Document ID: EPA-HQ-OAR-2015-0730-0197
Agency: epa
Document Type: Rule
Title: National Emission Standards for Hazardous Air Pollutants: Nutritional Yeast Manufacturing Residual Risk and Technology Review
Posted Date: 2017-10-16T04:00Z

[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Rules and Regulations]
[Pages 48156-48187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21937]

[[Page 48155]]

Vol. 82

Monday,

No. 198

October 16, 2017

Part II

 Environmental Protection Agency

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40 CFR Part 63

 National Emission Standards for Hazardous Air Pollutants: Nutritional 
Yeast Manufacturing Residual Risk and Technology Review; Final Rule

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

[[Page 48156]]

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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.

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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?

[[Page 48157]]

    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
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                                                               NAICS \1\
                 NESHAP and Source Category                      Code
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Manufacturing of Nutritional Yeast..........................     311999
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\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-air-pollution/manufacturing-nutritional-yeast-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

[[Page 48158]]

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 best-
performing 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).
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    \1\ The 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.'').
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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

[[Page 48159]]

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 data-gathering 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

[[Page 48160]]

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-by-case 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 off-line 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 well-
performing 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

[[Page 48161]]

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 product-
loss 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 product-loss 
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

[[Page 48162]]

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

[[Page 48163]]

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 CAA-required 
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 CAA-required 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
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                             Maximum individual cancer    Estimated population at     Estimated annual cancer   Maximum chronic non-cancer        Maximum screening acute non-cancer HQ \4\
                             risk  (in 1 million) \2\    increased risk of cancer   incidence (cases per year)           TOSHI \3\         -----------------------------------------------------
                           ----------------------------      >= 1-in-1 million     --------------------------------------------------------
                                                       ----------------------------
 Number of facilities \1\     Based on      Based on      Based on      Based on      Based on      Based on      Based on      Based on    Based on actual emissions      Based on allowable
                               actual       allowable      actual       allowable      actual       allowable      actual       allowable           level \2\               emissions level
                              emissions     emissions     emissions     emissions     emissions     emissions     emissions     emissions
                              level \2\       level       level \2\       level       level \2\       level       level \2\       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.
\4\ The 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.

[[Page 48164]]

    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 non-cancer 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

[[Page 48165]]

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

[[Page 48166]]

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

[[Page 48167]]

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

[[Page 48168]]

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

[[Page 48169]]

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 batch-specific 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-to-exhaust 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

[[Page 48170]]

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 cost-prohibitive 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.

[[Page 48171]]

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, quality-
assurance 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

[[Page 48172]]

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.
---------------------------------------------------------------------------

    \2\ Available at https://cfpub.epa.gov/webfire/index.cfm?action=fire.searchERTSubmission.
    \3\ Available at https://cfpub.epa.gov/webfire/index.cfm?action=fire.searchERTSubmission.
    \4\ The 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.
    \5\ While 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)].
---------------------------------------------------------------------------

    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

[[Page 48173]]

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,

[[Page 48174]]

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).

[[Page 48175]]

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 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).

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

[[Page 48176]]

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 Socio-Economic 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.
---------------------------------------------------------------------------

    \6\ Policy 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.
    \7\ Supplemental 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.
---------------------------------------------------------------------------

    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 non-cancer 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/laws-regulations/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.

[[Page 48177]]

    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-gaseous-organic-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/epa-traceability-protocol-assay-and-certification-gaseous-calibration-standards.

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, low-income 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.

[[Page 48178]]

    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

0
1. The authority citation for part 63 continues to read as follows:

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

0
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:

Sec.  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 Sec.  63.2163(b).
* * * * *

0
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

Sec.  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.

Sec.  63.2131   Am I subject to this subpart?

