[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Proposed Rules]
[Pages 95810-95846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30645]



[[Page 95809]]

Vol. 81

Wednesday,

No. 249

December 28, 2016

Part IV





 Environmental Protection Agency





-----------------------------------------------------------------------





40 CFR Part 63





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

Federal Register / Vol. 81 , No. 249 / Wednesday, December 28, 2016 / 
Proposed Rules

[[Page 95810]]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2015-0730; FRL-9956-21-OAR]
RIN 2060-AS93


National Emission Standards for Hazardous Air Pollutants: 
Nutritional Yeast Manufacturing Risk and Technology Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is proposing 
amendments to the National Emission Standards for Hazardous Air 
Pollutants (NESHAP) for the Manufacturing of Nutritional Yeast source 
category. The proposed amendments address the results of the residual 
risk and technology reviews (RTRs) conducted as required under the 
Clean Air Act (CAA) as well as other actions deemed appropriate during 
the review of these standards. The proposed amendments include revising 
the form of the fermenter volatile organic compounds (VOC) emission 
limits, changing the testing and monitoring requirements, and updating 
the reporting and recordkeeping requirements.

DATES: Comments. Comments must be received on or before February 13, 
2017. Under the Paperwork Reduction Act (PRA), comments on the 
information collection provisions are best assured of consideration if 
the Office of Management and Budget (OMB) receives a copy of your 
comments on or before January 27, 2017.
    Public Hearing. A public hearing will be held, if requested by 
January 3, 2017.

ADDRESSES: Comments. Submit your comments, identified by Docket ID No. 
EPA-HQ-OAR-2015-0730, at http://www.regulations.gov. Follow the online 
instructions for submitting comments. Once submitted, comments cannot 
be edited or removed from Regulations.gov. The EPA may publish any 
comment received to its public docket. Do not submit electronically any 
information you consider to be Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. 
Multimedia submissions (audio, video, etc.) must be accompanied by a 
written comment. The written comment is considered the official comment 
and should include discussion of all points you wish to make. The EPA 
will generally not consider comments or comment contents located 
outside of the primary submission (i.e., on the Web, cloud, or other 
file sharing system). For additional submission methods, the full EPA 
public comment policy, information about CBI or multimedia submissions, 
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: For questions about this proposed 
action, contact Allison Costa, Sector Policies and Programs Division 
(Mail Code E140), 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) 541-3470; 
and email address: costa.allison@epa.gov. For specific information 
regarding the risk modeling methodology, contact Chris Sarsony, Health 
and Environmental Impacts Division (Mail Code 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; fax number: (919) 541-0840; and email address: 
sarsony.chris@epa.gov. For information about the applicability of the 
NESHAP to a particular entity, contact Scott Throwe, Office of 
Enforcement and Compliance Assurance, U.S. Environmental Protection 
Agency, EPA WJC South Building (Mail Code 2227A), 1200 Pennsylvania 
Avenue NW., Washington, DC 20460; telephone number: (919) 564-7013; fax 
number: (202) 564-0050; and email address: throwe.scott@epa.gov.

SUPPLEMENTARY INFORMATION: 
    Docket. The EPA has established a docket for this rulemaking under 
Docket ID No. EPA-HQ-OAR-2015-0730. All documents in the docket are 
listed in the Regulations.gov index. Although listed in the index, some 
information is not publicly available, e.g., 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. Publicly available docket 
materials are available either electronically in Regulations.gov or in 
hard copy at the EPA Docket Center, Room 3334, EPA WJC West Building, 
1301 Constitution Avenue NW., Washington, DC. The Public Reading Room 
is open from 8:30 a.m. to 4:30 p.m., 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.
    Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-
2015-0730. The EPA's policy is that all comments received will be 
included in the public docket without change and may be made available 
online at http://www.regulations.gov, including any personal 
information provided, unless the comment includes information claimed 
to be CBI or other information whose disclosure is restricted by 
statute. Do not submit information that you consider to be CBI or 
otherwise protected through http://www.regulations.gov or email. The 
http://www.regulations.gov Web site is an ``anonymous access'' system, 
which means the EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an email 
comment directly to the EPA without going through http://www.regulations.gov, your email address will be automatically captured 
and included as part of the comment that is placed in the public docket 
and made available on the Internet. If you submit an electronic 
comment, the EPA recommends that you include your name and other 
contact information in the body of your comment and with any disk or 
CD-ROM you submit. If the EPA cannot read your comment due to technical 
difficulties and cannot contact you for clarification, the EPA may not 
be able to consider your comment. Electronic files should not include 
special characters or any form of encryption and be free of any defects 
or viruses. For additional information about the EPA's public docket, 
visit the EPA Docket Center homepage at https://www.epa.gov/dockets.
    Public Hearing. A public hearing will be held, if requested by 
January 3, 2017, to accept oral comments on this proposed action. If a 
hearing is requested, it will be held at the EPA's North Carolina 
campus located at 109 T.W. Alexander Drive, Research Triangle Park, NC 
27711. The hearing, if requested, will begin at 9:00 a.m. (local time) 
and will conclude at 8:00 p.m. (local time). To request a hearing, to 
register to speak at a hearing, or to inquire if a hearing will be 
held, please contact Aimee St. Clair at (919) 541-1063 or by email at 
StClair.Aimee@epa.gov. The last day to pre-register to speak at a 
hearing, if one is held, will be January 10, 2017. Additionally, 
requests to speak will be taken the day of the hearing at the hearing 
registration desk, although preferences on speaking times may not be 
able to be fulfilled. Please note that registration requests

[[Page 95811]]

received before the hearing will be confirmed by the EPA via email. The 
EPA will make every effort to accommodate all speakers who arrive and 
register. Because the hearing will be held at a U.S. governmental 
facility, individuals planning to attend the hearing should be prepared 
to show valid picture identification to the security staff in order to 
gain access to the meeting room. Please note that the REAL ID Act, 
passed by Congress in 2005, established new requirements for entering 
federal facilities. If your driver's license is issued by Alaska, 
American Samoa, Arizona, Kentucky, Louisiana, Maine, Massachusetts, 
Minnesota, Montana, New York, Oklahoma or the state of Washington, you 
must present an additional form of identification to enter the federal 
building. Acceptable alternative forms of identification include: 
federal employee badges, passports, enhanced driver's licenses and 
military identification cards. In addition, you will need to obtain a 
property pass for any personal belongings you bring with you. Upon 
leaving the building, you will be required to return this property pass 
to the security desk. No large signs will be allowed in the building, 
cameras may only be used outside of the building and demonstrations 
will not be allowed on federal property for security reasons.
    Please note that any updates made to any aspect of the hearing, 
including whether or not a hearing will be held, will be posted online 
at https://www.epa.gov/stationary-sources-air-pollution/manufacturing-nutritional-yeast-national-emission-standards. We ask that you contact 
Aimee St. Clair at (919) 541-1063 or by email at StClair.Aimee@epa.gov 
or monitor our Web site to determine if a hearing will be held. The EPA 
does not intend to publish a notice in the Federal Register announcing 
any such updates. Please go to https://www.epa.gov/stationary-sources-air-pollution/manufacturing-nutritional-yeast-national-emission-standards for more information on the public hearing.
    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:

AEGL Acute exposure guideline levels
AERMOD Air dispersion model used by the HEM-3 model
ATSDR Agency for Toxic Substances and Disease Registry
CAA Clean Air Act
CalEPA California EPA
CBI Confidential Business Information
CDX Central Data Exchange
CEDRI Compliance and Emissions Data Reporting Interface
CEMS Continuous emission monitoring system
CFR Code of Federal Regulations
EGU Electric generation unit
EPA Environmental Protection Agency
ERPG Emergency Response Planning Guidelines
FR Federal Register
HAP Hazardous air pollutants
HCl Hydrochloric acid
HEM-3 Human Exposure Model, Version 1.1.0
HF Hydrogen fluoride
HI Hazard index
HQ Hazard quotient
ICR Information Collection Request
IRIS Integrated Risk Information System
km Kilometer
MACT Maximum achievable control technology
MATS Mercury Air Toxics Standard
mg/kg-day Milligrams per kilogram per day
mg/m\3\ Milligrams per cubic meter
MIR Maximum individual risk
MON Miscellaneous organic chemical manufacturing NESHAP
NAAQS National Ambient Air Quality Standards
NAICS North American Industry Classification System
NAS National Academy of Sciences
NATA National Air Toxics Assessment
NEI National Emissions Inventory
NESHAP National emissions standards for hazardous air pollutants
NOX Nitrogen oxides
NRC National Research Council
QA/QC Quality assurance/quality control
OAQPS Office of Air Quality Planning and Standards
OMB Office of Management and Budget
PB-HAP Hazardous air pollutants known to be persistent and bio-
accumulative in the environment
POM Polycyclic organic matter
ppmv Parts per million by volume
PRA Paperwork Reduction Act
PS Performance Specification
RBLC RACT/BACT/LAER Clearinghouse
REL Reference exposure level
RFA Regulatory Flexibility Act
RfC Reference concentration
RfD Reference dose
RTO Regenerative thermal oxidizer
RTR Residual risk and technology review
SAB Science Advisory Board
SBA Small Business Administration
SOP Standing Operating Procedures
SSM Startup, shutdown, and malfunction
TOSHI Target organ-specific hazard index
tpy Tons per year
TRIM.FaTE Total Risk Integrated Methodology. Fate, Transport, and 
Ecological Exposure model
TTN Technology Transfer Network
UF Uncertainty factor
[micro]g/m\3\ Microgram per cubic meter
UMRA Unfunded Mandates Reform Act
URE Unit risk estimate
VOC Volatile organic compounds

    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. What should I consider as I prepare my comments for the EPA?
II. Background
    A. What is the statutory authority for this action?
    B. What is this source category and how does the current NESHAP 
regulate its HAP emissions?
    C. What data collection activities were conducted to support 
this action?
    D. What other relevant background information and data are 
available?
III. Analytical Procedures
    A. How did we estimate post-MACT risks posed by the source 
category?
    B. How did we consider the risk results in making decisions for 
this proposal?
    C. How did we perform the technology review?
IV. Analytical Results and Proposed Decisions
    A. What are the results of the risk assessment and analyses?
    B. What are our proposed decisions regarding risk acceptability, 
ample margin of safety, and adverse environmental effects?
    C. What are the results and proposed decisions based on our 
technology review?
    D. What other actions are we proposing?
    E. What compliance dates are we proposing?
V. Summary of Cost, Environmental, and Economic Impacts
    A. What are the affected sources?
    B. What are the air quality impacts?
    C. What are the cost impacts?
    D. What are the economic impacts?
    E. What are the benefits?
VI. Request for Comments
VII. Submitting Data Corrections
VIII. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and 
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act (PRA)
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act (UMRA)
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination with 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children from 
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act (NTTAA) and 
1 CFR part 51
    J. Executive Order 12898: Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations

[[Page 95812]]

I. General Information

A. Does this action apply to me?

    Table 1 of this preamble lists the NESHAP and the associated 
regulated industrial source category that is the subject of this 
proposal. Table 1 is not intended to be exhaustive, but rather provides 
a guide for readers regarding the entities that this proposed action is 
likely to affect. The proposed standards, once promulgated, will be 
directly applicable to the affected sources. Federal, state, local, and 
tribal government entities would not be affected by this proposed 
action. As defined in the Initial List of Categories of Sources Under 
Section 112(c)(1) of the Clean Air Act Amendments of 1990 (see 57 FR 
31576, July 16, 1992), the Manufacturing of Nutritional Yeast source 
category includes any facility engaged in the manufacture of baker's 
yeast by fermentation (both active dry yeast and compressed yeast). The 
category includes, but is not limited to, the following manufacturing 
process units: fermentation vessels and the drying and packaging 
system. The original source category was named Baker's Yeast 
Manufacturing, but it was revised to Manufacturing of Nutritional Yeast 
to provide clarity on the scope (63 FR 55812, October 19, 1998).

    Table 1--NESHAP and Industrial Source Categories Affected By This
                             Proposed Action
------------------------------------------------------------------------
               NESHAP and  source category                NAICS code \1\
------------------------------------------------------------------------
Manufacturing of Nutritional Yeast......................          311999
------------------------------------------------------------------------
\1\ North American Industry Classification System (NAICS).

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 action is available on the Internet. Following signature by the 
EPA Administrator, the EPA will post a copy of this proposed 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 of 
the proposal and key technical documents at this same Web site. 
Information on the overall RTR program is available at https://www3.epa.gov/ttn/atw/rrisk/rtrpg.html.

C. What should I consider as I prepare my comments for the EPA?

    Submitting CBI. Do not submit information containing CBI to the EPA 
through http://www.regulations.gov or email. Clearly mark the part or 
all of the information that you claim to be CBI. For CBI information on 
a disk or CD-ROM that you mail to the EPA, mark the outside of the disk 
or CD-ROM as CBI and then identify electronically within the disk or 
CD-ROM the specific information that is claimed as CBI. In addition to 
one complete version of the comments that includes information claimed 
as CBI, you must submit a copy of the comments that does not contain 
the information claimed as CBI for inclusion in the public docket. If 
you submit a CD-ROM or disk that does not contain CBI, mark the outside 
of the disk or CD-ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and the EPA's 
electronic public docket without prior notice. Information marked as 
CBI will not be disclosed except in accordance with procedures set 
forth in 40 Code of Federal Regulations (CFR) part 2. Send or deliver 
information identified as CBI only to the following address: OAQPS 
Document Control Officer (C404-02), OAQPS, U.S. Environmental 
Protection Agency, Research Triangle Park, North Carolina 27711, 
Attention Docket ID No. EPA-HQ-OAR-2015-0730.

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, after the EPA has identified categories of 
sources emitting one or more of the HAP listed in CAA section 112(b), 
CAA section 112(d) requires us to promulgate technology-based NESHAP 
for those sources. ``Major sources'' are those that emit or have the 
potential to emit 10 tons per year (tpy) or more of a single HAP or 25 
tpy or more of any combination of HAP. For major sources, the 
technology-based NESHAP must reflect the maximum degree of emission 
reductions of HAP achievable (after considering cost, energy 
requirements and non-air quality health and environmental impacts) and 
are commonly referred to as maximum achievable control technology 
(MACT) standards.
    MACT standards must reflect the maximum degree of emissions 
reduction achievable through the application of measures, processes, 
methods, systems or techniques, including, but not limited to, measures 
that: (1) Reduce the volume of or eliminate pollutants through process 
changes, substitution of materials, or other modifications; (2) enclose 
systems or processes to eliminate emissions; (3) capture or treat 
pollutants when released from a process, stack, storage, or fugitive 
emissions point; (4) are design, equipment, work practice, or 
operational standards (including requirements for operator training or 
certification); or (5) are a combination of the above. CAA section 
112(d)(2)(A)-(E). The MACT standards may take the form of design, 
equipment, work practice, or operational standards where the EPA first 
determines either that: (1) A pollutant cannot be emitted through a 
conveyance designed and constructed to emit or capture the pollutant, 
or that any requirement for, or use of, such a conveyance would be 
inconsistent with law; or (2) the application of measurement 
methodology to a particular class of sources is not practicable due to 
technological and economic limitations. CAA section 112(h)(1)-(2).
    The MACT ``floor'' is the minimum control level allowed for MACT 
standards promulgated under CAA section 112(d)(3) and may not be based 
on cost considerations. For new sources, the MACT floor cannot be less 
stringent than the emissions control that is achieved in practice by 
the best-controlled similar source. The MACT floor for existing sources 
can be less stringent than floors for new sources, but not less 
stringent than the average emissions 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, the EPA must also consider control options that are more 
stringent than the floor. We may establish standards more stringent 
than the floor based on considerations of the cost of achieving the 
emission reductions, any non-air quality health and environmental 
impacts, and energy requirements.
    The EPA is then required to review these 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. CAA section 112(d)(6). In conducting this review, 
the EPA is not required to recalculate the MACT floor. Natural 
Resources Defense Council (NRDC) v. EPA, 529 F.3d 1077, 1084 (D.C. Cir. 
2008). Association of Battery Recyclers,

[[Page 95813]]

Inc. v. EPA, 716 F.3d 667 (D.C. Cir. 2013).
    The second stage in standard-setting focuses on reducing any 
remaining (i.e., ``residual'') risk according to CAA section 112(f). 
CAA section 112(f)(1) required that the EPA prepare a report to 
Congress discussing (among other things) methods of calculating the 
risks posed (or potentially posed) by sources after implementation of 
the MACT standards, the public health significance of those risks, and 
the EPA's recommendations as to legislation regarding such remaining 
risk. The EPA prepared and submitted the ``Residual Risk Report to 
Congress,'' EPA-453/R-99-001 (``Risk Report'') in March 1999. CAA 
section 112(f)(2) then provides that if Congress does not act on any 
recommendation in the Risk Report, the EPA must analyze and address 
residual risk for each category or subcategory of sources 8 years after 
promulgation of such standards pursuant to CAA section 112(d).
    Section 112(f)(2) of the CAA requires the EPA to determine for 
source categories subject to MACT standards whether the emission 
standards provide an ample margin of safety to protect public health. 
Section 112(f)(2)(B) of the CAA expressly preserves the EPA's use of 
the two-step process for developing standards to address any residual 
risk and the Agency's interpretation of ``ample margin of safety'' 
developed in the National Emissions Standards for Hazardous Air 
Pollutants: Benzene Emissions from Maleic Anhydride Plants, 
Ethylbenzene/Styrene Plants, Benzene Storage Vessels, Benzene Equipment 
Leaks, and Coke By-Product Recovery Plants (Benzene NESHAP) (54 FR 
38044, September 14, 1989). The EPA notified Congress in the Risk 
Report that the Agency intended to use the Benzene NESHAP approach in 
making CAA section 112(f) residual risk determinations (EPA-453/R-99-
001, p. ES-11). The EPA subsequently adopted this approach in its 
residual risk determinations and in a challenge to the risk review for 
the Synthetic Organic Chemical Manufacturing source category, the 
United States Court of Appeals for the District of Columbia Circuit 
upheld as reasonable the EPA's interpretation that CAA section 
112(f)(2) incorporates the approach established in the Benzene NESHAP. 
See NRDC v. EPA, 529 F.3d 1077, 1083 (D.C. Cir. 2008)(``[S]ubsection 
112(f)(2)(B) expressly incorporates the EPA's interpretation of the 
Clean Air Act from the Benzene standard, complete with a citation to 
the Federal Register.''); see also, A Legislative History of the Clean 
Air Act Amendments of 1990, vol. 1, p. 877 (Senate debate on Conference 
Report).
    The first step in the process of evaluating residual risk is the 
determination of acceptable risk. If risks are unacceptable, the EPA 
cannot consider cost in identifying the emissions standards necessary 
to bring risks to an acceptable level. The second step is the 
determination of whether standards must be further revised in order to 
provide an ample margin of safety to protect public health. The ample 
margin of safety is the level at which the standards must be set, 
unless an even more stringent standard is necessary to prevent, taking 
into consideration costs, energy, safety, and other relevant factors, 
an adverse environmental effect.
1. Step 1--Determination of Acceptability
    The Agency in the Benzene NESHAP concluded that ``the acceptability 
of risk under section 112 is best judged on the basis of a broad set of 
health risk measures and information'' and that the ``judgment on 
acceptability cannot be reduced to any single factor.'' Benzene NESHAP 
at 38046. The determination of what represents an ``acceptable'' risk 
is based on a judgment of ``what risks are acceptable in the world in 
which we live'' (Risk Report at 178, quoting NRDC v. EPA, 824 F.2d 
1146, 1165 (D.C. Cir. 1987) (en banc) (``Vinyl Chloride''), recognizing 
that our world is not risk-free.
    In the Benzene NESHAP, we stated that ``EPA will generally presume 
that if the risk to [the maximum exposed] individual is no higher than 
approximately one in 10 thousand, that risk level is considered 
acceptable.'' 54 FR at 38045, September 14, 1989. We discussed the 
maximum individual lifetime cancer risk (or maximum individual risk 
(MIR)) as being ``the estimated risk that a person living near a plant 
would have if he or she were exposed to the maximum pollutant 
concentrations for 70 years.'' Id. We explained that this measure of 
risk ``is an estimate of the upper bound of risk based on conservative 
assumptions, such as continuous exposure for 24 hours per day for 70 
years.'' Id. We acknowledged that maximum individual lifetime cancer 
risk ``does not necessarily reflect the true risk, but displays a 
conservative risk level which is an upper-bound that is unlikely to be 
exceeded.'' Id.
    Understanding that there are both benefits and limitations to using 
the MIR as a metric for determining acceptability, we acknowledged in 
the Benzene NESHAP that ``consideration of maximum individual risk * * 
* must take into account the strengths and weaknesses of this measure 
of risk.'' Id. Consequently, the presumptive risk level of 100-in-1 
million (1-in-10 thousand) provides a benchmark for judging the 
acceptability of maximum individual lifetime cancer risk, but does not 
constitute a rigid line for making that determination. Further, in the 
Benzene NESHAP, we noted that:

    ``[p]articular attention will also be accorded to the weight of 
evidence presented in the risk assessment of potential 
carcinogenicity or other health effects of a pollutant. While the 
same numerical risk may be estimated for an exposure to a pollutant 
judged to be a known human carcinogen, and to a pollutant considered 
a possible human carcinogen based on limited animal test data, the 
same weight cannot be accorded to both estimates. In considering the 
potential public health effects of the two pollutants, the Agency's 
judgment on acceptability, including the MIR, will be influenced by 
the greater weight of evidence for the known human carcinogen.''

