impact actual 

emissions because process controls 

could still be used to limit emissions. In 

the unlikely event that a source fails to 

comply with the applicable CAA section 

112(d) standards as a result of a 

malfunction event, the EPA would 

determine an appropriate response 

based on, among other things, the good 

faith efforts of the source to minimize 

emissions during malfunction periods, 

including preventative and corrective 

actions, as well as root cause analyses 

to ascertain and rectify excess 

emissions. The EPA would also 

consider whether the source’s failure to 

comply with the CAA section 112(d) 

standard was, in fact, sudden, 

infrequent, not reasonably preventable 

and not instead caused in part by poor 

maintenance or careless operation. 40 

CFR 63.2 (definition of malfunction). 

If the EPA determines in a particular 

case that an enforcement action against 

a source for violation of an emission 

standard is warranted, the source can 

raise any and all defenses in that 

enforcement action and the federal 

district court will determine what, if 

any, relief is appropriate. The same is 

true for citizen enforcement actions. 

Similarly, the presiding officer in an 

administrative proceeding can consider 

any defense raised and determine 

whether administrative penalties are 

appropriate. 

In summary, the EPA interpretation of 

the CAA and, in particular, CAA section 

112 is reasonable and encourages 

practices that will avoid malfunctions. 

Administrative and judicial procedures 

for addressing exceedances of the 

standards fully recognize that violations 

may occur despite good faith efforts to 

comply and can accommodate those 

situations. U.S. Sugar Corp. v. EPA, 830 

F.3d 579, 606–610 (D.C. Cir. 2016). 

1. 40 CFR 63.2150 General Duty 

We are revising the General 

Provisions table (Table 6 to subpart 

CCCC) entry for 40 CFR 63.6(e)(1)(i) to 

specify that 40 CFR 63.6(e)(1)(i) does 

not apply to subpart CCCC. Section 

63.6(e)(1)(i) describes the general duty 

to minimize emissions. Some of the 

language in that section is no longer 

necessary or appropriate in light of the 

elimination of the SSM exemption. The 

current language in 40 CFR 63.6(e)(1)(i) 

characterizes what the general duty 

entails during periods of SSM; with the 

elimination of the SSM exemption, 

there is no need to differentiate between 

normal operations, startup and 

shutdown, and malfunction events in 

describing the general duty. Therefore, 

we are adding instead general duty 

regulatory text at 40 CFR 63.2150(d) that 

reflects the general duty to minimize 

emissions while eliminating the 

reference to periods covered by an SSM 

exemption. 

We are also revising the General 

Provisions table (Table 6 to subpart 

CCCC) entry for 40 CFR 63.6(e)(1)(ii) to 

specify that 40 CFR 63.6(e)(1)(ii) does 

not apply to subpart CCCC. Section 

63.6(e)(1)(ii) imposes requirements that 

are not necessary with the elimination 

of the SSM exemption or are redundant 

with the general duty requirement being 

added at 40 CFR 63.2150. 

2. SSM Plan 

We are revising the General 

Provisions table (Table 6 to subpart 

CCCC) to specify that 40 CFR 63.6(e)(3) 

does not apply to subpart CCCC. 

Generally, these paragraphs require 

development of an SSM plan and 

specify SSM recordkeeping and 

reporting requirements related to the 

SSM plan. As noted, the EPA is 

removing the SSM exemptions. 

Therefore, affected units will be subject 

to an emission standard during such 

events. The applicability of a standard 

during such events will ensure that 

sources have ample incentive to plan for 

and achieve compliance and, thus, the 

SSM plan requirements are no longer 

necessary. 

3. Compliance With Standards 

We are revising the General 

Provisions table (Table 6 to subpart 

CCCC) to specify that 40 CFR 63.6(f)(1) 

does not apply to subpart CCCC. The 

current language of 40 CFR 63.6(f)(1) 

exempts sources from non-opacity 

standards during periods of SSM. As 

discussed above, the Court in Sierra 

Club vacated the exemptions contained 

in this provision and held that the CAA 

requires that some CAA section 112 

standard apply continuously. Consistent 

with Sierra Club, the EPA is revising 

standards in this rule to apply at all 

times. 

4. 40 CFR 63.2161 Performance 

Testing 

We are revising the General 

Provisions table (Table 6 to subpart 

CCCC) to specify that 40 CFR 63.7(e)(1) 

does not apply to subpart CCCC. Section 

63.7(e)(1) describes performance testing 

requirements. The EPA is instead 

adding a performance testing 

requirement at 40 CFR 63.2161(b). The 

performance testing requirements we 

are adding differ from the General 

Provisions performance testing 

provisions in several respects. The 

regulatory text does not include the 

language in 40 CFR 63.7(e)(1) that 

restated the SSM exemption and 

language that precluded startup and 

shutdown periods from being 

considered ‘‘representative’’ for 

purposes of performance testing. As in 

40 CFR 63.7(e)(1), performance tests 

conducted under this subpart should 

not be conducted during malfunctions 

because conditions during malfunctions 

are often not representative of normal 


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operating conditions. The EPA is adding 

language in 63.2161(b) that requires the 

owner or operator to record the process 

information that is necessary to 

document operating conditions during 

the test and include in such record an 

explanation to support that such 

conditions represent normal operation. 

Section 63.7(e) requires that the owner 

or operator make available to the 

Administrator such records ‘‘as may be 

necessary to determine the condition of 

the performance test’’ available to the 

Administrator upon request, but does 

not specifically require the information 

to be recorded. The regulatory text the 

EPA is adding to subpart CCCC builds 

on that requirement and makes explicit 

the requirement to record the 

information. 

5. Monitoring 

We are revising the General 

Provisions table (Table 6 to subpart 

CCCC) to specify that 40 CFR 63.8 

(c)(1)(i) and (iii) do not apply to subpart 

CCCC. The cross-references to the 

general duty and SSM plan 

requirements in those subparagraphs are 

not necessary in light of other 

requirements of 40 CFR 63.8 that require 

good air pollution control practices (40 

CFR 63.8(c)(1)) and that set out the 

requirements of a quality control 

program for monitoring equipment (40 

CFR 63.8(d)). 

We are revising the General 

Provisions table (Table 6 to subpart 

CCCC) to specify that 40 CFR 63.8(d)(3) 

does not apply to subpart CCCC. The 

final sentence in 40 CFR 63.8(d)(3) 

refers to the General Provisions’ SSM 

plan requirement which is no longer 

applicable. The EPA is adding to the 

rule at 40 CFR 63.2182(c)(3) and 

63.2183(e) text that contains the same 

requirements as 40 CFR 63.8(d)(3), 

except that we are requiring the program 

of corrective action for a malfunctioning 

monitoring system to be included in the 

quality control program for a CEMS (as 

described in 40 CFR 63.8(d)(2)) instead 

of in the SSM plan. 

6. 40 CFR 63.2182 Recordkeeping 

We are revising the General 

Provisions table (Table 6 to subpart 

CCCC) to specify that 40 CFR 

63.10(b)(2)(ii) does not apply to subpart 

CCCC. Section 63.10(b)(2)(ii) describes 

the recordkeeping requirements during 

a malfunction. The EPA is adding such 

requirements to 40 CFR 63.2182(a)(2) 

and (c)(5). The regulatory text we are 

adding differs from the text in the 

General Provisions it is replacing in that 

the General Provisions requires the 

creation and retention of a record of the 

occurrence and duration of each 

malfunction of process, air pollution 

control, and monitoring equipment. The 

EPA is now applying the recordkeeping 

requirement to any failure to meet an 

applicable standard and is requiring that 

the source record the date, time, and 

duration of the failure rather than the 

‘‘occurrence.’’ The EPA is also adding to 

40 CFR 63.2182(a)(2) and (c)(5) a 

requirement that sources keep records 

that include a list of the affected source 

or equipment and actions taken to 

minimize emissions, an estimate of the 

quantity of each regulated pollutant 

emitted over the standard for which the 

source failed to meet the standard, and 

a description of the method used to 

estimate the emissions. Examples of 

such methods would include productloss calculations, mass balance 

calculations, measurements when 

available, or engineering judgment 

based on known process parameters. 

The EPA is requiring that sources keep 

records of this information to ensure 

that there is adequate information to 

allow the EPA to determine the severity 

of any failure to meet a standard, and to 

provide data that may document how 

the source met the general duty to 

minimize emissions when the source 

has failed to meet an applicable 

standard. 

We are revising the General 

Provisions table (Table 6 to subpart 

CCCC) to specify that 40 CFR 

63.10(b)(2)(iv) does not apply to subpart 

CCCC. When applicable, the provision 

requires sources to record actions taken 

during SSM events when actions were 

inconsistent with their SSM plan. The 

requirement is no longer appropriate 

because SSM plans will no longer be 

required. The requirement previously 

applicable under 40 CFR 

63.10(b)(2)(iv)(B) to record actions to 

minimize emissions and record 

corrective actions is now specified at 40 

CFR 63.2182(a)(2) and (c)(5). 

We are revising the General 

Provisions table (Table 6 to subpart 

CCCC) to specify that 40 CFR 

63.10(b)(2)(v) does not apply to subpart 

CCCC. When applicable, the provision 

requires sources to record actions taken 

during SSM events to show that actions 

taken were consistent with their SSM 

plan. The requirement is no longer 

appropriate because SSM plans will no 

longer be required. 

We are revising the General 

Provisions table (Table 6 to subpart 

CCCC) to specify that 40 CFR 

63.10(c)(15) does not apply to subpart 

CCCC. The provision allows an owner 

or operator to use the affected source’s 

SSM plan or records kept to satisfy the 

recordkeeping requirements of the SSM 

plan to also satisfy the requirements of 

40 CFR 63.10(c)(10) through (12) 

concerning additional recordkeeping 

requirements for sources with 

continuous monitoring systems. The 

EPA is eliminating this requirement 

because SSM plans will no longer be 

required, and, therefore, 40 CFR 

63.10(c)(15) no longer serves any useful 

purpose for affected units. 

7. 40 CFR 63.2181 Reporting 

We are revising the General 

Provisions table (Table 6 to subpart 

CCCC) to specify that 40 CFR 63.10(d)(5) 

does not apply to subpart CCCC. Section 

63.10(d)(5) describes the reporting 

requirements for startups, shutdowns, 

and malfunctions. To replace the 

General Provisions reporting 

requirement, the EPA is adding 

reporting requirements to 40 CFR 

63.2181(c)(5) and (7). The replacement 

language differs from the General 

Provisions requirement in that it 

eliminates periodic SSM reports as 

stand-alone reports. We are 

promulgating language that requires 

sources that fail to meet an applicable 

standard at any time to report the 

information concerning such events in 

the semiannual compliance report 

already required under this rule in 40 

CFR 63.2181. We are requiring that the 

report must contain the number, date, 

time, duration, and the cause of such 

events (including unknown cause, if 

applicable), a list of the affected source 

or equipment, an estimate of the 

quantity of each regulated pollutant 

emitted over any emission limitation, 

and a description of the method used to 

estimate the emissions. Examples of 

such methods would include productloss calculations, mass balance 

calculations, measurements when 

available, or engineering judgment 

based on known process parameters. 

The EPA is promulgating this 

requirement to ensure that there is 

adequate information to determine 

compliance, to allow the EPA to 

determine the severity of the failure to 

meet an applicable standard, and to 

provide data that may document how 

the source met the general duty to 

minimize emissions during a failure to 

meet an applicable standard. 

We will no longer require owners or 

operators to determine whether actions 

taken to correct a malfunction are 

consistent with an SSM plan, because 

plans will no longer be required. The 

final amendments, therefore, eliminate 

the cross reference to 40 CFR 

63.10(d)(5)(i) that contains the 

description of the previously required 

SSM report format and submittal 

schedule from this section. These 

specifications are no longer necessary 


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because the events will be reported in 

otherwise required reports with similar 

format and submittal requirements. 

We are revising the General 

Provisions table (Table 6 to subpart 

CCCC) to specify that 40 CFR 

63.10(d)(5)(ii) does not apply to subpart 

CCCC. Section 63.10(d)(5)(ii) describes 

an immediate report for startups, 

shutdown, and malfunctions when a 

source failed to meet an applicable 

standard, but did not follow the SSM 

plan. We will no longer require owners 

or operators to report when actions 

taken during a startup, shutdown, or 

malfunction were not consistent with an 

SSM plan, because such plans will no 

longer be required. 

D. What other changes have been made 

to the NESHAP? 

This rule finalizes revisions to several 

other Manufacturing of Nutritional 

Yeast NESHAP requirements. We 

describe the revisions in the following 

paragraphs. 

We are finalizing the proposed 

amendments to revise the form of the 

fermenter VOC limits that require 

facilities to demonstrate compliance 

using either the Average Option or 

Batch Option. In response to comments, 

we are allowing facilities up to 1 year 

to demonstrate compliance with the 

revised form of the emission limitations. 

The EPA originally proposed that 

facilities would have to demonstrate 

compliance immediately upon 

promulgation of the final rule. 

We are also finalizing the proposed 

amendments to several testing, 

monitoring, recordkeeping, and 

reporting provisions. First, we are 

finalizing amendments to require all 

facilities to monitor VOC emissions 

using VOC CEMS and to remove the 

option to monitor brew ethanol in the 

fermenter liquid and determine an 

annual correlation to VOC concentration 

in the fermenter exhaust in order to 

demonstrate compliance with fermenter 

VOC emission limitations. In reponse to 

comments, we are allowing the affected 

facility up to 3 years to comply with 

these requirements. The EPA originally 

proposed that the affected facility would 

have 1 year to comply with these 

requirements. We are also finalizing the 

related revisions to the rule text that 

corrected references to ‘‘brew ethanol 

monitors’’ that had erroneously referred 

to CEMS. 

Second, we are finalizing the 

proposed amendments to remove the 

option to use GC CEMS to monitor VOC 

emissions. The use of GC CEMS requires 

facilities to identify specific VOC 

species to monitor and no facilities are 

currently using this method. 

Third, we are finalizing the proposed 

amendments to require the collection of 

all valid CEMS data during batch 

monitoring periods and the reporting of 

missing data as deviations. In response 

to comments, we have added clarifying 

language in the rule specifying a 

minimum CEMS cycle time of 15 

minutes and allowing a minimum of 

two data points (representing 15-minute 

periods) to constitute a valid hour of 

data collection during periods of 

calibration, quality assurance, or 

maintenance activities; and modified 

the recordkeeping requirements 

accordingly (as stated in the General 

Provisions). 

Fourth, we are finalizing the proposed 

amendments to require facilities to 

conduct regular RATA using Procedure 

1 of Appendix F to part 60 to evaluate 

the ongoing performance of CEMS. In 

response to comments, we are requiring 

RATA to be conducted once every 3 

years, instead of annually as proposed. 

We are also adding language to the rule 

to clarify that cylinder gas audits or 

relative accuracy audits must be 

conducted in the quarters that RATA are 

not conducted, consistent with the 

requirements of Procedure 1 of 

Appendix F to part 60. 

To increase the ease and efficiency of 

data submittal and data accessibility, we 

are finalizing, as proposed, a 

requirement that owners or operators of 

nutritional yeast manufacturing 

facilities submit electronic copies of 

certain required performance test or 

evaluation reports through the EPA’s 

Central Data Exchange (CDX) Web site 

using the Electronic Reporting Tool 

(ERT). This requirement to submit 

performance test data or performance 

evaluation information electronically to 

the EPA applies only to those 

performance tests or evaluations 

conducted using test methods or 

evaluations that are supported by the 

ERT. 

Lastly, we are finalizing the proposed 

minor language changes throughout 

subpart CCCC that clarify the existing 

requirements and restate the 

requirements in active voice. These 

amendments do not change any existing 

requirements, but are intended to 

improve the readability of subpart 

CCCC. 

E. What are the effective and 

compliance dates of the standards? 

The revisions to the MACT standards 

being promulgated in this action are 

effective on October 16, 2017. 

The compliance date for the removal 

of GC CEMS, collection of all valid 

CEMS data from the entire batch 

monitoring period, requirement to 

conduct RATA, use of Procedure 1 of 

Appendix F to part 60 for VOC CEMS, 

revised SSM requirements, and the 

electronic reporting requirements for 

nutritional yeast manufacturing 

facilities is October 16, 2017. 

Existing facilities must comply with 

the revised form of the fermenter VOC 

emission limitations by October 16, 

2018. Until October 16, 2018, facilities 

must continue to demonstrate 

compliance, either using the existing 

form of the fermenter VOC emission 

limitations or the revised form of the 

fermenter VOC limits, in their 

semiannual compliance reports. As 

discussed in section IV.G of this 

preamble, this timeframe was revised 

from immediate compliance in the 

proposed rule, based on public 

comments, in order to allow facilities 

time to train staff and update the 

necessary recordkeeping and reporting 

procedures. 

Facilities that currently demonstrate 

compliance by monitoring brew ethanol 

concentration in the fermenter liquid 

must install CEMS by October 16, 2020. 

Until October 16, 2020, emissions data 

must be collected for each batch, either 

using the existing compliance method 

(monitoring brew ethanol concentration) 

or with CEMS, for use in the semiannual 

compliance reports with the applicable 

emission limitations. As discussed in 

section IV.G of this preamble, this was 

revised from the proposed 1-year 

compliance period, based on public 

comments, to allow facilities adequate 

time to procure equipment; train staff; 

and update operations and 

maintenance, recordkeeping, and 

reporting procedures. 

Sources that are constructed or 

reconstructed after promulgation of the 

rule revisions must comply with the 

emission limitations and compliance 

requirements upon the effective date of 

the rule, October 16, 2017, or upon 

startup of the affected source, whichever 

is later. 

F. What are the requirements for 

submission of performance test data to 

the EPA? 

The EPA is requiring owners or 

operators of manufacturing of 

nutritional yeast facilities to submit 

electronic copies of certain required 

performance test reports and 

performance evaluation reports (e.g., 

RATAs that are supported by the EPA’s 

ERT) at the time of the evaluation, 

through the EPA’s CDX using the 

Compliance and Emissions Data 

Reporting Interface (CEDRI). The 

electronic submittal will increase the 

usefulness of the data contained in 

those reports, is in keeping with current 


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trends in data availability and 

transparency, will further assist in the 

protection of public health and the 

environment, will improve compliance 

by facilitating the ability of regulated 

facilities to demonstrate compliance 

with requirements and by facilitating 

the ability of delegated state, local, 

tribal, and territorial air agencies and 

the EPA to assess and determine 

compliance, and will ultimately reduce 

burden on regulated facilities, delegated 

air agencies, and the EPA. Electronic 

reporting also eliminates paper-based, 

manual processes, thereby saving time 

and resources, simplifying data entry, 

eliminating redundancies, minimizing 

data reporting errors, and providing data 

quickly and accurately to the affected 

facilities, air agencies, the EPA, and the 

public. 

The EPA Web site that stores the 

submitted electronic data, WebFIRE, 

provides a user-friendly interface 

accessible to all stakeholders. By 

making the records, data, and reports 

addressed in this rulemaking readily 

available, the EPA, the regulated 

community, and the public will benefit 

when the EPA conducts its CAArequired technology and risk-based 

reviews. As a result of having reports 

readily accessible, our ability to carry 

out comprehensive reviews will be 

increased and achieved within a shorter 

period of time. 

We anticipate fewer or less substantial 

Information Collection Requests (ICRs) 

in conjunction with prospective CAArequired technology and risk-based 

reviews may be needed as a result of 

electronic reporting, which results in a 

decrease in time spent by industry to 

respond to data collection requests. We 

also expect the ICRs to contain less 

extensive stack testing provisions, as we 

will already have stack test data 

electronically. Reduced testing 

requirements would be a cost savings to 

industry. The EPA should also be able 

to conduct these required reviews more 

quickly. Although the regulated 

community may benefit from a reduced 

burden of ICRs, the general public 

benefits from the Agency’s ability to 

provide these required reviews more 

quickly, resulting in increased public 

health and environmental protection. 

Air agencies, as well as the EPA, can 

benefit from more streamlined and 

automated review of the electronically 

submitted data. Standardizing report 

formats allows air agencies to review 

reports and data more quickly. Having 

reports and associated data in electronic 

format will facilitate review through the 

use of software ‘‘search’’ options, as 

well as the downloading and analyzing 

of data in spreadsheet format. 