    (a) You are subject to this subpart if you own or operate a 
nutritional yeast manufacturing facility that is, is located at, or is 
part of a major source of HAP emissions.
    (1) A manufacturer of nutritional yeast is a facility that makes 
yeast for the purpose of becoming an ingredient in dough for bread or 
any other yeast-raised baked product, or for becoming a nutritional 
food additive intended for consumption by humans. A manufacturer of 
nutritional yeast does not include production of yeast intended for 
consumption by animals, such as an additive for livestock feed.
    (2) A major source of HAP emissions is any stationary source or 
group of stationary sources located within a contiguous area and under 
common control that emits or has the potential to emit, considering 
controls, any single HAP at a rate of 9.07 megagrams (10 tons) or more 
per year or any combination of HAP at a rate of 22.68 megagrams (25 
tons) or more per year.
    (b) [Reserved]

Sec.  63.2132   What parts of my plant does this subpart cover?

    (a) This subpart applies to each new, reconstructed, or existing 
``affected source'' that produces Saccharomyces cerevisiae at a 
nutritional yeast manufacturing facility.
    (b) The affected source is the collection of equipment used in the 
manufacture of the nutritional yeast species Saccharomyces cerevisiae. 
This collection of equipment includes 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 Sec.  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, 
pure-culture, yeasting-tank, or any other set-batch (as defined in 
Sec.  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 Sec.  63.2192).

[[Page 48179]]

    (f) An affected source is a ``new affected source'' if you 
commenced construction of the affected source after October 19, 1998, 
and you met the applicability criteria in Sec.  63.2131 at the time you 
commenced construction.
    (g) An affected source is ``reconstructed'' if it meets the 
criteria for reconstruction as defined in Sec.  63.2.
    (h) An affected source is ``existing'' if it is not new or 
reconstructed.

Sec.  63.2133  When do I have to comply with this subpart?

    (a) If you have a new or reconstructed affected source, 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 Sec.  63.2180 
according to the schedule in Sec.  63.2180 and in subpart A of this 
part.

Emission Limitations

Sec.  63.2140   What emission limitations must I meet?

    You must meet the applicable emission limitations in Table 1 to 
this subpart, according to the timeline provided in Table 7 to this 
subpart.

General Compliance Requirements

Sec.  63.2150   What are my general requirements for complying with 
this subpart?

    (a) You must be in compliance with the 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 Sec.  
63.2171(b).
    (2) To demonstrate compliance with emission limitations by using 
the Average Option, you must follow the procedures of Sec.  63.2171(c).
    (3) To demonstrate compliance with emission limitations by using 
the Batch Option, you must follow the procedures of Sec.  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 Sec.  63.2160 falls after the compliance date specified 
for your affected source in Sec.  63.2133, then you must maintain a log 
detailing the operation and maintenance of the continuous 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

Sec.  63.2160   By what date must I conduct an initial compliance 
demonstration?

    (a) For each emission limitation in Table 1 to this subpart for 
which 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 
Sec.  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 Sec.  
63.2133).

Sec.  63.2161   What performance tests and other procedures must I use 
if I monitor brew ethanol?

    (a) You must conduct each performance test in Table 2 to this 
subpart that applies to you, 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 Sec.  63.2164 
concurrently with conducting a performance test for VOC

[[Page 48180]]

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.
[GRAPHIC] [TIFF OMITTED] TR16OC17.000

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

Sec.  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 Sec.  63.2161, you must conduct 
an EPA Test Method 25A of 40 CFR part 60, appendix A-7, performance 
test and establish a brew-to-exhaust correlation according to the 
procedures in Table 2 to this subpart and in Sec.  63.2161, at least 
once every year.
    (b) The first subsequent performance test must be conducted no 
later than 365 calendar days after the initial performance test 
conducted according to Sec.  63.2160. Each subsequent performance test 
must be conducted no later than 365 calendar days after the previous 
performance test. You must conduct a performance test for each 365 
calendar day period during which you demonstrate compliance using the 
brew ethanol correlation developed according to Sec.  63.2161.

Sec.  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 Sec.  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 Sec.  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 Sec.  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 (low-level) 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 high-level 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

[[Page 48181]]

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.

Sec.  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 Sec.  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 Sec.  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[supreg] 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[supreg] 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.