Id. at 38046. The Agency also explained in the Benzene NESHAP that:

    ``[i]n establishing a presumption for MIR, rather than a rigid 
line for acceptability, the Agency intends to weigh it with a series 
of other health measures and factors. These include the overall 
incidence of cancer or other serious health effects within the 
exposed population, the numbers of persons exposed within each 
individual lifetime risk range and associated incidence within, 
typically, a 50 kilometers (km) exposure radius around facilities, 
the science policy assumptions and estimation uncertainties 
associated with the risk measures, weight of the scientific evidence 
for human health effects, other quantified or unquantified health 
effects, effects due to co-location of facilities, and co-emission 
of pollutants.''

Id. at 38045. In some cases, these health measures and factors taken 
together may provide a more realistic description of the magnitude of 
risk in the exposed population than that provided by maximum individual 
lifetime cancer risk alone.
    As noted earlier, in NRDC v. EPA, the Court held that CAA section 
112(f)(2) ``incorporates the EPA's interpretation of the Clean Air Act 
from the Benzene Standard.'' The Court further held that Congress' 
incorporation of the Benzene standard applies equally to carcinogens 
and non-carcinogens. 529 F.3d at 1081-82. Accordingly, we also consider 
non-cancer risk metrics in our determination of risk acceptability and 
ample margin of safety.
2. Step 2--Determination of Ample Margin of Safety
    CAA section 112(f)(2) requires the EPA to determine, for source 
categories

[[Page 95814]]

subject to MACT standards, whether those standards provide an ample 
margin of safety to protect public health. As explained in the Benzene 
NESHAP, ``the second step of the inquiry, determining an `ample margin 
of safety,' again includes consideration of all of the health factors, 
and whether to reduce the risks even further. . . . Beyond that 
information, additional factors relating to the appropriate level of 
control will also be considered, including costs and economic impacts 
of controls, technological feasibility, uncertainties, and any other 
relevant factors. Considering all of these factors, the agency will 
establish the standard at a level that provides an ample margin of 
safety to protect the public health, as required by section 112.'' 54 
FR 38046, September 14, 1989.
    According to CAA section 112(f)(2)(A), if the MACT standards for 
HAP ``classified as a known, probable, or possible human carcinogen do 
not reduce lifetime excess cancer risks to the individual most exposed 
to emissions from a source in the category or subcategory to less than 
one in one million,'' the EPA must promulgate residual risk standards 
for the source category (or subcategory), as necessary to provide an 
ample margin of safety to protect public health. In doing so, the EPA 
may adopt standards equal to existing MACT standards if the EPA 
determines that the existing standards (i.e., the MACT standards) are 
sufficiently protective. 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.'') The EPA must 
also adopt more stringent standards, if necessary, to prevent an 
adverse environmental effect,\1\ but must consider cost, energy, 
safety, and other relevant factors in doing so.
---------------------------------------------------------------------------

    \1\ ``Adverse environmental effect'' is defined as any 
significant and widespread adverse effect, which may be reasonably 
anticipated to wildlife, aquatic life, or natural resources, 
including adverse impacts on populations of endangered or threatened 
species or significant degradation of environmental qualities over 
broad areas. CAA section 112(a)(7).
---------------------------------------------------------------------------

    The CAA does not specifically define the terms ``individual most 
exposed,'' ``acceptable level,'' and ``ample margin of safety.'' In the 
Benzene NESHAP, 54 FR 38044, September 14, 1989, we stated as an 
overall objective:

    In protecting public health with an ample margin of safety under 
section 112, EPA strives to provide maximum feasible protection 
against risks to health from hazardous air pollutants by (1) 
protecting the greatest number of persons possible to an individual 
lifetime risk level no higher than approximately 1-in-1 million and 
(2) limiting to no higher than approximately 1-in-10 thousand [i.e., 
100-in-1 million] the estimated risk that a person living near a 
plant would have if he or she were exposed to the maximum pollutant 
concentrations for 70 years.

    The Agency further stated that ``[t]he EPA also considers incidence 
(the number of persons estimated to suffer cancer or other serious 
health effects as a result of exposure to a pollutant) to be an 
important measure of the health risk to the exposed population. 
Incidence measures the extent of health risks to the exposed population 
as a whole, by providing an estimate of the occurrence of cancer or 
other serious health effects in the exposed population.'' Id. at 38045.
    In the ample margin of safety decision process, the Agency again 
considers all of the health risks and other health information 
considered in the first step, including the incremental risk reduction 
associated with standards more stringent than the MACT standard or a 
more stringent standard that the EPA has determined is necessary to 
ensure risk is acceptable. In the ample margin of safety analysis, the 
Agency considers additional factors, including costs and economic 
impacts of controls, technological feasibility, uncertainties, and any 
other relevant factors. Considering all of these factors, the Agency 
will establish the standard at a level that provides an ample margin of 
safety to protect the public health, as required by CAA section 112(f). 
54 FR 38046, September 14, 1989.

B. What is this source category and how does the current NESHAP 
regulate its HAP emissions?

    In the original 1992 list of sources under CAA section 112(c)(1), 
the EPA defined the Baker's Yeast Manufacturing source category as 
including any facility engaged in the manufacture of baker's yeast by 
fermentation (both active dry yeast and compressed yeast) (57 FR 
31576). The EPA explained that the category included, but was not 
limited to, the following manufacturing process units: Fermentation 
vessels and the drying and packaging system. The original source 
category was renamed to Manufacturing of Nutritional Yeast in 1998 to 
clarify that the source category covered the manufacturing of yeast, 
not its use in facilities such as breweries or bakeries. Both ``baker's 
yeast'' and ``nutritional yeast'' are common names for Saccharomyces 
cerevisiae, which is a specific species of yeast that is used to 
produce many common food and beverage products and whose manufacturing 
process typically emits HAP. The 40 CFR part 63, subpart CCCC NESHAP, 
which was finalized in 2001, defines a manufacturer of nutritional 
yeast as 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 (66 FR 27876). 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, the NESHAP clarifies that 
fermenters are not subject to emission limits during the production of 
specialty yeast (e.g., yeast for use in wine, champagne, whiskey, or 
beer) in 40 CFR 63.2132. We are not proposing to amend the source 
category definition in this action and are, therefore, not seeking 
comment on the source category definition at this time.
    Only facilities that are located at or are part of a major source 
of HAP emissions are subject to the Manufacturing of Nutritional Yeast 
NESHAP; area sources of HAP are not subject to the rule. The HAP 
emitted by nutritional yeast manufacturing facilities is acetaldehyde, 
a probable carcinogen. In 2016, there are four nutritional yeast 
manufacturing facilities that are subject to the NESHAP.
    The affected sources at nutritional yeast manufacturing facilities 
are the collection of equipment used to manufacture Saccharomyces 
cerevisiae yeast, including fermenters. The sizes of the fermenters 
vary; generally smaller fermenters are used for earlier fermentation 
stages and larger fermenters are used for later fermentation stages. 
The initial, smaller fermenters, where the sugar source is added only 
at the start of the batch (e.g., laboratory and pure culture 
fermenters), are not subject to emission limits. The 40 CFR part 63, 
subpart CCCC emission limits apply to the final three stages of the 
fermentation process where the sugar source is added intermittently 
throughout the 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 emission 
limits 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. VOC is used as a surrogate for the HAP of interest, 
acetaldehyde. The batch

[[Page 95815]]

average VOC 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 current NESHAP, 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 limits. 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 data collection activities were conducted to support this 
action?

    The EPA visited three nutritional yeast manufacturing facilities 
during the development of the NESHAP. Those facilities were the 
American Yeast and AB Mauri Fleischmann's Yeast facilities in Memphis, 
Tennessee, which we visited in December 2015, and the Red Star Yeast 
facility in Cedar Rapids, Iowa, which we visited in June 2016. We also 
held a conference call with the Minn-Dak Wahpeton facility, located in 
Wahpeton, North Dakota, in May 2016. The EPA discussed the specific 
yeast fermentation processes employed by each facility, including a 
discussion of the number and design of their fermenters and associated 
emission points, the process controls and monitors used, unregulated 
emission sources, and other aspects of facility operations. The site 
visits and conference call are documented in separate memoranda: ``Site 
Visit Report--American Yeast Corporation, Memphis Plant,'' ``Site Visit 
Report--AB Mauri Fleischmann's Yeast, Memphis Plant,'' ``Site Visit 
Report--Red Star Yeast, Cedar Rapids, IA,'' and ``Notes from May 6, 
2016 Conference Call Between the EPA and Minn-Dak Wahpeton,'' which are 
available in the docket for this action.

D. What other relevant background information and data are available?

    The EPA used information from the National Emissions Inventory 
(NEI) and the RACT/BACT/LAER Clearinghouse (RBLC) to support this 
proposed rulemaking. We used the NEI emissions and supporting data to 
develop the modeling file for the risk review. The EPA utilized the 
RBLC to identify additional control technologies for the technology 
review. See sections III.A, III.C, and IV.C of this preamble for 
further details on the use of these sources of information.

III. Analytical Procedures

    In this section, we describe the analyses performed to support the 
proposed decisions for the RTR and other issues addressed in this 
proposal.

A. How did we estimate post-MACT risks posed by the source category?

    The EPA conducted a risk assessment that provides estimates of the 
MIR posed by the HAP emissions from each source in the source category, 
the hazard index (HI) for chronic exposures to HAP with the potential 
to cause non-cancer health effects, and the hazard quotient (HQ) for 
acute exposures to HAP with the potential to cause non-cancer health 
effects. The assessment also provides estimates of the distribution of 
cancer risks within the exposed populations, cancer incidence, and an 
evaluation of the potential for adverse environmental effects. The 
eight sections that follow this paragraph describe how we estimated 
emissions and conducted the risk assessment. The docket for this 
rulemaking contains the following document which provides more 
information on the risk assessment inputs and models: ``Residual Risk 
Assessment for the Manufacturing of Nutritional Yeast Source Category 
in Support of the December 2016 Risk and Technology Review Proposed 
Rule.'' The methods used to assess risks (as described in the eight 
primary steps below) are consistent with those peer-reviewed by a panel 
of the EPA's Science Advisory Board (SAB) in 2009 and described in 
their peer review report issued in 2010; \2\ they are also consistent 
with the key recommendations contained in that report.
---------------------------------------------------------------------------

    \2\ U.S. EPA SAB. Risk and Technology Review (RTR) Risk 
Assessment Methodologies: For Review by the EPA's Science Advisory 
Board with Case Studies--MACT I Petroleum Refining Sources and 
Portland Cement Manufacturing, May 2010.
---------------------------------------------------------------------------

1. How did we estimate actual emissions and identify the emissions 
release characteristics?
    Fermenters are the primary emission source at nutritional yeast 
facilities. Each fermenter emission source has a stack through which 
the emissions are vented. The HAP emitted is acetaldehyde, which is a 
by-product of the fermentation process. We used acetaldehyde emissions 
data from the 2011 NEI and state emission reports (i.e., Iowa Emissions 
Inventory Questionnaire reports) as the basis of the actual emission 
estimates for each facility. The stack parameters used for each 
fermenter were obtained from the 2011 NEI, title V permits, or were 
provided to the Agency during site visits. We used default parameters 
if site-specific information was not available. Additional details on 
the data and methods used to develop actual emissions for the risk 
modeling are provided 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.
2. How did we estimate MACT-allowable emissions?
    The available emissions data in the RTR emissions dataset include 
estimates of the mass of HAP emitted during the specified annual time 
period. In some cases, these ``actual'' emission levels are lower than 
the emission levels required to comply with the current MACT standards. 
The emissions level allowed to be emitted by the MACT standards is 
referred to as the ``MACT-allowable'' emissions level. We discussed the 
use of both MACT-allowable and actual emissions in the final Coke Oven 
Batteries RTR (70 FR 19998-19999, April 15, 2005) and in the proposed 
and final Hazardous Organic NESHAP RTRs (71 FR 34428, June 14, 2006, 
and 71 FR 76609, December 21, 2006, respectively). In those actions, we 
noted that assessing the risks at the MACT-allowable level is 
inherently reasonable since these risks reflect the maximum level 
facilities could emit and still comply with national emission 
standards. We also explained that it is reasonable to consider actual 
emissions, where such data are available, in both steps of the risk 
analysis, in accordance with the Benzene NESHAP approach. (54 FR 38044, 
September 14, 1989.)
    For nutritional yeast manufacturing facilities, we used the actual 
emissions as the basis for the MACT-allowable emissions in the risk 
assessment. We set allowable emissions equal to actual emissions based 
on information gathered during the site visits that the facilities are 
operating near maximum capacity and close to the level of emissions 
allowed under the NESHAP. It is difficult to calculate a precise 
allowable emissions level for this industry because the emission limits 
are based on the average emissions concentration during each batch and 
the absolute number of batches produced at a facility fluctuates each 
year based on market demand for yeast.
    Furthermore, facilities are also unlikely to emit significantly 
higher levels of HAP due to a business incentive to minimize 
acetaldehyde

[[Page 95816]]

emissions and continuous monitoring requirements in the rule. 
Acetaldehyde is a by-product of sub-optimal yeast production. 
Increasing concentrations of acetaldehyde indicate decreases relative 
to the potential amount and/or quality of yeast that can be produced 
within a fermentation batch, resulting in a loss of profit for the 
yeast manufacturer. Therefore, companies have a business incentive to 
reduce HAP emissions as much as possible. Additionally, continuous 
monitoring ensures that the facilities receive real-time information 
about emissions throughout the yeast manufacturing process. These 
monitoring systems have enabled facilities to set up control systems 
that automatically adjust process parameters in real-time to reduce 
emissions if they reach a specified level.
    As stated above, MACT-allowable emissions are used to develop 
estimates of risk when actual emissions are lower than those required 
to meet current emission standards. Due to the difficulties that limit 
the calculation of allowable emissions (e.g., the current NESHAP 
standard requirements) and the low likelihood of facilities emitting 
significantly higher levels of HAP than current amounts, actual 
emissions provide the most accurate estimate of emissions that will be 
emitted from nutritional yeast manufacturing facilities. Therefore, we 
determined that the use of actual emissions as the basis of the MACT-
allowable emissions in this risk assessment is the most appropriate 
option for this subpart.
3. How did we conduct dispersion modeling, determine inhalation 
exposures, and estimate individual and population inhalation risks?
    Both long-term and short-term inhalation exposure concentrations 
and health risks from the source category addressed in this proposal 
were estimated using the Human Exposure Model (Community and Sector 
HEM-3 version 1.1.0). The HEM-3 performs three primary risk assessment 
activities: (1) Conducting dispersion modeling to estimate the 
concentrations of HAP in ambient air, (2) estimating long-term and 
short-term inhalation exposures to individuals residing within 50 km of 
the modeled sources,\3\ and (3) estimating individual and population-
level inhalation risks using the exposure estimates and quantitative 
dose-response information.
---------------------------------------------------------------------------

    \3\ This metric comes from the Benzene NESHAP. See 54 FR 38046.
---------------------------------------------------------------------------

    The air dispersion model used by the HEM-3 model (AERMOD) is one of 
the EPA's preferred models for assessing pollutant concentrations from 
industrial facilities.\4\ To perform the dispersion modeling and to 
develop the preliminary risk estimates, HEM-3 draws on three data 
libraries. The first is a library of meteorological data, which is used 
for dispersion calculations. This library includes 1 year (2014) of 
hourly surface and upper air observations for more than 800 
meteorological stations, selected to provide coverage of the United 
States and Puerto Rico. A second library of United States Census Bureau 
census block \5\ internal point locations and populations provides the 
basis of human exposure calculations (U.S. Census, 2010). In addition, 
for each census block, the census library includes the elevation and 
controlling hill height, which are also used in dispersion 
calculations. A third library of pollutant unit risk factors and other 
health benchmarks is used to estimate health risks. These risk factors 
and health benchmarks are the latest values recommended by the EPA for 
HAP and other toxic air pollutants. These values are available at 
https://www.epa.gov/fera/dose-response-assessment-assessing-health-risks-associated-exposure-hazardous-air-pollutants and are discussed in 
more detail later in this section.
---------------------------------------------------------------------------

    \4\ U.S. EPA. Revision to the ``Guideline on Air Quality Models: 
Adoption of a Preferred General Purpose (Flat and Complex Terrain) 
Dispersion Model and Other Revisions'' (70 FR 68218, November 9, 
2005).
    \5\ A census block is the smallest geographic area for which 
census statistics are tabulated.
---------------------------------------------------------------------------

    In developing the risk assessment for chronic exposures, we used 
the estimated annual average ambient air concentrations of each HAP 
emitted by each source for which we have emissions data in the source 
category. The air concentrations at each nearby census block centroid 
were used as a surrogate for the chronic inhalation exposure 
concentration for all the people who reside in that census block. We 
calculated the MIR for each facility as the cancer risk associated with 
a continuous lifetime (24 hours per day, 7 days per week, and 52 weeks 
per year for a 70-year period) exposure to the maximum concentration at 
the centroid of inhabited census blocks. Individual cancer risks were 
calculated by multiplying the estimated lifetime exposure to the 
ambient concentration of each of the HAP (in micrograms per cubic meter 
([mu]g/m\3\)) by its unit risk estimate (URE). The URE is an upper 
bound estimate of an individual's probability of contracting cancer 
over a lifetime of exposure to a concentration of 1 microgram of the 
pollutant per cubic meter of air. For residual risk assessments, we 
generally use URE values from the EPA's Integrated Risk Information 
System (IRIS). For carcinogenic pollutants without IRIS values, we look 
to other reputable sources of cancer dose-response values, often using 
California EPA (CalEPA) URE values, where available. In cases where 
new, scientifically credible dose response values have been developed 
in a manner consistent with the EPA guidelines and have undergone a 
peer review process similar to that used by the EPA, we may use such 
dose-response values in place of, or in addition to, other values, if 
appropriate.
    The EPA estimated incremental individual lifetime cancer risks 
associated with emissions from the facilities in the source category as 
the sum of the risks for each of the carcinogenic HAP (including those 
classified as carcinogenic to humans, likely to be carcinogenic to 
humans, and suggestive evidence of carcinogenic potential) \6\ emitted 
by the modeled sources. Cancer incidence and the distribution of 
individual cancer risks for the population within 50 km of the sources 
were also estimated for the source category as part of this assessment 
by summing individual risks. A distance of 50 km is consistent with 
both the analysis supporting the 1989 Benzene NESHAP (54 FR 38044, 
September 14, 1989) and the limitations of Gaussian dispersion models, 
including AERMOD.
---------------------------------------------------------------------------

    \6\ These classifications also coincide with the terms ``known 
carcinogen, probable carcinogen, and possible carcinogen,'' 
respectively, which are the terms advocated in the EPA's previous 
``Guidelines for Carcinogen Risk Assessment,'' published in 1986 (51 
FR 33992, September 24, 1986). Summing the risks of these individual 
compounds to obtain the cumulative cancer risks is an approach that 
was recommended by the EPA's SAB in their 2002 peer review of the 
EPA's National Air Toxics Assessment (NATA) titled, ``NATA--
Evaluating the National-scale Air Toxics Assessment 1996 Data--an 
SAB Advisory,'' available at http://yosemite.epa.gov/sab/
sabproduct.nsf/214C6E915BB04E14852570CA007A682C/$File/
ecadv02001.pdf.
---------------------------------------------------------------------------

    To assess the risk of non-cancer health effects from chronic 
exposures, we summed the HQ for each of the HAP that affects a common 
target organ system to obtain the HI for that target organ system (or 
target organ-specific HI, TOSHI). The HQ is the estimated exposure 
divided by the chronic reference value, which is a value selected from 
one of several sources. First, the chronic reference level can be the 
EPA reference concentration (RfC) (https://ofmpub.epa.gov/sor_internet/
registry/termreg/searchandretrieve/glossariesandkeywordlists/
search.do?details=&glossaryName=Risk

[[Page 95817]]

%20Assessment%20Glossary), defined as ``an estimate (with uncertainty 
spanning perhaps an order of magnitude) of a continuous inhalation 
exposure to the human population (including sensitive subgroups) that 
is likely to be without an appreciable risk of deleterious effects 
during a lifetime.'' Alternatively, in cases where an RfC from the 
EPA's IRIS database is not available or where the EPA determines that 
using a value other than the RfC is appropriate, the chronic reference 
level can be a value from the following prioritized sources: (1) The 
Agency for Toxic Substances and Disease Registry Minimum Risk Level 
(http://www.atsdr.cdc.gov/mrls/index.asp), which is defined as ``an 
estimate of daily human exposure to a hazardous substance that is 
likely to be without an appreciable risk of adverse non-cancer health 
effects (other than cancer) over a specified duration of exposure''; 
(2) the CalEPA Chronic Reference Exposure Level (REL) (http://oehha.ca.gov/media/downloads/crnr/2015guidancemanual.pdf), which is 
defined as ``the concentration level (that is expressed in units of 
micrograms per cubic meter ([mu]g/m\3\) for inhalation exposure and in 
a dose expressed in units of milligram per kilogram-day (mg/kg-day) for 
oral exposures), at or below which no adverse health effects are 
anticipated for a specified exposure duration''; or (3), as noted 
above, a scientifically credible dose-response value that has been 
developed in a manner consistent with the EPA guidelines and has 
undergone a peer review process similar to that used by the EPA, in 
place of or in concert with other values.
    As mentioned above, in order to characterize non-cancer chronic 
effects, and in response to key recommendations from the SAB, the EPA 
selects dose-response values that reflect the best available science 
for all HAP included in RTR risk assessments.\7\ More specifically, for 
a given HAP, the EPA examines the availability of inhalation reference 
values from the sources included in our tiered approach (e.g., IRIS 
first, Agency for Toxic Substances and Disease Registry (ATSDR) second, 
CalEPA third) and determines which inhalation reference value 
represents the best available science. Thus, as new inhalation 
reference values become available, the EPA will typically evaluate them 
and determine whether they should be given preference over those 
currently being used in RTR risk assessments.
---------------------------------------------------------------------------