Additionally, air agencies and the EPA 

can access reports wherever and 

whenever they want or need, as long as 

they have access to the Internet. The 

ability to access and review reports 

electronically assists air agencies in 

determining compliance with applicable 

regulations more quickly and 

accurately, potentially allowing a faster 

response to violations which could 

minimize harmful air emissions. This 

benefits both air agencies and the 

general public. 

For a more thorough discussion of 

electronic reporting required by this 

rule, see the discussion in the preamble 

of the proposal (81 FR 95829, December 

28, 2016). In summary, in addition to 

supporting regulation development, 

control strategy development, and other 

air pollution control activities, having 

an electronic database populated with 

performance test data will save 

industry, air agencies, and the EPA 

significant time, money, and effort 

while improving the quality of emission 

inventories and air quality regulations, 

and enhancing the public’s access to 

this important information. 

IV. What is the rationale for our final 

decisions and amendments for the 

Manufacturing of Nutritional Yeast 

source category? 

For each issue, this section provides 

a description of what we proposed and 

what we are finalizing, the EPA’s 

rationale for the final decisions and 

amendments, and a summary of key 

comments and responses. For all 

comments not discussed in this 

preamble, comment summaries and the 

EPA’s responses can be found in the 

comment summary and response 

document available in the docket for 

this rulemaking (EPA–HQ–OAR–2015– 

0730). 

A. Residual Risk Review for the 

Manufacturing of Nutritional Yeast 

Source Category 

1. What did we propose pursuant to 

CAA section 112(f) for the 

Manufacturing of Nutritional Yeast 

source category? 

Pursuant to CAA section 112(f), the 

EPA conducted a residual risk review 

and presented the results of this review, 

along with our proposed decisions 

regarding risk acceptability and ample 

margin of safety, in the December 28, 

2016, proposed rule for subpart CCCC 

(81 FR 95825). The results of the risk 

assessment for the proposal are 

presented briefly below in Table 2 of 

this preamble, and in more detail in the 

proposal residual risk document, 

‘‘Residual Risk Assessment for the 

Manufacturing of Nutritional Yeast 

Source Category in Support of the 

December 2016 Risk and Technology 

Review Proposed Rule,’’ which is 

available in the docket for this 

rulemaking. 

TABLE 2—NUTRITIONAL YEAST MANUFACTURING INHALATION RISK ASSESSMENT RESULTS

Number of 

facilities 1

Maximum individual cancer 

risk 

(in 1 million) 2

Estimated population at 

increased risk of cancer ≥ 1-in-1 million 

Estimated annual cancer 

incidence (cases per year) 

Maximum chronic 

non-cancer TOSHI 3

Maximum screening acute 

non-cancer HQ 4

Based on 

actual 

emissions 

level 2

Based on 

allowable 

emissions 

level 

Based on 

actual 

emissions 

level 2

Based on 

allowable 

emissions 

level 

Based on 

actual 

emissions 

level 2

Based on 

allowable 

emissions 

level 

Based on 

actual 

emissions 

level 2

Based on 

allowable 

emissions 

level 

Based on 

actual 

emissions 

level 2

Based on 

allowable 

emissions 

level 

4 ................. 2 2 750 750 0.0009 0.0009 0.08 0.08 HQREL = 0.2 HQREL = 

0.2. 

1 Number of facilities evaluated in the risk analysis. 

2 Maximum individual excess lifetime cancer risk due to HAP emissions from the source category. 

3 Maximum target organ-specific hazard index (TOSHI). The target organ with the highest TOSHI for the Manufacturing of Nutritional Yeast source category is the 

respiratory system. 4The maximum estimated acute exposure concentration was divided by available short-term threshold values to develop an array of hazard quotient (HQ) values. 

HQ values shown use the lowest available acute threshold value, which in most cases is the recommended exposure limit (REL). When HQ values exceed 1, we also 

show HQ values using the next lowest available acute dose-response value. See section III.A.3 of the proposal preamble (81 FR 95816, December 28, 2016) for explanation of acute dose-response values. 


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Based on both actual and allowable 

emissions for the Manufacturing of 

Nutritional Yeast source category, the 

maximum lifetime individual cancer 

risk was estimated to be up to 2-in-1 

million, the maximum chronic noncancer TOSHI value was estimated to be 

up to 0.08, and the maximum off-facility 

site acute HQ value was estimated to be 

up to 0.2. The total estimated national 

cancer incidence from these facilities 

was 0.0009 excess cancer cases per year 

or 1 case in every 1,100 years. 

There are no persistent and 

bioaccumulative HAP emitted by 

facilities in this source category. 

Therefore, we did not consider any 

human health multi-pathway risks as a 

result of emissions from this source 

category. 

We weighed all health risk factors, 

including those shown in Table 2 of this 

preamble, in our risk acceptability 

determination, and proposed that the 

residual risks from the Manufacturing of 

Nutritional Yeast source category are 

acceptable (section IV.B. of proposal 

preamble, 81 FR 95825, December 28, 

2016). 

We then considered whether subpart 

CCCC provides an ample margin of 

safety to protect public health and 

prevents, taking into consideration 

costs, energy, safety, and other relevant 

factors, an adverse environmental effect. 

In considering whether the standards 

should be tightened to provide an ample 

margin of safety to protect public health, 

we considered the same risk factors that 

we considered for our acceptability 

determination and also considered the 

costs, technological feasibility, and 

other relevant factors related to 

emissions control options that might 

reduce risk associated with emissions 

from the source category. Two control 

options were evaluated for further 

reducing acetaldehyde emissions from 

fermenters at nutritional yeast facilities: 

thermal oxidizers and wet (packed bed) 

scrubbers. Due to the additional 

environmental impacts (increased 

energy use and emissions of 

approximately 89 tpy of nitrogen oxides 

that would be imposed by the control 

options and the low level of current 

human health risk), along with the 

substantial costs associated with these 

control options, we proposed that 

additional emissions controls for this 

source category are not necessary to 

provide an ample margin of safety 

(section IV.B.2 of proposal preamble, 81 

FR 95825, December 28, 2016). 

In addition, none of the seven 

pollutants identified by the EPA as 

‘‘environmental HAP’’ (cadmium, 

dioxins/furans, polycyclic organic 

matter, mercury, lead compounds, 

hydrogen chloride, and hydrogen 

fluoride), which are known to cause 

adverse environmental effects, are 

emitted; therefore, we did not conduct 

a separate environmental risk analysis 

for this source category (see section 

III.A.6 of the proposal preamble (81 FR 

95819, December 28, 2016)). 

2. How did the risk review change for 

the Manufacturing of Nutritional Yeast 

source category? 

During the public comment period, 

the EPA received information that the 

acetaldehyde emissions rate was tested 

at the AB Mauri facility in 2017 and was 

approximately 50 percent lower than 

the rate used to estimate the total annual 

emissions included in the residual risk 

analysis. The residual risk analysis 

performed for the proposed rule was 

based on data reported in the 2011 

National Emissions Inventory (NEI) 

from all facilities. The new emissions 

rate cannot be used to change 

previously reported data from a facility 

because there is no clear evidence or 

test history to establish when the 

emission rate decreased. Complete 2017 

emissions data is not yet available for 

AB Mauri, so the EPA could not repeat 

the risk analysis using newer data for 

this facility. Importantly, the risk review 

had already found that the risks are 

acceptable and the standards provide an 

ample margin of safety using the higher 

2011 NEI emissions data for this facility, 

so it is possible that the residual risk 

from the Manufacturing of Nutritional 

Yeast source category has decreased 

even farther. Since the EPA concluded 

it was reasonable to not update the risk 

review following proposal, we have 

finalized the risk assessment report and 

re-submitted it to the docket as 

‘‘Residual Risk Assessment for the 

Manufacturing of Nutritional Yeast 

Source Category in Support of the 

October, 2017 Risk and Technology 

Review Final Rule.’’ 

3. What key comments did we receive 

on the risk review and what are our 

responses? 

We received comments in support of 

and against the proposed residual risk 

review and our determination that no 

revisions were warranted under CAA 

section 112(f)(2). Generally, the 

comments that were not supportive of 

the determination from the risk review 

suggested changes to the underlying risk 

assessment methodology. After review 

of these comments, we determined that 

no changes were necessary. The 

comments and our specific responses 

can be found in the document, 

‘‘Nutritional Yeast Manufacturing Risk 

and Technology Review: Summary of 

Public Comments and Responses,’’ 

which is available in the docket for this 

action. 

4. What is the rationale for our final 

approach and final decisions for the risk 

review? 

For the reasons explained in the 

proposed rule, we determined that the 

risks from the Manufacturing of 

Nutritional Yeast source category are 

acceptable, and the current standards 

provide an ample margin of safety to 

protect public health and prevent an 

adverse environmental effect. Since 

proposal, neither the risk assessment 

nor our determinations regarding risk 

acceptability, ample margin of safety, or 

adverse environmental effects have 

changed. Therefore, we are not revising 

subpart CCCC to require additional 

controls pursuant to CAA section 

112(f)(2) based on the residual risk 

review and are readopting the existing 

standards under CAA section 112(f)(2). 

B. Technology Review for the 

Manufacturing of Nutritional Yeast 

Source Category 

1. What did we propose pursuant to 

CAA section 112(d)(6) for the 

Manufacturing of Nutritional Yeast 

source category? 

Pursuant to CAA section 112(d)(6), 

the EPA conducted a technology review 

and summarized the results of the 

review in the proposed rule for subpart 

CCCC (81 FR 95825, December 28, 

2016). The results of the technology 

review are briefly discussed below, and 

in more detail in the memorandum, 

‘‘Technology Review for the 

Manufacturing of Nutritional Yeast 

Source Category,’’ which is available in 

the docket for this action (Docket ID No. 

EPA–HQ–OAR–2015–0730–0016). 

The technology review focused on 

identifying and evaluating 

developments in practices, processes, 

and control technologies for the 

Manufacturing of Nutritional Yeast 

source category. We identified two 

control technologies for further 

evaluation that were technically feasible 

for further reducing acetaldehyde 

emissions from nutritional yeast 

fermenters: thermal oxidizers, and wet 

(packed bed) scrubbers. After 

identifying the control technologies that 

were technically feasible, we then 

evaluated the costs and emissions 

reductions associated with installing 

regenerative thermal oxidizers (RTOs) 

and packed bed scrubbers at each of the 

four existing nutritional yeast facilities. 

Considering the high cost per ton of 

acetaldehyde reduced and potential 

adverse environmental impacts 


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associated with the installation of RTOs 

or packed bed scrubbers, we did not 

consider these technologies to be cost 

effective for further reducing 

acetaldehyde emissions from fermenters 

at nutritional yeast manufacturing 

facilities. In light of the results of the 

technology review, we proposed to 

conclude that changes to the fermenter 

emission limitations were not warranted 

pursuant to CAA section 112(d)(6) (81 

FR 95825, December 28, 2016). 

2. How did the technology review 

change for the Manufacturing of 

Nutritional Yeast source category? 

The technology review for the 

Manufacturing of Nutritional Yeast 

source category has not changed since 

proposal. As proposed, the EPA is not 

making changes to the standards 

pursuant to CAA section 112(d)(6). 

3. What key comments did we receive 

on the technology review and what are 

our responses? 

We received comments in support of 

the proposed determination from the 

technology review that no revisions 

were warranted under CAA section 

112(d)(6). We also received one 

comment that asserted that cost 

effectiveness should not be a 

consideration when examining 

standards under CAA section 112(d)(6). 

We evaluated the comments and 

determined that no changes regarding 

our determination were needed. These 

comments and our specific responses to 

those comments can be found in the 

comment summary and response 

document titled, ‘‘Nutritional Yeast 

Manufacturing Risk and Technology 

Review: Summary of Public Comments 

and Responses,’’ which is available in 

the docket for this action. 

4. What is the rationale for our final 

approach for the technology review? 

For the reasons explained in the 

preamble to the proposed rule, we 

determined there were no new 

developments in practices or processes, 

nor were cost-effective control 

technologies available to further reduce 

acetaldehyde emissions from fermenters 

at nutritional yeast manufacturing 

facilities (81 FR 95825, December 28, 

2016). Since proposal, neither the 

technology review nor our 

determination as a result of the 

technology review has changed, and we 

are not revising subpart CCCC pursuant 

to CAA section 112(d)(6). 

C. Revised Form of the Fermenter VOC 

Standard 

1. What did we propose? 

At proposal, the EPA explained that 

the current form of the standards for 

VOC limits on fermenters was in direct 

conflict with the statutory requirement 

that emission standards limit emissions 

on a continuous basis, i.e., that some 

emission limitation applies at all times, 

and, therefore, proposed to establish a 

revised form of the standards (‘‘Batch 

Option’’) as well as an alternate 

standard for compliance (‘‘Average 

Option’’) in Table 1 to subpart CCCC (81 

FR 95826, December 28, 2016). Under 

the proposed Batch Option, each 

individual batch manufactured must 

meet the existing VOC emission limits 

(300 ppmv for stock fermentation, 200 

ppmv for first generation fermentation, 

and 100 ppmv for trade fermentation). 

Under the proposed Average Option, all 

batch average VOC concentration data 

for each fermentation stage in a 12- 

month period must be averaged together 

and not exceed certain VOC emission 

limits, which are 5 percent lower than 

the VOC emission limits established for 

individual batches in 2001 for subpart 

CCCC (285 ppmv for stock fermentation, 

190 ppmv for first generation 

fermentation, and 95 ppmv for trade 

fermentation). We referred to this 

reduction as a ‘‘discount factor,’’ 

consistent with our use of the term in 

other MACT standards that allow 

averaging of emissions data for 

compliance. 

Additionally, the proposed revisions 

to the general compliance requirements 

in 40 CFR 63.2150(a) and (c) that 

remove the exemption for compliance 

with emission limits during periods of 

malfunction will also impact the 

determination of compliance with 

emission limits. The practical effect of 

this change is that emissions from 

batches of yeast produced during 

periods of malfunction, other than 

monitoring system malfunctions, must 

now be included in calculations for 

compliance purposes. 

2. How did the requirements change 

since proposal? 

The EPA has not changed either the 

form or the level of emission reductions 

that would be required under either the 

Batch or Average Option. We have, 

however, revised our characterization of 

which option represents the updated 

form of the original MACT standard and 

which can be used as the alternative 

compliance method, as described in 

section IV.C.3 of this preamble. 

3. What key comments did we receive 

and what are our responses? 

Comment: Two commenters stated 

that the EPA improperly assumed a 

need to change the fermenter VOC 

standards based on the Sierra Club v. 

EPA SSM policy ruling that standards 

must apply at all times. One commenter 

asserted that the EPA is confusing the 

concept of continuous compliance as 

opposed to relief from compliance. Both 

commenters remarked that the existing 

fermenter VOC standards apply at all 

times and the facility must be in 

continuous compliance with the 

standard, meaning that VOC 

concentration must be continuously 

monitored to ensure that 98 percent of 

all batches do not exceed the VOC 

standards. A commenter also stated that 

yeast manufacturers do continuously 

comply with the existing fermenter VOC 

standards, as calculated under the 

statistical averaging approach set out in 

the standard. The commenter continued 

that the Sierra Club v. EPA SSM ruling 

did not say that calculations embedded 

into MACT standards must be 

invalidated under the logic the Court 

used to invalidate the EPA’s general 

SSM policy. 

The commenter stated that other 

Court decisions addressing the EPA’s 

SSM policy similarly have no bearing 

on the Nutritional Yeast rule. For 

example, the commenter remarked that 

in NRDC v. EPA, the Court invalidated 

the affirmative defense provision of the 

Cement Kiln NESHAP that excused 

Portland cement manufacturers if they 

experienced a process malfunction. The 

commenter stated the Nutritional Yeast 

rule does not provide any affirmative 

defense for non-compliance. 

Response: We disagree that the 

changes to the form of the standard are 

unwarranted and that the Sierra Club v. 

EPA decision is inapplicable in this 

context because we disagree with the 

commenters’ characterization of the 

existing form of the standard as an 

emission limitation that applies at all 

times. A standard that allows up to 2 

percent of batches to be produced 

without any applicable limitation on 

emissions does not provide continuous 

emission reductions within the 

meanings of CAA sections 112 and 

302(k). 

The existing form of the standard is 

inconsistent with the D.C. Circuit’s 

holding that CAA sections 112 and 

302(k), when read together, require that 

emission standards apply on a 

continuous basis, and we are remedying 

that inconsistency here. See Sierra Club 

v. EPA, 551 F.3d at 1027. While the 

Court was specifically addressing SSM 


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requirements in that case, its analysis 

was based on CAA section 302(k)’s 

requirement that emission standards, 

including those required under CAA 

section 112(d)(2) and (3), ‘‘assure 

continuous emission reduction.’’ Id. The 

Court discussed the legislative history of 

CAA section 302(k), noting that ‘‘the 

committee has made clear that constant 

or continuous means of reducing 

emissions must be used to meet these 

requirements. By the same token, 

intermittent or supplemental controls or 

other temporary, periodic, or limited 

systems of control would not be 

permitted as a final means of 

compliance.’’ Id. (quoting H.R. Rep. 95– 

294, at 92 (1977)). The Court’s 

disposition of the SSM issue was based 

on its determination that CAA section 

302(k) does not allow the EPA ‘‘to relax 

emission standards on a temporal 

basis.’’ Id. at 1028 (citing NRDC v. EPA, 

489 F.3d at 1364, 1374 (D.C. Cir. 2007)). 

That same analysis—that some emission 

standard must provide emission 

reductions at all times—is directly 

applicable to the emission standard at 

issue here. The existing MACT standard 

for yeast manufacturing allows up to 2 

percent of batches to be produced 

without any kind of emission reduction 

requirement, which is in direct conflict 

with CAA section 302(k) and Sierra 

Club v. EPA. 

We disagree with the commenter’s 

overly narrow interpretation of Sierra 

Club v. EPA as applying only to SSM 

exemptions, as it ignores the underlying 

determination that such exemptions are 

illegal because they are inconsistent 

with the requirement that emission 

reductions must be continuous. The 

existing form of the standard for yeast 

manufacturing creates a limited or 

intermittent system of control. The fact 

that this exemption was originally built 

into the standard does not excuse its 

fundamental inconsistency with the 

statutory requirements. We also disagree 

that we are confusing continuous 

compliance with relief from 

compliance; again, the issue is broader 

than just whether sources must comply 

continuously with a standard—it is also, 

according to the D.C. Circuit’s analysis, 

whether that standard provides 

continuous emission reductions. 

The EPA acknowledges and 

understands that, in the current 

standard, nutritional yeast facilities 

continuously monitor VOC 

concentration during each batch. This is 

done both to monitor emissions for 

compliance purposes and also because 

facilities use the data for process 

control. However, continuous 

monitoring is not equivalent to having 

a continuous emission standard when 

the continuous monitoring is not 

accompanied by an emission reduction 

requirement. Critically, facilities may 

currently exceed the VOC standards for 

up to 2 percent of batches and these 

batches are allowed to emit an 

unlimited amount of HAP and VOC 

emissions. The revised forms of the 

standards, be it the Batch or Average 

Option, require that all monitored batch 

data are included to determine 

compliance, which ensures that the 

standards do not provide allowances for 

some batches of yeast to emit an 

unlimited amount of HAP and VOC 

emissions. 

The EPA also notes that nutritional 

yeast facilities make hundreds to 

thousands of batches of yeast within a 

12-month period; therefore, the 2- 

percent exemption allows a significant 

number of batches to exceed the limits. 

For example, if there are 1,000 batches 

during a 12-month period, up to 20 

batches may operate without emission 

limits. Again, there is no cap on their 

emissions and no penalty for these 

exceedances, regardless of how much 

they exceed the emission limit or the 

cause of the excursion. This ‘‘time out’’ 

from application of the emission 

standard is inconsistent with the 

requirement that such standards provide 

for continuous emission reductions. 

Relatedly, we further clarify that, 

separate from updating the form of the 

standard so that an emission limitation 

applies to all batches (i.e., 

continuously), we are also removing 

cross-references to sections of the 

General Provisions that allow for 

exemptions from compliance during 

periods of malfunction. These are two 

separate issues in the context of this 

rulemaking, both of which were 

precipitated by the Sierra Club v. EPA 

decision, as explained above. While 

removal of the malfunction exemption 

means that owners or operators of 

nutritional yeast manufacturing 

facilities must include data from every 

batch when determining whether they 

have complied with the standard, this 

does not preclude the EPA from 

appropriately addressing 

noncompliance when it results from 

emissions that occur during periods of 

malfunction as defined in 40 CFR 63.2, 

which is discussed in section III.C of 

this preamble. 

