AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

The U.S. Environmental Protection Agency (EPA) is proposing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Solvent Extraction for Vegetable Oil Production. The source category addressed in this action is the Solvent Extraction for Vegetable Oil Production source category. The EPA is proposing the results of the residual risk and technology review (RTR) that the EPA is required to conduct in accordance with the Clean Air Act (CAA). Based on the results of the EPA's risk review, the Agency is proposing that risk due to emissions of air toxics from this source category is acceptable and that the current NESHAP provides an ample margin of safety to protect public health. Under the technology review, the EPA is proposing there are no developments in practices, processes, or control technologies that necessitate revision of the standards. Therefore, the EPA is proposing no revisions to the numerical emission limits based on these analyses. However, the EPA is proposing to revise provisions pertaining to emissions during periods of startup, shutdown, and malfunction (SSM); add requirements for electronic reporting of certain notifications and reports and performance test results; and make other minor clarifications and corrections. Although the proposed amendments would not result in reductions in emissions of hazardous air pollutants (HAP), if finalized, they would result in improved compliance and implementation of the rule.

DATES:

 

Comments. Comments must be received on or before August 12, 2019. 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 July 29, 2019.

Public hearing. If anyone contacts us requesting a public hearing on or before July 2, 2019, we will hold a hearing. Additional information about the hearing, if requested, will be published in a subsequent Federal Register document and posted at https://www.epa.gov/​stationary-sources-air-pollution/​solvent-extraction-vegetable-oil-production-national-emission. See SUPPLEMENTARY INFORMATION for information on requesting and registering for a public hearing.

ADDRESSES:

You may send comments, identified by Docket ID No. EPA-HQ-OAR-2019-0208, by any of the following methods:

• Federal eRulemaking Portal: https://www.regulations.gov/​ (our preferred method). Follow the online instructions for submitting comments.
• Email: a-and-r-docket@epa.gov. Include Docket ID No. EPA-HQ-OAR-2019-0208 in the subject line of the message.
• Fax: (202) 566-9744. Attention Docket ID No. EPA-HQ-OAR-2019-0208.
• Mail: U.S. Environmental Protection Agency, EPA Docket Center, Docket ID No. EPA-HQ-OAR-2019-0208, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
• Hand/Courier Delivery: EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. The Docket Center's hours of operation are 8:30 a.m.-4:30 p.m., Monday-Friday (except Federal holidays).

Instructions: All submissions received must include the Docket ID No. for this rulemaking. Comments received may be posted without change to https://www.regulations.gov/​, including any personal information provided. For detailed instructions on sending comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:

For questions about this proposed action, contact Mr. Bill Schrock, Natural Resources Group, Sector Policies and Programs Division (E143-03), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-5032; fax number: (919) 541-0516; and email address: schrock.bill@epa.gov. For specific information regarding the risk modeling methodology, contact Matthew Woody, Health and Environmental Impacts Division (C539-02), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-1535; fax number: (919) 541-0840; and email address: woody.matthew@epa.gov. For questions about monitoring and testing requirements, contact Brandon Little, Sector Policies and Programs Division (D243-05), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-4059; fax number: (919) 541-4991; and email address: little.brandon@epa.gov. For information about the applicability of the NESHAP to a particular entity, contact Maria Malave, Office of Enforcement and Compliance Assurance, U.S. Environmental Protection Agency, WJC South Building (Mail Code 2227A), 1200 Pennsylvania Avenue NW, Washington DC 20460; telephone number: (202) 564-7027; and email address: malave.maria@epa.gov.

SUPPLEMENTARY INFORMATION:

Public hearing. Please contact Ms. Virginia Hunt at (919) 541-0632 or by email at hunt.virginia@epa.gov to request a public hearing, to register to speak at the public hearing, or to inquire as to whether a public hearing will be held.

Docket. The EPA has established a docket for this rulemaking under Docket ID No. EPA-HQ-OAR-2019-0208. All documents in the docket are listed in Regulations.gov. Although listed, some information is not publicly available, e.g., CBI (Confidential Business Information) 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, 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-2019-0208. 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 https://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 https://www.regulations.gov or email. This type of information should be submitted by mail as discussed below.

The EPA may publish any comment received to its public docket. 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.

The https://www.regulations.gov/​ website allows you to submit your comment anonymously, 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 https://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 digital storage media 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.

Submitting CBI. Do not submit information containing CBI to the EPA through https://www.regulations.gov/​ or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information on any digital storage media that you mail to the EPA, mark the outside of the digital storage media as CBI and then identify electronically within the digital storage media 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 directly to the public docket through the procedures outlined in Instructions above. If you submit any digital storage media that does not contain CBI, mark the outside of the digital storage media 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-2019-0208.

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 level

AERMOD air dispersion model used by the HEM-3 model

BACT Best Available Control Technology

CAA Clean Air Act

CalEPA California EPA

CBI Confidential Business Information

CDX Central Data Exchange

CEDRI Compliance and Emissions Data Reporting Interface

CFR Code of Federal Regulations

EPA Environmental Protection Agency

ERPG Emergency Response Planning Guideline

ERT Electronic Reporting Tool

HAP hazardous air pollutant(s)

HCl hydrochloric acid

HEM-3 Human Exposure Model, Version 1.1.0

HF hydrogen fluoride

HI hazard index

HQ hazard quotient

IRIS Integrated Risk Information System

km kilometer

LAER Lowest Achievable Emission Rate

MACT maximum achievable control technology

mg/kg-day milligrams per kilogram per day

mg/m³ milligrams per cubic meter

MIR maximum individual risk

NAICS North American Industry Classification System

NESHAP national emission standards for hazardous air pollutants

NOPA National Oil Producers Association

NSR New Source Review

NTTAA National Technology Transfer and Advancement Act

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

PDF portable document format

ppm parts per million

QA quality assurance

RACT Reasonably Available Control Technology

RBLC RACT/BACT/LAER Clearinghouse

REL reference exposure level

RFA Regulatory Flexibility Act

RfC reference concentration

RfD reference dose

RTR residual risk and technology review

SAB Science Advisory Board

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

UF uncertainty factor

µg/m³ microgram per cubic meter

UMRA Unfunded Mandates Reform Act

URE unit risk estimate

VCS voluntary consensus standards

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?

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 and Decision-Making

A. How do we consider risk in our decision-making?

B. How do we perform the technology review?

C. How do we estimate post-MACT risk posed by the source category?

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 effect?

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. Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs

C. Paperwork Reduction Act (PRA)

D. Regulatory Flexibility Act (RFA)

E. Unfunded Mandates Reform Act (UMRA)

F. Executive Order 13132: Federalism

G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

H. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

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

J. National Technology Transfer and Advancement Act (NTTAA)

K. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

I. General Information

A. Does this action apply to me?

Table 1 of this preamble lists the NESHAP and associated regulated industrial source categories that are 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) and Documentation for Developing the Initial Source Category List, Final Report (see EPA-450/3-91-030, July 1992) as the “Vegetable Oil Production” source category, and subsequently revised to the “Solvent Extraction for Vegetable Oil Production” source category (66 FR 8220, January 30, 2001) is defined as any facility engaged in producing crude vegetable oil and meal products by removing oil from listed oilseeds through direct contact with an organic solvent. The term “oilseed” refers to the following agricultural products: Corn germ, cottonseed, flax, peanut, safflower, soybean, sunflower, and rapeseed (source of canola oil).

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/​solvent-extraction-vegetable-oil-production-national-emission. Following publication in the Federal Register, the EPA will post the Federal Register version of the proposal and key technical documents at this same website. Information on the overall RTR program is available at http://www3.epa.gov/​ttn/​atw/​rrisk/​rtrpg.html.

A redline version of the regulatory language that incorporates the proposed changes in this action is available in the docket for this action (Docket ID No. EPA-HQ-OAR-2019-0208).