    \7\ The SAB peer review of RTR Risk Assessment Methodologies is 
available at http://yosemite.epa.gov/sab/sabproduct.nsf/
4AB3966E263D943A8525771F00668381/$File/EPA-SAB-10-007-unsigned.pdf.
---------------------------------------------------------------------------

    The EPA also evaluated screening estimates of acute exposures and 
risks for each of the HAP (for which appropriate acute dose-response 
values are available) at the point of highest potential off-site 
exposure for each facility. To do this, the EPA estimated the risks 
when both the peak hourly emissions rate and worst-case dispersion 
conditions occur. We also assume that a person is located at the point 
of highest impact during that same time. In accordance with our mandate 
in section 112 of the CAA, we use the point of highest off-site 
exposure to assess the potential risk to the maximally exposed 
individual. The acute HQ is the estimated acute exposure divided by the 
acute dose-response value. In each case, the EPA calculated acute HQ 
values using best available, short-term dose-response values. These 
acute dose-response values, which are described below, include the 
acute REL, acute exposure guideline levels (AEGL) and emergency 
response planning guidelines (ERPG) for 1-hour exposure durations. As 
discussed below, we used conservative assumptions for emissions rates, 
meteorology, and exposure location.
    As described in the CalEPA's ``Air Toxics Hot Spots Program Risk 
Assessment Guidelines, Part I, The Determination of Acute Reference 
Exposure Levels for Airborne Toxicants,'' an acute REL value (http://oehha.ca.gov/media/downloads/crnr/acuterel.pdf) is defined as ``the 
concentration level at or below which no adverse health effects are 
anticipated for a specified exposure duration.'' Id. at page 2. Acute 
REL values are based on the most sensitive, relevant, adverse health 
effect reported in the peer-reviewed medical and toxicological 
literature. Acute REL values are designed to protect the most sensitive 
individuals in the population through the inclusion of margins of 
safety. Because margins of safety are incorporated to address data gaps 
and uncertainties, exceeding the REL does not automatically indicate an 
adverse health impact.
    AEGL values were derived in response to recommendations from the 
National Research Council (NRC). As described in ``Standing Operating 
Procedures (SOP) of the National Advisory Committee on Acute Exposure 
Guideline Levels for Hazardous Substances'' (https://www.epa.gov/sites/production/files/2015-09/documents/sop_final_standing_operating_procedures_2001.pdf),\8\ ``the NRC's 
previous name for acute exposure levels--community emergency exposure 
levels was replaced by the term AEGL to reflect the broad application 
of these values to planning, response, and prevention in the community, 
the workplace, transportation, the military, and the remediation of 
Superfund sites.'' Id. at 2. This document also states that AEGL values 
``represent threshold exposure limits for the general public and are 
applicable to emergency exposures ranging from 10 minutes to eight 
hours.'' Id. at 2.
---------------------------------------------------------------------------

    \8\ National Academy of Sciences (NAS), 2001. Standing Operating 
Procedures for Developing Acute Exposure Levels for Hazardous 
Chemicals, page 2.
---------------------------------------------------------------------------

    The document lays out the purpose and objectives of AEGL by stating 
that ``the primary purpose of the AEGL program and the National 
Advisory Committee for Acute Exposure Guideline Levels for Hazardous 
Substances is to develop guideline levels for once-in-a-lifetime, 
short-term exposures to airborne concentrations of acutely toxic, high-
priority chemicals.'' Id. at 21. In detailing the intended application 
of AEGL values, the document states that ``[i]t is anticipated that the 
AEGL values will be used for regulatory and nonregulatory purposes by 
U.S. Federal and state agencies and possibly the international 
community in conjunction with chemical emergency response, planning, 
and prevention programs. More specifically, the AEGL values will be 
used for conducting various risk assessments to aid in the development 
of emergency preparedness and prevention plans, as well as real-time 
emergency response actions, for accidental chemical releases at fixed 
facilities and from transport carriers.'' Id. at 31.
    The AEGL-1 value is then specifically defined as ``the airborne 
concentration (expressed as ppm (parts per million) or mg/m\3\ 
(milligrams per cubic meter)) of a substance above which it is 
predicted that the general population, including susceptible 
individuals, could experience notable discomfort, irritation, or 
certain asymptomatic nonsensory effects. However, the effects are not 
disabling and are transient and reversible upon cessation of 
exposure.'' Id. at 3. The document also notes that, ``Airborne 
concentrations below AEGL-1 represent exposure levels that can produce 
mild and progressively increasing but transient and nondisabling odor, 
taste, and sensory irritation or certain asymptomatic, nonsensory 
effects.'' Id. Similarly, the document defines AEGL-2 values as

[[Page 95818]]

``the airborne concentration (expressed as parts per million or 
milligrams per cubic meter) of a substance above which it is predicted 
that the general population, including susceptible individuals, could 
experience irreversible or other serious, long-lasting adverse health 
effects or an impaired ability to escape.'' Id.
    ERPG values are derived for use in emergency response, as described 
in the American Industrial Hygiene Association's ERP Committee document 
titled, ``ERPGS Procedures and Responsibilities'' (https://www.aiha.org/get-involved/AIHAGuidelineFoundation/EmergencyResponsePlanningGuidelines/Documents/ERPG%20Committee%20Standard%20Operating%20Procedures%20%20-%20March%202014%20Revision%20%28Updated%2010-2-2014%29.pdf), which 
states that, ``Emergency Response Planning Guidelines were developed 
for emergency planning and are intended as health based guideline 
concentrations for single exposures to chemicals.'' \9\ Id. at 1. The 
ERPG-1 value is defined as ``the maximum airborne concentration below 
which it is believed that nearly all individuals could be exposed for 
up to 1 hour without experiencing other than mild transient adverse 
health effects or without perceiving a clearly defined, objectionable 
odor.'' Id. at 2. Similarly, the ERPG-2 value is defined as ``the 
maximum airborne concentration below which it is believed that nearly 
all individuals could be exposed for up to one hour without 
experiencing or developing irreversible or other serious health effects 
or symptoms which could impair an individual's ability to take 
protective action.'' Id. at 1.
---------------------------------------------------------------------------

    \9\ ERP Committee Procedures and Responsibilities. March 2014. 
American Industrial Hygiene Association.
---------------------------------------------------------------------------

    As can be seen from the definitions above, the AEGL and ERPG values 
include the similarly-defined severity levels 1 and 2. For many 
chemicals, a severity level 1 value AEGL or ERPG has not been developed 
because the types of effects for these chemicals are not consistent 
with the AEGL-1/ERPG-1 definitions; in these instances, we compare 
higher severity level AEGL-2 or ERPG-2 values to our modeled exposure 
levels to screen for potential acute concerns. When AEGL-1/ERPG-1 
values are available, they are used in our acute risk assessments.
    Acute REL values for 1-hour exposure durations are typically lower 
than their corresponding AEGL-1 and ERPG-1 values. Even though their 
definitions are slightly different, AEGL-1 values are often the same as 
the corresponding ERPG-1 values, and AEGL-2 values are often equal to 
ERPG-2 values. Maximum HQ values from our acute screening risk 
assessments typically result when basing them on the acute REL value 
for a particular pollutant. In cases where our maximum acute HQ value 
exceeds 1, we also report the HQ value based on the next highest acute 
dose-response value (usually the AEGL-1 and/or the ERPG-1 value).
    To develop screening estimates of acute exposures in the absence of 
hourly emissions data, generally we first develop estimates of maximum 
hourly emissions rates by multiplying the average actual annual hourly 
emissions rates by a default factor to cover routinely variable 
emissions. We choose the factor to use partially based on process 
knowledge and engineering judgment. The factor chosen also reflects a 
Texas study of short-term emissions variability, which showed that most 
peak emission events in a heavily-industrialized four-county area 
(Harris, Galveston, Chambers, and Brazoria Counties, Texas) were less 
than twice the annual average hourly emissions rate. The highest peak 
emissions event was 74 times the annual average hourly emissions rate, 
and the 99th percentile ratio of peak hourly emissions rate to the 
annual average hourly emissions rate was 9.\10\ Considering this 
analysis, to account for more than 99 percent of the peak hourly 
emissions, we apply a conservative screening multiplication factor of 
10 to the average annual hourly emissions rate in our acute exposure 
screening assessments as our default approach. However, we use a factor 
other than 10 if we have information that indicates that a different 
factor is appropriate for a particular source category.
---------------------------------------------------------------------------

    \10\ Allen, et al., Variable Industrial VOC Emissions and their 
impact on ozone formation in the Houston Galveston Area. Texas 
Environmental Research Consortium, 2004, and available online at: 
https://www.researchgate.net/publication/237593060_Variable_Industrial_VOC_Emissions 
and_their_Impact_on_Ozone_Formation_in_the_Houston_Galveston_Area
---------------------------------------------------------------------------

    For this source category, we used an acute multiplication factor of 
1.2 for all emission sources from nutritional yeast manufacturing 
facilities. The factor equals the average peak-to-mean ratio developed 
using 5 years of batch-averaged fermenter VOC concentration data from 
the facility with the highest emissions in the 2011 NEI. While the 
current rule requires continuous monitoring of emissions, facilities 
are required to report whether the percentage of batches that meet 
emission limits based on the average concentration of VOC emitted from 
each batch meets the current compliance requirements; not the 
continuous levels of emissions at the facility. Using the data above, 
we developed a multiplier to estimate potential acute emissions from 
each facility in this source category. A further discussion of why this 
factor was chosen can be found in the memorandum, ``Emissions Data and 
Acute Risk Factor Used in Residual Risk Modeling: Manufacturing of 
Nutritional Yeast Source Category,'' available in the docket for this 
rulemaking.
    As part of our acute risk assessment process, for cases where acute 
HQ values from the screening step were less than or equal to 1 (even 
under the conservative assumptions of the screening analysis), acute 
impacts were deemed negligible and no further analysis was performed 
for these HAP. In cases where an acute HQ from the screening step was 
greater than 1, additional site-specific data were considered to 
develop a more refined estimate of the potential for acute impacts of 
concern. For this source category, all acute HQ screening values were 
less than 1. Therefore, we did not employ additional data refinements.
    Ideally, we would prefer to have continuous measurements over time 
to see how the emissions vary by each hour over an entire year. Having 
a frequency distribution of hourly emissions rates over a year would 
allow us to perform a probabilistic analysis to estimate potential 
threshold exceedances and their frequency of occurrence. Such an 
evaluation could include a more complete statistical treatment of the 
key parameters and elements adopted in this screening analysis. 
Recognizing that this level of data is rarely available, we instead 
rely on the multiplier approach.
    To better characterize the potential health risks associated with 
estimated acute exposures to HAP, and in response to a key 
recommendation from the SAB's peer review of the EPA's RTR risk 
assessment methodologies,\11\ we generally examine a wider range of 
available acute health metrics (e.g., RELs, AEGLs) than we do for our 
chronic risk assessments. This is in response to the SAB's 
acknowledgement that there are generally more data gaps and 
inconsistencies in acute reference values than there are in chronic 
reference values. In some cases, when

[[Page 95819]]

Reference Value Arrays \12\ for HAP have been developed, we consider 
additional acute values (i.e., occupational and international values) 
to provide a more complete risk characterization.
---------------------------------------------------------------------------

    \11\ The SAB peer review of RTR Risk Assessment Methodologies is 
available at http://yosemite.epa.gov/sab/sabproduct.nsf/
4AB3966E263D943A8525771F00668381/$File/EPA-SAB-10-007-unsigned.pdf.
    \12\ U.S. EPA. Chapter 2.9, Chemical Specific Reference Values 
for Formaldehyde in Graphical Arrays of Chemical-Specific Health 
Effect Reference Values for Inhalation Exposures (Final Report). 
U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-09/
061, 2009, and available online at http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=211003.
---------------------------------------------------------------------------

4. How did we conduct the multi-pathway exposure and risk screening?
    The EPA conducted a screening analysis examining the potential for 
significant human health risks due to exposures via routes other than 
inhalation (i.e., ingestion). We first determined whether any sources 
in the source category emitted any HAP known to be persistent and 
bioaccumulative in the environment (PB-HAP). The PB-HAP compounds or 
compound classes are identified for the screening from the EPA's Air 
Toxics Risk Assessment Library (available at http://www2.epa.gov/fera/risk-assessment-and-modeling-air-toxics-risk-assessment-reference-library).
    For the Manufacturing of Nutritional Yeast source category, we did 
not identify emissions of any PB-HAP. Because we did not identify PB-
HAP emissions, no further evaluation of multi-pathway risk was 
conducted for this source category.
5. How did we assess risks considering emissions control options?
    The proposed rule amendments include changes to the form of the 
current emission limits, additional testing requirements, changes to 
the current monitoring requirements, and updates to the reporting and 
recordkeeping requirements. The proposed amendments to the emission 
limits may lead to a slight decrease in the overall emissions from the 
facilities, but we are unable to quantify this reduction. Facilities 
will continue to employ current process controls to comply with the 
emission limits (i.e., they are not required to install additional 
control technologies); however, the facilities may need to make minor 
adjustments to the level of process controls to comply with the new 
limits.
    The proposed amendments to testing and monitoring requirements will 
increase the reliability of the emissions data that is monitored by 
each facility to ensure that the current emission limits are being met 
consistently. Therefore, risks considering the proposed amendments are 
estimated to be the same as actual risks under the current MACT 
standard.
6. How did we conduct the environmental risk screening assessment?
a. Adverse Environmental Effect
    The EPA conducts a screening assessment to examine the potential 
for adverse environmental effects as required under section 
112(f)(2)(A) of the CAA. Section 112(a)(7) of the CAA defines ``adverse 
environmental effect'' as ``any significant and widespread adverse 
effect, which may reasonably be anticipated, to wildlife, aquatic life, 
or other natural resources, including adverse impacts on populations of 
endangered or threatened species or significant degradation of 
environmental quality over broad areas.''
b. Environmental HAP
    The EPA focuses on seven HAP, which we refer to as ``environmental 
HAP,'' in its screening analysis: Five PB-HAP and two acid gases. The 
five PB-HAP are cadmium, dioxins/furans, polycyclic organic matter 
(POM), mercury (both inorganic mercury and methyl mercury), and lead 
compounds. The two acid gases are hydrogen chloride (HCl) and hydrogen 
fluoride (HF). The rationale for including these seven HAP in the 
environmental risk screening analysis is presented below.
    HAP that persist and bioaccumulate are of particular environmental 
concern because they accumulate in the soil, sediment, and water. The 
PB-HAP are taken up, through sediment, soil, water, and/or ingestion of 
other organisms, by plants or animals (e.g., small fish) at the bottom 
of the food chain. As larger and larger predators consume these 
organisms, concentrations of the PB-HAP in the animal tissues increases 
as does the potential for adverse effects. The five PB-HAP we evaluate 
as part of our screening analysis account for 99.8 percent of all PB-
HAP emissions nationally from stationary sources (on a mass basis from 
the 2005 NEI.
    In addition to accounting for almost all of the mass of PB-HAP 
emitted, we note that the TRIM.FaTE model that we use to evaluate 
multi-pathway risk allows us to estimate concentrations of cadmium 
compounds, dioxins/furans, POM, and mercury in soil, sediment and 
water. For lead compounds, we currently do not have the ability to 
calculate these concentrations using the TRIM.FaTE model. Therefore, to 
evaluate the potential for adverse environmental effects from lead 
compounds, we compare the estimated HEM-modeled exposures from the 
source category emissions of lead with the level of the secondary 
National Ambient Air Quality Standards (NAAQS) for lead.\13\ We 
consider values below the level of the secondary lead NAAQS to be 
unlikely to cause adverse environmental effects.
---------------------------------------------------------------------------

    \13\ The secondary lead NAAQS is a reasonable measure of 
determining whether there is an adverse environmental effect since 
it was established considering ``effects on soils, water, crops, 
vegetation, man-made materials, animals, wildlife, weather, 
visibility and climate, damage to and deterioration of property, and 
hazards to transportation, as well as effects on economic values and 
on personal comfort and well-being.''
---------------------------------------------------------------------------

    Due to their well-documented potential to cause direct damage to 
terrestrial plants, we include two acid gases, HCl, and HF in the 
environmental screening analysis. According to the 2005 NEI, HCl, and 
HF account for about 99 percent (on a mass basis) of the total acid gas 
HAP emitted by stationary sources in the U.S. In addition to the 
potential to cause direct damage to plants, high concentrations of HF 
in the air have been linked to fluorosis in livestock. Air 
concentrations of these HAP are already calculated as part of the human 
multi-pathway exposure and risk screening analysis using the HEM3-
AERMOD air dispersion model, and we are able to use the air dispersion 
modeling results to estimate the potential for an adverse environmental 
effect.
    The EPA acknowledges that other HAP beyond the seven HAP discussed 
above may have the potential to cause adverse environmental effects. 
Therefore, the EPA may include other relevant HAP in its environmental 
risk screening in the future, as modeling science and resources allow. 
The EPA invites comment on the extent to which other HAP emitted by the 
source category may cause adverse environmental effects. Such 
information should include references to peer-reviewed ecological 
effects benchmarks that are of sufficient quality for making regulatory 
decisions, as well as information on the presence of organisms located 
near facilities within the source category that such benchmarks 
indicate could be adversely affected.
c. Screening Methodology
    For the environmental risk screening analysis, the EPA first 
determined whether any facilities in the Manufacturing of Nutritional 
Yeast source category emitted any of the seven environmental HAP. For 
this source category, we did not identify emissions

[[Page 95820]]

of any of the seven environmental HAP included in the screen. Because 
we did not identify environmental HAP emissions, we did not conduct a 
further evaluation of environmental risk.
7. How did we conduct facility-wide assessments?
    To put the source category risks in context, we typically examine 
the risks from the entire ``facility,'' where the facility includes all 
HAP-emitting operations within a contiguous area and under common 
control. In other words, we examine the HAP emissions not only from the 
source category emission points of interest, but also emissions of HAP 
from all other emission sources at the facility for which we have data. 
The current NESHAP does not set emission limits for equipment other 
than fermenters at the affected sources. There is a potential for 
temporary wastewater storage tanks (e.g., pH adjustment tanks) and 
dryers to emit small amounts of acetaldehyde at nutritional yeast 
facilities covered by this subpart. The NEI does not include emissions 
from wastewater storage tanks at any of the four facilities subject to 
this rule. Only one of the four facilities has dryers; the NEI did 
report estimated emissions from these dryers, which were included in 
the risk assessment for this source category.
    We did not perform a separate facility-wide risk assessment for 
facilities that manufacture nutritional yeast. One facility (American 
Yeast) reported 43 pounds of additional HAP emissions, composed largely 
of hexane and formaldehyde, from equipment sources not covered by 40 
CFR part 63, subpart CCCC (e.g., boilers, equipment covered by other 
NESHAP).\14\ However, because these emissions were so low and from 
pollutants with low risk factors, we concluded that a facility-wide 
risk assessment would yield the same or only very slightly different 
results as the source category assessment.
---------------------------------------------------------------------------

    \14\ Because these emissions originate from sources outside the 
manufacturing of nutritional yeast source category, they were also 
excluded from the source category risk analysis.
---------------------------------------------------------------------------

8. How did we consider uncertainties in risk assessment?
    In the Benzene NESHAP, we concluded that risk estimation 
uncertainty should be considered in our decision-making under the ample 
margin of safety framework. Uncertainty and the potential for bias are 
inherent in all risk assessments, including those performed for this 
proposal. Although uncertainty exists, we believe that our approach, 
which used conservative tools and assumptions, ensures that our 
decisions are health protective and environmentally protective. A brief 
discussion of the uncertainties in the RTR emissions dataset, 
dispersion modeling, inhalation exposure estimates, and dose-response 
relationships follows below. A more thorough discussion of these 
uncertainties is included in the ``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 action.
a. Uncertainties in the RTR Emissions Dataset
    Although the development of the RTR emissions dataset involved 
quality assurance/quality control processes, the accuracy of emissions 
values will vary depending on the source of the data, the degree to 
which data are incomplete or missing, the degree to which assumptions 
made to complete the datasets are accurate, errors in emission 
estimates, and other factors. The emission estimates considered in this 
analysis generally are annual totals for certain years, and they do not 
reflect short-term fluctuations during the course of a year or 
variations from year to year. The estimates of peak hourly emission 
rates for the acute effects screening assessment were based on an 
emission adjustment factor applied to the average annual hourly 
emission rates, which are intended to account for emission fluctuations 
due to normal facility operations.
b. Uncertainties in Dispersion Modeling
    We recognize there is uncertainty in ambient concentration 
estimates associated with any model, including the EPA's recommended 
regulatory dispersion model, AERMOD. In using a model to estimate 
ambient pollutant concentrations, the user chooses certain options to 
apply. For RTR assessments, we select some model options that have the 
potential to overestimate ambient air concentrations (e.g., not 
including plume depletion or pollutant transformation). We select other 
model options that have the potential to underestimate ambient impacts 
(e.g., not including building downwash). Other options that we select 
have the potential to either under- or overestimate ambient levels 
(e.g., meteorology and receptor locations). On balance, considering the 
directional nature of the uncertainties commonly present in ambient 
concentrations estimated by dispersion models, the approach we apply in 
the RTR assessments should yield unbiased estimates of ambient HAP 
concentrations.
c. Uncertainties in Inhalation Exposure
    The EPA did not include the effects of human mobility on exposures 
in the assessment. Specifically, short-term mobility and long-term 
mobility between census blocks in the modeling domain were not 
considered.\15\ The approach of not considering short or long-term 
population mobility does not bias the estimate of the theoretical MIR 
(by definition), nor does it affect the estimate of cancer incidence 
because the total population number remains the same. It does, however, 
affect the shape of the distribution of individual risks across the 
affected population, shifting it toward higher estimated individual 
risks at the upper end and reducing the number of people estimated to 
be at lower risks, thereby increasing the estimated number of people at 
specific high risk levels (e.g., 1-in-10 thousand or 1-in-1 million).
---------------------------------------------------------------------------