We did not include affirmative 

defense language in the nutritional yeast 

proposal and did not consider it for the 

rule revisions. Thus, we agree that the 

NRDC v. EPA decision is not relevant to 

the revisions to the form of the 

standards. 

Comment: Two commenters stated 

that allowing up to 2 percent of batches 

to exceed the fermenter VOC emission 

limits is inherent in the standards to 

account for the natural variability of the 

yeast manufacturing process. One 

commenter remarked that changing the 

fermenter VOC standards would be to 

reject the EPA’s prior determination that 

the standards needed to reflect the 

actual functioning of the yeast 

fermentation process. 

Response: The EPA disagrees that an 

exemption from emission limitations is 

the only option to address variability 

within a standard. There are other 

options for addressing variability 

besides raising the level of the standard. 

One such option is to express the 

emission limitation as the average of 

emissions from all batches. Our 

proposed Average Option, where a 

facility may average BAVOC emissions 

from all batches within a given 

fermentation stage together within a 12- 

month period, provides flexibility for 

individual batches to emit both below 

and above the prescribed numerical 

limits. Therefore, we disagree that 

changing the form of the standard 

rejects the EPA’s prior determination 

that the standards needed to reflect the 

actual functioning of the yeast 

fermentation process. 

Comment: Two commenters stated 

that the Average Option could be 

adopted if no discount factor were 

applied because the Average Option 

accounts for variability within the yeast 

manufacturing process. One of the 

commenters does not support the 5- 

percent discount factor that is part of 

the Average Option and suggested the 

EPA would be required to re-open the 

MACT standard and revisit the 

administrative record that it established 

in 2001 in order to justify such a 

change. 

Response: To address the requirement 

that the emission standards must 

provide for continuous emission 

reductions, the EPA proposed to change 

the current emissions standards in 

subpart CCCC that allow 2 percent of 

the batches to be exempted from the 

otherwise applicable emission 

limitation. The EPA proposed that the 

‘‘Batch Option’’ would be the updated 

form of the MACT standard and would 

set emission limits for different 

fermentation stages by simply 

eliminating the exemption from the 

otherwise applicable emission 

limitation for up to 2 percent of batches. 

However, we now recognize that 

requiring 100 percent of batches to meet 

the original emission limitations, as 

opposed to 98 percent, is not what we 

determined to be MACT in the 2001 

rulemaking. That rulemaking 

acknowledged that there is a degree of 


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natural variance in the yeast 

fermentation process, such that the 

maximum degree of emissions reduction 

achievable is the level represented by 98 

percent of batches meeting the 

applicable emission limits (66 FR 

27880, May 21, 2001). Therefore, while 

we are retaining the Batch Option as an 

alternative compliance option, it does 

not represent MACT. 

The EPA also proposed the Average 

Option for determining compliance with 

the applicable emission limitations. 

Because we formulated this option to 

reflect the level of emission reductions 

represented by the original MACT 

standard, including the allowance for 

variability built into that standard, we 

are now determining that it is the 

Average Option that actually represents 

MACT. As the commenters 

acknowledge, assessing compliance 

based on a 12-month rolling average of 

batch emissions serves the same 

purpose of addressing batch variability 

as the 2-percent exemption. We applied 

a discount factor specifically because 

averaging multiple batches inherently 

provides more flexibility to emit above 

such limits. We have also used discount 

factors in conjunction with annual 

average emission limitations in the 

Boiler MACT, where a 10-percent 

discount was applied for emissions 

averaging. Allowing annual average 

BAVOC emissions to meet the original 

VOC concentration limits established as 

MACT in 2001 (i.e., applying a 0- 

percent discount factor) would actually 

relax the standard, both due to the 

inherent flexibility of an averaging 

method and by potentially allowing 

more than 2 percent of batches to 

exceed the emission limitations set for 

each fermentation stage. To ensure that 

the annual averaging method will 

maintain the level of emission 

reductions represented by MACT, the 

EPA is finalizing a 5-percent discount 

factor in the VOC emission limit for 

each fermentation stage, as described in 

detail in the memorandum titled, 

‘‘Average Option Analysis for the 

Manufacturing of Nutritional Yeast 

Source Category,’’ available in the 

docket for this rulemaking. The EPA 

believes that it is necessary to include 

both components of the Average Option, 

as the 12-month rolling average 

provides for a degree of flexibility to 

account for the natural variance in the 

manufacturing process, while the 5- 

percent discount factor maintains the 

level of emission reductions consistent 

with the MACT determination, which is 

the level of emission reductions that 

protect public health and prevent 

adverse effects on the environment. 

As discussed previously in this 

section, the changes to the form of the 

standard were precipitated by the D.C. 

Circuit’s 2008 ruling in Sierra Club v. 

EPA that some emission standard must 

apply at all times. 551 F.3d 1019, 1027– 

28 (D.C. Cir. 2008). We did not re-open 

the MACT calculation in this 

rulemaking; the revised form must 

continue to reflect the emission 

reductions achieved by the best 

performers as determined in the 2001 

rule. The Average Option as finalized 

meets these requirements. 

Comment: One commenter stated the 

EPA did not offer sufficient technical 

support to justify that the proposed 

fermenter VOC emission limits are 

merely a change in the ‘‘form of the 

standards’’ and not a change in the 

standards themselves. The commenter 

contended that the revised fermenter 

VOC standards are not equivalent to the 

existing standards and there is no legal 

or technical basis for any changes to the 

existing fermenter VOC standards. In 

addition, the commenter maintained the 

proposed revisions fundamentally alter 

the standards, and their stringency, by 

changing the formula used to assess 

whether facilities are in compliance. 

Response: The EPA disagrees that 

there is no legal basis for changing the 

form of the standard and that our 

revision to the form of the standard 

fundamentally alters the standard itself. 

As discussed previously in this section, 

we have not recalculated the MACT 

floor or revisited the MACT 

determination; however, we have 

revised the current form of the standard 

consistent with the D.C. Circuit’s Sierra 

Club v. EPA decision. It is not possible, 

strictly speaking, to demonstrate that 

the revised form of the standard is 

‘‘equivalent to’’ the existing form of the 

standard because changing the form 

necessarily makes a direct comparison 

between the current standard and the 

revised standard infeasible. However, 

when revising the form, we have taken 

a reasonable approach to make the 

MACT standard apply continuously and 

to ensure that the revised form remains 

consistent with the level of emission 

reductions we originally determined to 

represent the MACT standard. That is, 

we have attempted to ensure, to the 

extent possible, that changing the form 

of the standard does not fundamentally 

alter the MACT standard that was 

finalized in 2001. 

The Average Option was developed to 

maintain flexibility for the sources 

subject to the rule and is expected to 

maintain the level of emission 

reductions represented by the existing 

MACT standard. To support an alternate 

form of emission limitations that would 

allow for emissions averaging and 

would also represent the existing MACT 

standard, we considered information 

from the development of the original 

MACT standard and analyzed more 

recent emissions data from the facilities 

currently subject to this rule. Multiple 

years of individual BAVOC emissions 

data were available for two facilities. 

Summary BAVOC data were available 

for three facilities. A detailed 

description of the analysis of the 

Average Option is available in the 

memorandum, ‘‘Average Option 

Analysis for the Manufacturing of 

Nutritional Yeast Source Category,’’ 

which is available in the docket for this 

rulemaking. 

With the revision of the form of the 

MACT standard, we retained certain 

characteristics of the 2001 standard 

(e.g., rolling 12-month calculation 

periods) to reduce the changes to 

ongoing operations and reporting and 

recordkeeping procedures for affected 

sources. We determined that an annual 

averaging method was the most 

appropriate form to maintain the 

flexibility established in the 2001 

MACT standard to account for the 

variability in emissions and retain 

elements of the reporting and 

recordkeeping provisions. We 

concluded, based on available data, that 

we could use a normal (bell-curve) 

distribution to simulate emissions from 

the yeast manufacturing process for the 

purposes of establishing annual average 

emission limits. 

The 2001 MACT standard did not set 

the annual mean for the distribution of 

BAVOC concentrations at 300 ppmv, 

200 ppmv, and 100 ppmv for each of the 

last three fermentation stages, 

respectively. Rather, it established an 

upper threshold that no more than 2 

percent of individual batches could 

exceed. As described in greater in the 

memorandum, the emission limitations 

established under the annual averaging 

compliance method will necessarily be 

lower than the upper threshold 

established for the 98 percent of batches 

with individual batch emission 

limitations under the 2001 MACT 

standard because the limitations 

established under the annual averaging 

method represent the mean of a normal 

distribution instead of an upper 

threshold. 

The simulated distribution depends 

on two parameters—mean and standard 

deviation. Because the mean and 

discount factor are directly related, we 

utilized the standard deviation as the 

key parameter for determining the 

discount factor that would maintain 

both flexibility for process variability 

and the level of emission reduction 


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established in the 2001 MACT standard. 

To do this we used the available 

BAVOC data from two facilities to 

calculate the standard deviation for 12- 

month rolling averages (65 total for each 

fermentation stage). The lowest 

observed standard deviations for each 

fermentation stage were 7 ppmv for the 

third-to-last stage, 5 ppmv for the 

second-to-last stage, and 3 ppmv for the 

last stage of yeast manufacturing. 

Utilizing the least-variable 12-month 

period to determine the average 

emission limitation results in the lowest 

discount factor and gives facilities the 

ability to operate at the highest annual 

average emission limit. Applying these 

standard deviations results in discount 

factors of 5 percent for the third-to-last 

and second-to-last stage, and 6 percent 

for the last stage. Instead of selecting 

different discount factors for each stage, 

we determined that a 5-percent discount 

factor was appropriate to apply to the 

2001 VOC concentration limitations to 

express the existing MACT standard in 

a new form. 

In summary, the Average Option uses 

an annual averaging methodology to 

achieve the flexibility originally 

accomplished by allowing 2 percent of 

batches to exceed the established 

emission limits (300 ppmv, 200 ppmv, 

100 ppmv). The revised form of the 

standard sets annual average emission 

limitations that are 5 percent lower than 

the 2001 upper threshold emission 

limitations for individual batches to 

maintain the level of emission 

reductions represented by the original 

form of the MACT standard. 

Comment: Two commenters asserted 

the EPA determined that only 98 

percent of batches could reasonably be 

expected to meet the emission limits 

and, thus, this was the MACT floor (66 

FR 27880, May 21, 2001). One of the 

commenters also contended that if the 

2001 fermenter VOC standards had been 

computed based on all batches, rather 

than 98 percent of the batches, the 

standards would necessarily have been 

set higher to accommodate process 

variability or some type of emissions 

averaging. 

Response: We agree that in setting the 

MACT floor in 2001, the EPA concluded 

that MACT is the control of 98 percent 

of the batches to either at or below the 

VOC concentration limits. However, we 

disagree that changing the form of the 

standard rejects our acknowledgment of 

the actual functioning of the yeast 

fermentation process or, as discussed 

previously in this section, the EPA’s 

prior MACT floor determination. The 

updated form of the standard, as 

expressed in the ‘‘Average Option,’’ 

maintains the level of emission 

reductions represented by MACT. This 

is a change from the proposal, which 

presented the ‘‘Batch Option’’ as the 

updated form of MACT. For further 

discussion of the determination of the 

Average Option as MACT, see the prior 

response in this section. 

The EPA disagrees that if the 2- 

percent exemption were not included in 

the original MACT limits, the standards 

would necessarily have been set higher. 

The numerical emission limits included 

in the MACT standard were not set 

based on the actual emissions levels 

achieved by 98 percent of the batches 

produced; rather they relied on the 

existing concentration-based limits 

included in two state rules, the state of 

Wisconsin and the state of Maryland, 

that were based on reasonably available 

control technology (RACT) and that 

were in place at the time (66 FR 27879, 

May 21, 2001). However, some states 

applied discretion concerning the 

number of exceedances of those 

emission limits that could occur before 

finding a facility in violation of the 

standards. For example, the state of 

Maryland’s continuous emissions 

monitoring policy allowed for one VOC 

concentration limit exceedance per 

facility per quarter. Consistent with this 

policy, the EPA calculated the average 

number of exceedances as a percent of 

the total number of batches 

manufactured at the five facilities 

subject to RACT or RACT-derived 

limitations during 1998 and calculated 

the overall average exceedances (based 

on dividing the average number of 

exceedances for the facilities by the 

average number of runs (where a run is 

a fermentation of any stage) for the 

facilities) to be 1.3 percent, noting that 

one of the facilities reported an 

unusually high number of exceedances 

due to ‘‘shakedown’’ (testing) of a new 

fermenter. Notably, one of the five yeast 

manufacturing facilities analyzed 

exceeded no concentration limits (66 FR 

27880, May 21, 2001). Given that one of 

the facilities did not exceed the limits, 

that Maryland only allowed four batches 

to exceed the limits each year, and that 

the average number of exceedances 

calculated using data from a facility 

with an ‘‘unusually high number of 

exceedances’’ was only 1.3 percent; as 

well as the statements from a 

commenter during promulgation of the 

MACT floor that ‘‘most batches display 

BAVOC below the . . . limits’’ (66 FR 

27880, May 21, 2001), we disagree that 

the limits would ‘‘necessarily have been 

set higher’’ as the commenter contends. 

Comment: One commenter stated the 

Batch Option would never be preferred 

from a compliance standpoint to the 

Average Option, and, thus, considered 

the inclusion of the Batch Option as an 

alternative to be illusory. 

Response: We acknowledge the 

comment. However, the EPA does not 

support or prefer one option over 

another (i.e., the Batch Option versus 

the Average Option). As explained 

above, while the EPA considered the 

Batch Option to be the revised form of 

the MACT standard at proposal, in light 

of comments received, we have 

determined that the Average Option is 

the revised form of the MACT standard. 

In recognition of information gathered 

from the development of the original 

rule and during the site visits conducted 

for the RTR that some facilities may be 

able to meet the current emission limits 

for all batches manufactured during a 

year, we have retained the Batch Option 

as an alternative compliance option that 

offers a more streamlined approach to 

determining and reporting compliance. 

4. What is the rationale for our final 

approach? 

For the reasons explained in the 

preamble to the proposed rule (81 FR 

95826, December 28, 2016) and in our 

comment responses in section IV.C.3 of 

this preamble, we are finalizing 

revisions to the form of the fermenter 

VOC standards in Tables 1 and 7 to 

subpart CCCC. As noted above, since 

proposal, the EPA’s determination of 

which option, the Batch Option or the 

Average Option, is the revised form of 

the original MACT standard has 

changed, and we now find that the 

Average Option represents MACT. 

However, we are finalizing both of the 

revised forms of the standard with no 

changes to the standards themselves, 

and are also finalizing the requirement 

that all sources must comply with one 

of the two revised forms with the 

changes related to frequency described 

in section IV.C.2 of this preamble. 

Additionally, we are finalizing revisions 

to 40 CFR 63.2150 to remove the 

emission limitation exemption during 

periods of malfunction, with the result 

that emissions from batches produced 

during periods of malfunction, other 

than monitoring system malfunctions, 

must now be included in calculations 

for compliance purposes. 

D. Removal of the Option To Monitor 

Brew Ethanol 

1. What did we propose? 

The EPA proposed to remove one of 

two options for demonstrating ongoing 

compliance in the 2001 rule, which 

allowed facilities to monitor brew 

ethanol concentration in the fermenter 

liquid. Specifically, we proposed to 

revise the requirements of 40 CFR 


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63.2166 and 63.2171, and Tables 3 and 

4 to subpart CCCC to remove the option 

to monitor brew ethanol as a means of 

demonstrating compliance. The method 

for monitoring brew ethanol requires 

facilities to develop an annual 

correlation of brew ethanol 

concentration to VOC concentration in 

the fermenter exhaust and use the 

correlation to determine compliance 

with the emission limitations. This 

method does not account for batchspecific characteristics affecting 

emissions and we subsequently 

determined it to be an unreliable 

indicator of a facility’s compliance with 

the standard. A detailed discussion is 

available in the preamble to the 

proposed rule (81 FR 95827, December 

28, 2016) and the supporting analysis is 

presented in the memorandum, ‘‘Brew 

Ethanol Correlation Review for the 

Manufacturing of Nutritional Yeast 

Source Category Memo Correction,’’ 

which is available in the docket for this 

action (Docket ID No. EPA–HQ–OAR– 

2015–0730–0181). We proposed to 

require facilities that monitor brew 

ethanol to adopt the remaining 

compliance demonstration option, 

which involves the installation and use 

of CEMS to monitor VOC emissions 

directly in the fermenter exhaust. 

2. How did the requirements change 

since proposal? 

The EPA is making no changes to the 

removal of the option to demonstrate 

compliance by monitoring brew ethanol 

in the fermenter liquid and is finalizing 

this amendment as proposed. However, 

as explained in section IV.G of this 

preamble, in response to public 

comments, the EPA has allowed 2 

additional years for facilities to comply 

with this amendment in addition to the 

1 year that was proposed. 

3. What key comments did we receive 

and what are our responses? 

Comment: One commenter challenged 

the EPA’s technical analysis supporting 

the proposed removal of the option to 

monitor brew ethanol as a method to 

demonstrate compliance with emission 

limitations, and claimed that the 

analysis was fundamentally flawed and 

misleading. The commenter disagreed 

with the EPA’s finding that brew 

ethanol monitoring resulted in a high 

level of inconsistency in the amount of 

VOC emissions estimated for a 

particular brew ethanol concentration 

and requested that brew ethanol 

monitoring be retained as a valid 

parametric CEMS. The commenter also 

suggested that the EPA erred by using 

‘‘hypothetical’’ VOC concentrations 

instead of the actual batch-average 

concentration values of brew ethanol in 

the fermenter liquid (BAE) from one of 

the performance tests to demonstrate the 

potential for emission limitation 

exceedances. 

The commenter provided a report that 

analyzed brew ethanol correlation 

performance tests from 2007 through 

2016 (see EPA–HQ–OAR–2015–0730– 

0191–A2). The report presented the 

conclusion that the combined 10 years 

(2007–2016) of performance test data 

demonstrated that when using the 

actual BAE and maximum BAE results 

for each fermentation stage over the 10- 

year period and applying the results to 

each year’s linear regression analysis, 

there was not a single year where the 

facility would have exceeded the 

prescribed VOC emission limitations for 

the tested batches. Furthermore, the 

commenter stated that even when using 

the highest BAE observed during one of 

the performance tests over the last 10 

years and applying the most unfavorable 

linear regression analysis from those 10 

years, there was no potential for the 

facility to have exceeded the 

corresponding VOC emission 

limitations. 

Response: The commenter has 

provided no evidence to dispute the 

EPA’s central conclusion that the 

calculated brew ethanol linear 

regression equations demonstrate an 

unacceptable level of variability. The 

EPA’s decision to disallow the brew 

ethanol monitoring option rests on this 

conclusion. The analysis of ‘‘higher 

end’’ brew ethanol concentrations, 

which the EPA believes remains 

reasonable (as discussed below), was 

utilized to illustrate the effect of relying 

on the highly variable brew ethanol 

linear regressions on compliance, and is 

not the primary support for the EPA’s 

decision to discontinue the brew 

ethanol monitoring option. 

The core point of the EPA’s analysis 

is that the level of VOCs emitted for a 

given percentage of brew ethanol 

measured in a fermenter is different for 

every batch that was tested in a given 

fermentation stage between 2012 and 

2016. The additional data submitted by 

the commenter for the years 2007 

through 2011 further support this 

finding. Depending on which of the 10 

performance test batches is evaluated, 

the BAVOC value that would be 

calculated for a BAE value of 0.14 from 

a batch manufactured in the third-to-last 

stage ranged from as low as 76 ppmv to 

as high as 207 ppmv. Similar results 

were reported for the second-to-last and 

last fermentation stages. Our analysis of 

the variability is provided in the 

memorandum titled, ‘‘Brew Ethanol 

Correlation Review for the 

Manufacturing of Nutritional Yeast 

Source Category—Final Rule,’’ which 

has been updated with the additional 

data submitted by the commenter and is 

available in the docket for this 

rulemaking. 