Sec.  63.2165   How do I demonstrate initial compliance with the 
emission limitations if I monitor fermenter exhaust?

    (a) You must demonstrate initial compliance with each emission 
limitation 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 Sec.  63.2180(f).

Continuous Compliance Requirements

Sec.  63.2170  How do I monitor and collect data to demonstrate 
continuous compliance?

    (a) You must monitor and collect data according to this section and 
Sec.  63.2163 or Sec.  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 quality-
assured 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.

Sec.  63.2171   How do I demonstrate continuous compliance with the 
emission limitations?

    (a) You must demonstrate continuous compliance with each emission

[[Page 48182]]

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 Sec.  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 Sec.  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

Sec.  63.2180   What notifications must I submit and when?

    (a) You must submit all of the notifications in Sec. Sec.  63.7(b) 
and (c); 63.8(e), (f)(4) and (6); and 63.9(b) through (h) that apply to 
you by the dates specified.
    (b) If you start up your affected source before May 21, 2001, you 
are not subject to the initial notification requirements of Sec.  
63.9(b)(2).
    (c) If you are required to conduct a performance test as specified 
in Sec.  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 Sec.  
63.7(b)(1).
    (d) If you are required to conduct a performance evaluation as 
specified in Sec.  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 Sec.  
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 Sec.  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 Sec.  
63.2160(a) or (b). The first compliance report, described in Sec.  
63.2181(b)(1), serves as the Notification of Compliance Status.

Sec.  63.2181   What reports must I submit and when?

    (a) You must submit each report in Table 5 to this subpart that 
applies to you.
    (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/electronic-reporting-air-emissions/electronic-reporting-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 Sec.  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.

[[Page 48183]]

    (ii) Within 60 days after the date of completing each continuous 
monitoring system performance evaluation (as defined in Sec.  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 Sec.  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 Sec.  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 Sec.  63.2133 and ending on 
either June 30 or December 31 (use whichever date is the first date 
following the end of the first 12 calendar months after the compliance 
date that is specified for your affected source in Sec.  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 Sec.  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 Sec.  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

[[Page 48184]]

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.

Sec.  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 Sec.  63.10(b)(2)(xiv).
    (2) Records of failures to meet a standard, specified in Sec.  
63.2181(c)(5) and (7).
    (3) Records of performance tests and performance evaluations as 
required in Sec.  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 Sec.  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 Sec.  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 Sec.  63.10(c)(1) through (6).
    (3) Records of the quality control program as specified in Sec.  
63.8(d), including the program of corrective action; the current 
version of the performance evaluation test plan, as specified in Sec.  
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 Sec.  
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.

Sec.  63.2183   In what form and how long must I keep my records?

    (a) Your records must be in a form suitable and readily available 
for expeditious review, according to Sec.  63.10(b)(1).
    (b) As specified in Sec.  63.10(b)(1), you must keep each record 
for 5 years following the date of each occurrence, measurement, 
maintenance, corrective action, report, or record.
    (c) You must keep each record on site for at least 2 years after 
the date of each occurrence, measurement, maintenance, corrective 
action, report, or record, according to Sec.  63.10(b)(1). You 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

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

    Table 6 to this subpart shows which parts of the General Provisions 
in Sec. Sec.  63.1 through 63.15 apply to you.

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

Sec.  63.2192   What definitions apply to this subpart?

    Terms used in this subpart are defined in the Clean Air Act, in 40 
CFR 63.2, in the General Provisions of this part (Sec. Sec.  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 (``batch-average 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

[[Page 48185]]