II. Background

A. What is the statutory authority for this action?

The statutory authority for this action is provided by sections 112 and 301 of the CAA, as amended (42 U.S.C. 7401 et seq.). Section 112 of the CAA establishes a two-stage regulatory process to develop standards for emissions of HAP from stationary sources. Generally, the first stage involves establishing technology-based standards and the second stage involves evaluating those standards that are based on maximum achievable control technology (MACT) to determine whether additional standards are needed to address any remaining risk associated with HAP emissions. This second stage is commonly referred to as the “residual risk review.” In addition to the residual risk review, the CAA also requires the EPA to review standards set under CAA section 112 every 8 years to determine if there are “developments in practices, processes, or control technologies” that may be appropriate to incorporate into the standards. This review is commonly referred to as the “technology review.” When the two reviews are combined into a single rulemaking, it is commonly referred to as the “risk and technology review.” The discussion that follows identifies the most relevant statutory sections and briefly explains the contours of the methodology used to implement these statutory requirements. A more comprehensive discussion appears in the document titled CAA Section 112 Risk and Technology Reviews: Statutory Authority and Methodology, in the docket for this rulemaking.

In the first stage of the CAA section 112 standard setting process, the EPA promulgates technology-based standards under CAA section 112(d) for categories of sources identified as emitting one or more of the HAP listed in CAA section 112(b). Sources of HAP emissions are either major sources or area sources, and CAA section 112 establishes different requirements for major source standards and area source standards. “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. All other sources are “area sources.” For major sources, CAA section 112(d)(2) provides that 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). These standards are commonly referred to as MACT standards. CAA section 112(d)(3) also establishes a minimum control level for MACT standards, known as the MACT “floor.” The EPA must also consider control options that are more stringent than the floor. Standards more stringent than the floor are commonly referred to as beyond-the-floor standards. In certain instances, as provided in CAA section 112(h), the EPA may set work practice standards where it is not feasible to prescribe or enforce a numerical emission standard. For area sources, CAA section 112(d)(5) gives the EPA discretion to set standards based on generally available control technologies or management practices (GACT standards) in lieu of MACT standards.

The second stage in standard-setting focuses on identifying and addressing any remaining (i.e., “residual”) risk according to CAA section 112(f). For source categories subject to MACT standards, section 112(f)(2) of the CAA requires the EPA to determine whether promulgation of additional standards is needed to provide an ample margin of safety to protect public health or to prevent an adverse environmental effect. Section 112(d)(5) of the CAA provides that this residual risk review is not required for categories of area sources subject to GACT standards. Section 112(f)(2)(B) of the CAA further expressly preserves the EPA's use of the two-step approach 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 the United States Court of Appeals for the District of Columbia Circuit (the Court) upheld 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).

The approach incorporated into the CAA and used by the EPA to evaluate residual risk and to develop standards under CAA section 112(f)(2) is a two-step approach. 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) ^[1] of approximately 1 in 10 thousand.” 54 FR 38045, September 14, 1989. If risks are unacceptable, the EPA must determine the emissions standards necessary to reduce risk to an acceptable level without considering costs. In the second step of the approach, the EPA considers whether the emissions standards provide an ample margin of safety to protect public health “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 to protect public health. 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.

CAA section 112(d)(6) separately requires the EPA to review standards promulgated under CAA section 112 and revise them “as necessary (taking into account developments in practices, processes, and control technologies)” no less often than every 8 years. In conducting this review, which we call the “technology 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, Inc. v. EPA, 716 F.3d 667 (D.C. Cir. 2013). The EPA may consider cost in deciding whether to revise the standards pursuant to CAA section 112(d)(6).

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

The current NESHAP for the Solvent Extraction for Vegetable Oil Production source category was promulgated on April 12, 2001 (66 FR 19006), and codified at 40 CFR part 63, subpart GGGG. As promulgated in 2001 and further amended on April 5, 2002 (67 FR 16317), and September 1, 2004 (69 FR 53338), the NESHAP regulates HAP emissions from solvent extraction for vegetable oil production processes at a facility that is a major source of HAP emissions. The affected source is each vegetable oil production process. A vegetable oil production process means the equipment comprising a continuous process for producing crude vegetable oil and meal products, including specialty soybean products, in which oil is removed from oilseeds listed in Table 1 of 40 CFR 63.2840 through direct contact with an organic solvent. Process equipment typically includes the following components: Oilseed preparation operations (including conditioning, drying, dehulling, and cracking), solvent extractors, desolventizer-toasters, meal dryers, meal coolers, meal conveyor systems, oil distillation units, solvent evaporators and condensers, solvent recovery system (also referred to as a mineral oil absorption system), vessels storing solvent-laden materials, and crude meal packaging and storage vessels. A vegetable oil production process does not include vegetable oil refining operations (including operations such as bleaching, hydrogenation, and deodorizing) and operations that engage in additional chemical treatment of crude soybean meals produced in specialty desolventizer units (including operations such as soybean isolate production).

The primary HAP emitted from vegetable oil production processes is n-hexane. The EPA does not consider n-hexane classifiable as a human carcinogen. However, short-term exposure to n-hexane can cause reactions such as irritations, dizziness, headaches, and nausea. Long-term exposure can cause permanent nerve damage.

The current NESHAP restricts facility-wide n-hexane emissions by setting emission limitations based on the number of gallons of HAP lost per ton of oilseeds processed, expressed as oilseed solvent loss ratios. Facilities demonstrate compliance by calculating a compliance ratio comparing the actual HAP loss to the allowable HAP loss for the previous 12 operating months. Allowable HAP loss is based on the oilseed solvent loss ratios provided in Table 1 of 40 CFR 63.2840 of the rule for new and existing sources. Compliance is demonstrated when the facility's calculated compliance ratio is less than 1 (i.e., the actual HAP loss is less than the calculated allowable HAP loss). Determination of compliance with the requirements of the Solvent Extraction for Vegetable Oil Production NESHAP requires the facility to keep records of the amount of n-hexane purchased, used, and recovered from the oilseed extraction process, the amount of oilseed processed, and the volume fraction of each HAP exceeding 1 percent in the extraction solvent used. Facilities may also adjust their solvent loss to account for cases where solvent is routed through a closed vent system to a control device that is used to reduce emissions to meet the standard.

Based on our search of the National Emission Inventory (NEI), the EPA's Enforcement and Compliance History Online (ECHO) database (https://www.echo.epa.gov/​), and consultation with industry representatives and EPA Regional offices, as of August 2018, there are 89 vegetable oil production facilities in operation and subject to the Solvent Extraction for Vegetable Oil Production NESHAP. A complete list of facilities that are currently subject to the Solvent Extraction for Vegetable Oil Production NESHAP is available in Appendix A of the memorandum, Residual Risk Modeling File Documentation for the Solvent Extraction for Vegetable Oil Production Source Category, which is available in Docket ID No. EPA-HQ-OAR-2019-0208.

C. What data collection activities were conducted to support this action?

The EPA used several means to collect the information necessary to conduct the residual risk assessment and technology review for the Solvent Extraction for Vegetable Oil Production source category. To confirm whether facilities identified as potentially subject to the NESHAP were, in fact, subject to the standards, we reviewed compliance data in the EPA's ECHO database and requested air operating permits from various state and local agencies and EPA Regional offices. Additional Web searches (online news articles, company and trade organization websites, and review of Google Earth® satellite and street view imagery) were conducted to verify facility acquisition or closure. After developing our list of affected facilities, the status of these facilities was confirmed in consultation with the National Oil Producers Association (NOPA). The EPA conducted site visits at two facilities and conducted calls with NOPA representatives and member facilities regarding the facilities' production process and emission sources, available emissions data and emissions estimates, measures used to control emissions, and other aspects of facility operations. The facility-specific information from state and local agencies and companies with affected facilities provided support for this action's risk and technology reviews.

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

The EPA used multiple sources of information to support this proposed action. Before developing the list of affected facilities described in section II.C of this preamble, the EPA's ECHO database was used as a tool to identify potentially affected facilities with vegetable oil production operations using solvent extraction that are subject to the NESHAP. The ECHO database provides integrated compliance and enforcement information for approximately 800,000 regulated facilities nationwide.