For many batches produced over the 

course of a year, the variability between 

annual correlation equations will not 

affect the facility’s compliance status 

because the batches are well under the 

established emission limitations for 

each of the correlation equations. 

However, for those batches with higher 

brew ethanol concentrations, the 

variability may have a significant 

impact on the resulting BAVOC value 

calculated for those batches and the 

overall compliance status of the yeast 

manufacturing facility, depending on 

the overall percentage of batches with 

higher BAE values. 

For the purposes of estimating 

emissions, the current method does not 

provide reliable information about the 

thousands of batches that are not tested, 

other than showing whether emissions 

are rising or falling. In order for the 

existing correlation method to be useful 

for compliance purposes, it is necessary 

that the relationship between BAE and 

BAVOC be relatively constant between 

batches for a given fermentation stage, 

regardless of the point-in-time in which 

they were tested. The manufacturing of 

yeast is a biological process and some 

degree of variation is expected. 

However, emissions are also determined 

by a few key process parameters, 

including the amount of available 

oxygen and the composition and 

amount of the sugar and nutrient 

mixture fed to the yeast in each batch. 

The review of the data in the 

memorandum titled, ‘‘Brew Ethanol 

Correlation Review for the 

Manufacturing of Nutritional Yeast 

Source Category—Final Rule,’’ which is 

available in the docket for this 

rulemaking, shows that the relationship 

between brew ethanol concentration 

and VOC emissions is affected by some 

combination of these or other process 

parameters since the correlation is not 

constant for each tested batch and each 

fermentation stage. The inconsistent 

correlations suggest that the brew-toexhaust correlation method does not 

yield reliable emissions information for 

batches of yeast other than those 

specific batches used for the annual 

performance tests. 

The EPA disagrees that the use of 

sample VOC concentrations other than 

the BAE values measured during a 

performance test with the corresponding 

correlation equation to assess the brew 

ethanol correlation method is 

misleading. Rather, this is the process 


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laid out in the rule for the facility to 

determine compliance with the 

emission limitations. Each year, the 

facility is required to test only three 

individual batches (one from each 

fermentation stage) out of the thousands 

of batches that are manufactured during 

the year. The facility then estimates 

BAVOC values for the thousands of 

other batches using the correlations 

obtained during the performance tests 

that year. The EPA analyzed 5 years of 

actual BAVOC values recorded by the 

facility and used the corresponding 

year’s correlation equations to calculate 

a BAE value for every batch 

manufactured during those 5 years. The 

‘‘higher end’’ values used in the 

memorandum, ‘‘Brew Ethanol 

Correlation Review for the 

Manufacturing of Nutritional Yeast 

Source Category—Final Rule’’ were all 

within the ranges of actual BAE values 

measured during the corresponding 

years by the facility. The commenter 

also stated that none of the 30 

individual batches that were used for an 

annual performance test between 2007 

and 2016 exceeded the prescribed VOC 

emission limitations. The EPA agrees; in 

fact, the linear regression must be 

calculated from a batch that does not 

exceed the emission limitations, as 

required by 40 CFR 63.2161(d)(3). If the 

commenter does not agree that the 

correlation equation should be applied 

to any BAE values other than those 

directly tested, the commenter would 

seem to be suggesting that a 

performance test must be conducted on 

each individual batch manufactured by 

a facility, which would be costprohibitive and is not feasible for a 

facility. To clarify, the EPA never stated 

that the facility exceeded the NESHAP 

emission limitations for any of the 

batches monitored during a performance 

test between 2011 and 2016. Rather, we 

demonstrated that the relationship 

between the concentration of VOC in 

the fermenter exhaust and the percent of 

brew ethanol in the fermenter liquid is 

not consistent between batches. 

Therefore, the use of the relationship 

between VOC concentration and percent 

of brew ethanol from one batch to 

calculate emissions from all other 

batches in the same fermentation stage 

over an arbitrary period of time is 

unreliable. While this could mean that 

the facility under-reports emissions 

from some batches, it also means that 

the facility could over-report emissions 

from some batches. This potential for 

over-reporting is best illustrated with 

the use of ‘‘higher end’’ BAE values. If 

a particular correlation was established 

one year for a batch that had an 

unusually high relationship between 

VOC concentration and brew ethanol 

percentage, the continued use of that 

correlation for the period of that year 

could conceivably cause the facility to 

calculate BAVOC values over the 

emission limitations for enough batches 

that the facility would appear to be out 

of compliance; such a circumstance 

would cause the facility to incur 

significant compliance costs, regardless 

of what the actual emissions were since 

actual emissions are not tested. 

As a point of clarification, the 

commenter refers to brew ethanol 

monitoring as a ‘‘parametric CEMS.’’ 

The commenter is combining two 

elements together that have different 

regulatory meanings. A continuous 

monitoring system can be a continuous 

parameter monitoring system (CPMS) or 

a CEMS, but a CPMS is not a CEMS. 

CPMS and CEMS are defined separately 

at 40 CFR 63.2, such that a CPMS is 

‘‘used to sample, condition (if 

applicable), analyze, and provide a 

record of process or control system 

parameters’’ and a CEMS is ‘‘used to 

sample, condition (if applicable), 

analyze, and provide a record of 

emissions’’. The EPA revised the rule 

language to use ‘‘brew ethanol monitor’’ 

instead of ‘‘CEMS’’ because a brew 

ethanol monitor does not record VOC 

emissions and, thus, is not a CEMS. A 

brew ethanol monitor is used to 

measure the brew ethanol concentration 

in the fermenter liquid, which is then 

used to estimate VOC emissions via the 

brew ethanol correlation. The change in 

terminology did not result in any 

changes to the existing requirements. 

Rather it ensured the existing language 

was technically correct. 

Comment: One commenter indicated 

that multiple facilities use brew ethanol 

monitoring to calculate VOC emissions 

and, thus, brew ethanol monitoring 

should not be eliminated as an 

acceptable option. The commenter 

described that one facility uses brew 

ethanol monitoring as well as CEMS to 

develop VOC emissions data, with the 

brew ethanol monitoring serving as a 

quality assurance step. 

Response: Only one facility currently 

uses brew ethanol monitoring to 

demonstrate compliance; the other 

facilities all utilize CEMS VOC data to 

demonstrate compliance with the 

standard. Use of brew ethanol 

monitoring for quality assurance does 

not prove its capability to provide 

accurate and reliable data for a 

compliance demonstration. The final 

rule does not prohibit the use of other 

methods of quality assurance for process 

control in addition to the systems 

necessary to meet the requirements of 

the rule. 

Comment: Two commenters argued 

that requiring facilities to install flame 

ionization detection (FID) CEMS to 

replace brew ethanol monitoring would 

not provide emissions data that is more 

reliable or less variable and that the EPA 

has not shown that CEMS would result 

in meaningful improvement to 

compliance or regulatory outcomes. One 

commenter cited a letter (see EPA–HQ– 

OAR–2015–0730–0191–A54) that 

commented on the accuracy of FID 

CEMS; the letter stated that the presence 

of oxygen, moisture, and hydrocarbons 

in fermenter emissions have the 

potential to interfere with FID CEMS 

technology and cause variability in any 

data collected using FID CEMS. 

Response: The EPA disagrees that the 

use of brew ethanol monitoring is 

comparable to the use of FID CEMS to 

monitor emissions from the 

manufacturing of nutritional yeast. As 

explained previously in this section and 

the memorandum, ‘‘Brew Ethanol 

Correlation Review for the 

Manufacturing of Nutritional Yeast 

Source Category—Final Rule,’’ which is 

available in the docket for this 

rulemaking, the brew ethanol method 

does not account for batch-specific 

variables affecting emissions. An FID 

CEMS, on the other hand, does indicate 

batch-specific emissions, which 

increases confidence that reported 

emissions are reliable. Additionally, 

such data can help a facility avoid the 

potential for erroneously determining 

that it is out of compliance compared to 

the scenario of using a batch with an 

unusually high ratio of VOC emissions 

to brew ethanol content for the annual 

performance test and the subsequent 

correlation calculation. 

While it is true that the accuracy of an 

FID CEMS can be affected by factors 

such as moisture, the commenter does 

not acknowledge the common 

procedures in place to minimize these 

effects (such as the use of heated sample 

lines) or the difference between 

monitoring system malfunctions and 

day-to-day reliability of these systems. 

Similarly, the letter discusses technical 

issues with response factors. Response 

factors are needed to establish the 

relationships of different gases to the 

one used as the calibration standard for 

a measurement instrument. Since the 

standard is expressed in terms of VOC 

as propane and the FID CEMS are 

calibrated with propane (as required by 

40 CFR 63.2163 (d)), response factors 

are not used and the commenter’s 

argument is irrelevant. 


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4. What is the rationale for our final 

approach? 

For the reasons explained in the 

preamble to the proposed rule (81 FR 

95827, December 28, 2016), in the 

comment responses in section IV.D.3 of 

this preamble, and in the memorandum, 

‘‘Brew Ethanol Correlation Review for 

the Manufacturing of Nutritional Yeast 

Source Category—Final Rule,’’ which is 

available in the docket for this 

rulemaking, we are finalizing the 

removal of the option to demonstrate 

compliance by monitoring brew ethanol 

in the fermenter liquid as proposed, 

with the changes related to frequency 

described in section IV.D.2 of this 

preamble. 

We finalized requirements at 40 CFR 

63.2150(b) and 63.2166, and Tables 3, 4, 

and 8 to subpart CCCC to remove the 

option to monitor brew ethanol. 

E. Requirement To Conduct RATA 

1. What did we propose? 

The EPA proposed a requirement in 

40 CFR 63.2163 to conduct annual 

RATA for all VOC CEMS, which were 

previously exempt from this quality 

assurance requirement. This proposed 

requirement specified the use of 

Procedure 1 of appendix F to part 60 to 

evaluate the performance of the 

installed VOC CEMS over an extended 

period of time (81 FR 95829, December 

28, 2016). The EPA also proposed to 

replace an outdated reference with the 

current version of the EPA’s traceability 

protocol for use in quality assurance 

procedures for CEMS. 

2. How did the requirements change 

since proposal? 

The EPA has maintained the proposed 

requirement to conduct ongoing RATA; 

however, in response to public 

comments, we are revising the 

frequency of the RATA. We are 

finalizing a requirement for facilities to 

conduct RATA for each CEMS at least 

once every 3 years, instead of annually. 

The EPA also corrected the proposed 

rule language (see 40 CFR 63.2163(b)(3)) 

to clarify that the current version of the 

EPA’s traceability protocol (EPA/600/R– 

12/531) replaces citation 2 of Procedure 

1 of appendix F to 40 CFR part 60; at 

proposal, the EPA incorrectly cited 

reference 2 of Performance Specification 

8 of appendix B to 40 CFR part 60. 

3. What key comments did we receive 

and what are our responses? 

Comment: A commenter did not 

support the proposed requirement to 

require annual RATA for all CEMS and 

stated that it was a costly procedure that 

would not enhance process control or 

achieve any valid regulatory goal. If 

RATA are required, the commenter 

suggested that RATA be conducted on a 

3- to 5-year cycle, rather than annually. 

The commenter also requested the final 

rule clarify that RATA are not required 

every time a CEMS is repaired or 

replaced. 

One commenter stated the more 

stringent monitoring requirements were 

not justified because it would not lead 

to a reduction in emissions and would 

unnecessarily increase cost. 

Response: During the site visits 

conducted for this rulemaking, it was 

noted that many of the malfunctions 

recorded by the facilities subject to this 

rule were due to malfunctions of the 

compliance monitoring systems. Regular 

RATA ensure the CEMS continue to 

produce valid data, which is necessary 

for the owner or operator, as well as the 

EPA, to ensure compliance. A RATA 

assesses both the instrument accuracy in 

measuring the target analyte in the 

emission matrix (which daily 

calibrations and audits using reference 

gases do not) as well as the 

representativeness of the CEMS 

sampling location. 

It is routine for the EPA to require 

annual RATA of CEMS. While the 

original rule did not require annual 

RATA for FID CEMS, the EPA has 

finalized revisions to require ongoing 

quality assurance procedures (including 

RATA) in many rules since 2001. For 

example, ongoing quality assurance 

procedures were included in the Metal 

Coil Surface Coating, Miscellaneous 

Coating Manufacturing, Plywood and 

Composite Wood Products, and 

Portland Cement Manufacturing MACT 

standards, promulgated on June 10, 

2002; December 11, 2003; July 30, 2004; 

and February 12, 2013, respectively. 

The addition of RATA procedures to the 

Nutritional Yeast rule helps complete 

this missing, but necessary, qualityassurance component. 

However, to reduce burden, the EPA 

is finalizing a requirement to conduct 

RATA at least once every 3 years, 

instead of annually, as proposed. 

The EPA is not revising the rule 

language to state that RATA are not 

required in certain instances. In fact, the 

replacement of a CEMS would require a 

RATA to ensure accuracy of the 

measured data. 

4. What is the rationale for our final 

approach? 

For the reasons explained in the 

preamble to the proposed rule (81 FR 

95829, December 28, 2016) and in the 

comment responses in section IV.E.3 of 

this preamble, we are finalizing 

requirements in 40 CFR 63.2163 to 

conduct RATA, as proposed, with the 

changes related to frequency and the 

traceability protocol citation described 

in section IV.E.2 of this preamble. 

F. Requirement To Collect All Valid 

CEMS Data 

1. What did we propose? 

The EPA proposed a requirement to 

collect CEMS data at all times during 

each batch monitoring period, except for 

periods of monitoring system 

malfunctions, required monitoring 

system quality assurance or quality 

control activities, and any scheduled 

maintenance (81 FR 95829, December 

28, 2016). The requirements were 

proposed at 40 CFR 63.2163, 63.2170, 

63.2181(c)(8), and 63.2182(b)(9). 

2. How did the requirements change 

since proposal? 

The EPA is finalizing, as proposed, 

the requirement to collect all valid 

CEMS data. In response to comments, 

we have also finalized clarifications to 

the rule text to reinstate 40 CFR 

63.8(c)(4)(ii), (c)(7), and (g)(2) of the 

General Provisions that specify the 

minimum operation requirements for 

CEMS (at least one cycle every 15 

minutes), the definition and 

requirements for ‘‘out of control’’ CEMS, 

and the procedures for the reduction of 

CEMS data to hourly averages. 

3. What key comments did we receive 

and what are our responses? 

Comment: A commenter stated that 

collecting CEMS data at all times, 

instead of for 75 percent of the batch 

hours, is an impossible bar that is not 

achievable in practice. The commenter 

stated that collecting data from 75 

percent of batch hours is a reasonable 

accommodation of the fact that 

monitoring equipment cannot operate 

perfectly or be calibrated 100 percent of 

the time in an industrial plant. The 

commenter suggested a monitoring 

requirement of total CEMS uptime of 75 

percent of fermentation time during 

rolling 12-month periods. The 

commenter also requested the EPA 

clarify that ‘‘at all times’’ means logging 

data once every 15 minutes. 

The commenter stated that nothing in 

the record supports the theory that more 

stringent monitoring will add precision 

to the measurement and that any such 

precision would not be meaningful from 

an operation or compliance standpoint. 

The commenter noted the existing 

monitoring requirements are sufficient 

to determine the average VOC 

concentration in a fermenter batch and 

across numbers of batches. The 

commenter was concerned that 


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2Available at https://cfpub.epa.gov/webfire/ 

index.cfm?action=fire.searchERTSubmission. 

3Available at https://cfpub.epa.gov/webfire/ 

index.cfm?action=fire.searchERTSubmission. 

4The facilities and periods over which THC 

monitoring was reported include: Ash Grove 

Cement in Durkee, Oregon, from July through 

December 2016; Signal Mountain Cement Company 

in Chattanooga, Tennessee, from September 2015 

through December 2016; Cemex Construction 

Materials Atlantic in Knoxville, Tennessee, from 

February through December 2016; Holcim (US) in 

Theodore, Alabama, from January through 

December 2016; and Lehigh Ready Mix Cement in 

Leeds, Alabama, from July through December 2016. 

5While the Portland cement manufacturing 

emission reports only require CEMS downtime 

greater than or equal to 90 percent to be reported 

[see 40 CFR 63.1354(b)(10)], subject facilities—just 

like as proposed for nutritional yeast 

manufacturers—are required to conduct all 

monitoring in continuous operation at all times that 

the units are operating [see 40 CFR 63.1350(i) and 

(m)(2)]. 

requiring more stringent monitoring 

could subject facilities to enforcement 

actions and citizen suits. 

The commenter recommended three 

alternative monitoring methods for 

periods that CEMS are not available. 

The commenter also requested the EPA 

define expressly the procedures for 

monitoring system out-of-calibration, 

downtime, or missing data in the rule 

language, rather than using cross 

references to other EPA technical 

procedures. 

Response: We emphasize that the 

proposed amendments specified that 

data must be collected ‘‘at all times 

during each batch monitoring period, 

except for periods of monitoring system 

malfunctions, required monitoring 

system quality assurance or quality 

control activities (including, as 

applicable, calibration checks and 

required zero and span adjustments), 

and any scheduled maintenance.’’ We 

disagree that a requirement to collect 

CEMS data at all other times is an 

impossible bar that is not achievable in 

practice. As far back as 1994, the EPA’s 

Office of Water reported that total 

hydrocarbon (THC) CEMS, which are a 

subset of VOC CEMS, along with other 

analyzers necessary to correct values to 

standard moisture and oxygen content, 

were ‘‘. . . able to demonstrate a data 

capture rate of 100 percent, based on 

four measurements per minute.’’ 2

Electronically submitted data from 

Portland cement source owners or 

operators currently using VOC CEMS as 

a compliance method also refutes the 

commenter’s assertion. As shown from 

a quick search of submissions to the 

EPA’s ERT,3 at least five separate 

facilities 4 report greater than 90-percent 

uptime for their THC CEMS.5 Moreover, 

none of the facilities reported an 

inability to collect monitoring data at all 

times that their units were operating 

and the commenter did not provide any 

examples of the inability to collect data 

other than monitor malfunctions or 

quality assurance/quality control 

activities. 

We find that the commenter 

misinterprets the requirement to collect 

data at all times. The proposed rule does 

not require the VOC CEMS to be 

operating perfectly or calibrated for 100 

percent of the time. In fact, the rule 

specifically prohibits data collection 

during periods of monitoring system 

malfunction or of required monitoring 

system quality assurance or control 

activities—such as calibrations and 

scheduled maintenance (see 40 CFR 

63.2170(b)). Moreover, the rule allows 

owners or operators to establish and 

follow their own CEMS quality control 

programs with site-specific performance 

evaluation plans that cover items such 

as initial and subsequent calibrations, 

calibration drift specifications, 

preventive maintenance, accuracy audit 

procedures, and CEMS corrective action 

procedures (see 40 CFR 63.8(d)(2)), as 

referenced by Table 6 of the rule). The 

commenter’s concern for practicality 

regarding 100-percent data collection is 

misplaced; while the rule requires 

complete data collection from certain 

periods, it does not require 100-percent 

data collection. Moreover, in the event 

that data are not collected as required 

during certain periods, the occurrences 

are specified as deviations, rather than 

automatic violations, of the rule; such 

deviations are to be reported by owners 

or operators to regulatory authorities 

who would take appropriate corrective 

action as necessary (see 40 CFR 

63.2170(d)). Finally, source owners or 

operators are able to use the 

aforementioned site-specific monitoring 

plans to obtain approval from regulatory 

authorities for replacement emissions 

monitoring capabilities through 

approaches such as redundant or 

independent temporary systems prior to 

their use. While we reasoned that a 

facility may achieve enhanced process 

control from the amendments to the 

rule, this potential enhancement was 

not the basis for requiring the collection 

of CEMS data at all times. Given the 

variability in emissions throughout the 

process of manufacturing a batch of 

yeast, it is necessary to collect data at all 

times the CEMS are operational (given 

the exemptions noted above) to 

calculate accurate BAVOC values. The 

goal of the revision is to ensure the 

values collected and reported are 

suitable for demonstrating compliance 

with the rule. The enhanced monitoring 

data will allow us, owners or operators, 

and the public to have greater 

confidence in compliance 

determinations based on those 

measurements, and, therefore, greater 

confidence that the expected health 

benefits of the rule are achieved. 