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
----------------------------------------------------------------------------------------------------------------
                                        98-percent option: You    Average option: You     Batch option: You must
                                         must not exceed the      must not exceed the         not exceed the
     For each fed-batch fermenter       following VOC emission   following VOC emission   following VOC emission
   producing yeast in the following         limitation \a\           limitation \a\           limitation \a\
       fermentation stage . . .            according to the         according to the         according to the
                                        timeline in Table 7 to   timeline in Table 7 to   timeline in Table 7 to
                                          this subpart . . .       this subpart . . .       this subpart . . .
----------------------------------------------------------------------------------------------------------------
Last stage...........................  100 ppmv (measured as    95 ppmv (measured as     100 ppmv (measured as
                                        propane) for BAVOC for   propane) for the         propane) for BAVOC for
                                        at least 98 percent of   average BAVOC of all     each batch.
                                        all batches in each 12-  batches in this stage
                                        month calculation        in each 12-month
                                        period described in      calculation period
                                        Sec.   63.2171(b) and    described in Sec.
                                        (e).                     63.2171(c) and (e).
Second-to-last stage.................  200 ppmv (measured as    190 ppmv (measured as    200 ppmv (measured as
                                        propane) for BAVOC for   propane) for the         propane) for BAVOC for
                                        at least 98 percent of   average BAVOC of all     each batch.
                                        all batches in each 12-  batches in this stage
                                        month calculation        in each 12-month
                                        period described in      calculation period
                                        Sec.   63.2171(b) and    described in Sec.
                                        (e).                     63.2171(c) and (e).
Third-to-last stage..................  300 ppmv (measured as    285 ppmv (measured as    300 ppmv (measured as
                                        propane) for BAVOC for   propane) for the         propane) for BAVOC for
                                        at least 98 percent of   average BAVOC of all     each batch.
                                        all batches in each 12-  batches in this stage
                                        month calculation        in each 12-month
                                        period described in      calculation period
                                        Sec.   63.2171(b) and    described in Sec.
                                        (e).                     63.2171(c) and (e).
----------------------------------------------------------------------------------------------------------------
\a\ The 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                              According to the
    concentration in the           Using . . .            following
 fermenter exhaust according                         requirements . . .
  to the procedures in Sec.
   63.2161, you must . . .
 
------------------------------------------------------------------------
Measure VOC as propane......  Method 25A,\a\ or an  You must measure the
                               alternative           VOC concentration
                               validated by EPA      in the fermenter
                               Method 301 \b\ and    exhaust at any
                               approved by the       point prior to the
                               Administrator.        dilution of the
                                                     exhaust stream.
------------------------------------------------------------------------
\a\ EPA Test Method 25A is found in appendix A-7 of 40 CFR part 60.
\b\ EPA 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
------------------------------------------------------------------------
                               Average option: You    Batch option: You
                                have demonstrated     have demonstrated
          For . . .            initial compliance    initial compliance
                                    if . . .              if . . .
------------------------------------------------------------------------
Each fed-batch fermenter      The average BAVOC of  BAVOC for each batch
 producing yeast in a          all batches in each   of each
 fermentation stage (last,     fermentation stage    fermentation stage
 second-to-last, or third-to-  during the initial    during the initial
 last) for which compliance    compliance period     compliance period
 is determined by monitoring   described in Sec.     described in Sec.
 VOC concentration in the      63.2160(a) does not   63.2160(b) does not
 fermenter exhaust.            exceed the            exceed the
                               applicable            applicable
                               concentration in      concentration in
                               Table 1 to this       Table 1 to this
                               subpart.              subpart.
------------------------------------------------------------------------

[[Page 48186]]