    \15\ Short-term mobility is movement from one micro-environment 
to another over the course of hours or days. Long-term mobility is 
movement from one residence to another over the course of a 
lifetime.
---------------------------------------------------------------------------

    In addition, the assessment predicted the chronic exposures at the 
centroid of each populated census block as surrogates for the exposure 
concentrations for all people living in that block. Using the census 
block centroid to predict chronic exposures tends to over-predict 
exposures for people in the census block who live farther from the 
facility and under-predict exposures for people in the census block who 
live closer to the facility. Thus, using the census block centroid to 
predict chronic exposures may lead to a potential understatement or 
overstatement of the true maximum impact, but is an unbiased estimate 
of average risk and incidence. We reduce this uncertainty by analyzing 
large census blocks near facilities using aerial imagery and adjusting 
the location of the block centroid to better represent the population 
in the block, as well as adding additional receptor locations where the 
block population is not well represented by a single location.
    The assessment evaluates the cancer inhalation risks associated 
with pollutant exposures over a 70-year period, which is the assumed 
lifetime of an individual. In reality, both the length of time that 
modeled emission sources at facilities actually operate (i.e., more or 
less than 70 years) and the domestic growth or decline of the modeled 
industry (i.e., the increase or decrease in the number or size of 
domestic facilities) will influence the future risks

[[Page 95821]]

posed by a given source or source category. Depending on the 
characteristics of the industry, these factors will, in most cases, 
result in an overestimate both in individual risk levels and in the 
total estimated number of cancer cases. However, in the unlikely 
scenario where a facility maintains, or even increases, its emissions 
levels over a period of more than 70 years, residents live beyond 70 
years at the same location, and the residents spend most of their days 
at that location, then the cancer inhalation risks could potentially be 
underestimated. However, annual cancer incidence estimates from 
exposures to emissions from these sources would not be affected by the 
length of time an emissions source operates.
    The exposure estimates used in these analyses assume chronic 
exposures to ambient (outdoor) levels of pollutants. Because most 
people spend the majority of their time indoors, actual exposures may 
not be as high, depending on the characteristics of the pollutants 
modeled. For many of the HAP, indoor levels are roughly equivalent to 
ambient levels, but for very reactive pollutants or larger particles, 
indoor levels are typically lower. This factor has the potential to 
result in an overestimate of 25 to 30 percent of exposures.\16\
---------------------------------------------------------------------------

    \16\ U.S. EPA. National-Scale Air Toxics Assessment for 1996. 
(EPA 453/R-01-003; January 2001; page 85.)
---------------------------------------------------------------------------

    In addition to the uncertainties highlighted above, there are 
several factors specific to the acute exposure assessment that the EPA 
conducts as part of the risk review under section 112 of the CAA that 
should be highlighted. The accuracy of an acute inhalation exposure 
assessment depends on the simultaneous occurrence of independent 
factors that may vary greatly, such as hourly emissions rates, 
meteorology, and the presence of humans at the location of the maximum 
concentration. In the acute screening assessment that we conduct under 
the RTR program, we assume that peak emissions from the source category 
and worst-case meteorological conditions co-occur, thus, resulting in 
maximum ambient concentrations. These two events are unlikely to occur 
at the same time, making these assumptions conservative. We then 
include the additional assumption that a person is located at this 
point during this same time period. For this source category, these 
assumptions would tend to be worst-case actual exposures as it is 
unlikely that a person would be located at the point of maximum 
exposure during the time when peak emissions and worst-case 
meteorological conditions occur simultaneously.
d. Uncertainties in Dose-Response Relationships
    There are uncertainties inherent in the development of the dose-
response values used in our risk assessments for cancer effects from 
chronic exposures and non-cancer effects from both chronic and acute 
exposures. Some uncertainties may be considered quantitatively, and 
others generally are expressed in qualitative terms. We note as a 
preface to this discussion a point on dose-response uncertainty that is 
brought out in the EPA's 2005 Cancer Guidelines; namely, that ``the 
primary goal of EPA actions is protection of human health; accordingly, 
as an Agency policy, risk assessment procedures, including default 
options that are used in the absence of scientific data to the 
contrary, should be health protective'' (EPA's 2005 Cancer Guidelines, 
pages 1-7). This is the approach followed here as summarized in the 
next several paragraphs. A complete detailed discussion of 
uncertainties and variability in dose-response relationships is given 
in the ``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 action.
    Cancer URE values used in our risk assessments are those that have 
been developed to generally provide an upper bound estimate of risk. 
That is, they represent a ``plausible upper limit to the true value of 
a quantity'' (although this is usually not a true statistical 
confidence limit).\17\ In some circumstances, the true risk could be as 
low as zero; however, in other circumstances the risk could be 
greater.\18\ When developing an upper bound estimate of risk and to 
provide risk values that do not underestimate risk, health-protective 
default approaches are generally used. To err on the side of ensuring 
adequate health protection, the EPA typically uses the upper bound 
estimates rather than lower bound or central tendency estimates in our 
risk assessments, an approach that may have limitations for other uses 
(e.g., priority-setting or expected benefits analysis).
---------------------------------------------------------------------------

    \17\ IRIS glossary (https://ofmpub.epa.gov/sor_internet/registry/termreg/searchandretrieve/glossariesandkeywordlists/search.do?details=&glossaryName=IRIS%20Glossary).
    \18\ An exception to this is the URE for benzene, which is 
considered to cover a range of values, each end of which is 
considered to be equally plausible, and which is based on maximum 
likelihood estimates.
---------------------------------------------------------------------------

    Chronic non-cancer RfC and reference dose (RfD) values represent 
chronic exposure levels that are intended to be health-protective 
levels. Specifically, these values provide an estimate (with 
uncertainty spanning perhaps an order of magnitude) of a continuous 
inhalation exposure (RfC) or a daily oral exposure (RfD) to the human 
population (including sensitive subgroups) that is likely to be without 
an appreciable risk of deleterious effects during a lifetime. To derive 
values that are intended to be ``without appreciable risk,'' the 
methodology relies upon an uncertainty factor (UF) approach (U.S. EPA, 
1993 and 1994), which considers uncertainty, variability, and gaps in 
the available data. The UF are applied to derive reference values that 
are intended to protect against appreciable risk of deleterious 
effects. The UF are commonly default values,\19\ e.g., factors of 10 or 
3, used in the absence of compound-specific data; where data are 
available, UF may also be developed using compound-specific 
information. When data are limited, more assumptions are needed and 
more UF are used. Thus, there may be a greater tendency to overestimate 
risk in the sense that further study might support development of 
reference values that are higher (i.e., less potent) because fewer 
default assumptions are needed. However, for some pollutants, it is 
possible that risks may be underestimated.
---------------------------------------------------------------------------

    \19\ According to the NRC report, ``Science and Judgment in Risk 
Assessment'' (NRC, 1994) ``[Default] options are generic approaches, 
based on general scientific knowledge and policy judgment, that are 
applied to various elements of the risk assessment process when the 
correct scientific model is unknown or uncertain.'' The 1983 NRC 
report, ``Risk Assessment in the Federal Government: Managing the 
Process,'' defined default option as ``the option chosen on the 
basis of risk assessment policy that appears to be the best choice 
in the absence of data to the contrary'' (NRC, 1983a, p. 63). 
Therefore, default options are not rules that bind the Agency; 
rather, the Agency may depart from them in evaluating the risks 
posed by a specific substance when it believes this to be 
appropriate. In keeping with the EPA's goal of protecting public 
health and the environment, default assumptions are used to ensure 
that risk to chemicals is not underestimated (although defaults are 
not intended to overtly overestimate risk). See EPA, ``An 
Examination of EPA Risk Assessment Principles and Practices,'' EPA/
100/B-04/001, 2004, available at https://nctc.fws.gov/resources/course-resources/pesticides/Risk%20Assessment/Risk%20Assessment%20Principles%20and%20Practices.pdf.
---------------------------------------------------------------------------

    While collectively termed ``UF,'' these factors account for a 
number of different quantitative considerations when using observed 
animal (usually rodent) or human toxicity data in the development of 
the RfC. The UF are intended to

[[Page 95822]]

account for: (1) Variation in susceptibility among the members of the 
human population (i.e., inter-individual variability); (2) uncertainty 
in extrapolating from experimental animal data to humans (i.e., 
interspecies differences); (3) uncertainty in extrapolating from data 
obtained in a study with less-than-lifetime exposure (i.e., 
extrapolating from sub-chronic to chronic exposure); (4) uncertainty in 
extrapolating the observed data to obtain an estimate of the exposure 
associated with no adverse effects; and (5) uncertainty when the 
database is incomplete or there are problems with the applicability of 
available studies.
    Many of the UF used to account for variability and uncertainty in 
the development of acute reference values are quite similar to those 
developed for chronic durations, but they more often use individual UF 
values that may be less than 10. The UF are applied based on chemical-
specific or health effect-specific information (e.g., simple irritation 
effects do not vary appreciably between human individuals, hence a 
value of 3 is typically used), or based on the purpose for the 
reference value (see the following paragraph). The UF applied in acute 
reference value derivation include: (1) Heterogeneity among humans; (2) 
uncertainty in extrapolating from animals to humans; (3) uncertainty in 
lowest observed adverse effect (exposure) level to no observed adverse 
effect (exposure) level adjustments; and (4) uncertainty in accounting 
for an incomplete database on toxic effects of potential concern. 
Additional adjustments are often applied to account for uncertainty in 
extrapolation from observations at one exposure duration (e.g., 4 
hours) to derive an acute reference value at another exposure duration 
(e.g., 1 hour).
    Not all acute reference values are developed for the same purpose, 
and care must be taken when interpreting the results of an acute 
assessment of human health effects relative to the reference value or 
values being exceeded. Where relevant to the estimated exposures, the 
lack of short-term dose-response values at different levels of severity 
should be factored into the risk characterization as potential 
uncertainties.
    For a group of compounds that are unspeciated (e.g., glycol 
ethers), we conservatively use the most protective reference value of 
an individual compound in that group to estimate risk. Similarly, for 
an individual compound in a group (e.g., ethylene glycol diethyl ether) 
that does not have a specified reference value, we also apply the most 
protective reference value from the other compounds in the group to 
estimate risk.

B. How did we consider the risk results in making decisions for this 
proposal?

    As discussed in section II.A of this preamble, in evaluating and 
developing standards under CAA section 112(f)(2), we apply a two-step 
process to address residual risk. In the first step, the EPA determines 
whether risks are acceptable. This determination ``considers all health 
information, including risk estimation uncertainty, and includes a 
presumptive limit on maximum individual lifetime [cancer] risk (MIR) 
\20\ of approximately [1-in-10 thousand] [i.e., 100-in-1 million].'' 54 
FR 38045, September 14, 1989. If risks are unacceptable, the EPA must 
determine the emissions standards necessary to bring risks to an 
acceptable level without considering costs. In the second step of the 
process, the EPA considers whether the emissions standards provide an 
ample margin of safety ``in consideration of all health information, 
including the number of persons at risk levels higher than 
approximately 1-in-1 million, as well as other relevant factors, 
including costs and economic impacts, technological feasibility, and 
other factors relevant to each particular decision.'' Id. The EPA must 
promulgate emission standards necessary to provide an ample margin of 
safety. After conducting the ample margin of safety analysis, we 
consider whether a more stringent standard is necessary to prevent, 
taking into consideration, costs, energy, safety, and other relevant 
factors, an adverse environmental effect.
---------------------------------------------------------------------------

    \20\ Although defined as ``maximum individual risk,'' MIR refers 
only to cancer risk. MIR, one metric for assessing cancer risk, is 
the estimated risk were an individual exposed to the maximum level 
of a pollutant for a lifetime.
---------------------------------------------------------------------------

    In past residual risk actions, the EPA considered a number of human 
health risk metrics associated with emissions from the categories under 
review, including the MIR, the number of persons in various risk 
ranges, cancer incidence, the maximum non-cancer HI and the maximum 
acute non-cancer hazard. See, e.g., 72 FR 25138, May 3, 2007; and 71 FR 
42724, July 27, 2006. The EPA considered this health information for 
both actual and allowable emissions. See, e.g., 75 FR 65068, October 
21, 2010; 75 FR 80220, December 21, 2010; 76 FR 29032, May 19, 2011. 
The EPA also discussed risk estimation uncertainties and considered the 
uncertainties in the determination of acceptable risk and ample margin 
of safety in these past actions. The EPA considered this same type of 
information in support of this action.
    The Agency is considering these various measures of health 
information to inform our determinations of risk acceptability and 
ample margin of safety under CAA section 112(f). As explained in the 
Benzene NESHAP, ``the first step judgment on acceptability cannot be 
reduced to any single factor'' and, thus, ``[t]he Administrator 
believes that the acceptability of risk under [previous] section 112 is 
best judged on the basis of a broad set of health risk measures and 
information.'' 54 FR 38046, September 14, 1989. Similarly, with regard 
to the ample margin of safety determination, ``the Agency again 
considers all of the health risk and other health information 
considered in the first step. Beyond that information, additional 
factors relating to the appropriate level of control will also be 
considered, including cost and economic impacts of controls, 
technological feasibility, uncertainties, and any other relevant 
factors.'' Id.
    The Benzene NESHAP approach provides flexibility regarding factors 
the EPA may consider in making determinations and how the EPA may weigh 
those factors for each source category. In responding to comment on our 
policy under the Benzene NESHAP, the EPA explained that:

    ``[t]he policy chosen by the Administrator permits consideration 
of multiple measures of health risk. Not only can the MIR figure be 
considered, but also incidence, the presence of non-cancer health 
effects, and the uncertainties of the risk estimates. In this way, 
the effect on the most exposed individuals can be reviewed as well 
as the impact on the general public. These factors can then be 
weighed in each individual case. This approach complies with the 
Vinyl Chloride mandate that the Administrator ascertain an 
acceptable level of risk to the public by employing [her] expertise 
to assess available data. It also complies with the Congressional 
intent behind the CAA, which did not exclude the use of any 
particular measure of public health risk from the EPA's 
consideration with respect to CAA section 112 regulations, and 
thereby implicitly permits consideration of any and all measures of 
health risk which the Administrator, in [her] judgment, believes are 
appropriate to determining what will `protect the public health'.''

    See 54 FR at 38057, September 14, 1989. Thus, the level of the MIR 
is only one factor to be weighed in determining acceptability of risks. 
The Benzene NESHAP explained that ``an MIR of approximately one in 10 
thousand should ordinarily be the upper end of the range of 
acceptability. As risks increase above this benchmark, they become 
presumptively less acceptable under CAA section 112, and would be 
weighed with the other health risk

[[Page 95823]]

measures and information in making an overall judgment on 
acceptability. Or, the Agency may find, in a particular case, that a 
risk that includes MIR less than the presumptively acceptable level is 
unacceptable in the light of other health risk factors.'' Id. at 38045. 
Similarly, with regard to the ample margin of safety analysis, the EPA 
stated in the Benzene NESHAP that: ``EPA believes the relative weight 
of the many factors that can be considered in selecting an ample margin 
of safety can only be determined for each specific source category. 
This occurs mainly because technological and economic factors (along 
with the health-related factors) vary from source category to source 
category.'' Id. at 38061. We also consider the uncertainties associated 
with the various risk analyses, as discussed earlier in this preamble, 
in our determinations of acceptability and ample margin of safety.
    The EPA notes that it has not considered certain health information 
to date in making residual risk determinations. At this time, we do not 
attempt to quantify those HAP risks that may be associated with 
emissions from other facilities that do not include the source 
categories in question, mobile source emissions, natural source 
emissions, persistent environmental pollution, or atmospheric 
transformation in the vicinity of the sources in these categories.
    The Agency understands the potential importance of considering an 
individual's total exposure to HAP in addition to considering exposure 
to HAP emissions from the source category and facility. We recognize 
that such consideration may be particularly important when assessing 
non-cancer risks, where pollutant-specific exposure health reference 
levels (e.g., RfCs) are based on the assumption that thresholds exist 
for adverse health effects. For example, the Agency recognizes that, 
although exposures attributable to emissions from a source category or 
facility alone may not indicate the potential for increased risk of 
adverse non-cancer health effects in a population, the exposures 
resulting from emissions from the facility in combination with 
emissions from all of the other sources (e.g., other facilities) to 
which an individual is exposed may be sufficient to result in increased 
risk of adverse non-cancer health effects. In May 2010, the SAB advised 
the EPA ``that RTR assessments will be most useful to decision makers 
and communities if results are presented in the broader context of 
aggregate and cumulative risks, including background concentrations and 
contributions from other sources in the area.'' \21\
---------------------------------------------------------------------------

    \21\ The EPA's responses to this and all other key 
recommendations of the SAB's advisory on RTR risk assessment 
methodologies (which is available at: http://yosemite.epa.gov/sab/
sabproduct.nsf/4AB3966E263D943A8525771F00668381/$File/EPA-SAB-10-
007-unsigned.pdf) are outlined in a memorandum to this rulemaking 
docket from David Guinnup titled, ``EPA's Actions in Response to the 
Key Recommendations of the SAB Review of RTR Risk Assessment 
Methodologies.''
---------------------------------------------------------------------------

    In response to the SAB recommendations, the EPA is incorporating 
cumulative risk analyses into its RTR risk assessments, including those 
reflected in this proposal. The Agency is: (1) Conducting facility-wide 
assessments, which include source category emission points, as well as 
other emission points within the facilities; (2) considering sources in 
the same category whose emissions result in exposures to the same 
individuals; and (3) for some persistent and bioaccumlative pollutants, 
analyzing the ingestion route of exposure. In addition, the RTR risk 
assessments have always considered aggregate cancer risk from all 
carcinogens and aggregate non-cancer HI from all non-carcinogens 
affecting the same target organ system.
    Although we are interested in placing source category and facility-
wide HAP risks in the context of total HAP risks from all sources 
combined in the vicinity of each source, we are concerned about the 
uncertainties of doing so. Because of the contribution to total HAP 
risk from emission sources other than those that we have studied in 
depth during this RTR review, such estimates of total HAP risks would 
have significantly greater associated uncertainties than the source 
category or facility-wide estimates. Such aggregate or cumulative 
assessments would compound those uncertainties, making the assessments 
too unreliable.

C. How did we perform the technology review?

    Our technology review focused on the identification and evaluation 
of developments in practices, processes, and control technologies that 
have occurred since the MACT standards were promulgated. Where we 
identified such developments, in order to inform our decision of 
whether it is ``necessary'' to revise the emissions standards, we 
analyzed the technical feasibility of applying these developments and 
the estimated costs, energy implications, non-air environmental 
impacts, as well as considering the emission reductions. We also 
considered the appropriateness of applying controls to new sources 
versus retrofitting existing sources.
    Based on our analyses of the available data and information, we 
identified potential developments in practices, processes, and control 
technologies. For this exercise, we considered any of the following to 
be a ``development'':
     Any add-on control technology or other equipment that was 
not identified and considered during development of the original MACT 
standards;
     Any improvements in add-on control technology or other 
equipment (that were identified and considered during development of 
the original MACT standards) that could result in additional emissions 
reduction;
     Any work practice or operational procedure that was not 
identified or considered during development of the original MACT 
standards;
     Any process change or pollution prevention alternative 
that could be broadly applied to the industry and that was not 
identified or considered during development of the original MACT 
standards; and
     Any significant changes in the cost (including cost 
effectiveness) of applying controls (including controls the EPA 
considered during the development of the original MACT standards).
    In addition to reviewing the practices, processes, and control 
technologies that were considered at the time we originally developed 
(or last updated) the NESHAP, we reviewed a variety of data sources in 
our investigation of potential practices, processes, or controls to 
consider. Among the sources we reviewed were the NESHAP for various 
industries that were promulgated since the MACT standards being 
reviewed in this action. We reviewed the regulatory requirements and/or 
technical analyses associated with these regulatory actions to identify 
any practices, processes, and control technologies considered in these 
efforts that could be applied to emission sources in the Manufacturing 
of Nutritional Yeast source category, as well as the costs, non-air 
impacts, and energy implications associated with the use of these 
technologies. Additionally, we requested information from facilities 
regarding developments in practices, processes, or control technology. 
Finally, we reviewed information from other sources, such as state and/
or local permitting agency databases and industry-supported databases.