We disagree with the commenter’s 

view that the monitoring is more 

stringent or could subject facilities to an 

increased number of enforcement 

actions or citizen suits, as the rule 

requires compliance with the emission 

limitations at all times. Monitoring itself 

does not affect a facility’s actual 

compliance status and, as stated above, 

monitoring downtime is characterized 

as a deviation from, rather than 

violation of, emission standards. 

Regarding enforcement discretion, we 

rely on our regulatory partners to assess 

the individual, case-specific facts and to 

take appropriate action when necessary 

to correct problems. Owners or 

operators can take steps under their own 

control to reduce or eliminate any 

compliance concerns through activities 

such as increased attention to 

emissions-causing processes; and 

development, acceptance, and use of 

redundant monitoring systems. 

We agree with the commenter’s 

suggestion to clarify in the rule a 

minimum CEMS cycle time of 15 

minutes, in which a value would be 

collected and recorded. This 

clarification was included by reinstating 

the applicability of 40 CFR 63.8(c)(4)(ii) 

of the General Provisions in Table 6. 

Furthermore, we have reinstated the 

applicability of 40 CFR 63.8(g)(2) of the 

General Provisions in Table 6 that 

allows a minimum of two data points 

(each representing 15-minute periods) 

or an arithmetic or integrated 1-hour 

average of CEMS data to constitute a 

valid hour of data collection during 

periods of calibration, quality assurance, 

or maintenance activities. These two 

sections of the General Provisions were 

not applicable to the 2001 

Manufacturing of Nutritional Yeast, 

because alternate definitions were 

included in the rule. Now that the 

CEMS requirements have been updated, 

there is no need for separate 

requirements for this source category 

and the requirements from the General 

Provisions can be applied. 

We do not agree with suggestions to 

write out monitoring system procedures 

when those procedures already exist in 

other applicable rules. Where relevant 

procedures already exist in other rules, 

our policy is to cross-reference those 

procedures; cross-referencing eliminates 

duplicative portions of rules and 

ensures consistency. While we do not 

see the need for alternative monitoring 

methods for periods when VOC CEMS 

are unavailable, since the 


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aforementioned data on the use of 

CEMS in other source categories from 

the EPA’s ERT showed no periods of 

VOC CEMS unavailability, the rule does 

not prohibit owners or operators from 

proposing—and from regulatory 

authorities accepting—alternate means 

for assessing emissions as part of 

corrective action procedures for a 

malfunctioning VOC CEMS as part of 

the source’s quality control program. 

Given the high level of variability in 

emissions between batches that was 

demonstrated by the data used to 

analyze the brew ethanol monitoring 

option, we would recommend owners or 

operators seek other means—perhaps 

redundant VOC CEMS—as better 

alternatives for determining compliance 

during periods when the primary VOC 

CEMS is malfunctioning. Of course, 

even with approval of other means for 

assessing emissions, failure to provide 

VOC CEMS data as required would 

remain a deviation and constitute 

monitor downtime, which must be 

reported according to rule requirements 

in 40 CFR 63.2181. 

4. What is the rationale for our final 

approach? 

For the reasons explained in the 

preamble to the proposed rule (81 FR 

95829, December 28, 2016) and in the 

comment responses in section IV.F.3 of 

this preamble, we are finalizing 

requirements to collect all valid CEMS 

data, as proposed, with the additional 

clarifications described in section IV.F.2 

of this preamble. The final requirements 

are specified at 40 CFR 63.2163, 

63.2170, 63.2181(c)(8), and 

63.2182(c)(5), and in Table 6 to subpart 

CCCC. 

G. Compliance Dates for the 

Amendments 

1. What did we propose? 

The EPA proposed that currently 

operating facilities must immediately 

comply with one of the two revised 

forms of the fermenter VOC standards 

upon the effective date of the final rule, 

and that facilities that currently 

demonstrate compliance by monitoring 

brew ethanol in the fermenter have up 

to 1 year to install CEMS. The EPA 

proposed that currently operating 

facilities must immediately comply with 

the additional testing, monitoring, 

reporting, and recordkeeping 

requirements (i.e., the removal of GC 

CEMS, collection of all valid CEMS data 

from the entire batch monitoring period, 

requirement to conduct RATA, use of 

Procedure 1 of Appendix F to part 60 for 

VOC CEMS, and the electronic reporting 

requirements), as well as with the 

revised SSM requirements. The EPA 

also proposed that sources that are 

constructed or reconstructed after 

promulgation of the rule revisions must 

comply with all amendments upon 

startup of the affected source (81 FR 

95834, December 28, 2016). 

2. How did the requirements change 

since proposal? 

Based on public comments, the EPA 

has changed the compliance date for 

existing sources to comply with the 

revised form of the fermenter VOC 

standards from immediate compliance 

upon promulgation of the rule to 1 year 

after the effective date of this rule. The 

EPA has clarified language in 40 CFR 

63.2181(c)(4) through (7) describing 

facilities’ reporting obligations under 

each of the three options for 

demonstrating compliance. The 

language, as finalized, allows facilities 

transitioning between compliance 

demonstration using the 98-Percent 

Option and the Average Option to report 

compliance in a semi-annual 

compliance report under different 

approaches for different 12-month 

calculation periods, as appropriate. This 

allows existing facilities the ability to 

continue to demonstrate compliance 

using the 98-Percent Option for all 12- 

month calculation periods that end 

before or on the compliance date for this 

amendment. For example, if the 

effective date of this final rule is 

October 31, 2017, then the compliance 

date for this amendment would be 

October 31, 2018. If an existing facility 

was scheduled to submit a semiannual 

compliance report by January 31, 2019, 

for the reporting period covering July 1, 

2018, through December 31, 2018; the 

facility could demonstrate compliance 

for the 12-month calculation periods 

ending on July 31, 2018, August 31, 

2018, September 30, 2018, and October 

31, 2018, using the 98-Percent Option 

and for the 12-month calculation 

periods ending on November 30, 2018, 

and December 31, 2018, using the 

Average Option. Facilites may 

voluntarily choose to demonstrate 

compliance using the revised form of 

the emission limitations earlier, so that 

all of the 12-month calculation periods 

ending within the semiannual 

compliance report demonstrate 

compliance using the same form of the 

emission limitations. Facilities that 

choose to use the Batch Option to 

demonstrate compliance with the 

emission limitations must apply the 

demonstration to all batches within a 

semiannual reporting period; that is, 

facilities cannot transition to 

demonstrating compliance under the 

Batch Option in the middle of a 

reporting period. Therefore, unless an 

existing facility that is transitioning 

from the 98-Percent Option to the Batch 

Option is due to begin a new 

semiannual reporting period in the 

month following the compliance date 

for this amendment, the facility has two 

interim options for demonstrating 

compliance. Assuming, for example 

purposes, a reporting period of July 1, 

2018, through December 31, 2018, and 

a compliance date for the final rule on 

October 31, 2018; the facility could 

demonstrate compliance for the entire 

reporting period using the Batch Option. 

Alternately, the facility could 

demonstrate compliance using the 98- 

Percent Option for 12-month calculation 

periods ending on July 31, August 31, 

September 30, and October 31, and 

demonstrate compliance for 12-month 

calculation periods ending on 

November 30 and December 31, 2018, 

using the Average Option. The facility 

could then begin demonstrating 

compliance for the January 1, 2019, 

through June 30, 2019, reporting period 

using the Batch Option. A new table, 

Table 7, has been added to the rule to 

summarize when existing and new 

affected sources must comply with the 

different requirements for the form of 

the emission limitations. 

Facilities that currently demonstrate 

compliance by monitoring brew ethanol 

have up to 3 years after the effective 

date of the rule to install CEMS, instead 

of the proposed 1 year. A new table, 

Table 8, has been added to the rule to 

summarize when existing and new 

affected sources must comply with the 

different requirements for emissions 

monitoring equipment. 

3. What key comments did we receive 

and what are our responses? 

Comment: One commenter does not 

support complying with the revised 

form of the fermenter standards 

immediately upon promulgation of the 

rule, and requested a minimum of 2 

years to demonstrate compliance. The 

commenter stated it would take time for 

facilities to convert to any new 

methodology, especially as it relates to 

recordkeeping and reporting. The 

commenter remarked that immediate 

compliance upon issuance of a final rule 

is impracticable and unduly 

burdensome; facilities will not know 

when the EPA plans to issue the final 

rule and will have no understanding in 

advance of what the final rule will 

require. 

Response: We disagree that immediate 

compliance would be impracticable for 

certain reasons the commenter noted; 

specifically, the commenter knows the 

final rule will be issued by October 1, 


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2017, due to the court-ordered deadline 

for this rulemaking. Furthermore, it is 

not accurate to say the commenter will 

have ‘‘no understanding’’ of what the 

final rule will require, given the nature 

of notice-and-comment rulemaking. The 

EPA notes that the emission limitations 

are simply expressed in a revised format 

and are not expected to result in any 

changes in compliance status. However, 

it is also reasonable to provide 

additional time to demonstrate 

continuous compliance with the revised 

form of the emission standard for 

facilities that are currently operating 

because it will require a change in 

recordkeeping and reporting 

procedures. CAA section 112(i)(3) 

requires that compliance dates for 

existing sources require compliance 

with any emission standard, limitation, 

or regulation promulgated under section 

112 ‘‘as expeditiously as practicable, but 

in no event later than 3 years after the 

effective date of such standard.’’ While 

we believe, based on information 

gathered during the site visits and 

phone calls conducted prior to the 

proposed rulemaking, that the facilities 

have all of the data needed to 

demonstrate continuous compliance 

with the amended requirements 

immediately, it is prudent to allow time 

to train staff and establish long-term 

procedures for the efficient management 

of this data. Therefore, the EPA has 

finalized amendments allowing the 

facilities up to 1 year to demonstrate 

continuous compliance with the revised 

form of the emission limitations and the 

associated reporting and recordkeeping 

requirements. We believe that 1 year is 

a sufficient period of time for facilities 

to update recordkeeping systems and 

train staff. The current emission 

limitations require facilities to record 

the emissions from each batch in a 

rolling 12-month period, compare the 

emissions from each batch with the 

standard, and count how many of the 

batches had emissions equal to or lower 

than the limit. A facility then 

determines the total number of batches 

that were manufactured during the 

rolling 12-month period and calculates 

the percentage of batches in that period 

that met the emission limitations. The 

revised form of the standard is slightly 

more streamlined in that facilities 

simply average the emissions from each 

batch produced in a given fermentation 

stage over the 12-month period and 

compare it to the emission limitation. 

While this necessitates a change in the 

overall calculation and reporting 

procedures, it does not require 

significant actions such as the selection, 

installation, and testing of new 

equipment or changes to the yeast 

manufacturing process that would 

warrant 2 years to implement the 

revisions. As specified in section III.E of 

this preamble to the rule, facilities must 

continue to demonstrate continuous 

compliance with the existing emission 

limitations and reporting and 

recordkeeping requirements during the 

time it takes them to transition to the 

revised requirements. The revised 

requirements are expected to be slightly 

more streamlined than the existing 

requirements and there is no prohibition 

against facilities from demonstrating 

compliance with the new form of the 

emission limitations and associated 

reporting and recordkeeping 

requirements immediately. 

Comment: Two commenters do not 

support having only 1 year to install 

CEMS if a facility currently monitors 

brew ethanol. The commenters 

requested a minimum of 3 years to 

comply to allow for the purchase, 

design, testing, and installation of new 

CEMS equipment. The commenters 

stated 3 years is consistent with the 

approach for sources when the rule was 

originally promulgated and the EPA has 

authority to allow 3 years to comply 

under CAA section 112(i)(3). 

Response: The EPA has finalized 

requirements allowing the one existing 

facility that currently demonstrates 

compliance by monitoring brew ethanol 

up to 3 years to install CEMS to 

demonstrate compliance. This facility 

must continue to meet the performance 

test and operation and maintenance 

requirements of 40 CFR 63.2161 and 40 

CFR 63.2164 during this time. 

Additionally, we note that the facility 

must comply with the revised form of 

the emission limitations at the specified 

time (within 1 year), regardless of the 

monitoring method used. 

4. What is the rationale for our final 

approach? 

For the reasons explained in the 

comment responses in section IV.G.3 of 

this preamble and in the response to 

comments document in the docket for 

this rulemaking, we are finalizing the 

requirements related to the compliance 

dates for the demonstration of 

compliance with the revised form of the 

fermenter VOC standards and the use of 

CEMS for existing facilities with the 

changes described in section IV.G.2 of 

this preamble. We finalized revisions in 

Table 7 and Table 8 to subpart CCCC to 

specify the emission limitation and 

monitoring system timelines. We 

finalized the revisions requiring 

immediate compliance for the 

additional testing, monitoring, 

reporting, and recordkeeping 

requirements (i.e., the removal of GC 

CEMS in 40 CFR 63.2163(a), collection 

of all valid CEMS data from the entire 

batch monitoring period in 40 CFR 

63.2163(h), requirement to conduct 

RATA in 40 CFR 63.2163(b)(1), use of 

Procedure 1 of Appendix F to part 60 for 

VOC CEMS in 40 CFR 63.2163(b)(3), 

and the electronic reporting 

requirements in 40 CFR 63.2181(a)), as 

well as with the revised SSM 

requirements as proposed. 

V. Summary of Cost, Environmental, 

and Economic Impacts and Additional 

Analyses Conducted 

A. What are the affected facilities? 

We anticipate that four nutritional 

yeast facilities currently operating in the 

United States will be affected by this 

final rule. 

B. What are the air quality impacts? 

The amendments to this subpart will 

have a positive impact on air quality. 

While facilities will not need to install 

additional controls to comply with the 

fermenter emission limitations, the 

revisions remove the exemption that 

allowed up to 2 percent of the total 

number of batches to be produced with 

no limit on emissions (i.e., the revisions 

apply the emission limitations 

continuously). The rule revisions also 

remove the exemption that allowed 

emissions from batches produced 

during periods of malfunction, other 

than monitoring system malfunctions, to 

be excluded when determining 

compliance with emission limitations. 

While the air quality impact of these 

changes cannot easily be quantified due 

to a current lack of data on the number 

of and emissions from previously 

exempted batches, the practical effect is 

that production of all batches of 

nutritional yeast at affected sources will 

now be required to meet emission 

limitations. The other revisions, which 

affect testing, monitoring, 

recordkeeping, and reporting 

requirements, will ensure that emissions 

monitoring equipment continues to 

perform as expected and provides 

reliable data from each facility to be 

used in determining compliance. For 

reference, the baseline emissions for 

each facility are documented in the 

memorandum, ‘‘Emissions Data and 

Acute Risk Factor Used in Residual Risk 

Modeling: Manufacturing of Nutritional 

Yeast Source Category,’’ which is 

available in the docket for this action 

(Docket ID. No EPA–HQ–OAR–2015– 

0730–0007). 


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C. What are the cost impacts? 

We have estimated compliance costs 

for all existing sources to perform RATA 

for VOC CEMS and for the single facility 

currently monitoring brew ethanol to 

install the necessary monitoring 

equipment (i.e., VOC CEMS). We 

estimated a total capital investment of 

$511,000 and an average annual cost of 

approximately $115,000. The details of 

the cost estimates are documented in 

the memorandum, ‘‘Costs for the 

Manufacturing of Nutritional Yeast 

Source Category—Final Rule,’’ which is 

available in the docket for this action. 

D. What are the economic impacts? 

The economic analysis conducted for 

this action is presented in the 

memorandum, ‘‘Economic Impact 

Analysis for the Manufacturing of 

Nutritional Yeast Risk and Technology 

Review (RTR),’’ which is available in 

the docket for this action. The costs of 

this action are associated with the 

installation and maintenance of CEMS 

at one facility, and ongoing RATA for 

CEMS at all four facilities subject to 

subpart CCCC. The equivalent 

annualized net cost of this action is 

approximately $86,000 under a 3- 

percent discount rate, and $89,000 

under a 7-percent discount rate. 

This action is projected to affect four 

facilities, and none of these facilities is 

ultimately owned by a small entity. Of 

the four facilities affected by this final 

action, two are ultimately owned by the 

same private entity. The remaining two 

facilities are each ultimately owned by 

different private entities. The equivalent 

annualized net costs for each of the 

three entities range from approximately 

$8,600 to $65,000 under a 3-percent 

discount rate, and from approximately 

$8,300 to $70,000 under a 7-percent 

discount rate. The equivalent 

annualized net compliance costs for the 

three entities are all estimated to be less 

than 0.1 percent of sales for their 

respective ultimate parent companies. 

Therefore, we expect that this final 

action will not have a significant 

economic impact on the affected 

entities. 

E. What are the benefits? 

As discussed above, the amendments 

to this subpart will have positive 

impacts on air quality and may improve 

air quality by removing the brew 

ethanol monitoring option and the 

exemption that allowed a portion of 

batches to be produced without being 

subject to emission limitations. The 

changes to monitoring methods will 

increase the reliability of emissions data 

collected by facilities by requiring 

continued maintenance of emission 

monitoring systems and monitoring of 

actual emission measurements at all 

times instead of allowing emission 

estimates based on brew ethanol 

correlations and collection of 100 

percent of valid CEMS data (instead of 

75 percent). These changes will allow 

regulators to clearly assess whether the 

standards for the protection of public 

health and the environment are being 

met. In particular, the demographics 

analysis shows that increased risk levels 

are concentrated around the facility that 

is not currently using CEMS. The 

amendments will directly benefit this 

population, of which 100 percent are 

definded as minority, by increasing the 

accuracy of the emissions data that is 

monitored and reported (see section V.F 

of this preamble). Other amendments 

will result in additional benefits, such 

as streamlined reporting through 

electronic methods for owners or 

operators of nutritional yeast 

manufacturing facilities and increased 

access to emissions data by 

stakeholders, as described in the 

preamble to the proposed rule (81 FR 

95834, December 28, 2016). 

F. What analysis of environmental 

justice did we conduct? 

To examine the potential for any 

environmental justice issues that might 

be associated with emissions from this 

source category, we performed a 

demographic analysis of the population 

close to the four affected facilities 

(within 50 kilometers (km) and within 

5 km). In this analysis, we evaluated the 

distribution of HAP-related cancer risks 

and non-cancer hazards from the four 

nutritional yeast manufacturing 

facilities across different social, 

demographic, and economic groups 

within the populations living near 

facilities identified as having the highest 

risks. 

The analysis indicated that the 

minority population living within 50 

km (1,700,000 people, of which 41 

percent are minority) and within 5 km 

(131,567 people, of which 68 percent 

are minority) of the four nutritional 

yeast manufacturing facilities is greater 

than the minority population found 

nationwide (28 percent). The specific 

demographics of the population within 

5 and 50 km of the facilities indicate 

potential disparities in certain 

demographic groups, including the 

‘‘African American,’’ ‘‘Below the 

Poverty Level,’’ and ‘‘Over 25 and 

without high school diploma’’ groups. 

When examining the risk levels of 

those exposed to emissions from the 

four nutritional yeast manufacturing 

facilities, we find approximately 750 

persons around one facility are exposed 

to a cancer risk greater than or equal to 

1-in-1 million with the highest exposure 

to these individuals of less than 2-in-1 

million. Of these 750 persons, all are 

defined as minority. When examining 

the non-cancer risks surrounding these 

facilities, no one is predicted to have a 

chronic non-cancer TOSHI greater than 

1. These findings are based on the level 

of acetaldehyde emissions the facility 

reported to the 2011 NEI. The facility 

calculated these emissions by applying 

acetaldehyde emissions rates (pounds of 

acetaldehyde per batch) for each 

fermentation stage determined from a 

stack test conducted in 2000. During the 

public comment period, the facility 

performed additional testing and 

determined that the acetaldehyde 

emissions rates during the Februray 

2017 test were approximately half of the 

previous rates. Therefore, the facility 

anticipates that future estimates of 

annual emissions will be reduced. 

Additionally, this facility currently 

monitors brew ethanol to comply with 

the emission limitations established in 

this NESHAP. The final amendments 

require the facility to install CEMS to 

monitor emissions. We anticipate that 

the use of CEMS will directly benefit 

this population by increasing the 

accuracy of the emissions data that are 

monitored and reported because the 

CEMS reflects batch-specific emission 

characteristics that are not accounted for 

with the brew ethanol correlation. 