The 2011 and 2014 NEI databases provided facility-specific data and MACT category data that were used in developing the modeling file for the risk review. The NEI is a database that contains information about sources that emit criteria air pollutants, their precursors, and HAP. The database includes estimates of annual air pollutant emissions from point, nonpoint, and mobile sources in the 50 states, the District of Columbia, Puerto Rico, and the Virgin Islands. The EPA collects this information and releases an updated version of the NEI database every 3 years. The 2014 NEI was used because it was the most recent version available; 2011 NEI data was used to supplement the information in the 2014 NEI (e.g., if a facility reported hexane loss as volatile organic compounds (VOC) in the 2014 NEI and as HAP in the 2011 NEI). The NEI includes information necessary for conducting risk modeling, including annual HAP emissions estimates from individual emission points at facilities and the related emissions release parameters. The EPA also consulted the 2014 Toxics Release Inventory (TRI) database for assessment of facility-specific data for development of the modeling file. The TRI database is a regularly updated dataset encompassing over 30 years of information. The TRI compiles reported annual air pollutant emissions from U.S. facilities from 30 industrial sectors and provides information about toxic chemical releases and pollution prevention activities reported by individual industrial and Federal facilities. The EPA collects the reported information, conducts data quality checks, and provides the information to the public through several internet-based tools and applications. The TRI provides individual HAP emissions estimates on a facility-level basis.

In conducting the technology review, we examined state air operating permits and related documentation, including permit applications, supporting documents and inventories, and consent decrees. We also reviewed information in the Reasonably Available Control Technology (RACT)/Best Available Control Technology (BACT)/Lowest Achievable Emission Rate (LAER) Clearinghouse (RBLC) to identify technologies in use and determine if there have been developments in practices, processes, or control technologies. The RBLC is a database that contains case-specific information of air pollution technologies that have been required to reduce the emissions of air pollutants from stationary sources. Under the EPA's New Source Review (NSR) program, if a facility is planning new construction or a modification that will increase the air emissions by a large amount, an NSR permit must be obtained. This central database promotes the sharing of information among permitting agencies and aids in case-by-case determinations for NSR permits.

The EPA also reviewed other information sources to determine if there have been developments in practices, processes, or control technologies in the Solvent Extraction for Vegetable Oil Production source category. We reviewed regulatory actions for emission sources similar to those included in the Solvent Extraction for Vegetable Oil Production source category, including sources engaged in solvent use and recovery operations, and conducted a review of literature published by industry organizations, technical journals, and government organizations.

III. Analytical Procedures and Decision-Making

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 do we consider risk in our decision-making?

As discussed in section II.A of this preamble and in the Benzene NESHAP, in evaluating and developing standards under CAA section 112(f)(2), we apply a two-step approach to determine whether or not risks are acceptable and to determine if the standards provide an ample margin of safety to protect public health. 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 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. The EPA conducts 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 noncancer health effects, and the hazard quotient (HQ) for acute exposures to HAP with the potential to cause noncancer health effects.^[2] The assessment also provides estimates of the distribution of cancer risk within the exposed populations, cancer incidence, and an evaluation of the potential for an adverse environmental effect. The scope of the EPA's risk analysis is consistent with the EPA's response to comments on our policy under the Benzene NESHAP where 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 his 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 his judgment, believes are appropriate to determining what will `protect the public health'.”

See 54 FR 38057, September 14, 1989. Thus, the level of the MIR is only one factor to be weighed in determining acceptability of risk. 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 measures and information in making an overall judgment on acceptability. Or, the Agency may find, in a particular case, that a risk that includes an 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 the HAP risk that may be associated with emissions from other facilities that do not include the source category under review, mobile source emissions, natural source emissions, persistent environmental pollution, or atmospheric transformation in the vicinity of the sources in the category.

The EPA 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 noncancer risk, where pollutant-specific exposure health reference levels (e.g., reference concentrations (RfCs)) are based on the assumption that thresholds exist for adverse health effects. For example, the EPA recognizes that, although exposures attributable to emissions from a source category or facility alone may not indicate the potential for increased risk of adverse noncancer 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 an increased risk of adverse noncancer health effects. In May 2010, the Science Advisory Board (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.” ^[3]

In response to the SAB recommendations, the EPA incorporates cumulative risk analyses into its RTR risk assessments, including those reflected in this proposal. The Agency (1) conducts facility-wide assessments, which include source category emission points, as well as other emission points within the facilities; (2) combines exposures from multiple sources in the same category that could affect the same individuals; and (3) for some persistent and bioaccumulative pollutants, analyzes the ingestion route of exposure. In addition, the RTR risk assessments consider aggregate cancer risk from all carcinogens and aggregated noncancer HQs for all noncarcinogens affecting the same target organ or target organ system.

Although the EPA is interested in placing source category and facility-wide HAP risk in the context of total HAP risk from all sources combined in the vicinity of each source, the EPA is concerned about the uncertainties of doing so. Estimates of total HAP risk from emission sources other than those that we have studied in depth during this RTR review 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.

B. How do we perform the technology review?

Our technology review focuses on the identification and evaluation of developments in practices, processes, and control technologies that have occurred since the MACT standards were promulgated. Where we identify such developments, we analyze their technical feasibility, estimated costs, energy implications, and non-air environmental impacts. We also consider the emission reductions associated with applying each development. This analysis informs our decision of whether it is “necessary” to revise the emissions standards. In addition, we consider the appropriateness of applying controls to new sources versus retrofitting existing sources. For this exercise, we consider 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 and last updated the NESHAP, we review a variety of data sources in our investigation of potential practices, processes, or controls to consider. See sections II.C and II.D of this preamble for information on the specific data sources that were reviewed as part of the technology review.

C. How do we estimate post-MACT risk posed by the source category?

In this section, we provide a complete description of the types of analyses that we generally perform during the risk assessment process. In some cases, we do not perform a specific analysis because it is not relevant. For example, in the absence of emissions of HAP known to be persistent and bioaccumulative in the environment (PB-HAP), we would not perform a multipathway exposure assessment. Where we do not perform an analysis, we state that we do not and provide the reason. While we present all of our risk assessment methods, we only present risk assessment results for the analyses actually conducted (see section IV.A of this preamble).

The EPA conducts a risk assessment that provides estimates of the MIR for cancer posed by the HAP emissions from each source in the source category, the HI for chronic exposures to HAP with the potential to cause noncancer health effects, and the HQ for acute exposures to HAP with the potential to cause noncancer health effects. The assessment also provides estimates of the distribution of cancer risk within the exposed populations, cancer incidence, and an evaluation of the potential for an adverse environmental effect. The seven 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 Solvent Extraction for Vegetable Oil Production Source Category in Support of the 2019 Risk and Technology Review Proposed Rule. The methods used to assess risk (as described in the seven primary steps below) are consistent with those described by the EPA in the document reviewed by a panel of the EPA's SAB in 2009; ^[4] and described in the SAB review report issued in 2010. They are also consistent with the key recommendations contained in that report.

1. How did we estimate actual emissions and identify the emissions release characteristics?

Data for 93 vegetable oil production process lines at 88 facilities were used to create the RTR emissions dataset as described in sections II.C and II.D of this preamble. We identified one additional vegetable oil production process line at one newly constructed facility, which did not begin operations until January 2018. At the time of the development of the RTR emissions dataset, emissions data were not available for the new facility, therefore, only 88 of 89 known facilities are included. The emission sources included in the RTR emissions dataset are the collection of oilseed preparation operations (including conditioning, drying, dehulling, and cracking), solvent extractors, desolventizer-toasters, meal dryers, meal coolers, meal conveyor systems, oil distillation units, solvent evaporators and condensers, solvent recovery systems (also referred to as mineral oil absorption systems), vessels storing solvent-laden materials, and crude meal packaging and storage vessels, which are the primary HAP emission sources at vegetable oil production facilities and currently regulated by the NESHAP.