[[Page 95824]]

IV. Analytical Results and Proposed Decisions

A. What are the results of the risk assessment and analyses?

    As described above, for the Manufacturing of Nutritional Yeast 
source category, we conducted an inhalation risk assessment for all HAP 
emitted. We present results of the risk assessment briefly below and in 
more detail in the 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 action.
1. Inhalation Risk Assessment Results
    Table 2 of this preamble provides a summary of the results of the 
inhalation risk assessment for the source category. As discussed in 
section III.A.2 of this preamble, we set MACT-allowable HAP emission 
levels at nutritional yeast manufacturing facilities equal to actual 
emissions. For more detail about the MACT-allowable emission levels, 
see 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.

                                       Table 2--Nutritional Yeast Manufacturing Inhalation Risk Assessment Results
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                    Maximum individual     Estimated population      Estimated annual      Maximum chronic  non-     Maximum screening
                                    cancer risk  (in 1     at  increased risk of     cancer incidence        cancer  TOSHI \3\     acute non-cancer  HQ
                                       million) \2\          cancer >= 1-in-1        (cases per year)    ------------------------           \4\
                                 ------------------------         Million        ------------------------                        -----------------------
    Number of facilities \1\                             ------------------------                          Based on    Based on
                                   Based on    Based on    Based on    Based on    Based on    Based on     actual     allowable   Based on    Based on
                                    actual     allowable    actual     allowable    actual     allowable   emissions   emissions    actual     allowable
                                   emissions   emissions   emissions   emissions   emissions   emissions   level \2\     level     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 =     HQREL =
                                                                                                                                        0.2        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 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 HQ values. HQ values
  shown use the lowest available acute threshold value, which in most cases is the 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 this preamble for explanation of acute dose-response values.

    The results of the inhalation risk modeling using actual emissions 
data, as shown in Table 2 of this preamble, indicate that the maximum 
lifetime individual cancer risk could be up to 2-in-1 million, the 
maximum chronic non-cancer TOSHI value could be up to 0.08, and the 
maximum off-facility site acute HQ value could be up to 0.2. The total 
estimated national cancer incidence from these facilities based on 
actual emission levels is 0.0009 excess cancer cases per year or 1 case 
in every 1,100 years.
2. Acute Risk Results
    Table 2 of this preamble shows the acute risk results for the 
Manufacturing of Nutritional Yeast source category. The screening 
analysis for acute impacts was based on an industry specific multiplier 
of 1.2, to estimate the peak emission rates from the average rates. For 
more detailed acute risk results, refer to the draft 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 
action.
3. Multi-Pathway Risk Screening Results
    There are no PB-HAP emitted by facilities in this source category. 
Therefore, we do not expect any human health multi-pathway risks as a 
result of emissions from this source category.
4. Environmental Risk Screening Results
    The emissions data for the Manufacturing of Nutritional Yeast 
source category indicate that sources within this source category do 
not emit any of the seven pollutants that we identified as 
``environmental HAP,'' as discussed earlier in this preamble. 
Additionally, the processes and materials used in the source category 
typically do not emit any of the seven environmental HAP. Also, we are 
unaware of any adverse environmental effect caused by emissions of HAP 
that are emitted by this source category (acetaldehyde). Therefore, we 
do not expect an adverse environmental effect as a result of HAP 
emissions from this source category.
5. Facility-Wide Risk Results
    As explained in section III.A.7 of this preamble, we did not 
perform a separate facility-wide risk assessment because we expect 
facility-wide risks to be equal to the risks we assessed for this 
source category.
6. What demographic groups might benefit from this regulation?
    To examine the potential for any environmental justice issues that 
might be associated with the source category, we performed a 
demographic analysis, which is an assessment of risks to individual 
demographic groups within the population near the four nutritional 
yeast manufacturing facilities that are subject to the NESHAP. In this 
analysis, we evaluated the distribution of HAP-related cancer risks and 
non-cancer hazards from the nutritional yeast manufacturing facilities 
across different social, demographic, and economic groups within the 
populations living near facilities identified as having the highest 
risks. The methodology and the results of the demographic analyses are 
included in a technical report, ``Risk and Technology Review--Analysis 
of Socio-Economic Factors for Populations Living Near Nutritional Yeast 
Manufacturing Facilities,'' available in the docket for this action.
    The analysis indicates that the minority population living within 
50 km (1,700,000 people, of whom 41 percent are minority) and within 5 
km (131,567 people, of whom 68 percent are minority) of the four 
nutritional yeast manufacturing facilities is greater than the minority 
population found nationwide (28 percent). The specific

[[Page 95825]]

demographics of the population within 5 and 50 km of the facilities 
indicate potential disparities in risks 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 are exposed to a cancer risk greater than or 
equal to 1-in-1 million, and the highest cancer risk for these 
individuals is less than 2-in-1 million. Of these 750 persons, 100 
percent of them are defined as minority. When examining the noncancer 
risks surrounding these facilities, no one is predicted to have a 
chronic non-cancer TOSHI greater than 1.

B. What are our proposed decisions regarding risk acceptability, ample 
margin of safety, and adverse environmental effects?

1. Risk Acceptability
    As noted in section III.B of this preamble, we weigh all health 
risk factors in our risk acceptability determination, including the 
cancer MIR, the number of persons in various cancer and non-cancer risk 
ranges, cancer incidence, the maximum non-cancer TOSHI, the maximum 
acute non-cancer HQ, the extent of non-cancer risks, the potential for 
adverse environmental effects, the distribution of cancer and non-
cancer risks in the exposed population, and risk estimation 
uncertainties (54 FR 38044, September 14, 1989).
    For the Manufacturing of Nutritional Yeast source category, the 
risk analysis indicates that the cancer risks to the individual most 
exposed could be up to 2-in-1 million due to actual emissions and up to 
2-in-1 million based on allowable emissions. As explained in section 
III.A.2 of this preamble, we determined that actual emissions provide 
an accurate representation of maximum emissions from the source 
category and used the actual emissions in both steps of the risk 
assessment (i.e., determination of risk based on actual and MACT-
allowable emissions). These risks are considerably less than 100-in-1 
million, which is the presumptive upper limit of acceptable risk. The 
risk analysis also shows very low cancer incidence (0.0009 cases per 
year), as well as no potential for adverse chronic or multi-pathway 
health effects. In addition, the risk assessment indicates no 
significant potential for multi-pathway health effects or adverse 
environmental effects. The acute non-cancer risks based on actual and 
allowable emissions are all below an HQ of 1. Therefore, we find there 
is little potential concern of acute non-cancer health impacts from 
actual and allowable emissions.
    Considering all of the health risk information and factors 
discussed above, including the uncertainties discussed in section 
III.A.8 of this preamble, we propose to find that the risks from the 
Manufacturing of Nutritional Yeast source category are acceptable.
2. Ample Margin of Safety Analysis
    Although we are proposing that the risks from the Manufacturing of 
Nutritional Yeast source category are acceptable, risk estimates for 
approximately 750 individuals in the exposed population are above 1-in-
1 million at the actual and MACT-allowable emissions levels. 
Consequently, we further considered whether the MACT standards for the 
Manufacturing of Nutritional Yeast source category provide an ample 
margin of safety to protect public health. In this ample margin of 
safety analysis, we investigated available emissions control options 
that might reduce the risk from the source category. We considered this 
information along with all of the health risks and other health 
information considered in our determination of risk acceptability.
    As discussed in section IV.C of this preamble, during the 
technology review for this source category, we evaluated two control 
technologies for reducing acetaldehyde emissions from fermenters at 
nutritional yeast facilities: Thermal oxidizers and wet (packed bed) 
scrubbers. Thermal oxidizers have the potential to reduce total 
acetaldehyde emissions from this source category by 11 tpy to 36 tpy, 
for a total of 90 tpy for the industry, but would also lead to 
increases in energy use and emissions of approximately 89 tpy of 
nitrogen oxides (NOX) from these facilities. The cost 
effectiveness for thermal oxidizers varied per facility, with an 
average cost of $56,000 per ton of acetaldehyde reduced. The average 
cost effectiveness for packed bed scrubbers was $74,000 per ton of 
acetaldehyde per facility. The use of packed bed scrubbers would also 
lead to additional environmental impacts, such as increased energy and 
water usage, as well as the need to use and dispose of solvents. These 
cost-effectiveness values are significantly higher than values that we 
have historically deemed to be cost effective for organic HAP in other 
NESHAP. Due to the additional environmental impacts that would be 
imposed and the low level of current risk, along with the substantial 
costs associated with these options, we are proposing that additional 
emissions controls for this source category are not necessary to 
provide an ample margin of safety.
3. Environmental Effects
    We did not identify emissions of any of the seven environmental HAP 
included in our environmental risk screening, and are unaware of any 
adverse environmental effects caused by HAP emitted by this source 
category (acetaldehyde). Therefore, we do not expect there to be an 
adverse environmental effect as a result of HAP emissions from this 
source category and we are proposing that it is not necessary to set a 
more stringent standard to prevent, taking into consideration costs, 
energy, safety, and other relevant factors, an adverse environmental 
effect.

C. What are the results and proposed decisions based on our technology 
review?

    In order to fulfill our obligations under CAA section 112(d)(6), we 
conducted a technology review to identify developments in practices, 
processes, and control technologies that may advise revisions to the 
current NESHAP standards applicable to the Manufacturing of Nutritional 
Yeast source category (i.e., 40 CFR part 63, subpart CCCC). In 
conducting our technology review, we utilized the RBLC database, 
reviewed title V permits for each nutritional yeast facility, and 
reviewed regulatory actions related to emissions controls at similar 
sources that could be applicable to nutritional yeast manufacturing 
facilities.
    After reviewing information from the sources above, we identified 
two control technologies for further evaluation that are technically 
feasible for use at nutritional yeast facilities: thermal oxidizers and 
wet scrubbers.\22\ These control technologies were identified both in 
the RBLC database and in a review of the miscellaneous organic chemical 
manufacturing NESHAP (MON). The RBLC database contains multiple sources 
with similar production processes as nutritional yeast manufacturing 
facilities that employ thermal oxidizers or wet scrubbers, e.g., 
fermenters at ethanol facilities. We also identified the MON in 
particular as being a potentially useful analog for manufacturing of 
nutritional yeast because the MON regulates

[[Page 95826]]

emissions from ethanol fermenters (the same sources identified in the 
RBLC) that are located at facilities that are major sources of HAP 
emissions. Our review of this rule revealed that facilities use thermal 
oxidizers as a control technology to comply with the process vent 
emission limits in the MON.
---------------------------------------------------------------------------

    \22\ Additional information about this determination is 
documented in the memorandum, ``Technology Review for the 
Manufacturing of Nutritional Yeast Source Category,'' which is 
available in the docket for this action.
---------------------------------------------------------------------------

    After identifying control technologies that are technically 
feasible for reducing acetaldehyde emissions from nutritional yeast 
fermenters, we then evaluated the costs and emissions reductions 
associated with installing regenerative thermal oxidizers (RTOs) and 
packed bed scrubbers at each of the four nutritional yeast facilities. 
The total capital investment to install RTOs ranged from $2 million to 
$6.9 million per facility for a total of approximately $14.9 million 
for the industry. Annual costs for each facility were approximately 
$0.8 million to $2.2 million, for a total of $5.2 million per year for 
the industry. Applying a control efficiency of 98 percent, acetaldehyde 
emissions for each facility would be reduced by approximately 11 tpy to 
36 tpy, for a total of 90 tpy for the industry. To install RTOs at each 
facility, the resulting cost effectiveness ranged from $32,000 to 
$90,000 per ton of acetaldehyde reduced. Furthermore, use of RTOs would 
result in increased energy use and NOX emissions of 
approximately 89 tpy from nutritional yeast manufacturing facilities. 
Additional information about the assumptions and methodologies used in 
these calculations is documented in the memorandum, ``Technology Review 
for the Manufacturing of Nutritional Yeast Source Category,'' which is 
available in the docket for this action.
    The total capital investment to install packed bed scrubbers on 
fermenters ranged from $3 million to $11.6 million per facility for a 
total of about $24.5 million for the industry. Annual costs for each 
facility were approximately $0.8 million to $2.5 million, for a total 
of $5.8 million per year for the industry. Applying a control 
efficiency of 85 percent, acetaldehyde emissions for each facility 
would be reduced by approximately 9.4 tpy to 31 tpy, for a total of 78 
tpy for the industry. To install packed bed scrubbers at each facility, 
the resulting cost effectiveness ranged from $43,000 to $110,000 per 
ton of acetaldehyde reduced. Furthermore, the use of packed bed 
scrubbers would lead to increased energy usage and other environmental 
impacts, such as the usage and disposal of water and caustic solutions 
(e.g., sodium hydroxide). These cost-effectiveness values are 
significantly higher than values that we have historically deemed to be 
cost effective for organic HAP in other NESHAP. Additional information 
about the assumptions and methodologies used in these calculation is 
documented in the memorandum, ``Technology Review for the Manufacturing 
of Nutritional Yeast Source Category,'' which is available in the 
docket for this action.
    Considering the high costs per ton of acetaldehyde reduced and 
potential adverse environmental impacts 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 
conclude that changes to the fermenter emission limits are not 
warranted pursuant to CAA section 112(d)(6). We solicit comment on our 
proposed decision.

D. What other actions are we proposing?

    We are proposing revisions to the malfunction provisions of the 
MACT rule in order to ensure that they are consistent with the Court 
decision in Sierra Club v. EPA, 551 F. 3d 1019 (D.C. Cir. 2008), which 
vacated two provisions that exempted sources from the requirement to 
comply with otherwise applicable CAA section 112(d) emission standards 
during periods of startup, shutdown, and malfunction (SSM). We are 
proposing revisions to the form of the VOC emission limits for 
fermenters to address this issue. We also are proposing various other 
changes to testing, monitoring, recordkeeping, and reporting 
requirements. Our analyses and proposed changes related to these issues 
are presented below.
1. Fermenter VOC Emission Limits
    The Manufacturing of Nutritional Yeast NESHAP currently requires 
that 98 percent of all batches meet the fermenter batch average VOC 
emission limits, on a 12-month rolling basis. However, this requirement 
allows 2 percent of the batches to exceed the standard. This 
formulation of the standard is in direct conflict with the statutory 
requirement that emission standards apply at all times, as discussed in 
Sierra Club v. EPA. 551 F. 3d 1019 (D.C. Cir. 2008). As a result, the 
EPA reviewed the current fermenter VOC emission limits and is proposing 
revisions to the form of the standard. We are proposing to revise the 
form of the standard in Table 1 to 40 CFR part 63, subpart CCCC such 
that each batch must meet the existing VOC concentration limits (300 
ppmv for stock fermentation, 200 ppmv for first generation 
fermentation, and 100 ppmv for trade fermentation), which is referred 
to as the ``Batch Option'' in the proposed revisions.
    In recognition that the yeast manufacturing process is biological 
and does not produce the exact same level of emissions from every 
batch, the proposed amendments also include an alternative compliance 
method in Table 1 to 40 CFR part 63, subpart CCCC that allows 
facilities to average the VOC concentration data from all batches 
within each fermentation stage over a rolling 12-month period. When 
manufacturing yeast, increased acetaldehyde levels indicate 
inefficiencies in the manufacturing process; consequently, facilities 
have a financial incentive to reduce emissions as much as possible 
through process controls. However, to ensure that the averaging method 
will be at least as stringent as the emission standards without 
averaging, we are proposing a 5-percent discount factor in the VOC 
emission limit for each stage, i.e., 285 ppmv for stock fermentation, 
190 ppmv for first generation fermentation, and 95 ppmv for trade 
fermentation. For example, if this alternative option is selected, all 
batch average VOC concentration data for the trade fermentation stage 
in a 12-month period must be averaged together and this average must 
not exceed 95 ppmv VOC instead of the limit of 100 ppmv VOC for 
individual batches. This option is referred to as the ``Average 
Option'' in the proposed revisions to 40 CFR part 63, subpart CCCC. 
This alternative provides sources with flexibility on ways to comply 
with the standard, while maintaining the sources' accountability for 
meeting health and environmental goals and maintaining the 
enforceability of the emission limits by regulatory authorities. We 
expect that allowing facilities to average emissions over the period of 
1 year will provide flexibility for changes in production over time 
without allowing for wide-ranging fluctuations in HAP emissions. The 
use of a rolling annual calculation period with semiannual compliance 
reports, including monthly updates of the annual average emission 
calculations, protects against emission peaks so health and welfare 
effects are avoided. This proposed alternative method of demonstrating 
compliance also minimizes the recordkeeping and reporting impacts of 
the changes for facilities and regulatory authorities, since the 
current rule requires the same compliance periods. The EPA requests

[[Page 95827]]

comment on the proposed revisions to the form of the fermenter VOC 
emission limits. Additionally, we request comment on whether it is 
appropriate to use a discount factor and what value between 0 and 10 
percent should be selected for the discount factor.
    We are also proposing changes to 40 CFR 63.2171 and Table 4 to 40 
CFR part 63, subpart CCCC that specify the procedures facilities must 
use to demonstrate continuous compliance with either of the two 
proposed forms of the emission limits in Table 1 to 40 CFR part 63, 
subpart CCCC. The proposed changes require facilities to immediately 
begin demonstrating continuous compliance with one of the two proposed 
forms of the emission limits (i.e., the Average Option or the Batch 
Option) upon the effective date of the final rule.
    For the proposed Average Option, the changes to 40 CFR 63.2171 and 
Table 4 to 40 CFR part 63, subpart CCCC require facilities to calculate 
compliance on a monthly basis using data from every batch produced 
during the previous 12 months. The proposed amendments to 40 CFR 
63.2150 remove the exemption that allows facilities to exceed emissions 
during periods of malfunction. The proposed amendments to 40 CFR 
63.2170 retain the provision that data recorded during monitoring 
malfunctions, associated repairs, and required quality assurance or 
quality control activities must not be used to report emissions. 
Therefore, data from batches that were produced during periods of 
malfunctions over the past 12 months, other than those related to the 
monitoring system, must now be included in the calculations used to 
determine compliance. Additionally, instead of calculating a single 
determination of compliance based on the emissions from all batches 
regardless of fermentation stage, facilities must now determine 
compliance for batches within each of the three fermentation stages 
that have specific emission limits in Table 1 to 40 CFR part 63, 
subpart CCCC. Based on information collected during the site visits, 
the EPA expects that facilities have the necessary data available to 
make these changes to the methods used to determine compliance upon 
promulgation of the final rule.
    For the proposed Batch Option, the changes to 40 CFR 63.2171 and 
Table 4 to 40 CFR part 63, subpart CCCC require facilities to 
demonstrate that the average VOC concentration for each individual 
batch produced during a semiannual compliance period did not exceed the 
applicable emission limits. As noted above, this now includes data from 
batches that were produced during periods of malfunctions, other than 
malfunctions related to the monitoring system. Based on information 
collected during the site visits, the EPA expects that facilities have 
the necessary data available to make these changes to the methods used 
to determine compliance upon promulgation of the final rule.
    The EPA requests comment on the proposed timeframe to demonstrate 
compliance using the revised form of the emission limits upon 
promulgation of the final rule and the availability of data necessary 
to comply within this timeframe.

2. Testing, Monitoring, Recordkeeping, and Reporting Requirements

    We propose to revise the rule's testing, monitoring, recordkeeping, 
and reporting requirements in five ways: (1) Owners or operators must 
demonstrate compliance by using a VOC continuous emission monitoring 
system (CEMS) to determine the VOC concentration in the fermenter 
exhaust (i.e., we are removing the option to monitor brew ethanol and 
calculate VOC concentration using a correlation); (2) owners or 
operators may not use a gas chromatographic (GC) CEMS to monitor VOC 
concentration; (3) owners or operators must have valid CEMS data from 
each hour of the entire batch monitoring period and report periods of 
missing data as deviations; (4) owners or operators of VOC CEMS must 
conduct annual performance tests (relative accuracy test audits 
(RATAs)) using Procedure 1 of appendix F to part 60 to evaluate the 
performance of the installed VOC CEMS over an extended period of time; 
and (5) owners or operators must provide compliance reports 
electronically.
a. Proposed Removal of the Option to Monitor Brew Ethanol
    Subpart CCCC of 40 CFR part 63 currently allows owners or operators 
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 limits. We are 
proposing to revise the requirements of 40 CFR 63.2166 and 63.2171 and 
Table 3 and Table 4 to 40 CFR part 63, subpart CCCC to remove the 
option to monitor brew ethanol.
    Currently, one facility demonstrates compliance by monitoring brew 
ethanol and submits annual reports showing the results of performance 
testing and development of the correlation equation for each 
fermentation stage.\23\ We reviewed reports for the past 5 years (2012-
2016) and found that individual equations showed strong correlations 
with the data obtained during the applicable performance tests. 
However, the reports also showed a high level of variability between 
the equations for each fermentation stage across the 5-year period. A 
fermentation stage characterized by a correlation equation with a 
higher slope results in higher VOC emissions estimates per percent 
ethanol measured in the brew, while a correlation equation with a lower 
slope results in lower VOC emissions estimates per percent ethanol in 
the brew. Therefore, applying equations with different slopes to the 
same brew ethanol concentration yields different estimates of VOC 
emissions. A review of reports from the previous 5 years shows a high 
level of inconsistency in the amount of VOC emissions estimated for a 
particular brew ethanol percentage each year. The practical effect of 
these variations is that estimates of VOC concentrations from a given 
fermentation stage can almost double for a single brew ethanol 
concentration, depending on the correlation equation used. This has the 
greatest effect on concentrations at the higher end of the normal range 
for each stage of fermentation. To illustrate the effect, we selected a 
brew ethanol concentration at the higher end of the range of brew 
ethanol concentration data for each of the fermentation stages and 
determined the corresponding range of VOC concentrations, based on the 
most recent 5 years of correlation data. The results showed that for 
each fermentation stage, a given brew ethanol concentration would meet 
the compliance emission limit in some years, but greatly exceed it in 
other years; see Table 3 of this preamble. The 5 years of correlation 
data are presented in the memorandum, ``Brew Ethanol Correlation Review 
for the Manufacturing of Nutritional Yeast Source Category,'' which is 
available in the docket for this action.
---------------------------------------------------------------------------

    \23\ The correlation equation is used to estimate the 
concentration of VOC in the fermenter exhaust for a given percentage 
of ethanol (measured in the fermenter brew).