The EPA has determined that this rule 

does not have disproportionately high 

and adverse human health or 

environmental effects on minority 

populations, low-income populations, 

and/or indigenous peoples because the 

health risks based on actual emissions 

are low (below 2-in-1 million), the 

population exposed to risks greater than 

1-in-1 million is relatively small (750 

persons), and the rule maintains or 

increases the level of environmental 

protection for all affected populations. 

The methodology and the results of 

the demographic analysis are included 

in the technical report, ‘‘Risk and 

Technology Review—Analysis of SocioEconomic Factors for Populations 

Living Near Nutritional Yeast 

Manufacturing Facilities,’’ which is 

available in the docket for this action 

(Docket ID No. EPA–HQ–OAR–2015– 

0730–0015). 

G. What analysis of children’s 

environmental health did we conduct? 

The EPA assessed risks to infants and 

children as part of the health and risk 

assessments, as well as the proximity 

analysis conducted for this action. 

These analyses are documented in the 


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6Policy on Evaluating Health Risks to Children, 

U.S. Environmental Protection Agency, 

Washington, DC. May 2014. Available at http://

www2.epa.gov/sites/production/files/2014-05/ 

documents/1995_childrens_health_policy_

statement.pdf. 

7Supplemental Guidance for Assessing 

Susceptibility from Early-Life Exposure to 

Carcinogens. Risk Assessment Forum, U.S. 

Environmental Protection Agency, Washington, DC. 

EPA/630/R–03/003F. March 2005. Available at 

http://www.epa.gov/raf/publications/pdfs/ 

childrens_supplement_final.pdf. 

memoranda, ‘‘Residual Risk Assessment 

for the Manufacturing of Nutritional 

Yeast Source Category in Support of the 

October, 2017 Risk and Technology 

Review Final Rule’’ and ‘‘Risk and 

Technology Review—Analysis of SocioEconomic Factors for Populations 

Living Near Nutritional Yeast 

Manufacturing Facilities,’’ which are 

available in the docket for this action. 

The results of the proximity analysis 

show that children 17 years and 

younger as a percentage of the 

population in close proximity to 

nutritional yeast manufacturing 

facilities and with an estimated cancer 

risk greater than or equal to 1-in-1 

million is similar to the percentage of 

the national population in this age 

group (25 percent versus 24 percent, 

respectively). The difference in the 

absolute number of percentage points of 

the population 17 years old and younger 

from the national average indicates a 1- 

percent over-representation near 

nutritional yeast manufacturing 

facilities. 

Consistent with the EPA’s Policy on 

Evaluating Health Risks to Children,6

we conducted inhalation risk 

assessments for the Manufacturing of 

Nutritional Yeast source category, 

considering risk to infants and children. 

Children are exposed to chemicals 

emitted to the atmosphere via two 

primary routes: Directly via inhalation 

or indirectly via ingestion or dermal 

contact with various media that have 

been contaminated with the emitted 

chemicals. The EPA considers the 

possibility that children might be more 

sensitive than adults to toxic chemicals, 

including chemical carcinogens. For 

each carcinogenic HAP included in this 

assessment that has a potency estimate 

available, the EPA calculated individual 

and population cancer risks by 

multiplying the corresponding lifetime 

average exposure estimate by the 

appropriate unit risk estimate (URE). 

This calculated cancer risk is defined as 

the upper-bound probability of 

developing cancer over a 70-year period 

(i.e., the assumed human lifespan) at 

that exposure. Because UREs for most 

HAP are upper-bound estimates, actual 

risks at a given exposure level may be 

lower than predicted, and could be zero. 

For the EPA’s list of carcinogenic HAP 

that act by a mutagenic mode-of action, 

we applied the EPA’s Supplemental 

Guidance for Assessing Susceptibility 

from Early-Life Exposure to 

Carcinogens.7 This guidance has the 

effect of adjusting the URE by factors of 

10 (for children aged 0–1), 3 (for 

children aged 2–15), or 1.6 (for 70 years 

of exposure beginning at birth), as 

needed in risk assessments. In this case, 

this has the effect of increasing the 

estimated lifetime risks for these 

pollutants by a factor of 1.6. With regard 

to other carcinogenic pollutants for 

which early-life susceptibility data are 

lacking, it is the EPA’s long-standing 

science policy position that use of the 

linear low-dose extrapolation approach 

(without further adjustment) provides 

adequate public health conservatism in 

the absence of chemical-specific data 

indicating differential early-life 

susceptibility or when the mode of 

action is not mutagenicity. The basis for 

this methodology is also provided in the 

2005 Supplemental Guidance. 

Unlike linear dose-response 

assessments for cancer, non-cancer 

health hazards generally are not 

expressed as a probability of an adverse 

occurrence. Instead, hazard of noncancer effects is expressed by comparing 

an exposure to a reference level as a 

ratio. The HQ is the estimated exposure 

divided by a reference level (e.g., the 

reference concentration, RfC). For a 

given HAP, exposures at or below the 

reference level (HQ≤1) are not likely to 

cause adverse health effects. As 

exposures increase above the reference 

level (HQs increasingly greater than 1), 

the potential for adverse effects 

increases. For exposures predicted to be 

above the RfC, the risk characterization 

includes the degree of confidence 

ascribed to the RfC values for the 

compound(s) of concern (i.e., high, 

medium, or low confidence) and 

discusses the impact of this on possible 

health interpretations. The reference 

levels used to determine the HQs 

incorporate generally conservative 

uncertainty factors that account for 

effects in the most susceptible 

populations including all life stages 

(e.g., infants and children). 

The EPA concludes that the standards 

provide an ample margin of safety to 

protect public health of all demographic 

groups, including children. 

VI. Statutory and Executive Order 

Reviews 

Additional information about these 

statutes and Executive Orders can be 

found at https://www.epa.gov/lawsregulations/laws-and-executive-orders. 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

This action is a significant regulatory 

action that was submitted to the Office 

of Management and Budget (OMB) for 

review. Any changes made in response 

to OMB recommendations have been 

documented in the docket. The EPA 

prepared an economic analysis of the 

potential costs and benefits associated 

with this action. This analysis, 

‘‘Economic Impact Analysis for the 

Manufacturing of Nutritional Yeast Risk 

and Technology Review (RTR),’’ is 

available in the docket for this rule. 

B. Executive Order 13771: Reducing 

Regulations and Controlling Regulatory 

Costs 

This rule is not subject to the 

requirements of Executive Order 13771 

because this rule results in no more than 

de minimis costs. 

C. Paperwork Reduction Act (PRA) 

The information collection activities 

in this rule have been submitted for 

approval to OMB under the PRA. The 

ICR document that the EPA prepared 

has been assigned EPA ICR number 

1886.03. You can find a copy of the ICR 

in the docket for this rule, and it is 

briefly summarized here. The 

information collection requirements are 

not enforceable until OMB approves 

them. 

Concurrent to the residual risk and 

technology reviews for the NESHAP, the 

EPA finalized amendments that change 

the form of the current emission 

limitations, require the use of VOC 

CEMS, require valid CEMS data from 

each hour of the batch monitoring 

period, require ongoing tests to evaluate 

the performance of the CEMS over time, 

require electronic reporting, and remove 

exemptions for malfunctions so that 

affected facilities would be subject to 

the emission standards at all times. This 

information collection request 

documents the recordkeeping and 

reporting requirements and burden 

imposed by the rule—both the 

requirements that were previously 

promulgated and retained, as well as the 

final amendments. 

Respondents/affected entities: 

Manufacturers of nutritional yeast. 

Respondent’s obligation to respond: 

Mandatory (40 CFR part 63, subpart 

CCCC). 

Estimated number of respondents: 

Four facilities. 


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Frequency of response: Initially and 

semiannually. 

Total estimated burden: 1,370 hours 

(per year) for the responding facilities 

and 175 hours (per year) for the Agency. 

Burden is defined at 5 CFR 1320.3(b). 

Total estimated cost: $817,000 (per 

year), which includes $695,000 

annualized capital and operation and 

maintenance costs for the responding 

facilities and $9,500 (per year) for the 

Agency to comply with all of the 

requirements in this NESHAP. 

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 the EPA’s regulations in 40 

CFR are listed in 40 CFR part 9. When 

OMB approves this ICR, the Agency will 

announce that approval in the Federal 

Register and publish a technical 

amendment to 40 CFR part 9 to display 

the OMB control number for the 

approved information collection 

activities contained in this final rule. 

D. Regulatory Flexibility Act (RFA) 

I certify that this action will not have 

a significant economic impact on a 

substantial number of small entities 

under the RFA. This action will not 

impose any requirements on small 

entities. 

This action is projected to affect four 

facilities, and none of these facilities is 

ultimately owned by a small entity. 

Details of the associated analysis are 

presented in the memorandum, 

‘‘Economic Impact Analysis for the 

Manufacturing of Nutritional Yeast Risk 

and Technology Review (RTR),’’ which 

is available in the docket for this action. 

At the time of proposal for this action, 

there was one entity which was 

assumed to be a small business for the 

purpose of the analysis, as the complex 

ownership structure made it difficult to 

clearly determine the entity’s size. 

However, between proposal and 

promulgation, this entity was sold to a 

company that owns other nutritional 

yeast manufacturing facilities, and 

which is not a small business. 

E. Unfunded Mandates Reform Act 

(UMRA) 

This action does not contain an 

unfunded mandate of $100 million or 

more as described in UMRA, 2 U.S.C. 

1531–1538, and does not significantly or 

uniquely affect small governments. The 

action imposes no enforceable duty on 

any state, local, or tribal governments. 

The nationwide equivalent annualized 

net cost of this action for affected 

industrial sources is approximately 

$86,000 under a 3 percent discount rate, 

and $89,000 under a 7 percent discount 

rate. Details of the associated economic 

analysis are presented in the 

memorandum ‘‘Economic Impact 

Analysis for the Manufacturing of 

Nutritional Yeast Risk and Technology 

Review (RTR),’’ which is available in 

the docket for this action. 

F. Executive Order 13132: Federalism 

This action does not have federalism 

implications. It 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. 

G. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have tribal 

implications as specified in Executive 

Order 13175. No tribal facilities are 

known to be engaged in the nutritional 

yeast manufacturing industry that 

would be affected by this action. Thus, 

Executive Order 13175 does not apply 

to this action. 

H. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

This action is not subject to Executive 

Order 13045 because it is not 

economically significant as defined in 

Executive Order 12866, and because the 

EPA does not believe the environmental 

health or safety risks addressed by this 

action present a disproportionate risk to 

children. This action’s health and risk 

assessments are contained in sections 

IV.A and V.G of this preamble. 

I. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not a ‘‘significant 

energy action’’ because it is not likely to 

have a significant adverse effect on the 

supply, distribution, or use of energy. 

The action is not related to the energy 

sector nor the supply, production, or 

price of energy. 

J. National Technology Transfer and 

Advancement Act (NTTAA) and 1 CFR 

Part 51 

This action involves technical 

standards that are reasonably available 

and already widely used by industry. 

The EPA conducted a search to identify 

potentially applicable voluntary 

consensus standards. However, the 

Agency identified no available 

standards that were practical for use as 

alternates and none were brought to our 

attention in comments. Therefore, the 

EPA has decided to use EPA Method 

25A of 40 CFR part 60, appendix A 

(Method) and EPA/600/R–12/531, EPA 

Traceability Protocol for Assay and 

Certification of Gaseous Calibration 

Standards (Protocol). The Method is 

used to determine total gaseous organic 

concentration using a flame ionization 

analyzer. More information about the 

Method is available at: https://

www.epa.gov/emc/method-25a-gaseousorganic-concentration-flame-ionization. 

The Protocol is used to certify 

calibration gases for continuous 

emission monitors and specifies 

methods for assaying gases and 

establishing traceability to National 

Institute of Standards and Technology 

reference standards. The Protocol and 

associated information is available at: 

https://www.epa.gov/air-research/epatraceability-protocol-assay-andcertification-gaseous-calibrationstandards. 

K. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

The EPA believes that this action does 

not have disproportionately high and 

adverse human health or environmental 

effects on minority populations, lowincome populations, and/or indigenous 

peoples, as specified in Executive Order 

12898 (58 FR 7629, February 16, 1994). 

The documentation for this decision 

is contained in the proposal (81 FR 

95824, December 28, 2016), section V.F 

of this preamble, and the technical 

report, ‘‘Risk and Technology Review— 

Analysis of Socio-Economic Factors for 

Populations Living Near Nutritional 

Yeast Manufacturing Facilities,’’ which 

is available in the docket for this action 

(Docket ID No. EPA–HQ–OAR–2015– 

0730–0015). 

L. Congressional Review Act (CRA) 

This action is subject to the CRA, and 

the EPA will submit a rule report to 

each House of the Congress and to the 

Comptroller General of the United 

States. This action is not a ‘‘major rule’’ 

as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 63 

Environmental protection, 

Administrative practice and procedures, 

Air pollution control, Hazardous 

substances, Incorporation by reference, 

Intergovernmental relations, Reporting 

and recordkeeping requirements. 


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Dated: September 29, 2017. 

E. Scott Pruitt, 

Administrator. 

For the reasons set forth in the 

preamble, the Environmental Protection 

Agency amends 40 CFR part 63 as 

follows: 

PART 63—NATIONAL EMISSION 

STANDARDS FOR HAZARDOUS AIR 

POLLUTANTS FOR SOURCE 

CATEGORIES 

■ 1. The authority citation for part 63 

continues to read as follows: 

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

■ 2. Section 63.14 is amended by 

redesignating paragraphs (m)(5) through 

(m)(23) as (m)(6) through (m)(24), 

respectively; and adding a new 

paragraph (m)(5) to read as follows: 

§ 63.14 Incorporations by reference. 

* * * * * 

(m) * * * 

(5) EPA/600/R–12/531, EPA 

Traceability Protocol for Assay and 

Certification of Gaseous Calibration 

Standards, May 2012, IBR approved for 

§ 63.2163(b). 

* * * * * 

■ 3. Part 63 is amended by revising 

subpart CCCC to read as follows: 

Subpart CCCC—National Emission 

Standards for Hazardous Air Pollutants: 

Manufacturing of Nutritional Yeast 

What This Subpart Covers 

Sec. 

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 if I monitor brew 

ethanol? 

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? 

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? 

Notification, 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? 

Table 1 to Subpart CCCC of Part 63— 

Emission Limitations 

Table 2 to Subpart CCCC of Part 63— 

Requirements for Performance Tests If 

You Monitor Brew Ethanol 

Table 3 to Subpart CCCC of Part 63—Initial 

Compliance With Emission Limitations 

Table 4 to Subpart CCCC of Part 63— 

Continuous Compliance With Emission 

Limitations 

Table 5 to Subpart CCCC of Part 63— 

Requirements for Reports 

Table 6 to Subpart CCCC of Part 63— 

Applicability of General Provisions to 

Subpart CCCC 

Table 7 to Subpart CCCC of Part 63— 

Emission Limitation Applicability 

Timeline 

Table 8 to Subpart CCCC of Part 63— 

Monitoring System Requirements 

Timeline 

Subpart CCCC—National Emission 

Standards for Hazardous Air 

Pollutants: Manufacturing of 

Nutritional Yeast 

What This Subpart Covers 

§ 63.2130 What is the purpose of this 

subpart? 

This subpart establishes national 

emission limitations for hazardous air 

pollutants (HAP) emitted from 

manufacturers of nutritional yeast. This 

subpart also establishes requirements to 

demonstrate initial and continuous 

compliance with the emission 

limitations. 

§ 63.2131 Am I subject to this subpart? 

(a) You are subject to this subpart if 

you own or operate a nutritional yeast 

manufacturing facility that is, is located 

at, or is part of a major source of HAP 

emissions. 

(1) A manufacturer of nutritional 

yeast is a facility that makes yeast for 

the purpose of becoming an ingredient 

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

nutritional food additive intended for 

consumption by humans. A 

manufacturer of nutritional yeast does 

not include production of yeast 

intended for consumption by animals, 

such as an additive for livestock feed. 

(2) A major source of HAP emissions 

is any stationary source or group of 

stationary sources located within a 

contiguous area and under common 

control that emits or has the potential to 

emit, considering controls, any single 

HAP at a rate of 9.07 megagrams (10 

tons) or more per year or any 

combination of HAP at a rate of 22.68 

megagrams (25 tons) or more per year. 

(b) [Reserved] 

§ 63.2132 What parts of my plant does this 

subpart cover? 

(a) This subpart applies to each new, 

reconstructed, or existing ‘‘affected 

source’’ that produces Saccharomyces 

cerevisiae at a nutritional yeast 

manufacturing facility. 

(b) The affected source is the 

collection of equipment used in the 

manufacture of the nutritional yeast 

species Saccharomyces cerevisiae. This 

collection of equipment includes 

fermentation vessels (fermenters), as 

described in paragraph (c) of this 

section. 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) and 

(2) of this section. 

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

defined in § 63.2192. 

(2) The fermenters are used to support 

one of the last three fermentation stages 

in a production run (i.e., third-to-last 

stage, second-to-last stage, and last 

stage), which may be referred to as 

‘‘stock, first generation, and trade,’’ 

‘‘seed, semi-seed, and commercial,’’ or 

‘‘CB4, CB5, and CB6’’ stages. 

(d) The emission limitations in this 

subpart do not apply to flask, pureculture, yeasting-tank, or any other setbatch (as defined in § 63.2192) 

fermentation, and they do not apply to 

any operations after the last dewatering 

operation, such as filtration. 

(e) The emission limitations in Table 

1 to this subpart do not apply to 

fermenters during the production of 

specialty yeast (defined in § 63.2192). 


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(f) An affected source is a ‘‘new 

affected source’’ if you commenced 

construction of the affected source after 

October 19, 1998, and you met the 

applicability criteria in § 63.2131 at the 

time you commenced construction. 

(g) An affected source is 

‘‘reconstructed’’ if it meets the criteria 

for reconstruction as defined in § 63.2. 

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

it is not new or reconstructed. 

§ 63.2133 When do I have to comply with 

this subpart? 

(a) If you have a new or reconstructed 

affected source, then you must comply 

with paragraph (a)(1) or (2) of this 

section. 

(1) If you start up your affected source 

before May 21, 2001, then you must 

comply with this subpart no later than 

May 21, 2001. 

(2) If you start up your affected source 

on or after May 21, 2001, then you must 

comply with this subpart upon startup 

of your affected source. 

(b) If you have an existing affected 

source, then you must comply with this 

subpart 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, then paragraphs (c)(1) 

and (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 affected 

source must be in compliance with this 

subpart by no later than 1 year after it 

becomes a major source. 

(d) You must meet the notification 

requirements in § 63.2180 according to 

the schedule in § 63.2180 and in subpart 

A of this part. 

Emission Limitations 

§ 63.2140 What emission limitations must I 

meet? 

You must meet the applicable 

emission limitations in Table 1 to this 

subpart, according to the timeline 

provided in Table 7 to this subpart. 

General Compliance Requirements 

§ 63.2150 What are my general 

requirements for complying with this 

subpart? 

(a) You must be in compliance with 

the applicable emission limitations in 

Table 1 to this subpart at all times, and 

demonstrate compliance according to 

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

section. 

(1) To demonstrate compliance with 

emission limitations by using the 98- 

Percent Option, you must follow the 

procedures of § 63.2171(b). 

(2) To demonstrate compliance with 

emission limitations by using the 

Average Option, you must follow the 

procedures of § 63.2171(c). 

(3) To demonstrate compliance with 

emission limitations by using the Batch 

Option, you must follow the procedures 

of § 63.2171(d). 

(b) You must monitor VOC 

concentration continuously for each 

batch by using the applicable 

monitoring method in Table 8 to this 

subpart. 

(c) If the date upon which you must 

demonstrate initial compliance as 

specified in § 63.2160 falls after the 

compliance date specified for your 

affected source in § 63.2133, then you 

must maintain a log detailing the 

operation and maintenance of the 

continuous emission monitoring 

systems and the process and emissions 

control equipment during the period 

between those dates. 