               Table 4 to Subpart CCCC of Part 63--Continuous Compliance With Emission Limitations
----------------------------------------------------------------------------------------------------------------
                                        98-percent option: You    Average option: You
                                           must demonstrate         must demonstrate      Batch option: You must
              For . . .                 continuous compliance    continuous compliance    demonstrate continuous
                                               by . . .                 by . . .           compliance by . . .
----------------------------------------------------------------------------------------------------------------
1. Each fed-batch fermenter producing  Showing that BAVOC for   Showing that the         Showing that BAVOC for
 yeast in a fermentation stage (last,   at least 98 percent of   average BAVOC of all     each batch within a
 second-to-last, or third-to-last)      the batches for each     batches in each          semiannual reporting
 for which compliance is determined     12-month calculation     fermentation stage       period described in
 by monitoring VOC concentration in     period ending within a   during each 12-month     Sec.   63.2181(b)(3)
 the fermenter exhaust.                 semiannual reporting     calculation period       does not exceed the
2. Each fed-batch fermenter producing   period described in      ending within a          applicable
 yeast in a fermentation stage (last,   Sec.   63.2181(b)(3)     semiannual reporting     concentration in Table
 second-to-last, or third-to-last)      does not exceed the      period described in      1 to this subpart.
 for which compliance is determined     applicable maximum       Sec.   63.2181(b)(3)
 by monitoring brew ethanol             concentration in Table   does not exceed the
 concentration and calculating VOC      1 to this subpart.       applicable
 concentration in the fermenter                                  concentration in Table
 exhaust according to the procedures                             1 to this subpart.
 in Sec.   63.2161 \a\.
----------------------------------------------------------------------------------------------------------------
\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
------------------------------------------------------------------------
                                 The report must     You must submit the
   You must submit a . . .        contain . . .         report . . .
------------------------------------------------------------------------
1. Compliance report........  a. The information    Semiannually
                               described in Sec.     according to the
                               63.2181(c), as        requirements in
                               appropriate.          Sec.   63.2181(b).
                              b. If you fail to     Semiannually
                               meet an applicable    according to the
                               standard during the   requirements in
                               reporting period,     Sec.   63.2181(b).
                               then the compliance
                               report must include
                               the information in
                               Sec.
                               63.2181(c)(5) or
                               (7).
2. Performance test report..  The results of the    At least once every
                               performance test,     365 calendar days
                               including the         and according to
                               information           the requirements in
                               described in Sec.     Sec.
                               63.7(g).              63.2181(a)(1)(i).
3. Performance evaluation     The results of the    At least once every
 report.                       performance           twelve calendar
                               evaluation,           quarters and
                               including             according to the
                               information from      requirements in
                               the performance       Sec.  Sec.
                               evaluation plan at    63.2163(f) and
                               Sec.   63.8(e)(3).    63.2181(a)(1)(ii).
------------------------------------------------------------------------

 Table 6 to Subpart CCCC of Part 63--Applicability of General Provisions
                             to Subpart CCCC
------------------------------------------------------------------------
                                                  Applicable to subpart
         Citation                Subject                  CCCC?
------------------------------------------------------------------------
Sec.   63.1..............  Applicability......  Yes.
Sec.   63.2..............  Definitions........  Yes.
Sec.   63.3..............  Units and            Yes.
                            Abbreviations.
Sec.   63.4..............  Prohibited           Yes.
                            Activities and
                            Circumvention.
Sec.   63.5..............  Construction and     Yes.
                            Reconstruction.
Sec.   63.6..............  Compliance With      1. Sec.   63.6(e)(1)(i)
                            Standards and        does not apply, instead
                            Maintenance          specified in Sec.
                            Requirements.        63.2150(d).
                                                2. Sec.
                                                 63.6(e)(1)(ii), (e)(3),
                                                 (f)(1), and (h) do not
                                                 apply.
                                                3. Otherwise, all apply.
Sec.   63.7..............  Performance Testing  1. Sec.   63.7(a)(1) and
                            Requirements.        (2) do not apply,
                                                 instead specified in
                                                 Sec.   63.2162.
                                                2. Sec.   63.7(e)(1) and
                                                 (e)(3) do not apply,
                                                 instead specified in
                                                 Sec.   63.2161(b).
                                                3. Otherwise, all apply.
Sec.   63.8..............  Monitoring           1. Sec.   63.8(a)(2) is
                            Requirements.        modified by Sec.
                                                 63.2163.
                                                2. Sec.   63.8(d)(3) is
                                                 modified by Sec.
                                                 63.2182(c)(3) and Sec.
                                                  63.2183(e).
                                                3. Sec.   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. Sec.   63.8(c)(6),
                                                 (c)(8), (e)(4), (g)(1),
                                                 and (g)(3) do not
                                                 apply, instead
                                                 specified in Sec.  Sec.
                                                   63.2163(b) and (j),
                                                 63.2164(c), and
                                                 63.2182(c)(1) and (5).
                                                5. Otherwise, all apply.
Sec.   63.9..............  Notification         1. Sec.   63.9(b)(2)
                            Requirements.        does not apply because
                                                 rule omits requirements
                                                 for initial
                                                 notification for
                                                 affected sources that
                                                 start up prior to May
                                                 21, 2001.
                                                2. Sec.   63.9(f) does
                                                 not apply.
                                                3. Otherwise, all apply.
Sec.   63.10.............  Recordkeeping and    1. Sec.
                            Reporting            63.10(b)(2)(ii) does
                            Requirements.        not apply, instead
                                                 specified in Sec.
                                                 63.2182(a)(2) and
                                                 (c)(5).
                                                2. Sec.
                                                 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. Sec.   63.10(d)(5)
                                                 does not apply, instead
                                                 specified in Sec.
                                                 63.2181(c)(5) and (7).
                                                4. Otherwise, all apply.
Sec.   63.11.............  Flares.............  No.
Sec.   63.12.............  Delegation.........  Yes.
Sec.   63.13.............  Addresses..........  Yes.