[[Page 95828]]



     Table 3--Range of VOC Concentration for Each Fermentation Stage, Based on Brew Ethanol Correlation Data
----------------------------------------------------------------------------------------------------------------
                                                                                                   VOC emission
                                                Brew ethanol    VOC concentration range, ppmv as    limitation,
              Fermentation stage               concentration,               propane                   ppmv as
                                                      %                                             propane\1\
----------------------------------------------------------------------------------------------------------------
Third-to-last................................            0.25  188 to 372.......................             300
Second-to-last...............................            0.20  109 to 227.......................             200
Last.........................................           0.125  73 to 170........................             100
----------------------------------------------------------------------------------------------------------------
\1\ As specified in Table 1 to 40 CFR part 63, subpart CCCC.

    As mentioned above, individual equations typically exhibited strong 
statistical correlations for the data used to develop them, which 
indicates that there is a relationship between VOC emissions and brew 
ethanol concentration for a given batch. However, the observed 
variability between equations indicates the correlation between VOC 
emissions and brew ethanol concentration is different for each batch. 
This means that the correlation developed for one batch may not be 
representative of the correlation between VOC emissions and brew 
ethanol concentration for any other batch. Given that estimates of VOC 
concentrations from a given fermentation stage can almost double for a 
single brew ethanol concentration, depending on the correlation 
equation used, a batch that appears to be in compliance could, in fact, 
be out of compliance.
    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. As noted on the site visits, the amount of 
oxygen does not vary significantly between batches. Fermenters are 
equipped with aeration systems, which operate at full capacity for 
every batch. In contrast, the composition of the sugar source can vary 
greatly from one batch to the next. Market factors (e.g., price, 
availability, competition) drive the purchase of sugar sources, such as 
molasses, throughout the year. Purchases are made frequently and there 
is some on-site storage, allowing operators of nutritional yeast 
manufacturing facilities to blend different materials together at 
times. While the composition of the mixture is optimized for yeast 
growth given the materials on hand at any given time, the specific 
composition fluctuates throughout the year. It is likely that the 
differences in composition of the sugar source for each batch explains 
much of the variance observed in the correlation equations analyzed 
above.
    In order to establish a reliable correlation between VOC emissions 
and brew ethanol for each batch, a new performance test would need to 
be conducted every time the sugar source changes. At facilities where 
the sugar source changes frequently, this requirement would pose a 
significant financial and logistic burden with results that were of 
limited applicability. In addition, it would create significant 
challenges for the regulatory authority responsible for enforcing the 
frequency and validity of the performance tests.
    Reliable emissions data are critical to ensuring compliance with 
the established emission limits, which is necessary to reduce the 
emissions of HAP and protect public health and the environment. 
Therefore, the EPA is proposing to remove the option to demonstrate 
compliance with the emission limits by monitoring brew ethanol, and to 
require all facilities to monitor fermenter exhaust using CEMS.
    We are proposing to allow facilities to continue to monitor brew 
ethanol for up to 1 year after the promulgation of any such proposed 
rule revisions. This transition period would help ensure continuous 
compliance with the emission limits while allowing time to install CEMS 
(see proposed 40 CFR 63.2171). Additionally, because no new facilities 
are currently under construction, we are proposing to remove 
requirements in 40 CFR 63.2160, 63.2166, 63.2180, and Table 3 to 40 CFR 
part 63, subpart CCCC related to the demonstration of initial 
compliance by monitoring brew ethanol. New affected sources would not 
be able to demonstrate initial compliance by monitoring brew ethanol.
    We are proposing to revise language in 40 CFR 63.2164 to reference 
a ``brew ethanol monitor'' and not a ``CEMS'' to monitor brew ethanol. 
CEMS is not the correct term to describe the monitoring device for brew 
ethanol. The term ``brew ethanol monitor'' is already defined in the 
current rule, and the proposed revisions correctly incorporate its use 
into the rule language.
    The EPA specifically requests comments on whether the option to 
demonstrate compliance by monitoring brew ethanol and developing a 
correlation to VOC concentration in the fermenter exhaust should be 
retained if performance tests to determine the correlation are 
conducted more frequently. Commenters should address the frequency of 
the correlation recalculation (using performance testing) needed to 
provide reliable emissions data that will consistently reflect accurate 
emissions for each batch and explain the basis for their conclusions.
b. Proposed Removal of GC CEMS
    The current rule allows the use of CEMS that generate a single 
combined response value for VOC (VOC CEMS) or that rely upon GC CEMS, 
if they are constructed and operated according to the applicable 
Performance Specification (PS) of 40 CFR part 60, appendix B, to 
monitor VOC emissions (40 CFR 63.2163). However, nutritional yeast 
manufacturing facilities emit a mixture of VOCs and the emission limits 
for these facilities are stated for total VOC (as opposed to specific 
VOC species). While VOC CEMS constructed and operated according to PS 8 
can measure total VOCs, GC CEMS constructed and operated according to 
PS 9 are suitable for measuring a few specific VOC species. Based on 
information collected during the site visits, we are not aware of any 
facilities currently using GC CEMS. Therefore, we propose to revise 40 
CFR 63.2163 to remove the option to use GC CEMS to monitor VOC 
concentration. The EPA requests comment on this proposed revision.
c. Proposed Collection of All Valid CEMS Data From the Entire Batch 
Monitoring Period.
    The current rule requires owners or operators who monitor fermenter 
exhaust to have valid CEMS data from at least 75 percent of the full 
hours over

[[Page 95829]]

the entire batch, and that a valid hour of data must have one data 
point for each 30-minute period. In the 15 years since the rule was 
promulgated, there have been continued improvements in CEMS reliability 
as well as a change in the data collection approach. In many NESHAP, 
CEMS are required to collect, process, and report results of the 
sampling at least once every 15 minutes. Some CEMS are able to complete 
the process cycle more often than every 15 minutes. Moreover, many 
regulatory authorities no longer have minimum valid data requirements 
for emissions data. Rather, each source owner or operator is expected 
to collect as much data as possible and to report periods of missing 
data, along with the reason for such periods, to the regulatory 
authority who determines what, if any, follow-up action would be 
required.\24\ Such an approach is included in our recently promulgated 
Mercury Air Toxics Standard (MATS). MATS requires owners or operators 
to collect data at all times the electric generation unit (EGU) 
operates; failure to collect the required data is a deviation from 
monitoring requirements. EGU owners or operators are to describe, 
explain, and report deviations in ongoing compliance reports and to 
keep records of deviations.\25\
---------------------------------------------------------------------------

    \24\ See Indiana's Compliance Branch CEMS Guidance Manual, 
section 4.5 on page 19 of chapter 2, available at http://www.in.gov/idem/files/aircom_cems_chapter_2.pdf.
    \25\ See 40 CFR 63.10020(b), 10020(d), 10021(g), 10031(c)(9), 
and 10032(a)(4).
---------------------------------------------------------------------------

    We propose to revise 40 CFR 63.2163, 63.2170, 63.2181(c)(7), and 
63.2182(b)(9) to require owners or operators of nutritional yeast 
sources to follow this model. Owners or operators would be required to 
collect VOC concentration data at all times of batch operation. Failure 
to collect VOC concentration data would be a deviation of monitoring 
requirements and would trigger generation of a report identifying the 
periods during which data were not collected, a description of the 
deviation event, and an explanation as to why the deviation occurred. 
The owner or operator would also be required to maintain records of 
each deviation. In addition, owners or operators would report the hours 
of deviation, along with the hours of batch operation. Relying on 
reported information, regulatory authorities would determine what, if 
any, follow-up correction or enforcement action should occur. The EPA 
requests comment on this proposed revision and its incorporation into 
the rule.
d. Proposed Use of Procedure 1 of Appendix F to Part 60 for VOC CEMS
    The current rule requires owners or operators of nutritional yeast 
manufacturing facilities to monitor compliance using either VOC or GC 
CEMS. Additionally, the rule exempts owners or operators that use a VOC 
CEMS with a flame ionization analyzer from conducting the RATAs 
required by PS 8. As discussed in section IV.D.2.b of this preamble, we 
are proposing to remove the option to monitor compliance using a GC 
CEMS and the related installation requirements. The current rule 
requires owners or operators to install and certify VOC CEMS according 
to PS 8. Use of PS 8 ensures that the VOC CEMS has been installed 
properly, but it lacks ongoing quality assurance and quality control 
(QA/QC) procedures to ensure that a properly installed VOC CEMS 
continues to operate appropriately. Such procedures are included in 
Procedure 1 of appendix F to part 60. In order to clarify the minimum 
requirements for owners or operators to ensure their VOC CEMS continue 
to produce valid data, we propose to revise 40 CFR 63.2163 to include 
the requirements of Procedure 1 of appendix F to part 60, where propane 
would be used for the calibration gas and Method 25A would be used as 
the Reference Method (RM). In doing so, we are also removing the 
exemption for owners and operators of nutritional yeast manufacturing 
facilities that monitor VOC emissions using a flame ionization analyzer 
from conducting the relative-accuracy test PS 8 requires. Incorporation 
of a consistent set of ongoing QA/QC requirements will not only provide 
assurance that the ongoing collected data are valid, but also ensure a 
consistent basis for collecting those data.
    Moreover, we propose to replace the outdated reference 2 of PS 8, 
``A Procedure for Establishing Traceability of Gas Mixtures to Certain 
National Bureau of Standards Standard Reference Materials,'' with the 
current version of our traceability protocol. In the revised regulatory 
text of 40 CFR part 63, subpart CCCC, the EPA is proposing to 
incorporate by reference EPA/600/R-12/531, EPA Traceability Protocol 
for Assay and Certification of Gaseous Calibration Standards, May 2012, 
at 40 CFR 63.2163(b)(2), in accordance with requirements of 1 CFR 51.5. 
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.\26\ The EPA has made, and will continue 
to make, documents that are incorporated by reference generally 
available electronically through http://www.regulations.gov and/or in 
hard copy at the appropriate EPA office (see the ADDRESSES section of 
this preamble for more information). The EPA requests comment on the 
proposed QA/QC procedures and CEMS RATA revisions.
---------------------------------------------------------------------------

    \26\ Additional information about the traceability protocol is 
available at https://www.epa.gov/air-research/epa-traceability-protocol-assay-and-certification-gaseous-calibration-standards.
---------------------------------------------------------------------------

e. Electronic Reporting
    Through this action, the EPA is proposing to amend 40 CFR 
63.2181(a) to require that owners or operators of nutritional yeast 
manufacturing facilities submit electronic copies of compliance 
reports, which include performance test and performance evaluation 
results, through the EPA's Central Data Exchange (CDX) using the 
Compliance and Emissions Data Reporting Interface (CEDRI). The EPA 
believes that the electronic submittal of the reports addressed in this 
proposed rulemaking will increase the usefulness of the data contained 
in those reports, is in keeping with current trends in data 
availability, will further assist in the protection of public health 
and the environment, and will ultimately result in less burden on the 
regulated community. Under current requirements, paper reports are 
often stored in filing cabinets or boxes, which make the reports more 
difficult to obtain and use for data analysis and sharing. Electronic 
storage of such reports would make data more accessible for review, 
analyses, and sharing. Electronic reporting can also eliminate 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.
    In 2011, in response to Executive Order 13563, the EPA developed a 
plan \27\ to periodically review its regulations to determine if they 
should be modified, streamlined, expanded, or repealed in an effort to 
make regulations more effective and less burdensome. The plan includes 
replacing outdated paper reporting with electronic reporting. In 
keeping with this plan and the White House's Digital Government

[[Page 95830]]

Strategy,\28\ in 2013 the EPA issued an agency-wide policy specifying 
that new regulations will require reports to be electronic to the 
maximum extent possible. By requiring electronic submission of 
specified reports in this proposed rule, the EPA is taking steps to 
implement this policy.
---------------------------------------------------------------------------

    \27\ EPA's Final Plan for Periodic Retrospective Reviews, August 
2011. Available at: https://www.epa.gov/sites/production/files/2015-09/documents/eparetroreviewplan-aug2011_0.pdf.
    \28\ Digital Government: Building a 21st Century Platform to 
Better Serve the American People, May 2012. Available at: https://www.whitehouse.gov/sites/default/files/omb/egov/digital-government/digital-government-strategy.pdf.
---------------------------------------------------------------------------

    The EPA Web site that stores the submitted electronic data, 
WebFIRE, will be easily accessible to everyone and will provide a user-
friendly interface that any stakeholder could access. By making data 
readily available, electronic reporting increases the amount of data 
that can be used for many purposes. One example is the development of 
emissions factors. An emissions factor is a representative value that 
attempts to relate the quantity of a pollutant released to the 
atmosphere with an activity associated with the release of that 
pollutant (e.g., kilograms of particulate emitted per megagram of coal 
burned). Such factors facilitate the estimation of emissions from 
various sources of air pollution and are an important tool in 
developing emissions inventories, which in turn are the basis for 
numerous efforts, including trends analysis, regional and local scale 
air quality modeling, regulatory impact assessments, and human exposure 
modeling. Emissions factors are also widely used in regulatory 
applicability determinations and in permitting decisions.
    The EPA has received feedback from stakeholders asserting that many 
of the EPA's emissions factors are outdated or not representative of a 
particular industry emission source. While the EPA believes that the 
emissions factors are suitable for their intended purpose, we recognize 
that the quality of emissions factors varies based on the extent and 
quality of underlying data. We also recognize that emissions profiles 
on different pieces of equipment can change over time due to a number 
of factors (fuel changes, equipment improvements, industry work 
practices), and it is important for emissions factors to be updated to 
keep up with these changes. The EPA is currently pursuing emissions 
factor development improvements that include procedures to incorporate 
the source test data that we are proposing be submitted electronically. 
By requiring the electronic submission of the reports identified in 
this proposed action, the EPA would be able to access and use the 
submitted data to update emissions factors more quickly and 
efficiently, creating factors that are characteristic of what is 
currently representative of the relevant industry sector. Likewise, an 
increase in the number of test reports used to develop the emissions 
factors will provide more confidence that the factor is of higher 
quality and representative of the whole industry sector.
    Additionally, by making the records, data, and reports addressed in 
this proposed 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 
performance test reports and air emission reports readily accessible, 
our ability to carry out comprehensive reviews will be increased and 
achieved within a shorter period of time. These data will provide 
useful information on control efficiencies being achieved and 
maintained in practice within a source category and across source 
categories for regulated sources and pollutants. These reports can also 
be used to inform the technology-review process by providing 
information on improvements to add-on control technology and new 
control technology.
    Under an electronic reporting system, the EPA's Office of Air 
Quality Planning and Standards (OAQPS) would have air emissions and 
performance test data in hand; OAQPS would not have to collect these 
data from the EPA Regional offices or from delegated air agencies or 
industry sources in cases where these reports are not submitted to the 
EPA Regional offices. Thus, we anticipate fewer or less substantial 
information collection requests (ICRs) in conjunction with prospective 
CAA-required technology and risk-based reviews may be needed. We expect 
this to result 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, as OAQPS will not have to include the 
ICR collection time in the process or spend time collecting reports 
from the EPA Regional Offices. While 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.
    Electronic reporting could minimize submission of unnecessary or 
duplicative reports in cases where facilities report to multiple 
government agencies and the agencies opt to rely on the EPA's 
electronic reporting system to view report submissions. Where air 
agencies continue to require a paper copy of these reports and will 
accept a hard copy of the electronic report, facilities will have the 
option to print paper copies of the electronic reporting forms to 
submit to the air agencies, and, thus, minimize the time spent 
reporting to multiple agencies. Additionally, maintenance and storage 
costs associated with retaining paper records could likewise be 
minimized by replacing those records with electronic records of 
electronically submitted data and reports.
    Air agencies could benefit from more streamlined and automated 
review of the electronically submitted data. For example, because the 
performance test data would be readily-available in a standard 
electronic format, air agencies would be able to review reports and 
data electronically rather than having to conduct a review of the 
reports and data manually. 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 would benefit from the 
reported data being accessible to them through the EPA's electronic 
reporting system wherever and whenever they want or need access (as 
long as they have access to the Internet). The ability to access and 
review air emission report information electronically will assist air 
agencies to more quickly and accurately determine compliance with the 
applicable regulations, potentially allowing a faster response to 
violations which could minimize harmful air emissions. This benefits 
both air agencies and the general public.
    The proposed electronic reporting of data is consistent with 
electronic data trends (e.g., electronic banking and income tax 
filing). Electronic reporting of environmental data is already common 
practice in many media offices at the EPA. The changes being proposed 
in this rulemaking are needed to continue the EPA's transition to 
electronic reporting.
3. Startup, Shutdown, and Malfunction Requirements
    In 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. Sierra Club v. EPA, 551 F.3d 1019 (D.C. Cir.

[[Page 95831]]

2008). Specifically, the Court vacated the SSM exemption 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 section 112 standards apply continuously.
    While the current rule does not exempt periods of startup and 
shutdown from emissions standards, we are proposing several changes to 
eliminate the malfunction exemption that is contained in this rule. 
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. As discussed earlier in this 
preamble (section IV.D.1), we are proposing standards in this rule that 
apply at all times (i.e., to all batches), consistent with Sierra Club 
v. EPA. We are also proposing revisions to several provisions of 40 CFR 
part 63, subpart CCCC and to Table 6 to 40 CFR part 63, subpart CCCC 
(the General Provisions Applicability Table) as is explained in more 
detail below. For example, we are proposing to eliminate the 
incorporation of the General Provisions' requirement that the source 
develop an SSM plan. We also are proposing to eliminate and revise 
certain recordkeeping and reporting requirements related to the SSM 
exemption as further described below.
    The EPA has attempted to ensure that the provisions we are 
proposing to eliminate are inappropriate, unnecessary, or redundant in 
the absence of the SSM exemption. We are specifically seeking comment 
on whether we have successfully identified all such provisions and 
whether any of the identified provisions retain utility even in the 
absence of the SSM exemption.
    In proposing the standards in this rule, the EPA has taken into 
account startup and shutdown periods and, for the reasons explained 
below, has not proposed 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 and 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 meet emission limits, 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. 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 EPA to 
consider such events in setting CAA section 112 standards.
    Further, 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. As such, the performance of units that are malfunctioning is not 
``reasonably'' foreseeable. See, 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 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 this instance, it is unlikely that a malfunction would result in 
a violation of the standards for fermenters. For fermenters, the rule 
provides an option for owners and operators to determine the average 
VOC concentration for all batches within each fermentation stage using 
data from 12-month periods. This option minimizes the effect of 
malfunctions on the ability of a facility to meet the emission limits 
because the averaging effectively minimizes ``spikes'' in emissions. 
Additionally, many of the common malfunctions described by owners and 
operators of nutritional yeast manufacturing facilities during the site 
visits were malfunctions of the emissions

[[Page 95832]]

monitoring equipment. While the equipment was unable to record accurate 
data during periods of malfunction, it did 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 was 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.\29\
---------------------------------------------------------------------------

    \29\ U.S. Sugar Corp. v. EPA, No. 11-1108, 2016 U.S. App. LEXIS 
13783, at *41-49 (D.C. Cir. July 29, 2016) (upholding EPA's approach 
to addressing periods of malfunction).
---------------------------------------------------------------------------

a. 40 CFR 63.2150 General Duty
    We are proposing to revise the General Provisions table (Table 6 to 
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.6(e)(1)(i) does 
not apply to 40 CFR part 63, 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. We are proposing instead to add 
general duty regulatory text at 40 CFR 63.2150(c) that reflects the 
general duty to minimize emissions while eliminating the reference to 
periods covered by an 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, the 
language the EPA is proposing at 40 CFR 63.2150(c) does not include 
that language from 40 CFR 63.6(e)(1).
    We are also proposing to revise the General Provisions table (Table 
6 to 40 CFR part 63, subpart CCCC) to specify that 40 CFR 
63.6(e)(1)(ii) does not apply to 40 CFR part 63, 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.
b. SSM Plan
    We are proposing to revise the General Provisions table (Table 6 to 
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.6(e)(3) does 
not apply to 40 CFR part 63, 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 
proposing to remove 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.
c. Compliance With Standards
    We are proposing to revise the General Provisions table (Table 6 to 
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.6(f)(1) does 
not apply to 40 CFR part 63, 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 section 112 standard apply continuously. Consistent 
with Sierra Club, the EPA is proposing standards in this rule that 
apply at all times.
d. 40 CFR 63.2161 Performance Testing
    We are proposing to revise the General Provisions table (Table 6 to 
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.7(e)(1) does 
not apply to 40 CFR part 63, subpart CCCC. Section 63.7(e)(1) describes 
performance testing requirements. The EPA is instead proposing to add a 
performance testing requirement at 40 CFR 63.2161(b). The performance 
testing requirements we are proposing to add differ from the General 
Provisions performance testing provisions in several respects. The 
proposed 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. The proposed performance testing 
provisions exclude periods of startup and shutdown. 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 operating conditions. The EPA is 
proposing to add language 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'' upon request, but does not 
specifically require the information to be recorded. The regulatory 
text the EPA is proposing to add to this provision builds on that 
requirement and makes explicit the requirement to record the 
information.
e. Monitoring
    We are proposing to revise the General Provisions table (Table 6 to 
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.8 (c)(1)(i) and 
(iii) do not apply to 40 CFR part 63, 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 proposing to revise the General Provisions table (Table 6 to 
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.8(d)(3) does 
not apply to 40 CFR part 63, subpart CCCC. The final sentence in 40 CFR 
63.8(d)(3) refers to the General Provisions' SSM plan requirement, 
which is no longer