As stated in section II.B of this preamble, the primary HAP emitted from these emissions sources is n-hexane, which accounts for 99.9 percent of emissions from the source category. For nine facilities, the facility data reported to the NEI from these emissions sources was reported as VOC instead of n-hexane. For these facilities, the reported VOC emissions were assumed as 100- percent n-hexane. We made this assumption to provide a conservative estimate of risk, as the n-hexane content of most commercially available solvents is generally 64 percent (with remaining content composed of non-HAP materials). For a very small number of facilities (six), emissions of additional HAP, including acrolein, acetaldehyde, formaldehyde, and methanol, appeared to exhaust from emission points within the source category. Although these HAP are not used in or a result of solvent extraction and are likely from collocated ethanol processing facilities, oilseed conditioning, vegetable oil refining, or chemical treatment operations (such as bleaching, hydrogenation, or deodorizing processes) that exhaust through similar stacks, we could not definitively determine whether they should be excluded from the Solvent Extraction for Vegetable Oil Production source category. Because they could not be easily separated from the source category emissions for modeling purposes, we included these HAP in the modeling file to provide a conservative estimate of risk.

Actual emission estimates for the vegetable oil production process equipment at the 88 affected facilities included in the dataset were based on 2011 and 2014 NEI data, 2014 TRI data, and inventories provided by individual facilities. Actual emission rates were provided separately for one facility (Cargill Corn Milling North America—Blair, Nebraska), due to discrepancies in the data reported to the NEI, and were based on facility testing and emission inventory data. Stack parameter data provided in the 2014 NEI, in addition to information identified from facility permits and associated documents, was used to assign actual emissions separately for these emission sources to individual emission release points (either as stack points or as fugitive emissions). For each emission release point, emissions release characteristic data such as emission release height, diameter, temperature, velocity, flow rate, and locational latitude/longitude coordinates were identified. The RTR emissions dataset also includes emissions reported as complete process solvent loss, which represent the facility's combined n-hexane emissions, and were reported to the NEI or TRI as a single emissions release point (either fugitive or stack emissions). Because facilities in the source category typically vent their process units to a solvent recovery system for n-hexane recovery, the RTR database retains these emissions as emitted from either a single stack or fugitive point. Where site-specific information was incomplete, the EPA estimated stack parameters and calculated industry averages using the available data, or assigned default parameter values based on MACT source category 2014 NEI information where there was insufficient information.

The EPA conducted a quality assurance (QA) check of source locations, emission release characteristics, and annual emissions estimates for all facilities. Additional details on the data and methods used to develop actual emissions estimates for the risk modeling, including the EPA's QA review, are provided in the memorandum, Residual Risk Modeling File Documentation for the Solvent Extraction for Vegetable Oil Production 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 a specified annual time period. These “actual” emission levels are often lower than the emission levels allowed under the requirements of the current MACT standards. The emissions allowed under the MACT standards are referred to as the “MACT-allowable” emissions. We discussed the consideration 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 RTR (71 FR 34428, June 14, 2006, and 71 FR 76609, December 21, 2006, respectively). In those actions, we noted that assessing the risk at the MACT-allowable level is inherently reasonable since that risk reflects 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.)

The EPA determined annual MACT-allowable emissions by evaluating and estimating an average emissions multiplier for the industry. We reviewed permits for a subset of facilities in the source category to determine the permitted annual allowable emissions based on individual permit limits that demonstrated compliance with the MACT standard. The permitted annual allowable emissions for each facility were then compared to the actual annual emissions reported for each facility in the 2014 NEI to develop a ratio that reflects the current compliance margin for these facilities. The calculated ratio of permit allowable emissions to actual emissions is 3.139:1, so a multiplier of 3.139 was selected. We applied the multiplier to the actual emissions of the remaining facilities to estimate the allowable emissions for these facilities. We considered the estimated emissions multiplier a conservative estimate of MACT-allowable emissions as the reported actual emissions reflected only 20 to 30 percent of facilities' permitted emission rates, on average. Additionally, we note that the MACT annual-allowable emissions conservatively assume that all loss of n-hexane in the solvent extraction process is emitted to the atmosphere. However, we note that the solvent extraction process results in a portion of the solvent (less than 100 parts per million) remaining in the crushed seed meal. Therefore, the estimated allowable emissions likely reflect higher emissions than are emitted by the process.

3. How do we conduct dispersion modeling, determine inhalation exposures, and estimate individual and population inhalation risk?

Both long-term and short-term inhalation exposure concentrations and health risk from the source category addressed in this proposal were estimated using the Human Exposure Model (HEM-3).^[5] 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 kilometers (km) of the modeled sources, and (3) estimating individual and population-level inhalation risk using the exposure estimates and quantitative dose-response information.

a. Dispersion Modeling

The air dispersion model AERMOD, used by the HEM-3 model, is one of the EPA's preferred models for assessing air pollutant concentrations from industrial facilities.^[6] 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 (2016) of hourly surface and upper air observations from 824 meteorological stations, selected to provide coverage of the United States and Puerto Rico. A second library of United States Census Bureau census block ^[7] 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-specific dose-response values is used to estimate health risk. These are discussed below.

b. Risk From Chronic Exposure to HAP

In developing the risk assessment for chronic exposures, we use the estimated annual average ambient air concentrations of each HAP emitted by each source in the source category. The HAP air concentrations at each nearby census block centroid located within 50 km of the facility are a surrogate for the chronic inhalation exposure concentration for all the people who reside in that census block. 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.

For each facility, we calculate the MIR as the cancer risk associated with a continuous lifetime (24 hours per day, 7 days per week, 52 weeks per year, 70 years) exposure to the maximum concentration at the centroid of each inhabited census block. We calculate individual cancer risk by multiplying the estimated lifetime exposure to the ambient concentration of each HAP (in micrograms per cubic meter (μg/m³)) by its unit risk estimate (URE). The URE is an upper-bound estimate of an individual's incremental risk 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 UREs 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) UREs, 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 pollutant-specific dose-response values used to estimate health risk are available at https://www.epa.gov/​fera/​dose-response-assessment-assessing-health-risks-associated-exposure-hazardous-air-pollutants.

To estimate individual lifetime cancer risks associated with exposure to HAP emissions from each facility in the source category, we sum the risks for each of the carcinogenic HAP ^[8] emitted by the modeled facility. We estimate cancer risk at every census block within 50 km of every facility in the source category. The MIR is the highest individual lifetime cancer risk estimated for any of those census blocks. In addition to calculating the MIR, we estimate the distribution of individual cancer risks for the source category by summing the number of individuals within 50 km of the sources whose estimated risk falls within a specified risk range. We also estimate annual cancer incidence by multiplying the estimated lifetime cancer risk at each census block by the number of people residing in that block, summing results for all of the census blocks, and then dividing this result by a 70-year lifetime.

To assess the risk of noncancer health effects from chronic exposure to HAP, we calculate either an HQ or a target organ-specific hazard index (TOSHI). We calculate an HQ when a single noncancer HAP is emitted. Where more than one noncancer HAP is emitted, we sum the HQ for each of the HAP that affects a common target organ or target organ system to obtain a TOSHI. The HQ is the estimated exposure divided by the chronic noncancer dose-response value, which is a value selected from one of several sources. The preferred chronic noncancer dose-response value is the EPA RfC, 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” (https://iaspub.epa.gov/​sor_​internet/​registry/​termreg/​searchandretrieve/​glossariesandkeywordlists/​search.do?​details=​&​vocabName=​IRIS%20Glossary). In cases where an RfC from the EPA's IRIS is not available or where the EPA determines that using a value other than the RfC is appropriate, the chronic noncancer dose-response value can be a value from the following prioritized sources, which define their dose-response values similarly to the EPA: (1) The Agency for Toxic Substances and Disease Registry (ATSDR) Minimum Risk Level (https://www.atsdr.cdc.gov/​mrls/​index.asp); (2) the CalEPA Chronic Reference Exposure Level (REL) (https://oehha.ca.gov/​air/​crnr/​notice-adoption-air-toxics-hot-spots-program-guidance-manual-preparation-health-risk-0); 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. The pollutant-specific dose-response values used to estimate health risks are available at https://www.epa.gov/​fera/​dose-response-assessment-assessing-health-risks-associated-exposure-hazardous-air-pollutants.

c. Risk From Acute Exposure to HAP That May Cause Health Effects Other Than Cancer

For each HAP for which appropriate acute inhalation dose-response values are available, the EPA also assesses the potential health risks due to acute exposure. For these assessments, the EPA makes conservative assumptions about emission rates, meteorology, and exposure location. In this proposed rulemaking, as part of our efforts to continually improve our methodologies to evaluate the risks that HAP emitted from categories of industrial sources pose to human health and the environment,^[9] the EPA is revising our treatment of meteorological data to use reasonable worst-case air dispersion conditions in our acute risk screening assessments instead of worst-case air dispersion conditions. This revised treatment of meteorological data and the supporting rationale are described in more detail in Residual Risk Assessment for the Vegetable Oil Production Source Category in Support of the 2019 Risk and Technology Review Proposed Rule and in Appendix 5 of the report: Technical Support Document for Acute Risk Screening Assessment. We will be applying this revision in RTR rulemakings proposed on or after June 3, 2019.