[[Page 48187]]

 
Sec.   63.14.............  Incorporation by     Yes.
                            Reference.
Sec.   63.15.............  Availability of      Yes.
                            Information.
------------------------------------------------------------------------

  Table 7 to Subpart CCCC of Part 63--Emission Limitation Applicability
                                Timeline
------------------------------------------------------------------------
                                                    You must comply with
                                                        the emission
       For each . . .           During this time    limitations in Table
                                   frame . . .        1 to this subpart
                                                       using the . . .
------------------------------------------------------------------------
Existing affected source....  Before 10/16/2017...  98-Percent Option.
                              Between 10/16/2017    98-Percent Option,
                               and October 16,       Average Option, or
                               2018.                 Batch Option.
                              On and after October  Average Option or
                               16, 2018.             Batch Option.
New or reconstructed          Before 10/16/2017...  98-Percent Option.
 affected source that you     Between 10/16/2017    98-Percent Option,
 start up prior to 10/16/      and October 16,       Average Option, or
 2017.                         2018.                 Batch Option.
                              On and after October  Average Option or
                               16, 2018.             Batch Option.
New or reconstructed          After 10/16/2017....  Average Option or
 affected source that you                            Batch Option.
 start up after 10/16/2017.
------------------------------------------------------------------------

   Table 8 to Subpart CCCC of Part 63--Monitoring System Requirements
                                Timeline
------------------------------------------------------------------------
                                                    You must monitor VOC
       For each . . .           During this time    concentration by . .
                                   frame . . .                .
------------------------------------------------------------------------
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    Monitoring fermenter
                               and October 16,       exhaust using a VOC
                               2020.                 CEMS or by
                                                     monitoring brew
                                                     ethanol
                                                     concentration using
                                                     a brew ethanol
                                                     monitor.
                              On and after October  Monitoring fermenter
                               16, 2020.             exhaust using a VOC
                                                     CEMS.
New or reconstructed          Before 10/16/2017...  Monitoring fermenter
 affected source that you                            exhaust using a
 start up prior to 10/16/                            CEMS or by
 2017.                                               monitoring brew
                                                     ethanol
                                                     concentration using
                                                     a brew ethanol
                                                     monitor.
                              Between 10/16/2017    Monitoring fermenter
                               and October 16,       exhaust using a VOC
                               2020.                 CEMS or by
                                                     monitoring brew
                                                     ethanol
                                                     concentration using
                                                     a brew ethanol
                                                     monitor.
                              On and after October  Monitoring fermenter
                               16, 2020.             exhaust using a VOC
                                                     CEMS.
New or reconstructed          After 10/16/2017....  Monitoring fermenter
 affected source that you                            exhaust using a VOC
 start up after 10/16/2017.                          CEMS.
------------------------------------------------------------------------

[FR Doc. 2017-21937 Filed 10-13-17; 8:45 am]
 BILLING CODE 6560-50-P