[[Page 95833]]

applicable. The EPA is proposing to add to the rule at 40 CFR 
63.2182(b)(7) and 63.2183(d) text that contains the same requirements 
as 40 CFR 63.8(d)(3), except that the final sentence is replaced with 
the following sentence: ``The program of corrective action should be 
included in the plan required under Sec.  63.8(d)(2).''
f. 40 CFR 63.2182 Recordkeeping
    We are proposing to revise the General Provisions table (Table 6 to 
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.10(b)(2)(i) 
does not apply to 40 CFR part 63, subpart CCCC. Section 63.10(b)(2)(i) 
describes the recordkeeping requirements during startup and shutdown. 
These recording provisions are no longer necessary because the EPA is 
proposing that recordkeeping and reporting applicable to normal 
operations will apply to startup and shutdown. In the absence of 
special provisions applicable to startup and shutdown, such as a 
startup and shutdown plan, there is no reason to retain additional 
recordkeeping for startup and shutdown periods.
    We are proposing to revise the General Provisions table (Table 6 to 
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.10(b)(2)(ii) 
does not apply to 40 CFR part 63, subpart CCCC. Section 63.10(b)(2)(ii) 
describes the recordkeeping requirements during a malfunction. The EPA 
is proposing to add such requirements to 40 CFR 63.2182(a)(2). The 
regulatory text we are proposing to add differs from 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 proposing that this requirement apply 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 proposing to add to 40 CFR 63.2182(a)(2) 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 proposing to require 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 proposing to revise the General Provisions table (Table 6 to 
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.10(b)(2)(iv) 
does not apply to 40 CFR part 63, 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 applicable by reference to 40 CFR 63.2182(a)(2).
    We are proposing to revise the General Provisions table (Table 6 to 
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.10(b)(2)(v) 
does not apply to 40 CFR part 63, 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 proposing to revise the General Provisions table (Table 6 to 
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.10(c)(15) does 
not apply to 40 CFR part 63, subpart CCCC. When applicable, 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, specified in 40 CFR 63.6(e), to also satisfy the requirements 
of 40 CFR 63.10(c)(10) through (12). The EPA is proposing to eliminate 
this requirement because SSM plans would no longer be required, and, 
therefore, 40 CFR 63.10(c)(15) no longer serves any useful purpose for 
affected units.
g. 40 CFR 63.2181 Reporting
    We are proposing to revise the General Provisions table (Table 6 to 
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.10(d)(5) does 
not apply to 40 CFR part 63, 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 proposing to add reporting requirements to 40 CFR 
63.2181(c)(5) and (6). The replacement language differs from the 
General Provisions requirement in that it eliminates periodic SSM 
reports as a stand-alone report. We are proposing language that 
requires sources that fail to meet an applicable standard at any time 
to report the information concerning such events in the semi-annual 
compliance report already required under this rule. We are proposing 
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 limit, 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 proposing 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 malfunction plans would no longer be required. The proposed 
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 because the events will be 
reported in otherwise required reports with similar format and 
submittal requirements.
    We are proposing to revise the General Provisions table (Table 6 to 
40 CFR part 63, subpart CCCC) to specify that 40 CFR 63.10(d)(5)(ii) 
does not apply to 40 CFR part 63, subpart CCCC. Section 63.10(d)(5)(ii) 
describes an immediate report for startups, shutdowns, and malfunctions 
when a source failed to meet an applicable standard but did not follow 
the SSM plan. We will no longer require owners and operators to report 
when actions taken during a startup, shutdown, or malfunction were not 
consistent with an SSM plan, because plans would no longer be required.

[[Page 95834]]

4. Rule Language Clarifications
    We are proposing other miscellaneous revisions that add clarity to 
rule language. For example, we are using active, second-person voice 
throughout the rule by incorporating ``you must . . .'' into the 
language. This is consistent with the EPA's current rule-writing 
practices and creates uniformity within 40 CFR part 63, subpart CCCC. 
We are also proposing the removal of ``but is not limited to'' in 40 
CFR 63.2132, because this language is not necessary. The 40 CFR part 
63, subpart CCCC requirements are limited to fermenters at this time, 
and the removal of this language clarifies this distinction. The EPA 
requests comment on each of these proposed revisions.

E. What compliance dates are we proposing?

    The EPA is proposing that currently operating facilities must 
immediately comply with the revised form of the fermenter VOC emission 
limits and general compliance requirements upon the effective date of 
the final rule. As discussed in section IV.D.2.a of this preamble, 
facilities that currently demonstrate compliance by monitoring brew 
ethanol in the fermenter have up to 1 year to install CEMS. During this 
time, emissions data must be collected for each batch using the 
existing compliance method (monitoring brew ethanol) for use in the 
semiannual compliance reports with the revised emission limits. Sources 
that are constructed or reconstructed after promulgation of the rule 
revisions must comply with the emission limits and compliance 
requirements upon startup of the affected source. We request comment on 
each of these timeframes.
    We are proposing to revise 40 CFR 63.2133 to specify that an area 
source that becomes a major source of HAP, and that is an existing 
affected source, must be in compliance with the subpart by not later 
than 1 year after it becomes a major source, instead of by not later 
than 3 years. This revision is consistent with the proposed requirement 
that facilities have 1 year to install CEMS if they currently monitor 
brew ethanol in the fermenter to determine compliance. The EPA requests 
comment on this timeframe.

V. Summary of Cost, Environmental, and Economic Impacts

A. What are the affected sources?

    We anticipate that four nutritional yeast facilities currently 
operating in the United States will be affected by these proposed 
amendments.

B. What are the air quality impacts?

    The proposed 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 proposed fermenter emission limits, the 
revisions will remove the exemption that allowed up to 2 percent of the 
total number of batches to exceed emission limits, as well as the 
exemption that allowed emissions from batches produced during periods 
of malfunction to not be used in determining compliance with emission 
limits. While these changes cannot easily be quantified due to a lack 
of data on the current number of exempted batches, the practical effect 
is that production of all batches of nutritional yeast at affected 
sources will be required to meet emission limits. The other proposed 
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 reported for 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.

C. What are the cost impacts?

    We have estimated compliance costs for all existing sources to 
install the necessary monitoring equipment (i.e., VOC CEMS) and perform 
annual RATAs for VOC CEMS. We estimated a total capital investment of 
$511,000 and an annualized cost of approximately $172,000. The details 
of the cost estimates are documented in the memorandum, ``Costs for the 
Manufacturing of Nutritional Yeast Source Category,'' which is 
available in the docket for this action.

D. What are the economic impacts?

    Total annualized costs for this proposal are estimated to be 
$172,000. Estimated annualized compliance costs range from $16,000 to 
$109,000 per facility. The EPA conducted economic impact screening 
analyses for this proposal, as detailed 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. Screening analyses suggest that the impacts of this action will 
be minimal, with all entities subject to this action estimated to have 
cost-to-sales ratios of less than 0.1 percent. We do not expect any 
adverse economic impacts to result from this action.

E. What are the benefits?

    As discussed above, the proposed amendments to this subpart will 
have positive impacts on air quality by removing the exemption for a 
portion of batches to meet emission limits. The proposed 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, which 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 proposed amendment will directly benefit this 
population by increasing the accuracy of the emissions data that is 
monitored and reported. Utilization of CEMS is also expected to 
facilitate more effective use of current process controls for 
acetaldehyde emissions versus use of the brew ethanol correlation 
approach. Other proposed amendments will result in additional benefits, 
such as streamlined reporting through electronic methods for owners/
operators of nutritional yeast manufacturing facilities and increased 
access to emissions data by stakeholders, as described in previous 
sections.

VI. Request for Comments

    We solicit comments on all aspects of this proposed action, 
including those aspects specifically called out elsewhere in this 
preamble. As noted previously, we are not seeking comment on the source 
category definition in this action. In addition to general comments on 
this proposed action, we are also interested in additional data that 
may improve the risk assessments and other analyses. We are 
specifically interested in receiving any improvements to the data used 
in the site-specific emissions profiles used for risk modeling. Such 
data should include supporting documentation in sufficient detail to 
allow characterization of the quality and representativeness of the 
data or information. Section VII of this preamble provides more 
information on submitting data.

[[Page 95835]]

VII. Submitting Data Corrections

    The site-specific emissions profiles used in the source category 
risk and demographic analyses and instructions are available for 
download on the RTR Web site at http://www.epa.gov/ttn/atw/rrisk/rtrpg.html. The data files include detailed information for each HAP 
emissions release point for the facilities in the source category.
    If you believe that the data are not representative or are 
inaccurate, please identify the data in question, provide your reason 
for concern, and provide any ``improved'' data that you have, if 
available. When you submit data, we request that you provide 
documentation of the basis for the revised values to support your 
suggested changes. To submit comments on the data downloaded from the 
RTR Web site, complete the following steps:
    1. Within this downloaded file, enter suggested revisions to the 
data fields appropriate for that information.
    2. Fill in the commenter information fields for each suggested 
revision (i.e., commenter name, commenter organization, commenter email 
address, commenter phone number, and revision comments).
    3. Gather documentation for any suggested emissions revisions 
(e.g., performance test reports, material balance calculations).
    4. Send the entire downloaded file with suggested revisions in 
Microsoft[supreg] Access format and all accompanying documentation to 
Docket ID No. EPA-HQ-OAR-2015-0730 (through the method described in the 
ADDRESSES section of this preamble).
    5. If you are providing comments on a single facility or multiple 
facilities, you need only submit one file for all facilities. The file 
should contain all suggested changes for all sources at that facility. 
We request that all data revision comments be submitted in the form of 
updated Microsoft[supreg] Excel files that are generated by the 
Microsoft[supreg] Access file. These files are provided on the RTR Web 
site at http://www.epa.gov/ttn/atw/rrisk/rtrpg.html.

VIII. 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 not a significant regulatory action and was, 
therefore, not submitted to OMB for review.

B. Paperwork Reduction Act (PRA)

    The information collection activities in this proposed rule have 
been submitted for approval to OMB under the PRA. The Information 
Collection Request (ICR) that the EPA prepared has been assigned EPA 
ICR number 1886.03. A copy of the ICR can be found in the docket for 
this rule, and it is summarized here.
    We are proposing new reporting and recordkeeping requirements to 
the Manufacturing of Nutritional Yeast source category as a result of 
additional requirements related to the use of CEMS.
    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.
    Frequency of response: Initially and semiannually.
    Total estimated burden: 1,340 hours (per year) for the responding 
facilities and 117 hours (per year) for the Agency. Of these, 43 hours 
(per year) for the responding facilities and 4 hours (per year) for the 
Agency is the incremental burden to comply with the proposed rule 
amendments. Burden is defined at 5 CFR 1320.3(b).
    Total estimated cost: $939,000 (per year), which includes $832,000 
annualized capital and operation and maintenance costs, for the 
responding facilities and $5,400 (per year) for the Agency to comply 
with all of the requirements in this NESHAP. Of the total, $175,000 
(per year), including $172,000 in annualized capital and operation and 
maintenance costs, for the responding facilities and $180 (per year) 
for the Agency, is the incremental cost to comply with the proposed 
amendments to this rule.
    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.
    Submit your comments on the Agency's need for this information, the 
accuracy of the provided burden estimates and any suggested methods for 
minimizing respondent burden to the EPA using the docket identified at 
the beginning of this rule. You may also send your ICR-related comments 
to OMB's Office of Information and Regulatory Affairs via email to 
OIRA_submission@omb.eop.gov, Attention: Desk Officer for the EPA. Since 
OMB is required to make a decision concerning the ICR between 30 and 60 
days after receipt, OMB must receive comments no later than January 27, 
2017. The EPA will respond to any ICR-related comments in the final 
rule.

C. 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. One 
entity subject to the requirements of this action is assumed to be a 
small business for the purposes of this analysis, as the complex 
ownership structure makes it difficult to clearly determine the 
entity's size. The Agency has determined that this entity may 
experience an impact of less than 0.01 percent of revenues. Details of 
this 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.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate that may result in 
expenditures 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 annualized cost of this 
action for affected industrial sources is estimated to be $172,000 per 
year.

E. 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.

F. 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.

G. 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. This 
action's

[[Page 95836]]

health and risk assessments are contained in sections III.A and B and 
sections IV.A and B of this preamble.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is 
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA) and 1 CFR 
Part 51

    This action involves technical standards. Therefore, the EPA 
conducted a search to identify potentially applicable voluntary 
consensus standards. However, the Agency identified no such standards. 
Therefore, the EPA has decided to use EPA Method 25A of 40 CFR part 60, 
appendix A. A thorough summary of the search conducted and results are 
included in the memorandum titled, ``Voluntary Consensus Standard 
Results for the Risk and Technology Review of the Manufacturing of 
Nutritional Yeast NESHAP,'' which is available in the docket for this 
action.

J. 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 section IV.A 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.
    As discussed in section IV.A of this preamble, we performed a 
demographic analysis, which is an assessment of risks to individual 
demographic groups, of the population close to the facilities (within 
50 km and within 5 km). In this analysis, we evaluated the distribution 
of HAP-related cancer risks and non-cancer hazards from the 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 indicates 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 (AB Mauri--Fleischmann's 
Yeast in Memphis, Tennessee) 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, 100 
percent of them are defined as minority. When examining the noncancer 
risks surrounding these facilities, no one is predicted to have a 
chronic non-cancer TOSHI greater than 1. This facility is also the only 
one that is not currently using CEMS. The proposed amendments will 
directly benefit this population by increasing the accuracy of the 
emissions data that is monitored and reported. Utilization of CEMS is 
also expected to facilitate more effective use of process controls for 
acetaldehyde emissions versus use of the brew ethanol correlation 
approach.
    The EPA has determined that this proposed 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 without having any disproportionately high and 
adverse human health or environmental effects on any population, 
including any minority, low-income, or indigenous populations. Further, 
the EPA believes that implementation of this rule will provide an ample 
margin of safety to protect public health of all demographic groups.

List of Subjects in 40 CFR Part 63

    Environmental protection, Air pollution control, Hazardous 
substances, Incorporation by reference, Reporting and recordkeeping 
requirements.

    Dated: December 13, 2016.
Gina McCarthy,
Administrator.

    For the reasons stated in the preamble, the Environmental 
Protection Agency proposes to amend part 63 of title 40, chapter I, of 
the Code of Federal Regulations 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.


Sec.  63.14  [Amended]

0
2. Section 63.14 is amended by adding paragraph (m)(24) to read as 
follows:
* * * * *
    (m) * * *
    (24) 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)(2).
* * * * *
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

Contents

Sec.

What This Subpart Covers

63.2130 What is the purpose of this subpart?
63.2131 Am I subject to this subpart?
63.2132 What parts of my plant does this subpart cover?
63.2133 When do I have to comply with this subpart?

Emission Limitations

63.2140 What emission limitations must I meet?

General Compliance Requirements

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

Testing and Initial Compliance Requirements

63.2160 By what date must I conduct an initial compliance 
demonstration?
63.2161 What performance tests and other procedures must I use if I 
monitor brew ethanol?
63.2162 When must I conduct subsequent performance tests?
63.2163 If I monitor fermenter exhaust, what are my monitoring 
installation, operation, and maintenance requirements?
63.2164 If I monitor brew ethanol, what are my monitoring 
installation, operation, and maintenance requirements?

[[Page 95837]]

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?

Tables for Subpart CCCC

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

What This Subpart Covers


Sec.  63.2130  What is the purpose of this subpart?

    This subpart establishes national emission limitations for 
hazardous air pollutants emitted from manufacturers of nutritional 
yeast. This subpart also establishes requirements to demonstrate 
initial and continuous compliance with the emission limitations.


Sec.  63.2131  Am I subject to this subpart?

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


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

    (a) This subpart applies to each new, reconstructed, or existing 
``affected source'' that produces Saccharomyces cerevisiae at a 
nutritional yeast manufacturing facility.
    (b) The affected source is the collection of equipment used in the 
manufacture of the nutritional yeast species Saccharomyces cerevisiae. 
This collection of equipment includes 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 (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).
    (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 the applicable emission limitations in Table 1 to 
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 the applicable emission limitations in Table 
1 to this subpart upon startup of your affected source.
    (b) If you have an existing affected source, then you must comply 
with the applicable emission limitations in Table 1 to 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) through (2) of this section apply.
    (1) Any portion of the existing facility that is a new affected 
source or a new reconstructed source must be in compliance with this 
subpart upon startup.
    (2) All other parts of the affected source must be in compliance 
with this subpart by not 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.

General Compliance Requirements


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

    (a) You must be in compliance with the emission limitations in 
Table 1 to this subpart at all times.
    (b) 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.
    (c) At all times, you must operate and maintain any affected 
source, including associated air pollution control

[[Page 95838]]

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.
    (d) To determine compliance before [date of publication of the 
final rule in the Federal Register], you must monitor the volatile 
organic compound (VOC) concentration or brew ethanol continuously for 
each batch and demonstrate that the VOC concentration for at least 98 
percent of the batches for each fermentation stage in each 12-month 
calculation period does not exceed the applicable emission limitations 
in Table 1 to this subpart. You must monitor VOC concentration either 
by installing and operating a continuous emission monitoring system 
(CEMS) to monitor VOC in the fermenter exhaust continuously or by 
monitoring the concentration of ethanol in the fermenter liquid 
continuously for each batch (i.e., brew ethanol monitoring) and 
determining VOC concentration in the exhaust using the correlation 
equation developed according to Sec.  63.2161.
    (e) To determine compliance on or after [date of publication of the 
final rule in the Federal Register], you must monitor VOC concentration 
continuously for each batch and demonstrate compliance with the 
applicable emission limitations of either the Average Option or the 
Batch Option in Table 1 to this subpart. You must monitor VOC 
concentration by installing and operating a CEMS to monitor the VOC 
concentration in the fermenter exhaust continuously.

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. (For example, if the compliance date is October 15, 
2017, then the first 12-month period for which you must demonstrate 
compliance would be October 15, 2017 through October 31, 2018.)
    (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 simultaneously with brew 
ethanol monitoring to establish a brew-to-exhaust correlation as 
specified in paragraph (f) 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 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 using the brew ethanol concentration data according to Equation 
1 of this section.

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

Where:

BAVOC = Batch-average concentration of VOC in fermenter exhaust 
(ppmv measured as propane), calculated for compliance demonstration
BAE = Batch-average concentration of brew ethanol in fermenter 
liquid (percent), measured by 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?

    (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

[[Page 95839]]

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.
    (1) You must conduct a relative accuracy test audit (RATA) at least 
annually, in accordance with sections 8 and 11, as applicable, of 
Performance Specification 8.
    (2) As necessary, rather than relying on reference 2 of Performance 
Specification 8 of appendix B to 40 CFR part 60, you must rely on EPA/
600/R-12/531, EPA Traceability Protocol for Assay and Certification of 
Gaseous Calibration Standards, May 2012 (incorporated by reference, see 
Sec.  63.14).
    (3) 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 (RM).
    (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 or 2 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, 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 calibration drift never exceeds 7.5 percent of the span 
value, 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.
    (k) If your CEMS is out of control, you must take corrective action 
according to paragraphs (k)(1) through (3) of this section.
    (1) Your CEMS is out of control if the zero (low-level) or high-
level calibration drift exceeds 2 times the limits of the applicable 
Performance Specification.
    (2) When the CEMS is out of control, you must take the necessary 
corrective action and repeat all necessary tests that indicate that the 
system is out of control. You must take corrective action and conduct 
retesting until the performance requirements are below the applicable 
limits.
    (3) You must not use data recorded during batch monitoring periods 
in which the CEMS is out of control in averages and calculations used 
to demonstrate compliance, or to meet any data availability requirement 
established under this subpart. The beginning of the out-of-control 
period is the beginning of the first batch monitoring period that 
follows the most recent calibration drift check during which the system 
was within allowable performance limits. The end of the out-of-control 
period is the end of the last batch monitoring period before you have 
completed corrective action and successfully demonstrated that the 
system is within the allowable limits. If your successful demonstration 
that the system is within the allowable limits occurs during a batch 
monitoring period, then the out-of-control period ends at the end of 
that batch monitoring period. If the CEMS is out of control for any 
part of a particular batch monitoring period, it is out of control for 
the whole batch monitoring period.


Sec.  63.2164  If I monitor brew ethanol, what are my monitoring 
installation, operation, and maintenance requirements?

    (a) You must install, operate, and maintain each brew ethanol 
monitor according to the manufacturer's specifications and in 
accordance with Sec.  63.2150(c).
    (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.

[[Page 95840]]

    (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 limit; note that we consider 
1.5 to 2.5 times the relevant emission limit 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 limit.
    (f) For each brew ethanol monitor, you must record the results of 
each inspection, calibration, and validation check.
    (g) The gas chromatographic (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) 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 CEMS 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 that applies to you according to Table 3 to this subpart.
    (b) You must submit the Notification of Compliance Status 
containing the results of the initial compliance demonstration 
according to the requirements in Sec.  63.2180(e).