To assess the potential acute risk to the maximally exposed individual, we use the peak hourly emission rate for each emission point,^[10] reasonable worst-case air dispersion conditions (i.e., 99th percentile), and the point of highest off-site exposure. Specifically, we assume that peak emissions from the source category and reasonable worst-case air dispersion conditions co-occur and that a person is present at the point of maximum exposure.

To characterize the potential health risks associated with estimated acute inhalation exposures to a HAP, we generally use multiple acute dose-response values, including acute RELs, acute exposure guideline levels (AEGLs), and emergency response planning guidelines (ERPG) for 1-hour exposure durations), if available, to calculate acute HQs. The acute HQ is calculated by dividing the estimated acute exposure concentration by the acute dose-response value. For each HAP for which acute dose-response values are available, the EPA calculates acute HQs.

An acute REL is defined as “the concentration level at or below which no adverse health effects are anticipated for a specified exposure duration.” ^[11] Acute RELs are based on the most sensitive, relevant, adverse health effect reported in the peer-reviewed medical and toxicological literature. They 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. AEGLs represent threshold exposure limits for the general public and are applicable to emergency exposures ranging from 10 minutes to 8 hours.^[12] They are guideline levels for “once-in-a-lifetime, short-term exposures to airborne concentrations of acutely toxic, high-priority chemicals.” Id. at 21. The AEGL-1 is specifically defined as “the airborne concentration (expressed as ppm (parts per million) or mg/m³ (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.” 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. AEGL-2 are defined as “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.

ERPGs are “developed for emergency planning and are intended as health-based guideline concentrations for single exposures to chemicals.” ^[13] Id. at 1. The ERPG-1 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 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.

An acute REL for 1-hour exposure durations is typically lower than its corresponding AEGL-1 and ERPG-1. Even though their definitions are slightly different, AEGL-1s are often the same as the corresponding ERPG-1s, and AEGL-2s are often equal to ERPG-2s. The maximum HQs from our acute inhalation screening risk assessment typically result when we use the acute REL for a HAP. In cases where the maximum acute HQ exceeds 1, we also report the HQ based on the next highest acute dose-response value (usually the AEGL-1 and/or the ERPG-1).

For this source category, the EPA estimated peak, short-term emissions using the available annual emissions data from the NEI. In previous RTR rulemakings, the EPA has assumed that a facility's peak, 1-hour emission rate could exceed its annual average hourly emission rate by as much as a factor of 10, accounting for process variability, less-than-full-time operations, and other factors.^[14] Because we had no information indicating that peak emissions were lower, we chose to use a default multiplier of 10 to estimate acute emissions from the Solvent Extraction for Vegetable Oil Production source category. Acute emissions values were calculated by multiplying the actual emissions by 10.

In our acute inhalation screening risk assessment, acute impacts are deemed negligible for HAP for which acute HQs are less than or equal to 1, and no further analysis is performed for these HAP. In cases where an acute HQ from the screening step is greater than 1, we assess the site-specific data to ensure that the acute HQ is at an off-site location. For this source category, the data refinements employed consisted of ensuring the locations where the maximum HQ occurred were off facility property and where the public could potentially be exposed. These refinements are discussed more fully in the Residual Risk Assessment for the Solvent Extraction for Vegetable Oil Production Source Category in Support of the 2019 Risk and Technology Review Proposed Rule, which is available in the docket for this source category.

4. How do we conduct the multipathway exposure and risk screening assessment?

The EPA conducts a tiered screening assessment examining the potential for significant human health risks due to exposures via routes other than inhalation (i.e., ingestion). We first determine whether any sources in the source category emit any PB-HAP, as identified in the EPA's Air Toxics Risk Assessment Library (See Volume 1, Appendix D, at https://www2.epa.gov/​fera/​risk-assessment-and-modeling-air-toxics-risk-assessment-reference-library.

For the Solvent Extraction for Vegetable Oil Production source category, we did not identify emissions of any PB-HAP. Because we did not identify PB-HAP emissions, no further evaluation of multipathway risk was conducted for this source category.

For further information on the multipathway assessment approach, see the Residual Risk Assessment for the Solvent Extraction for Vegetable Oil Production Source Category in Support of the Risk and Technology Review 2018 Proposed Rule, which is available in the docket for this action.

5. How do we conduct the environmental risk screening assessment?

The EPA conducts a screening assessment to examine the potential for an adverse environmental effect 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.”

The EPA focuses on eight HAP, which are referred to as “environmental HAP,” in its screening assessment: Six PB-HAP and two acid gases. The PB-HAP included in the screening assessment are arsenic compounds, cadmium compounds, dioxins/furans, polycyclic organic matter, mercury (both inorganic mercury and methyl mercury), and lead compounds. The acid gases included in the screening assessment are hydrochloric acid (HCl) and hydrogen fluoride (HF).

HAP that persist and bioaccumulate are of particular environmental concern because they accumulate in the soil, sediment, and water. The acid gases, HCl and HF, are included due to their well-documented potential to cause direct damage to terrestrial plants. For the Solvent Extraction for Vegetable Oil Production source category, we did not identify emissions of any environmental HAP. Because we did not identify environmental HAP emissions, no further evaluation of environmental risk was conducted for this source category.

6. How do 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.

For this source category, we conducted the facility-wide assessment using a dataset that the EPA compiled from the 2014 NEI. We used the NEI data for the facility and did not adjust any category or “non-category” data. Therefore, there could be differences in the dataset from that used for the source category assessments described in this preamble. We analyzed risks due to the inhalation of HAP that are emitted “facility-wide” for the populations residing within 50 km of each facility, consistent with the methods used for the source category analysis described above. For these facility-wide risk analyses, we made a reasonable attempt to identify the source category risks, and these risks were compared to the facility-wide risks to determine the portion of facility-wide risks that could be attributed to the source category addressed in this proposal. We also specifically examined the facility that was associated with the highest estimate of risk and determined the percentage of that risk attributable to the source category of interest. The Residual Risk Assessment for the Solvent Extraction for Vegetable Oil Production Source Category in Support of the Risk and Technology Review 2019 Proposed Rule, available through the docket for this action, provides the methodology and results of the facility-wide analyses, including all facility-wide risks and the percentage of source category contribution to facility-wide risks.

7. How do we consider uncertainties in risk assessment?

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 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. Also included are those uncertainties specific to our acute screening assessments, multipathway screening assessments, and our environmental risk screening assessments. A more thorough discussion of these uncertainties is included in the Residual Risk Assessment for the Solvent Extraction for Vegetable Oil Production Source Category in Support of the Risk and Technology Review 2019 Proposed Rule, which is available in the docket for this action. If a multipathway site-specific assessment was performed for this source category, a full discussion of the uncertainties associated with that assessment can be found in Appendix 11 of that document, Site-Specific Human Health Multipathway Residual Risk Assessment Report.

a. Uncertainties in the RTR Emissions Dataset

Although the development of the RTR emissions dataset involved QA/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. We also note that the selection of meteorology dataset location could have an impact on the risk estimates. As we continue to update and expand our library of meteorological station data used in our risk assessments, we expect to reduce this variability.

c. Uncertainties in Inhalation Exposure Assessment

Although every effort is made to identify all of the relevant facilities and emission points, as well as to develop accurate estimates of the annual emission rates for all relevant HAP, the uncertainties in our emission inventory likely dominate the uncertainties in the exposure assessment. Some uncertainties in our exposure assessment include human mobility, using the centroid of each census block, assuming lifetime exposure, and assuming only outdoor exposures. For most of these factors, there is neither an under nor overestimate when looking at the maximum individual risk or the incidence, but the shape of the distribution of risks may be affected. With respect to outdoor exposures, actual exposures may not be as high if people spend time indoors, especially for very reactive pollutants or larger particles. For all factors, we reduce uncertainty when possible. For example, with respect to census-block centroids, we analyze large blocks using aerial imagery and adjust locations of the block centroids to better represent the population in the blocks. We also add additional receptor locations where the population of a block is not well represented by a single location.