(d) At all times, you must operate and 

maintain any affected source, including 

associated air pollution control 

equipment and monitoring equipment, 

in a manner consistent with safety and 

good air pollution control practices for 

minimizing emissions. The general duty 

to minimize emissions does not require 

you to make any further efforts to 

reduce emissions if levels required by 

the applicable standard have been 

achieved. Determination of whether an 

affected source is operating in 

compliance with operation and 

maintenance requirements will be based 

on information available to the 

Administrator that may include, but is 

not limited to, monitoring results, 

review of operation and maintenance 

procedures, review of operation and 

maintenance records, and inspection of 

the affected source. 

Testing and Initial Compliance 

Requirements 

§ 63.2160 By what date must I conduct an 

initial compliance demonstration? 

(a) For each emission limitation in 

Table 1 to this subpart for which you 

demonstrate compliance using the 

Average Option, 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 

affected source is the first day of the 

month) after the compliance date that is 

specified for your affected source in 

§ 63.2133. 

(b) For each emission limitation in 

Table 1 to this subpart for which you 

demonstrate compliance using the Batch 

Option, you must demonstrate initial 

compliance for the period ending June 

30 or December 31 (use whichever date 

is the first date following the 

compliance date that is specified for 

your affected source in § 63.2133). 

§ 63.2161 What performance tests and 

other procedures must I use if I monitor 

brew ethanol? 

(a) You must conduct each 

performance test in Table 2 to this 

subpart that applies to you, as specified 

in paragraphs (b) through (f) of this 

section. 

(b) You must conduct performance 

tests under such conditions as the 

Administrator specifies, based on 

representative performance of the 

affected source for the period being 

tested, 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. You must record the process 

information that is necessary to 

document operating conditions during 

the test and include in such record an 

explanation to support that such 

conditions represent normal operation. 

Upon request, you must make available 

to the Administrator such records as 

may be necessary to determine the 

conditions of performance tests. 

(1) You must conduct each 

performance test concurrently with 

brew ethanol monitoring to establish a 

brew-to-exhaust correlation as specified 

in paragraph (e) of this section. 

(2) For each fermentation stage, you 

must conduct one run of the EPA Test 

Method 25A of 40 CFR part 60, 

appendix A–7, over the entire length of 

a batch. The three fermentation stages 

do not have to be from the same 

production run. 

(3) You must obtain your test sample 

at a point in the exhaust-gas stream 

before you inject any dilution air. For 

fermenters, dilution air is any air not 

needed to control fermentation. 

(4) You must record the results of the 

test for each fermentation stage. 

(c) You may not conduct performance 

tests during periods of malfunction. 

(d) You must collect data to correlate 

the brew ethanol concentration 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 

constitutes the largest percentage (by 

mass) of average annual production. 

(2) You must measure brew ethanol as 

specified in § 63.2164 concurrently with 

conducting a performance test for VOC 


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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) You must 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–7, performance test. 

(e) For each set of data that you 

collected under paragraphs (b) and (d) 

of this section, you must perform a 

linear regression of brew ethanol 

concentration (percent) on VOC 

fermenter exhaust concentration (parts 

per million by volume (ppmv) measured 

as propane). You must ensure the 

correlation between the brew ethanol 

concentration, as measured by the brew 

ethanol monitor, and the VOC fermenter 

exhaust concentration, as measured by 

EPA Test Method 25A of 40 CFR part 

60, appendix A–7, is linear with a 

correlation coefficient of at least 0.90. 

(f) You must calculate the VOC 

concentration in the fermenter exhaust 

for each batch using the brew ethanol 

concentration data according to 

Equation 1 of this section, and using the 

constants (CF and y) calculated by the 

applicable linear regression performed 

under paragraph (e) of this section. 

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 the brew ethanol monitor 

CF = Constant established at performance test 

and representing the slope of the 

regression line 

y = Constant established at performance test 

and representing the y-intercept of the 

regression line 

§ 63.2162 When must I conduct 

subsequent performance tests if I monitor 

brew ethanol? 

(a) For each emission limitation in 

Table 1 to this subpart for which 

compliance is demonstrated by 

monitoring brew ethanol concentration 

and calculating VOC concentration in 

the fermenter exhaust according to the 

procedures in § 63.2161, you must 

conduct an EPA Test Method 25A of 40 

CFR part 60, appendix A–7, 

performance test and establish a brewto-exhaust correlation according to the 

procedures in Table 2 to this subpart 

and in § 63.2161, at least once every 

year. 

(b) The first subsequent performance 

test must be conducted no later than 365 

calendar days after the initial 

performance test conducted according 

to § 63.2160. Each subsequent 

performance test must be conducted no 

later than 365 calendar days after the 

previous performance test. You must 

conduct a performance test for each 365 

calendar day period during which you 

demonstrate compliance using the brew 

ethanol correlation developed according 

to § 63.2161. 

§ 63.2163 If I monitor fermenter exhaust, 

what are my monitoring installation, 

operation, and maintenance requirements? 

(a) You must install and certify a 

CEMS that generates a single combined 

response value for VOC concentration 

(VOC CEMS) according to the 

procedures and requirements in 

Performance Specification 8— 

Performance Specifications for Volatile 

Organic Compound Continuous 

Emission Monitoring Systems in 

Stationary Sources in appendix B to part 

60 of this chapter. 

(b) You must operate and maintain 

your VOC CEMS according to the 

procedures and requirements in 

Procedure 1—Quality Assurance 

Requirements for Gas Continuous 

Emission Monitoring Systems Used for 

Compliance Determination in appendix 

F to part 60 of this chapter, except with 

regard to provisions concerning relative 

accuracy test audit (RATA), cylinder gas 

audit (CGA), and relative accuracy audit 

(RAA) frequencies; out of control period 

definition; and CEMS data status during 

out of control periods; which are instead 

specified in this paragraph for 

frequencies; and § 63.8(c)(7) for the 

definition of and status of CEMS data 

during out of control periods. 

(1) You must conduct a RATA at least 

once every 12 calendar quarters, in 

accordance with sections 8 and 11, as 

applicable, of Performance Specification 

8. 

(2) You must conduct a CGA or RAA 

in the calendar quarters during which a 

RATA is not conducted, but in no more 

than 11 quarters in succession. 

(3) As necessary, rather than relying 

on citation 2 of Procedure 1 of appendix 

F to 40 CFR part 60, you must rely on 

EPA/600/R–12/531 (incorporated by 

reference, see § 63.14). 

(4) Your affected source must meet 

the criteria of Performance Specification 

8, section 13.2. 

(c) You must use Method 25A in 

appendix A–7 to part 60 of this chapter 

as the Reference Method. 

(d) You must calibrate your VOC 

CEMS with propane. 

(e) You must set your VOC CEMS 

span at less than 5 times the relevant 

VOC emission limitation given in Table 

1 of this subpart. Note that the EPA 

considers 1.5 to 2.5 times the relevant 

VOC emission limitation to be the 

optimum range, in general. 

(f) You must complete the 

performance evaluation and submit the 

performance evaluation report before 

the compliance date that is specified for 

your affected source in § 63.2133. 

(g) You must monitor VOC 

concentration in fermenter exhaust at 

any point prior to dilution of the 

exhaust stream. 

(h) You must collect data using the 

VOC CEMS at all times during each 

batch monitoring period, except for 

periods of monitoring system 

malfunctions, required monitoring 

system quality assurance or quality 

control activities (including, as 

applicable, calibration checks and 

required zero and span adjustments), 

and any scheduled maintenance. 

(i) For each CEMS, you must record 

the results of each inspection, 

calibration, and validation check. 

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

for each CEMS in accordance with the 

applicable Performance Specification of 

40 CFR part 60, appendix B. You must 

adjust the zero (low-level) and highlevel calibration drifts, at a minimum, 

whenever the zero (low-level) drift 

exceeds 2 times the limits of the 

applicable Performance Specification. 

You must perform the calibration drift 

checks at least once daily except 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, then 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 in 

fewer than 5 percent of the checks over 

a 1-month period, and the 24-hour 


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calibration drift never exceeds 7.5 

percent of the span value, then you may 

reduce the frequency of calibration drift 

checks 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, 

then you must resume a frequency of at 

least 24-hour interval calibration checks 

until the 24-hour calibration checks 

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

section. 

§ 63.2164 If I monitor brew ethanol, what 

are my monitoring installation, operation, 

and maintenance requirements? 

(a) You must install, operate, and 

maintain each brew ethanol monitor 

according to the manufacturer’s 

specifications and in accordance with 

§ 63.2150(d). 

(b) Each of your brew ethanol 

monitors 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. 

(c) You must reduce the brew ethanol 

monitor data 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 must 

consist of at least one data point 

representing a 30-minute period. 

(d) You must have valid brew ethanol 

monitor data from all operating hours 

over the entire batch monitoring period. 

(e) You must set the brew ethanol 

monitor span to correspond to not 

greater than 5 times the relevant 

emission limitation; note that we 

consider 1.5 to 2.5 times the relevant 

emission limitation to be the optimum 

range, in general. You must use the 

brew-to-exhaust correlation equation 

established under § 63.2161(f) to 

determine the span value for your brew 

ethanol monitor that corresponds to the 

relevant emission limitation. 

(f) For each brew ethanol monitor, 

you must record the results of each 

inspection, calibration, and validation 

check. 

(g) The gas chromatograph (GC) that 

you use to calibrate your brew ethanol 

monitor must meet the requirements of 

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

section. 

(1) You must 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, you 

must 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, 

you must dry the ethanol by adding a 

small amount of anhydrous magnesium 

sulfate (granular) to 15–20 milliliters 

(ml) of ethanol. 

(ii) You must place approximately 50 

ml of water into a 100-ml volumetric 

flask and place the flask on a balance. 

You must tare the balance. You must 

weigh 2.3670 grams of the dry 

(anhydrous) ethanol into the volumetric 

flask. 

(iii) You must add the 100-ml 

volumetric flask contents to a 1000-ml 

volumetric flask. You must rinse the 

100-ml volumetric flask with water into 

the 1000-ml flask. You must bring the 

volume to 1000 ml with water. 

(iv) You must place an aliquot into a 

sample bottle labeled ‘‘0.3% Ethanol.’’ 

(v) You must fill a 50-ml volumetric 

flask from the contents of the 1000-ml 

flask. You must 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. 

You must bring the volume to 100 ml 

with water. You must place the contents 

into a sample bottle labeled ‘‘0.15% 

Ethanol.’’ 

(vi) With a 10-ml volumetric pipette, 

you must add two 10.0-ml volumes of 

water to a sample bottle labeled ‘‘0.05% 

Ethanol.’’ With a 10.0-ml volumetric 

pipette, you must 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, you 

must 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. You may keep refrigerated 

samples unopened for 1 month. You 

must prepare new calibration standards 

of ethanol in water at least monthly. 

(h) You must calibrate the brew 

ethanol monitor according to paragraphs 

(h)(1) through (3) of this section. 

(1) To calibrate the brew ethanol 

monitor, you must inject a brew sample 

into a calibrated GC and compare the 

simultaneous ethanol value given by the 

brew ethanol monitor to that given by 

the GC. You must use either the 

Porapak® Q, 80–100 mesh, 6′ x 1⁄8′′, 

stainless steel packed column; or the DB 

Wax, 0.53 millimeter x 30 meter 

capillary column. 

(2) If a brew ethanol monitor value for 

ethanol differs by 20 percent or more 

from the corresponding GC ethanol 

value, you must determine the brew 

ethanol values throughout the rest of the 

batch monitoring period by injecting 

brew samples into the GC not less 

frequently than once every 30 minutes. 

From the time at which you detect a 

difference of 20 percent or more until 

the batch monitoring period ends, the 

GC data will serve as the brew ethanol 

monitor data. 

(3) You must perform a calibration of 

the brew ethanol monitor at least four 

times per batch. 

§ 63.2165 How do I demonstrate initial 

compliance with the emission limitations if 

I monitor fermenter exhaust? 

(a) You must demonstrate initial 

compliance with each emission 

limitation in Table 1 to this subpart that 

applies to you according to the methods 

in Table 3 to this subpart. 

(b) You must submit the Notification 

of Compliance Status containing the 

results of the initial compliance 

demonstration according to the 

requirements in § 63.2180(f). 

Continuous Compliance Requirements 

§ 63.2170 How do I monitor and collect 

data to demonstrate continuous 

compliance? 

(a) You must monitor and collect data 

according to this section and § 63.2163 

or § 63.2164. 

(b) Except for periods of monitoring 

system malfunctions, required 

monitoring system quality assurance or 

control activities (including, as 

applicable, calibration checks and 

required zero and span adjustments), 

and any scheduled maintenance, you 

must collect data using the CEMS or 

brew ethanol monitor, as applicable, at 

all times 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 data collection requirement. 

You must use all the data collected 

during all other periods in assessing the 

operation of the control system. 

(d) Any hour during the batch 

monitoring period for which qualityassured VOC CEMS data or brew 

ethanol monitor data, as applicable, are 

not obtained is a deviation from 

monitoring requirements and is counted 

as an hour of monitoring system 

downtime. 

§ 63.2171 How do I demonstrate 

continuous compliance with the emission 

limitations? 

(a) You must demonstrate continuous 

compliance with each emission 


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limitation in Table 1 to this subpart that 

applies to you according to the methods 

specified in Table 4 to this subpart and 

the applicable procedures of this 

section. 

(b) To demonstrate compliance with 

emission limitations by using the 98- 

Percent Option, you must calculate the 

percentage of within-concentration 

batches (as defined in § 63.2192) for 

each 12-month calculation period by 

following the procedures in this 

paragraph and paragraphs (e)(1) and (2) 

of this section. At the end of each 

calendar month, you must determine 

the percentage of batches that were in 

compliance with the applicable 

maximum concentration in the 12- 

month calculation period. The total 

number of batches in the calculation 

period is the sum of the numbers of 

batches of each fermentation stage for 

which emission limitations apply. To 

determine which batches are in the 12- 

month calculation period, you must 

include those batches for which the 

batch monitoring period ended at or 

after midnight on the first day of the 

period and exclude those batches for 

which the batch monitoring period did 

not end before midnight on the last day 

of the period. 

(c) To demonstrate compliance with 

emission limitations by using the 

Average Option, you must follow the 

procedures in this paragraph and 

paragraphs (e)(1) and (2) of this section. 

At the end of each calendar month, you 

must determine the average VOC 

concentration from all batches in each 

fermentation stage in a 12-month 

calculation period. To determine which 

batches are in a 12-month calculation 

period, you must include those batches 

for which the batch monitoring period 

ended at or after midnight on the first 

day of the period and exclude those 

batches for which the batch monitoring 

period did not end before midnight on 

the last day of the period. 

(d) To demonstrate compliance with 

emission limitations by using the Batch 

Option, you must determine the average 

VOC concentration in the fermenter 

exhaust for each batch of each 

fermentation stage in a semiannual 

reporting period (i.e., January 1 through 

June 30 or July 1 through December 31). 

To determine which batches are in the 

semiannual reporting period, you must 

include those batches for which the 

batch monitoring period ended at or 

after midnight on the first day of the 

period and exclude those batches for 

which the batch monitoring period did 

not end before midnight on the last day 

of the period. 

(e) To demonstrate compliance with 

an emission limitation using a 12-month 

calculation period, you must follow the 

procedures in paragraphs (e)(1) and (2) 

of this section. 

(1) The first 12-month calculation 

period begins on the compliance date 

that is specified for your affected source 

in § 63.2133 and ends on the last day of 

the month that includes the date 1 year 

after your compliance date, unless the 

compliance date for your affected 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. 

(2) The second 12-month calculation 

period and each subsequent 12-month 

calculation period begins on the first 

day of the month following the first full 

month of the previous 12-month 

calculation period and ends on the last 

day of the month 11 calendar months 

later. 

Notification, Reports, and Records 

§ 63.2180 What notifications must I submit 

and when? 

(a) You must submit all of the 

notifications in §§ 63.7(b) and (c); 

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

through (h) that apply to you by the 

dates specified. 

(b) If you start up your affected source 

before May 21, 2001, you are not subject 

to the initial notification requirements 

of § 63.9(b)(2). 

(c) If you are required to conduct a 

performance test as specified in 

§ 63.2161 to this subpart, you must 

submit a notification of intent to 

conduct a performance test at least 60 

calendar days before the performance 

test is scheduled to begin as required in 

§ 63.7(b)(1). 

(d) If you are required to conduct a 

performance evaluation as specified in 

§ 63.2163, you must submit a 

notification of the date of the 

performance evaluation at least 60 days 

prior to the date the performance 

evaluation is scheduled to begin as 

required in § 63.8(e)(2). 

(e) If you are required to conduct a 

performance test as specified in Table 2 

to this subpart, you must submit a 

Notification of Compliance Status 

according to § 63.9(h)(2)(ii). 

(f) For each initial compliance 

demonstration required in Table 3 to 

this subpart, you must submit the 

Notification of Compliance Status no 

later than July 31 or January 31, 

whichever date follows the initial 

compliance period that is specified for 

your affected source in § 63.2160(a) or 

(b). The first compliance report, 

described in § 63.2181(b)(1), serves as 

the Notification of Compliance Status. 

§ 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. 

(1) On and after October 16, 2017, you 

must also comply with reporting for 

performance tests or for performance 

evaluations as specified in paragraphs 

(a)(1)(i) and (ii) of this section. 

(i) Within 60 days after the date of 

completing each performance test as 

required by this subpart, you must 

submit the results of the performance 

test following the procedures specified 

in paragraphs (a)(1)(i)(A) through (C) of 

this section. 

(A) For data collected using test 

methods supported by the EPA’s 

Electronic Reporting Tool (ERT) as 

listed on the EPA’s ERT Web site 

(https://www.epa.gov/electronicreporting-air-emissions/electronicreporting-tool-ert) at the time of the test, 

you must submit the results of the 

performance test to the EPA via the 

Compliance and Emissions Data 

Reporting Interface (CEDRI). (CEDRI can 

be accessed through the EPA’s Central 

Data Exchange (CDX) (https://

cdx.epa.gov/).) Performance test data 

must be submitted in a file format 

generated through the use of the EPA’s 

ERT or an alternate electronic file 

format consistent with the extensible 

markup language (XML) schema listed 

on the EPA’s ERT Web site. 

(B) For data collected using test 

methods that are not supported by the 

EPA’s ERT as listed on the EPA’s ERT 

Web site at the time of the test, you must 

submit the results of the performance 

test to the Administrator at the 

appropriate address listed in § 63.13, 

unless the Administrator agrees to or 

specifies an alternate reporting method. 

(C) If you claim that some of the 

performance test information being 

submitted under paragraph (a)(1)(i)(A) 

of this section is confidential business 

information (CBI), you must submit a 

complete file generated through the use 

of the EPA’s ERT or an alternate 

electronic file consistent with the XML 

schema listed on the EPA’s ERT Web 

site, including information claimed to 

be CBI, on a compact disc, flash drive, 

or other commonly used electronic 

storage media to the EPA. The electronic 

media must be clearly marked as CBI 

and mailed to U.S. EPA/OAQPS/CORE 

CBI Office, Attention: Group Leader, 

Measurement Policy Group, MD C404– 

02, 4930 Old Page Rd., Durham, NC 

27703. The same ERT or alternate file 

with the CBI omitted must be submitted 

to the EPA via the EPA’s CDX as 

described in paragraph (a)(1)(i)(A) of 

this section. 


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(ii) Within 60 days after the date of 

completing each continuous monitoring 

system performance evaluation (as 

defined in § 63.2), you must submit the 

results of the performance evaluation 

following the procedures specified in 

paragraphs (a)(1)(ii)(A) through (C) of 

this section. 

(A) For performance evaluations of 

continuous monitoring systems 

measuring RATA pollutants that are 

supported by the EPA’s ERT as listed on 

the EPA’s ERT Web site at the time of 

the evaluation, you must submit the 

results of the performance evaluation to 

the EPA via the CEDRI. Performance 

evaluation data must be submitted in a 

file format generated through the use of 

the EPA’s ERT or an alternate file format 

consistent with the XML schema listed 

on the EPA’s ERT Web site. 

(B) For any performance evaluations 

of continuous monitoring systems 

measuring RATA pollutants that are not 

supported by the EPA’s ERT as listed on 

the EPA’s ERT Web site at the time of 

the evaluation, you must submit the 

results of the performance evaluation to 

the Administrator at the appropriate 

address listed in § 63.13, unless the 

Administrator agrees to or specifies an 

alternate reporting method. 