Continuous Compliance Requirements


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

    (a) You must monitor and collect data according to this section.
    (b) Except for 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 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 data 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 
limitation in Table 1 to this subpart that applies to you according to 
methods specified in Table 4 to this subpart and the applicable 
procedures of this section.
    (1) To demonstrate compliance prior to [date one year after the 
date of publication of the final rule in the Federal Register], you 
must install, operate, and maintain a CEMS in accordance with Sec.  
63.2163 to monitor VOC concentration in the fermenter exhaust or 
install, operate, and maintain a brew ethanol monitor in accordance 
with Sec.  63.2164 to monitor the brew ethanol concentration in the 
fermenter liquid.
    (2) To demonstrate compliance on and after [date 1 year after the 
date of publication of the final rule in the Federal Register], you 
must install, operate, and maintain a CEMS in accordance with Sec.  
63.2163 to monitor VOC concentration in the fermenter exhaust.
    (b) To demonstrate compliance with emission limitations prior to 
[date of publication of the final rule in the Federal Register], you 
must calculate the percentage of within-concentration batches (defined 
in Sec.  63.2192) for each 12-month calculation period by following the 
procedures in paragraphs (b)(1) through (4) of this section.
    (1) You must determine the percentage of batches over a 12-month 
calculation period that were in compliance with the applicable maximum 
concentration. The total number of batches in the calculation period is 
the sum of the numbers of batches of each fermentation stage for which 
emission limits apply. To determine which batches are in the 12-month 
calculation period, you must

[[Page 95841]]

include those batches for which the batch monitoring period ended on 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.
    (2) You must determine the percentage of batches in compliance with 
the applicable emission limitations for each 12-month calculation 
period at the end of each calendar month.
    (3) 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. (For example, if the 
compliance date for your affected source is October 15, 2017, the first 
12-month calculation period would begin on October 15, 2017, and end on 
October 31, 2018. If the compliance date for your affected source is 
October 1, 2017, the first 12-month calculation period would begin on 
October 1, 2017, and end on September 30, 2018.)
    (4) 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 averaging period and ends 
on the last day of the month 11 calendar months later. (For example, if 
the compliance date for your affected source is October 15, 2017, the 
second calculation period would begin on December 1, 2017, and end on 
November 30, 2018.)
    (c) To demonstrate compliance with emission limitations on and 
after [date of publication of the final rule in the Federal Register] 
by using the Average Option, you must follow the procedures in 
paragraphs (c)(1) through (3) of this section.
    (1) 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 on 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.
    (2) 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. (For example, if the 
compliance date for your affected source is October 15, 2017, the first 
12-month calculation period would begin on October 15, 2017, and end on 
October 31, 2018. If the compliance date for your affected source is 
October 1, 2017, the first 12-month calculation period would begin on 
October 1, 2017, and end on September 30, 2018.)
    (3) 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 averaging period and ends 
on the last day of the month 11 calendar months later. (For example, if 
the compliance date for your affected source is October 15, 2017, the 
second calculation period would begin on December 1, 2017, and end on 
November 30, 2018.)
    (d) To demonstrate compliance with emission limitations on and 
after [date of publication of the final rule in the Federal Register] 
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 on 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.

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 Table 2 to this subpart, you must submit a notification of intent to 
conduct a performance test at least 60 calendar days before the 
performance test is scheduled to begin as required in Sec.  63.7(b)(1).
    (d) If you are required to conduct a performance evaluation as 
specified in Sec.  63.2163, 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 date 
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 [date of publication of the final rule in the 
Federal Register], you must also comply with electronic reporting for 
compliance tests 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 procedure specified in either paragraph 
(a)(1)(i)(A) or (B) 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://www3.epa.gov/ttn/chief/ert/ert_info.html) 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. If you claim that some 
of the performance test information being submitted is confidential 
business information (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

[[Page 95842]]

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 earlier in this 
paragraph.
    (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.
    (ii) Within 60 days after the date of completing each CEMS 
performance evaluation (as defined in Sec.  63.2), you must submit the 
results of the performance evaluation following the procedure specified 
in either paragraph (ii)(A) or (B) of this section.
    (A) For performance evaluations of CEMS 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. 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) For any performance evaluations of continuous emission 
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.
    (b) Unless the Administrator has approved a different schedule for 
submission of reports under Sec.  63.10(a), you must submit each report 
by the date in Table 5 to this subpart and according to paragraphs 
(b)(1) through (5) of this section.
    (1) The first compliance report must 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). (For 
example, if the compliance date for your affected source is October 15, 
2017, then the first compliance report would cover the period from 
October 15, 2017 to December 31, 2018.) 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)(a)(iii)(A) or 40 CFR 
71.6(a)(3)(a)(iii)(A), you may submit the first and subsequent 
compliance reports according to the dates the permitting authority has 
established instead of according to the dates in paragraphs (b)(1) 
through (4) of this section.
    (c) The compliance report must contain the information listed in 
paragraphs (c)(1) through (7) 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 reporting periods ending before [date of publication of the 
final rule in the Federal Register], the percentage of batches that are 
within-concentration batches for each 12-month period ending on a 
calendar month that falls within the reporting period.
    (5) For reporting periods ending before [date of publication of the 
final rule in the Federal Register], if an affected source fails to 
meet an applicable standard, the information for each batch for which 
the batch-average VOC concentration exceeded the applicable maximum VOC 
concentration in Table 1 to this subpart and whether the batch was in 
production during a period of malfunction or during another period.
    (6) For reporting periods ending on or after [date of publication 
of the final rule in the Federal Register], if an 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 using the Average Option in Table 1 to this subpart, the 
average VOC concentration in the fermenter exhaust from all batches in 
each fermentation stage for each 12-month period ending on a calendar 
month that falls within the reporting period that did not exceed the 
applicable emission limitation.
    (ii) If using the Batch Option in Table 1 to this subpart, a 
certification that the average VOC concentration in the fermenter 
exhaust for each batch did not exceed applicable emission limitations.
    (7) For reporting periods ending on and after [date of publication 
of the final rule in the Federal Register], if an 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 using the Average Option in Table 1 to this subpart, the 
average VOC concentration in the fermenter exhaust from all batches in 
each fermentation

[[Page 95843]]

stage for each 12-month 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 using the Batch Option in Table 1 to this subpart, 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 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 and hours of monitoring system 
downtime for each fermenter.


Sec.  63.2182   What records must I keep?

    (a) You must keep the records listed in paragraphs (a)(1) through 
(4) 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).
    (4) Records of results of brew-to-exhaust correlation tests 
specified in Sec.  63.2161.
    (b) For each CEMS, you must keep the records listed in paragraphs 
(b)(1) through (9) of this section.
    (1) Records described in Sec.  63.10(b)(2)(vi).
    (2) All required measurements needed to demonstrate compliance with 
a relevant standard (including, but not limited to, CEMS data, raw 
performance testing measurements, and raw performance evaluation 
measurements that support data that you are required to report).
    (3) Records described in Sec.  63.10(b)(2)(viii) through (xi). The 
CEMS system must allow the amount of excess zero (low-level) and high-
level calibration drift measured at the interval checks to be 
quantified and recorded.
    (4) All required CEMS measurements (including monitoring data 
recorded during CEMS breakdowns and out-of-control periods).
    (5) Identification of each time period during which the CEMS was 
inoperative, except for zero (low-level) and high-level checks.
    (6) Identification of each time period during which the CEMS was 
out of control, as defined in Sec.  63.2163(k).
    (7) Current version of the performance evaluation test plan, as 
specified in Sec.  63.8(d)(2), including the program of corrective 
action for a malfunctioning CEMS, and previous (i.e., superseded) 
versions of the performance evaluation test plan for a period of 5 
years after each revision to the plan. The program of corrective action 
should be included in the plan required under Sec.  63.8(d)(2).
    (8) Request for alternatives to relative accuracy test audits for 
CEMS as required in Sec.  63.8(f)(6)(i).
    (9) Records of each deviation from monitoring system requirements, 
including a description and explanation of each deviation.
    (c) You must keep the records required in Table 4 to this subpart 
to show continuous compliance with each emission limitation that 
applies to you.
    (d) You must also keep the records listed in paragraphs (d)(1) 
through (3) of this section for each batch in your affected source.
    (1) Unique batch identification number.
    (2) Fermentation stage for which you are using the fermenter.
    (3) Unique CEMS equipment identification number.


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

    (a) Your records must be in a form suitable and readily available 
for expeditious review, according to Sec.  63.10(b)(1).
    (b) As specified in Sec.  63.10(b)(1), you must keep each record 
for 5 years following the date of each occurrence, measurement, 
maintenance, corrective action, report, or record.
    (c) You must keep each record on site for at least 2 years after 
the date of each occurrence, measurement, maintenance, corrective 
action, report, or record, according to Sec.  63.10(b)(1). You may keep 
the records off site for the remaining 3 years.
    (d) 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 63.13 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, the General Provisions of this part, and in this section as 
follows:
    Batch means a single fermentation cycle in a single fermentation 
vessel (fermenter).
    Batch monitoring period means the period that begins at the later 
of either the start of aeration or the addition of yeast to the 
fermenter; the period ends at the earlier of either the end of aeration 
or the point at which the yeast has begun being emptied from the 
fermenter.
    Brew means the mixture of yeast and additives in the fermenter.
    Brew ethanol means the ethanol in fermenter liquid.
    Brew ethanol monitor means the monitoring system that you use to

[[Page 95844]]

measure brew ethanol to demonstrate compliance with this subpart. The 
monitoring system includes a resistance element used as an ethanol 
sensor, with the measured resistance proportional to the concentration 
of ethanol in the brew.
    Brew-to-exhaust correlation means the correlation between the 
concentration of ethanol in the brew and the concentration of VOC in 
the fermenter exhaust. This correlation is specific to each fed-batch 
fermentation stage and is established while manufacturing the product 
that comprises the largest percentage (by mass) of average annual 
production.
    Emission limitation means any emission limit or operating limit.
    Fed-batch means the yeast is fed carbohydrates and additives during 
fermentation in the vessel.
    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 60-minute period commencing on the minute 
at which the batch monitoring period begins.
    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 the average VOC 
concentration 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
----------------------------------------------------------------------------------------------------------------
                                           Before [date of       On and after [date of publication of the final
                                          publication of the     rule in the Federal Register], you must comply
                                          final rule in the        with either the Average Option or the Batch
     For each fed-batch fermenter      Federal Register] . . .                    Option . . .
   producing yeast in the following   --------------------------------------------------------------------------
       fermentation stage . . .        You must not exceed the    Average Option: You     Batch Option: You must
                                        following VOC emission    must not exceed the         not exceed the
                                         limitation \a\ . . .    following VOC emission   following VOC emission
                                                                  limitation \a\ . . .     limitation \a\ . . .
----------------------------------------------------------------------------------------------------------------
Last stage...........................  100 parts per million    95 ppmv (measured as     100 ppmv (measured as
                                        by volume (ppmv)         propane) for the         propane) for the
                                        (measured as propane)    average VOC              average VOC
                                        in the fermenter         concentration in the     concentration in the
                                        exhaust for at least     fermenter exhaust from   fermenter exhaust for
                                        98 percent of all        all batches \b\ in       each batch.\b\
                                        batches \b\ in each 12-  this stage in each 12-
                                        month calculation        month calculation
                                        period described in      period \c\.
                                        Sec.   63.2171(b).
Second-to-last stage.................  200 ppmv (measured as    190 ppmv (measured as    200 ppmv (measured as
                                        propane) in the          propane) for the         propane) for the
                                        fermenter exhaust for    average VOC              average VOC
                                        at least 98 percent of   concentration in the     concentration in the
                                        all batches \b\ in       fermenter exhaust from   fermenter exhaust for
                                        each 12-month            all batches\b\ in this   each batch.\b\
                                        calculation period       stage in each 12-month
                                        described in Sec.        calculation period \c\.
                                        63.2171(b).
Third-to-last stage..................  300 ppmv (measured as    285 ppmv (measured as    300 ppmv (measured as
                                        propane) in the          propane) for the         propane) for the
                                        fermenter exhaust for    average VOC              average VOC
                                        at least 98 percent of   concentration in the     concentration in the
                                        all batches \b\ in       fermenter exhaust from   fermenter exhaust for
                                        each 12-month            all batches \b\ in       each batch.\b\
                                        calculation period       this stage in each 12-
                                        described in Sec.        month calculation
                                        63.2171(b).              period \c\.
----------------------------------------------------------------------------------------------------------------
\a\ The emission limitation does not apply during the production of specialty yeast.
\b\ The average VOC concentration for each batch equals the average VOC concentration over the duration of a
  batch.
\c\ Determined as the average of all batch-average VOC concentration data for this stage in each 12-month
  calculation period as described in Sec.  Sec.   63.2160(a) and 63.2171(c).


 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                        According to the
    VOC concentration in the          Using . . .          following
 fermenter exhaust according to                       requirements . . .
     the procedures in Sec.
     63.2161, you must . . .
------------------------------------------------------------------------
Measure VOC as propane..........  Method 25A \a\, or  You must measure
                                   an alternative      the VOC
                                   validated by EPA    concentration in
                                   Method 301 \b\      the fermenter
                                   and approved by     exhaust at any
                                   the Administrator.  point prior to
                                                       the 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.


[[Page 95845]]


                Table 3 to Subpart CCCC of Part 63--Initial Compliance With Emission Limitations
----------------------------------------------------------------------------------------------------------------
                                           Before [date of       On and after [date of publication of the final
                                          publication of the           rule in the Federal Register] . . .
                                          final rule in the    -------------------------------------------------
              For . . .                 Federal Register], you    Average Option: You
                                          have demonstrated        have demonstrated      Batch Option: You have
                                       initial compliance if .  initial compliance if .    demonstrated initial
                                                 . .                      . .              compliance if . . .
----------------------------------------------------------------------------------------------------------------
Each fed-batch fermenter producing     The average VOC          The average VOC          The average VOC
 yeast in a fermentation stage (last    concentration in the     concentration in the     concentration in the
 (Trade), second-to-last (First         fermenter exhaust for    fermenter exhaust from   fermenter exhaust for
 Generation), or third-to-last          at least 98 percent of   all batches in each      each batch of each
 (Stock)) for which compliance is       the batches (sum of      fermentation stage       fermentation stage
 determined by monitoring VOC           batches from last,       during the initial       during the initial
 concentration in the fermenter         second-to-last, and      compliance period        compliance period
 exhaust.                               third-to-last stages)    described in Sec.        described in Sec.
                                        during the initial       63.2160(a) does not      63.2160(b) does not
                                        compliance period does   exceed the applicable    exceed the applicable
                                        not exceed the           concentration in Table   concentration in Table
                                        applicable maximum       1 to this subpart.       1 to this subpart.
                                        concentration in Table
                                        1 to this subpart.
----------------------------------------------------------------------------------------------------------------


               Table 4 to Subpart CCCC of Part 63--Continuous Compliance With Emission Limitations
----------------------------------------------------------------------------------------------------------------
                                           Before [date of       On and after [date of publication of the final
                                          publication of the           rule in the Federal Register] . . .
                                          final rule in the    -------------------------------------------------
              For . . .                 Federal Register], you    Average Option: You
                                           must demonstrate         must demonstrate      Batch Option: You must
                                        continuous compliance    continuous compliance    demonstrate continuous
                                               by . . .                 by . . .           compliance by . . .
----------------------------------------------------------------------------------------------------------------
1. Each fed-batch fermenter producing  Showing that for at      Showing that the         Showing that the
 yeast in a fermentation stage (last    least 98 percent of      average VOC              average VOC
 (Trade), second-to-last (First         the batches (sum of      concentration in the     concentration in the
 Generation), or third-to-last          batches from last,       fermenter exhaust from   fermenter exhaust for
 (Stock)) for which compliance is       second-to-last, and      all batches in each      each batch within a
 determined by monitoring VOC           third-to-last stages)    fermentation stage       semiannual reporting
 concentration in the fermenter         for each 12-month        during each 12-month     period described in
 exhaust.                               period ending within a   calculation period       Sec.   63.2181(b)(3)
                                        semiannual reporting     ending within a          does not exceed the
                                        period described in      semiannual reporting     applicable
                                        Sec.   63.2181(b)(3),    period described in      concentration in Table
                                        the batch-average VOC    Sec.   63.2181(b)(3)     1 to this subpart.
                                        concentration in the     does not exceed the
                                        fermenter exhaust does   applicable
                                        not exceed the           concentration in Table
                                        applicable maximum       1 to this subpart.
                                        concentration in Table
                                        1 to this subpart.
2. Each fed-batch fermenter producing  Showing that for at      Showing that the         Showing that the
 yeast in a fermentation stage (last    least 98 percent of      average VOC              average VOC
 (Trade), second-to-last (First         the batches (sum of      concentration in the     concentration in the
 Generation), or third-to-last          batches from last,       fermenter exhaust from   fermenter exhaust for
 (Stock)) for which compliance is       second-to-last, and      all batches in each      each batch within a
 determined by monitoring brew          third-to-last stages)    fermentation stage       semiannual reporting
 ethanol concentration and              for each 12-month        during each 12-month     period described in
 calculating VOC concentration in the   period ending within a   calculation period       Sec.   63.2181(b)(3)
 fermenter exhaust according to the     semiannual reporting     ending within a          does not exceed the
 procedures in Sec.   63.2161.          period described in      semiannual reporting     applicable
                                        Sec.   63.2181(b)(3),    period described in      concentration in Table
                                        the batch-average VOC    Sec.   63.2181(b)(3)     1 to this subpart.\a\
                                        concentration in the     does not exceed the
                                        fermenter exhaust does   applicable
                                        not exceed the           concentration in Table
                                        applicable maximum       1 to this subpart \a\.
                                        concentration in Table
                                        1 to this subpart.
----------------------------------------------------------------------------------------------------------------
\a\ Monitoring brew ethanol to demonstrate compliance is not allowed on and after [date one year after the date
  of publication of the final rule in the Federal Register], as specified in Sec.   63.2171(a)(2).


      Table 5 to Subpart CCCC of Part 63--Requirements for Reports
------------------------------------------------------------------------
                                    The report must     You must submit
     You must submit a . . .         contain . . .     the report . . .
------------------------------------------------------------------------
1. Compliance report............  a. The information  Semiannually
                                   described in Sec.   according to the
                                     63.2181(c), for   requirements in
                                   12-month            Sec.
                                   calculation         63.2181(b).
                                   periods ending on
                                   each calendar
                                   month that falls
                                   within the
                                   reporting period.
                                  b. If you had a     Semiannually
                                   malfunction         according to the
                                   during the          requirements in
                                   reporting period,   Sec.
                                   then the            63.2181(b).
                                   compliance report
                                   must include the
                                   information in
                                   Sec.
                                   63.2181(c)(5) and
                                   (7).
2. Performance Evaluation Report  The results of the  At least annually
                                   performance         and according to
                                   evaluation,         the requirements
                                   including           in Sec.  Sec.
                                   information from    63.2163(f) and
                                   the performance     63.2181(a)(1)(ii)
                                   evaluation plan     .
                                   at 63.8(e)(3).
------------------------------------------------------------------------


[[Page 95846]]


 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.
                                 Standards and      63.6(e)(1)(i) does
                                 Maintenance        not apply, instead
                                 Requirements.      specified in Sec.
                                                    63.2150(c).
                                                   2. Sec.
                                                    63.6(e)(1)(ii),
                                                    (e)(3), (f)(1), and
                                                    (h) do not apply.
                                                   3. Otherwise, all
                                                    apply.
Sec.   63.7...................  Performance        1. Sec.   63.7(a)(1)-
                                 Testing            (2) do not apply,
                                 Requirements.      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)
                                 Requirements.      is modified by Sec.
                                                     63.2163.
                                                   2. Sec.   63.8(d)(3)
                                                    does not apply,
                                                    instead specified in
                                                    Sec.   63.2182(b)(7)
                                                    and Sec.
                                                    63.2183(d).
                                                   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)(4)(ii),
                                                    (c)(6)-(8), (e)(4),
                                                    and (g)(1)-(4) do
                                                    not apply, instead
                                                    specified in Sec.
                                                    63.2163, Sec.
                                                    63.2170(b), and Sec.
                                                      63.2182(b)(6).
                                                   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).
                                                   2. Sec.   63.10(c)(1)-
                                                    (6) do not apply,
                                                    instead specified in
                                                    Sec.   63.2182(b)(4)-
                                                    (6).
                                                   3. Sec.   63.10
                                                    (b)(2)(i),
                                                    (b)(2)(iv),
                                                    (b)(2)(v), (c)(15),
                                                    (d)(3), (e)(2)(ii),
                                                    and (e)(3)-(4) do
                                                    not apply.
                                                   4. Sec.   63.10(d)(5)
                                                    does not apply,
                                                    instead specified in
                                                    Sec.   63.2181(c)(5)
                                                    and (7).
                                                   5. Otherwise, all
                                                    apply.
Sec.   63.11..................  Flares...........  No.
Sec.   63.12..................  Delegation.......  Yes.
Sec.   63.13..................  Addresses........  Yes.
Sec.   63.14..................  Incorporation by   Yes.
                                 Reference.
Sec.   63.15..................  Availability of    Yes.
                                 Information.
------------------------------------------------------------------------

[FR Doc. 2016-30645 Filed 12-27-16; 8:45 am]
 BILLING CODE 6560-50-P