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 noncancer effects from both chronic and acute exposures. Some uncertainties are generally expressed quantitatively, and others are generally expressed in qualitative terms. We note, as a preface to this discussion, a point on dose-response uncertainty that is stated in the EPA's 2005 Guidelines for Carcinogen Risk Assessment; 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 Guidelines for Carcinogen Risk Assessment, page 1-7). This is the approach followed here as summarized in the next paragraphs.

Cancer UREs used in our risk assessments are those that have been developed to generally provide an upper bound estimate of risk.^[15] 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). In some circumstances, the true risk could be as low as zero; however, in other circumstances the risk could be greater.^[16] Chronic noncancer RfC and reference dose (RfD) values represent chronic exposure levels that are intended to be health-protective levels. To derive dose-response values that are intended to be “without appreciable risk,” the methodology relies upon an uncertainty factor (UF) approach,^[17] which considers uncertainty, variability, and gaps in the available data. The UFs are applied to derive dose-response values that are intended to protect against appreciable risk of deleterious effects.

Many of the UFs used to account for variability and uncertainty in the development of acute dose-response values are quite similar to those developed for chronic durations. 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 dose-response value at another exposure duration (e.g., 1 hour). Not all acute dose-response 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 dose-response value or values being exceeded. Where relevant to the estimated exposures, the lack of acute dose-response values at different levels of severity should be factored into the risk characterization as potential uncertainties.

Uncertainty also exists in the selection of ecological benchmarks for the environmental risk screening assessment. We established a hierarchy of preferred benchmark sources to allow selection of benchmarks for each environmental HAP at each ecological assessment endpoint. We searched for benchmarks for three effect levels (i.e., no-effects level, threshold-effect level, and probable effect level), but not all combinations of ecological assessment/environmental HAP had benchmarks for all three effect levels. Where multiple effect levels were available for a particular HAP and assessment endpoint, we used all of the available effect levels to help us determine whether risk exists and whether the risk could be considered significant and widespread.

For a group of compounds that are unspeciated (e.g., glycol ethers), we conservatively use the most protective dose-response 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 dose-response value, we also apply the most protective dose-response value from the other compounds in the group to estimate risk.

e. Uncertainties in Acute Inhalation Screening Assessments

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. 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 a person. In the acute screening assessment that we conduct under the RTR program, we assume that peak emissions from the source category and reasonable worst-case air dispersion conditions (i.e., 99th percentile) co-occur. We then include the additional assumption that a person is located at this point at the same time. Together, these assumptions represent a reasonable worst-case exposure scenario. In most cases, it is unlikely that a person would be located at the point of maximum exposure during the time when peak emissions and reasonable worst-case air dispersion conditions occur simultaneously.

IV. Analytical Results and Proposed Decisions

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

As described above, for the Solvent Extraction for Vegetable Oil Production 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 Residual Risk Assessment for the Solvent Extraction for Vegetable Oil Production Source Category in Support of the 2019 Risk and Technology Review Proposed Rule, which is available in the docket for this action.

1. Chronic Inhalation Risk Assessment Results

The results of the chronic baseline inhalation cancer risk assessment indicate that, based on estimates of current actual and allowable emissions, the MIR posed by the source category is less than 1-in-1 million. The total estimated cancer incidence based on actual emission levels is 0.00005 excess cancer cases per year, or 1 case every 20,000 years, and for allowable emissions is 0.0002 excess cancer cases per year, or 1 case every 5,000 years driven by emissions of acetaldehyde and formaldehyde. The population exposed to cancer risks greater than or equal to 1-in-1 million considering actual and allowable emissions is 0 (see Table 2 of this preamble).

The maximum modeled chronic noncancer TOSHI for the source category based on actual emissions is estimated to be 0.7 and, for allowable emissions, is estimated to be 2, with n-hexane emissions accounting for the TOSHI. Approximately 13 people are estimated to have exposures resulting in a TOSHI greater than 1 if exposed to allowable emissions from this source category.

2. Screening Level Acute Risk Assessment Results

As presented in Table 2 of this preamble, the acute exposures to emissions from the Solvent Extraction for Vegetable Oil Production source category result in a maximum HQ < 1 (0.7 based on the REL for acrolein). For more detail on the screening level acute risk assessment results, refer to the draft residual risk document: Residual Risk Assessment for the Solvent Extraction for Vegetable Oil Production Source Category in Support of the 2019 Risk and Technology Review Proposed Rule, which is available in the docket for this action.

3. Multipathway Risk Screening Results

For the Solvent Extraction for Vegetable Oil Production source category, we did not identify emissions of any PB-HAP. Because we did not identify PB-HAP emissions, no further evaluation of multipathway risk was conducted for this source category.

4. Environmental Risk Screening Results

For the Solvent Extraction for Vegetable Oil Production source category, we did not identify emissions of any environmental HAP. Because we did not identify environmental HAP emissions, no further evaluation of environmental risk was conducted for this source category.

5. Facility-Wide Risk Results

An assessment of facility-wide risks was performed as described above to characterize the source category risk in the context of facility-wide risks. Facility-wide risks were estimated using the NEI-based data described in section II.D of this preamble. The maximum lifetime individual cancer risk posed by the 88 facilities, based on facility-wide emissions, is 5-in-1 million with cadmium, nickel, arsenic, chromium (VI), and formaldehyde emissions from facility-wide external combustion boilers driving the risk. Regarding the noncancer risk assessment, the maximum chronic noncancer HI posed by facility-wide emissions is estimated to be 0.7 (for the nervous system) driven by source category n-hexane emissions.

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 of the populations living within 5 km and within 50 km of the facilities. In the analysis, we evaluated the distribution of HAP-related cancer and noncancer risks from the Solvent Extraction for Vegetable Oil Production source category across different demographic groups within the populations living near facilities.^[18]

Results of the demographic analysis indicate that, for 6 of the 11 demographic groups, minority, African American, ages 0 to 17, ages 18 to 64, over 25 without a high school diploma, and below the poverty level, the percentage of the population living within 5 km of facilities in the source category is greater than the corresponding national percentage for the same demographic groups. When examining the risk levels of those exposed to emissions from solvent extraction for vegetable oil production facilities, we find that no one is exposed to a cancer risk at or above 1-in-1 million or to a chronic noncancer TOSHI greater than 1.

The methodology and the results of the demographic analysis are presented in a technical report, Risk and Technology Review—Analysis of Demographic Factors for Populations Living Near Solvent Extraction for Vegetable Oil Production, available in the docket for this action.

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

1. Risk Acceptability

As noted in section II.A of this preamble, the EPA sets standards under CAA section 112(f)(2) using “a two-step standard-setting approach, with an analytical first step to determine an `acceptable risk' that considers all health information, including risk estimation uncertainty, and includes a presumptive limit on MIR of approximately 1-in-10 thousand.” (54 FR 38045, September 14, 1989).

In this proposal, the EPA estimated risks based on actual and allowable emissions from the Solvent Extraction for Vegetable Oil Production source category.

In determining whether risks are acceptable, the EPA considered all available health information and risk estimation uncertainty, as described above. The results indicate that both the actual and allowable inhalation cancer risks to the individual most exposed are less than 1-in-1 million, well below the presumptive limit of acceptability of 100-in-1 million.

The maximum chronic noncancer TOSHI due to inhalation exposures is less than 1 for actual emissions. For MACT-allowable emissions, the maximum chronic noncancer TOSHI due to inhalation exposures is 2, and an estimated 13 people exposed to allowable emissions would have a TOSHI greater than 1 due to n-hexane. Finally, the results of the acute screening analysis showed that acute risks were below a level of concern.