(C) If you claim that some of the 

performance evaluation information 

being submitted is CBI, then you must 

submit a complete file generated 

through the use of the EPA’s ERT or an 

alternate electronic file consistent with 

the XML schema listed on the EPA’s 

ERT Web site, including information 

claimed to be CBI, on a compact disc, 

flash drive or other commonly used 

electronic storage media to the EPA. The 

electronic storage media must be clearly 

marked as CBI and mailed to U.S. EPA/ 

OAQPS/CORE CBI Office, Attention: 

Group Leader, Measurement Policy 

Group, MD C404–02, 4930 Old Page Rd., 

Durham, NC 27703. The same ERT or 

alternate file with the CBI omitted must 

be submitted to the EPA via the EPA’s 

CDX as described earlier in this 

paragraph. 

(b) Unless the Administrator has 

approved a different schedule for 

submission of reports under § 63.10(a), 

you must submit each report according 

to the schedule in Table 5 to this 

subpart and according to paragraphs 

(b)(1) through (5) of this section. 

(1) The first compliance report must 

include the information specified in 

paragraph (c) of this section. If you are 

demonstrating compliance with an 

emission limitation using a 12-month 

calculation period (e.g., the Average 

Option), then the first compliance report 

must cover the period beginning on the 

compliance date that is specified for 

your affected source in § 63.2133 and 

ending on either June 30 or December 

31 (use whichever date is the first date 

following the end of the first 12 

calendar months after the compliance 

date that is specified for your affected 

source in § 63.2133). If you are 

demonstrating compliance with an 

emission limitation using the Batch 

Option, then the first compliance report 

must cover the period beginning on the 

compliance date that is specified for 

your affected source in § 63.2133 and 

ending on either June 30 or December 

31 (use whichever date is the first date 

following the compliance date that is 

specified for your affected source in 

§ 63.2133). 

(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 compliance 

reporting period specified in paragraph 

(b)(1) of this section. 

(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 information specified 

in paragraph (c) of this section. 

(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)(iii)(A) or 40 CFR 

71.6(a)(3)(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 (8) 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) For each 12-month calculation 

period ending on a calendar month that 

falls within a reporting period for which 

you are using the 98-Percent Option to 

comply, the percentage of batches that 

are within-concentration batches. 

(5) For each 12-month calculation 

period ending on a calendar month that 

falls within a reporting period for which 

you are using the 98-Percent Option to 

comply and your affected source fails to 

meet an applicable standard, the 

information for each batch for which 

BAVOC 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. 

(6) For each 12-month calculation 

period ending on a calendar month that 

falls within a reporting period for which 

you are using the Average Option to 

comply or for any reporting period for 

which you are using the Batch Option 

to comply, and your affected source 

meets an applicable standard, the 

information in paragraph (c)(6)(i) or (ii) 

of this section, depending on the 

compliance option selected from Table 

1 to this subpart. 

(i) If you are using the Average Option 

to comply, the average BAVOC of all 

batches in each fermentation stage for 

each 12-month calculation period 

ending on a calendar month that falls 

within the reporting period that did not 

exceed the applicable emission 

limitation. 

(ii) If you are using the Batch Option 

to comply, a certification that BAVOC 

for each batch manufactured during the 

reporting period did not exceed 

applicable emission limitations. 

(7) For each 12-month calculation 

period ending on a calendar month that 

falls within a reporting period for which 

you are using the Average Option to 

comply or for any reporting period for 

which you are using the Batch Option 

to comply and your affected source fails 

to meet an applicable standard, the 

information in paragraph (c)(7)(i) or (ii) 

of this section, depending on the 

compliance option selected from Table 

1 to this subpart. 

(i) If you are using the Average Option 

to comply, the average BAVOC of all 

batches in each fermentation stage for 

each 12-month calculation period that 

failed to meet the applicable standard; 

the fermenters that operated in each 

fermentation stage that failed to meet 

the applicable standard; the duration of 

each failure; an estimate of the quantity 

of VOC emitted over the emission 

limitation; a description of the method 

used to estimate the emissions; and the 

actions taken to minimize emissions 

and correct the failure. 

(ii) If you are using the Batch Option 

to comply, the fermenters and batches 

that failed to meet the applicable 

standard; the date, time, and duration of 

each failure; an estimate of the quantity 

of VOC emitted over the emission 


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limitation; a description of the method 

used to estimate the emissions; and the 

actions taken to minimize emissions 

and correct the failure. 

(8) The total operating hours for each 

fermenter, the total hours of monitoring 

system operation for each CEMS or brew 

ethanol monitor, and the total hours of 

monitoring system downtime for each 

CEMS or brew ethanol monitor. 

§ 63.2182 What records must I keep? 

(a) You must keep the records listed 

in paragraphs (a)(1) through (3) of this 

section. 

(1) A copy of each notification and 

report that you submitted to comply 

with this subpart, including all 

documentation supporting any 

Notification of Compliance Status and 

compliance report that you submitted, 

according to the requirements in 

§ 63.10(b)(2)(xiv). 

(2) Records of failures to meet a 

standard, specified in § 63.2181(c)(5) 

and (7). 

(3) Records of performance tests and 

performance evaluations as required in 

§ 63.10(b)(2)(viii) and (ix). 

(b) For each affected source that 

monitors brew ethanol, you must keep 

records demonstrating the calculation of 

the brew-to-exhaust correlations 

specified in § 63.2161. 

(c) For each CEMS and brew ethanol 

monitor, you must keep the records 

listed in paragraphs (c)(1) through (5) of 

this section. 

(1) Records described in 

§ 63.10(b)(2)(vi), (vii), (x), and (xi). The 

CEMS must allow the amount of excess 

zero (low-level) and high-level 

calibration drift measured at the interval 

checks to be quantified and recorded. 

(2) Records described in § 63.10(c)(1) 

through (6). 

(3) Records of the quality control 

program as specified in § 63.8(d), 

including the program of corrective 

action; the current version of the 

performance evaluation test plan, as 

specified in § 63.8(e)(3); and previous 

(i.e., superseded) versions of the 

performance evaluation test plan for a 

period of 5 years after each revision to 

the plan. 

(4) Requests for alternatives to RATA 

for CEMS as required in § 63.8(f)(6)(i). 

(5) Records of each deviation from 

monitoring requirements, including a 

description of the time period during 

which the deviation occurred, the 

nature and cause of the deviation, the 

corrective action taken or preventive 

measures adopted, and the nature of 

repairs or adjustments to the monitoring 

system. 

(d) You must keep the records 

required to show continuous 

compliance with each emission 

limitation that applies to you according 

to the requirements in Table 4 to this 

subpart. 

(e) You must also keep the records 

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

this section for each batch in your 

affected source. 

(1) Unique batch identification 

number. 

(2) Fermentation stage for which you 

are using the fermenter. 

(3) Unique CEMS equipment 

identification number. 

§ 63.2183 In what form and how long must 

I keep my records? 

(a) Your records must be in a form 

suitable and readily available for 

expeditious review, according to 

§ 63.10(b)(1). 

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

must keep each record for 5 years 

following the date of each occurrence, 

measurement, maintenance, corrective 

action, report, or record. 

(c) You must keep each record on site 

for at least 2 years after the date of each 

occurrence, measurement, maintenance, 

corrective action, report, or record, 

according to § 63.10(b)(1). You may 

keep the records off site for the 

remaining 3 years. 

(d) Any records required to be 

maintained by this part that are 

submitted electronically via the EPA’s 

CEDRI may be maintained in electronic 

format. This ability to maintain 

electronic copies does not affect the 

requirement for facilities to make 

records, data, and reports available 

upon request to a delegated air agency 

or the EPA as part of an on-site 

compliance evaluation. 

(e) You must keep written procedures 

documenting the CEMS quality control 

program on record for the life of the 

affected source or until the affected 

source is no longer subject to the 

provisions of this part, to be made 

available for inspection, upon request, 

by the Administrator. 

Other Requirements and Information 

§ 63.2190 What parts of the General 

Provisions apply to me? 

Table 6 to this subpart shows which 

parts of the General Provisions in 

§§ 63.1 through 63.15 apply to you. 

§ 63.2191 Who implements and enforces 

this subpart? 

(a) We, the U.S. EPA, or a delegated 

authority such as your state, local, or 

tribal agency, can implement and 

enforce this subpart. If our 

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 the U.S. EPA 

Regional Office that serves you 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 our 

Administrator 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 listed in paragraphs (c)(1) 

through (4) of this section. 

(1) Approval of alternatives to the 

non-opacity emission limitations in 

§ 63.2140 under § 63.6(g). 

(2) Approval of major alternatives to 

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

(f) and as defined in § 63.90. 

(3) Approval of major alternatives to 

monitoring under § 63.8(f) and as 

defined in § 63.90. 

(4) Approval of major alternatives to 

recordkeeping and reporting under 

§ 63.10(f) and as defined in § 63.90. 

§ 63.2192 What definitions apply to this 

subpart? 

Terms used in this subpart are 

defined in the Clean Air Act, in 40 CFR 

63.2, in the General Provisions of this 

part (§§ 63.1 through 63.15), 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. 

BAVOC means the average VOC 

concentration in the fermenter exhaust 

over the duration of a batch (‘‘batchaverage VOC concentration’’). 

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 


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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. 

Monitoring system malfunction means 

any sudden, infrequent, and not 

reasonably preventable failure of the 

monitoring system to provide valid data. 

Monitoring system failures that are 

caused in part by poor maintenance or 

careless operation are not malfunctions. 

You are required to complete 

monitoring system repairs in response 

to monitoring system malfunctions and 

to return the monitoring system to 

operation as expeditiously as 

practicable. 

1-hour period means any successive 

period commencing on the minute at 

which the batch monitoring period 

begins and continuing for 60 minutes, 

except for the last period, which may be 

less than 60 minutes. 

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. 

Set-batch means the yeast is fed 

carbohydrates and additives only at the 

start of the batch. 

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 BAVOC is not higher 

than the maximum concentration that is 

allowed as part of the applicable 

emission limitation. 

TABLE 1 TO SUBPART CCCC OF PART 63—EMISSION LIMITATIONS

For each fed-batch fermenter producing yeast in the following fermentation stage . . . 

98-percent option: You must not 

exceed the following VOC emission limitation a according to the 

timeline in Table 7 to this subpart 

. . . 

Average option: You must not exceed the following VOC emission 

limitation a according to the 

timeline in Table 7 to this subpart 

. . . 

Batch option: You must not exceed the following VOC emission 

limitation a according to the 

timeline in Table 7 to this subpart 

. . . 

Last stage ...................................... 100 ppmv (measured as propane) 

for BAVOC for at least 98 percent of all batches in each 12- 

month calculation period described in § 63.2171(b) and (e).

95 ppmv (measured as propane) 

for the average BAVOC of all 

batches in this stage in each 

12-month calculation period described in § 63.2171(c) and (e).

100 ppmv (measured as propane) 

for BAVOC for each batch. 

Second-to-last stage ...................... 200 ppmv (measured as propane) 

for BAVOC for at least 98 percent of all batches in each 12- 

month calculation period described in § 63.2171(b) and (e).

190 ppmv (measured as propane) 

for the average BAVOC of all 

batches in this stage in each 

12-month calculation period described in § 63.2171(c) and (e).

200 ppmv (measured as propane) 

for BAVOC for each batch. 

Third-to-last stage .......................... 300 ppmv (measured as propane) 

for BAVOC for at least 98 percent of all batches in each 12- 

month calculation period described in § 63.2171(b) and (e).

285 ppmv (measured as propane) 

for the average BAVOC of all 

batches in this stage in each 

12-month calculation period described in § 63.2171(c) and (e).

300 ppmv (measured as propane) 

for BAVOC for each batch. 

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

TABLE 2 TO SUBPART CCCC OF PART 63—REQUIREMENTS FOR PERFORMANCE TESTS IF YOU MONITOR BREW ETHANOL

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

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

procedures in § 63.2161, you must . . . 

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

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

EPA Method 301 b and approved by the Administrator.

You must measure the VOC concentration in 

the fermenter exhaust at any point prior to 

the dilution of the exhaust stream. 

aEPA Test Method 25A is found in appendix A–7 of 40 CFR part 60. 

bEPA Test Method 301 is found in appendix A of 40 CFR part 63. 

TABLE 3 TO SUBPART CCCC OF PART 63—INITIAL COMPLIANCE WITH EMISSION LIMITATIONS

For . . . Average option: You have demonstrated initial 

compliance if . . . 

Batch option: You have demonstrated initial 

compliance if . . . 

Each fed-batch fermenter producing yeast in a 

fermentation stage (last, second-to-last, or 

third-to-last) for which compliance is determined by monitoring VOC concentration in 

the fermenter exhaust.

The average BAVOC of all batches in each 

fermentation stage during the initial compliance period described in § 63.2160(a) does 

not exceed the applicable concentration in 

Table 1 to this subpart.

BAVOC for each batch of each fermentation 

stage during the initial compliance period 

described in § 63.2160(b) does not exceed 

the applicable concentration in Table 1 to 

this subpart. 


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TABLE 4 TO SUBPART CCCC OF PART 63—CONTINUOUS COMPLIANCE WITH EMISSION LIMITATIONS

For . . . 

98-percent option: You must demonstrate continuous compliance 

by . . . 

Average option: You must demonstrate continuous compliance 

by . . . 

Batch option: You must demonstrate continuous compliance 

by . . . 

1. Each fed-batch fermenter producing yeast in a fermentation 

stage (last, second-to-last, or 

third-to-last) for which compliance is determined by monitoring VOC concentration in the 

fermenter exhaust.

2. Each fed-batch fermenter producing yeast in a fermentation 

stage (last, second-to-last, or 

third-to-last) for which compliance is determined by monitoring brew ethanol concentration and calculating VOC concentration in the fermenter exhaust according to the procedures in § 63.2161 a.

Showing that BAVOC for at least 

98 percent of the batches for 

each 12-month calculation period ending within a semiannual 

reporting period described in 

§ 63.2181(b)(3) does not exceed the applicable maximum 

concentration in Table 1 to this 

subpart.

Showing that the average BAVOC 

of all batches in each fermentation stage during each 12- 

month calculation period ending 

within a semiannual reporting 

period described in 

§ 63.2181(b)(3) does not exceed the applicable concentration in Table 1 to this subpart.

Showing that BAVOC for each 

batch within a semiannual reporting period described in 

§ 63.2181(b)(3) does not exceed the applicable concentration in Table 1 to this subpart. 

a Monitoring brew ethanol concentration to demonstrate compliance is not allowed on and after October 16, 2020, as specified in Table 8 to 

this subpart. 

TABLE 5 TO SUBPART CCCC OF PART 63—REQUIREMENTS FOR REPORTS

You must submit a . . . The report must contain . . . You must submit the report . . . 

1. Compliance report ........... a. The information described in § 63.2181(c), as appropriate.Semiannually according to the requirements in 

§ 63.2181(b). 

b. If you fail to meet an applicable standard during the 

reporting period, then the compliance report must include the information in § 63.2181(c)(5) or (7).

Semiannually according to the requirements in 

§ 63.2181(b). 

2. Performance test report ... The results of the performance test, including the information described in § 63.7(g).At least once every 365 calendar days and according 

to the requirements in § 63.2181(a)(1)(i). 

3. Performance evaluation 

report.

The results of the performance evaluation, including information from the performance evaluation plan at 

§ 63.8(e)(3).

At least once every twelve calendar quarters and according to the requirements in §§ 63.2163(f) and 

63.2181(a)(1)(ii). 

TABLE 6 TO SUBPART CCCC OF PART 63—APPLICABILITY OF GENERAL PROVISIONS TO SUBPART CCCC 

Citation Subject Applicable to subpart CCCC? 

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

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

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

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

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

§ 63.6 ................. Compliance With Standards and Maintenance Requirements.1. § 63.6(e)(1)(i) does not apply, instead specified in § 63.2150(d). 

2. § 63.6(e)(1)(ii), (e)(3), (f)(1), and (h) do not apply. 

3. Otherwise, all apply. 

§ 63.7 ................. Performance Testing Requirements ....... 1. § 63.7(a)(1) and (2) do not apply, instead specified in § 63.2162. 

2. § 63.7(e)(1) and (e)(3) do not apply, instead specified in § 63.2161(b). 

3. Otherwise, all apply. 

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

2. § 63.8(d)(3) is modified by § 63.2182(c)(3) and § 63.2183(e). 

3. § 63.8(a)(4), (c)(1)(i), (c)(1)(iii), (c)(4)(i), (c)(5), (e)(5)(ii), and (g)(5) do not apply. 

4. § 63.8(c)(6), (c)(8), (e)(4), (g)(1), and (g)(3) do not apply, instead specified in 

§§ 63.2163(b) and (j), 63.2164(c), and 63.2182(c)(1) and (5). 

5. Otherwise, all apply. 

§ 63.9 ................. Notification Requirements ....................... 1. § 63.9(b)(2) does not apply because rule omits requirements for initial notification for affected sources that start up prior to May 21, 2001. 

2. § 63.9(f) does not apply. 

3. Otherwise, all apply. 

§ 63.10 ............... Recordkeeping and Reporting Requirements.1. § 63.10(b)(2)(ii) does not apply, instead specified in § 63.2182(a)(2) and (c)(5). 

2. § 63.10(b)(2)(i), (b)(2)(iv), (b)(2)(v), (c)(15), (d)(3), (e)(2)(ii), and (e)(3) and (4) 

do not apply. 

3. § 63.10(d)(5) does not apply, instead specified in § 63.2181(c)(5) and (7). 

4. Otherwise, all apply. 

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

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

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


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TABLE 6 TO SUBPART CCCC OF PART 63—APPLICABILITY OF GENERAL PROVISIONS TO SUBPART CCCC—Continued 

Citation Subject Applicable to subpart CCCC? 

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

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

TABLE 7 TO SUBPART CCCC OF PART 63—EMISSION LIMITATION APPLICABILITY TIMELINE

For each . . . During this time frame . . . You must comply with the emission limitations 

in Table 1 to this subpart using the . . . 

Existing affected source ..................................... Before 10/16/2017 ...........................................

Between 10/16/2017 and October 16, 2018 ...

On and after October 16, 2018 .......................

98-Percent Option. 

98-Percent Option, Average Option, or Batch 

Option. 

Average Option or Batch Option. 

New or reconstructed affected source that you 

start up prior to 10/16/2017.

Before 10/16/2017 ...........................................

Between 10/16/2017 and October 16, 2018 ...

On and after October 16, 2018 .......................

98-Percent Option. 

98-Percent Option, Average Option, or Batch 

Option. 

Average Option or Batch Option. 

New or reconstructed affected source that you 

start up after 10/16/2017.

After 10/16/2017 .............................................. Average Option or Batch Option. 

TABLE 8 TO SUBPART CCCC OF PART 63—MONITORING SYSTEM REQUIREMENTS TIMELINE

For each . . . During this time frame . . . You must monitor VOC concentration by . . . 

Existing affected source ..................................... Before 10/16/2017 ........................................... Monitoring fermenter exhaust using a CEMS 

or by monitoring brew ethanol concentration 

using a brew ethanol monitor. 

Between 10/16/2017 and October 16, 2020 ... Monitoring fermenter exhaust using a VOC 

CEMS or by monitoring brew ethanol concentration using a brew ethanol monitor. 

On and after October 16, 2020 ....................... Monitoring fermenter exhaust using a VOC 

CEMS. 

New or reconstructed affected source that you 

start up prior to 10/16/2017.

Before 10/16/2017 ........................................... Monitoring fermenter exhaust using a CEMS 

or by monitoring brew ethanol concentration 

using a brew ethanol monitor. 

Between 10/16/2017 and October 16, 2020 ... Monitoring fermenter exhaust using a VOC 

CEMS or by monitoring brew ethanol concentration using a brew ethanol monitor. 

On and after October 16, 2020 ....................... Monitoring fermenter exhaust using a VOC 

CEMS. 

New or reconstructed affected source that you 

start up after 10/16/2017.

After 10/16/2017 .............................................. Monitoring fermenter exhaust using a VOC 

CEMS. 

[FR Doc. 2017–21937 Filed 10–13–17; 8:45 am] 

BILLING CODE 6560–50–P 


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