Taking into account this information, the EPA proposes that the risks remaining after implementation of the existing MACT standards for the Solvent Extraction for Vegetable Oil Production source category are acceptable.

2. Ample Margin of Safety Analysis

Under the ample margin of safety analysis, we evaluated the cost and feasibility of available control technologies and other measures (including those considered under the technology review) that could be applied in this source category to further reduce the risks (or potential risks) due to emissions of HAP identified in the risk assessment. Although the EPA is proposing that the risks from this source category are acceptable, the maximum HI for allowable emissions is 2 (caused by n-hexane emissions from fugitive process solvent loss). In addition, the HQ for acrolein is 0.7 as a result of acrolein emissions from flaker conditioner aspiration and cooker expeller aspiration. We considered whether the MACT standards applicable to these emission points in particular, as well as all the current MACT standards applicable to this source category, provide an ample margin of safety to protect public health.

We identified in BACT analyses performed for two vegetable oil production processes the consideration of a cryogenic condenser after the main vent as an add-on control option for the reduction of n-hexane. Our analysis found that the use of a cryogenic condenser on the main vent is not cost effective for reduction of HAP ($61,694/ton). Therefore, the EPA is proposing that the current standards provide an ample margin of safety to protect public health and revision of the standards is not required.

3. Adverse Environmental Effect

For the Solvent Extraction for Vegetable Oil Production source category, we did not identify emissions of any environmental HAP. Because we did not identify environmental HAP emissions, we expect no adverse environmental effects and are proposing that more stringent standards are not necessary to prevent an adverse environmental effect.

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

As described in section III.B of this preamble, our technology review focused on identifying developments in practices, processes, and control technologies for control of n-hexane emissions from vegetable oil production facilities. In conducting the technology review, we reviewed information on practices, processes, and control technologies that were not considered during the development of the Solvent Extraction for Vegetable Oil Production NESHAP and looked for information on improvements in practices, processes, and control technologies that have occurred since the development of the Solvent Extraction for Vegetable Oil Production NESHAP. The review included a search of the RBLC database and reviews of air permits for vegetable oil production facilities, regulatory actions for emission sources similar to vegetable oil production process sources, site visits to operating vegetable oil production facilities, including the newest U.S. facility, and a review of relevant literature. After reviewing information from the aforementioned sources, we did not identify any developments in practices, processes, or control technologies to reduce n-hexane emissions from the vegetable oil production facilities. In the BACT analyses performed for two vegetable oil production processes, we identified the use of a cryogenic condenser after the main vent as a possible an add-on control option. Our analysis found that the use of a cryogenic condenser on the main vent is not cost effective for reduction of HAP ($61,694/ton). Additionally, our analysis found no additional significant or cost-effective changes in the practices, processes, and control technologies that may be used by vegetable oil production facilities that warrant revisions to the MACT standards for this source category. Therefore, the EPA is proposing that revisions to the Solvent Extraction for Vegetable Oil Production NESHAP are not necessary based on our review under CAA section 112(d)(6). Additional details of our technology review can be found in the memorandum, CAA Section 112(d)(6) Technology Review for the Solvent Extraction for Vegetable Oil Production Source Category, which is available in the docket for this action. We solicit comment on our proposed decision.

D. What other actions are we proposing?

In addition to the proposed actions described above, the EPA is proposing additional revisions to the NESHAP. The EPA is proposing revisions to the SSM 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 (DC 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 SSM. We also are proposing various other changes to the recordkeeping and reporting requirements and miscellaneous other technical and editorial changes to the regulatory text. Our analyses and proposed changes related to these issues are discussed below.

1. SSM Requirements

In its 2008 decision in Sierra Club v. EPA, 551 F.3d 1019 (DC Cir. 2008), the Court vacated portions of two provisions in the EPA's CAA section 112 regulations governing the emissions of HAP during periods of SSM. Specifically, the Court vacated the SSM 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 CAA section 112 standards apply continuously.

The EPA is proposing the elimination of the SSM exemption in this rule, which appears at 40 CFR 63.2840(a) and Table 1 to 40 CFR 63.2870 (General Provisions Applicability Table). Consistent with Sierra Club v. EPA, the EPA is proposing that standards in this rule apply at all times. The EPA is also proposing several revisions to the General Provisions Applicability Table as explained in more detail below. For example, the EPA is 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 the EPA is proposing to eliminate are inappropriate, unnecessary, or redundant in the absence of the SSM exemption. The EPA is specifically seeking comment on whether we have successfully done so.

In proposing the standards in this rule, the EPA has taken into account startup and shutdown periods. The proposed standards would apply at all times during shutdown and malfunction. For the reasons explained below, the EPA is proposing alternate standards for initial startup periods.

The standards, as promulgated in 2001, provide an option for facilities to meet separate compliance requirements during periods of initial startup for new and significantly modified sources. Table 1 of 40 CFR 63.2850 provides the requirements for compliance with the HAP emissions standards during periods of normal operation, initial startup periods, or malfunction periods. Both new/reconstructed sources and modified sources may comply by meeting the requirements for periods of normal operation in Table 1 of 40 CFR 63.2850. However, the standards also provide that for a period of up to 6 months after startup of a new/reconstructed source, the new source may meet separate compliance requirements for initial startup periods in Table 1 of 40 CFR 63.2850. For significantly modified sources, the standards provide an initial startup period of up to 3 months after startup.^[19] The initial startup period provisions were provided in the 2001 final rule with the recognition that the MACT limits, which are based on calculating a compliance ratio of a facility's actual HAP loss emissions to allowable HAP loss emissions over a 12-month period, apply to the entire vegetable oil production process, and that the MACT allowables were based on periods of normal operation. In lieu of add-on control equipment to specific pieces of equipment, control of n-hexane emissions at vegetable oil production facilities is accomplished through solvent recovery, and is based on inter-related process equipment that is often custom built to the specific configuration and needs of the plant. During an initial startup period, facility equipment is tested, added, or replaced as the facility gradually increases production, and emissions during this period may reflect variances that are not generally reflective of normal or steady-state operations. New and modified equipment is often brought online in a phased approach, and each phase can require adjustments in both new and existing equipment in the process in order to identify and correct problems, such as equipment that is not operating as designed and requires repair or replacement. The 2001 MACT floor solvent loss allowables are based on emissions data from normal operating periods achieved after facilities reached their steady-state production rates, and do not account for emissions during these initial startup periods. Therefore the HAP emissions during an initial startup period were excluded from the 12-month rolling compliance determinations. Sources were instead required to minimize emissions to the extent practicable throughout the initial startup period, following the facility's SSM plan.

Because the EPA is proposing to eliminate the SSM provisions for the Solvent Extraction for Vegetable Oil Production source category, we evaluated the available data to establish potential standards for periods of initial startup. The EPA reviewed operating permits from various state and local agencies and EPA Regional offices to identify new facilities operating in an initial startup period. Construction of new or modification of existing vegetable oil production facilities happens relatively infrequently (every 5-6 years), and there are a limited number of facilities that have modified or constructed following the promulgation of the final rule. The standards do not require—and state, local, and regional offices have not collected—emissions data for these facilities during their initial startup periods. In our review of permits for newly constructed sources, the Agency identified one recently constructed facility (January 2018) with permitted MACT solvent loss allowables for an initial startup period. However, we determined that the allowables for the facility were not based on measured data, and further, because the facility is located in a non-attainment area and manufactures only one type of oilseed, the permitted solvent loss allowables would not be representative of initial startup periods for other facilities in the source category.

Although we requested information on emissions and the operation of processes during initial startup periods in our consultations with industry, we did not receive any emissions data collected during an initial startup period, and are unsure these data exist. The Agency recognizes that the initial startup period, which is a one-time event for new sources and an infrequent event for signficantly modified sources, is not a typical startup period that may occur as part of routine or seasonal startups of a plant, and includes evaluation and replacement of new equipment as each phase is brought online and production is gradually increased. As such, the initial startup period reflects a non-steady state of operations and production. The current standards are production-based and limit emissions by the HAP lost per ton of oilseeds processed. Because the initial startup period reflects a non-steady state of production, emissions testing during this period would not likely be representative or acquire meaningful results. Therefore, emissions testing during initial startup would be both economically and technically infeasible. Consequently, the EPA is proposing a work practice standard rather than an emissions limit for periods of initial startup.

Based on the information available in permits and obtained from NOPA, we have concluded that certain process solvent recovery equipment, including mineral oil scrubbers and condensers, could be operated normally during periods of initial startup. Further, facilities set site-specific operating ranges for temperature and vacuum for the desolventizing and oil distillation units to maximize solvent recovery. Therefore, the EPA is proposing that facilities operating in an initial startup period would operate the mineral oil absorption system and solvent condensers at all times during the initial startup period. The EPA is also proposing that facilities establish and follow site-specific operating ranges for temperature and vacuum for the desolventizing and oil distillation units associated with solvent recovery. Facilities would also continue to have the option to meet the requirements for normal operating periods in Table 1 of 40 CFR 63.2850. We anticipate that the proposed work practices would minimize solvent losses and emissions of n-hexane from solvent extraction operations during the initial startup period by maximizing solvent recovery. The EPA is proposing that facilities following the initial startup period would include parameters for the work practice standards in their compliance plan in 40 CFR 63.2851, and are proposing associated recordkeeping and reporting for these periods, as discussed in sections IV.D.1.e and IV.D.1.f of this preamble. We anticipate that facilities would already conduct these work practice standards during their initial startup periods, and we do not expect any costs of control with this proposed work practice requirement. However, the EPA is soliciting information on other industry best practices and the best level of emission control during initial startup periods for the Solvent Extraction for Vegetable Oil Production source category. The EPA is also soliciting information on the costs associated with these practices. In addition, the EPA is soliciting specific supporting data on HAP emissions during initial startup periods for this category, including whether the data are from a new or modified source, the duration of the initial startup period, the total solvent usage and total solvent loss during the initial startup period, and the estimate of HAP emitted during the initial startup period.

The EPA is proposing to revise the definition of “initial startup period.” The proposed revisions are necessary to clarify the time at which an initial startup period ends and a normal operating period begins. The 2001 MACT rule provided that the initial startup period of a new or reconstructed source consisted of 6 calendar months, and the initial startup period following a significant modification consisted of 3 calendar months. The EPA is proposing to revise this definition and the requirements of 40 CFR 62.2850(c)(2) and (d)(2) to clarify that the end of the initial startup period is based on when the plant meets and maintains steady-state operations, defined as operating at or above 90 percent of the extractor nominal design production rate or at or above 90 percent of the production rate in the plant's permit for 15 consecutive days, not to exceed 6 calendar months after startup for new or reconstructed sources or 3 calendar months after startup for modified sources. The proposed definition would clarify that new or reconstructed sources that reach steady-state production prior to the end of the 6-month period or modified sources that reach steady-state production prior to the end of the 3-month period would be required to meet the requirements in Table 1 of 40 CFR 63.2850 for sources under normal operation, and, thus, minimizing the initial startup period.

Periods of startup, normal operations, and shutdown are all predictable and routine aspects of a source's operations. Malfunctions, in contrast, are neither predictable nor routine. Instead, they are, by definition, sudden, infrequent, and not reasonably preventable failures of emissions control, process, or monitoring equipment (40 CFR 63.2) (Definition of malfunction). The EPA interprets CAA section 112 as not requiring emissions that occur during periods of malfunction to be factored into development of CAA section 112 standards and this reading has been upheld as reasonable by the Court in U.S. Sugar Corp. v. EPA, 830 F.3d 579, 606-610 (2016). 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 Court 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 (DCCir. 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. The EPA is not required to treat a malfunction in the same manner as the type of variation in performance that occurs during routine operations of a source. A malfunction is a failure of the source to perform in a “normal or usual manner” and no statutory language compels the EPA to consider such events in setting CAA section 112 standards.

As the Court recognized in U.S. Sugar Corp, accounting for malfunctions in setting standards would be difficult, if not impossible, given the myriad different types of malfunctions that can occur across all sources in the category and given the difficulties associated with predicting or accounting for the frequency, degree, and duration of various malfunctions that might occur. Id. at 608 (“the EPA would have to conceive of a standard that could apply equally to the wide range of possible boiler malfunctions, ranging from an explosion to minor mechanical defects. Any possible standard is likely to be hopelessly generic to govern such a wide array of circumstances.”) As such, the performance of units that are malfunctioning is not “reasonably” foreseeable. See, e.g., Sierra Club v. EPA, 167 F.3d 658, 662 (D.C. Cir. 1999) (“The EPA typically has wide latitude in determining the extent of data-gathering necessary to solve a problem. We generally defer to an agency's decision to proceed on the basis of imperfect scientific information, rather than to `invest the resources to conduct the perfect study.' ”). See also, Weyerhaeuser v. Costle, 590 F.2d 1011, 1058 (DC 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.

Although no statutory language compels the EPA to set standards for malfunctions, the EPA has the discretion to do so where feasible. For example, in the Petroleum Refinery Sector RTR, the EPA established a work practice standard for unique types of malfunction that result in releases from pressure relief devises or emergency flaring events because the EPA had information to determine that such work practices reflected the level of control that applies to the best performers (80 FR 75178, 75211-14, December 1, 2015). The EPA will consider whether circumstances warrant setting standards for a particular type of malfunction and, if so, whether the EPA has sufficient information to identify the relevant best performing sources and establish a standard for such malfunctions. We also encourage commenters to provide any such information.

The EPA anticipates that it is unlikely that a malfunction will result in a violation of the standard, and, therefore, the EPA is proposing to remove malfunction periods as a source operating status. The MACT standards are based on calculating a compliance ratio of a facility's actual HAP loss emissions to allowable HAP loss emissions over a 12-month rolling period, and apply to the entire vegetable oil production process. Therefore, the malfunction of a singular piece of equipment in a single month over this period is unlikely to result in an exceedance of the standard. However, it is possible that a malfunction could result in a violation of the standards; therefore, the EPA is considering the need for a work practice for periods of malfunction for these facilities. For example, the EPA has received information that it is possible that a malfunction of the extractor for sources in the Solvent Extraction for Vegetable Oil Production source category could potentially result in an emissions increase and potential violation of the emissions limit. During these periods, it is possible that an immediate line shutdown may not be feasible due to safety concerns. Such a major malfunction could lead to solvent losses that could result in multiple months of exceedances. In those cases, it may be appropriate to establish a standard for malfunctions. We would anticipate that a separate standard would be in the form of a work practice standard. Therefore, the EPA is soliciting information on the type of events that constitute a malfunction event, and industry best practices and the best level of emission control during such malfunction events for the Solvent Extraction for Vegetable Oil Production source category. The EPA is also soliciting information on the cost savings associated with these practices. In addition, the EPA is soliciting specific supporting data on HAP emissions during malfunction events for this category, including the cause of malfunction, the frequency of malfunction, duration of malfunction, and the estimate of HAP emitted during each malfunction.

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. U.S. Sugar Corp. v. EPA, 830 F.3d 579, 606-610 (2016).

a. 40 CFR 63.2840 General Duty

The EPA is proposing to revise the General Provisions Applicability Table (Table 1 of 40 CFR 63.2870) entry for 40 CFR 63.6(e)(1)(i) by changing the “Yes” in column 4 to a “No.” Section 63.6(e)(1)(i) describes the general duty to minimize emissions. Some of the language in that section is no longer necessary or appropriate in light of the elimination of the SSM exemption. The EPA is proposing instead to add general duty regulatory text at 40 CFR 63.2840(g) to reflect 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 for 40 CFR 63.2840(g) does not include that language from 40 CFR 63.6(e)(1).

The EPA is also proposing to revise the General Provisions Applicability Table (Table 1 of 40 CFR 63.2870) entry for 40 CFR 63.6(e)(1)(ii) by changing the “Yes” in column 4 to a “No.” 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 63.2840(g).

b. SSM Plan

The EPA is proposing to revise the General Provisions Applicability Table (Table 1 of section 63.2870) entries for 40 CFR 63.6(e)(3)(i) through (e)(3)(ii), 40 CFR 63.6(e)(3)(v) through (vii), and 40 CFR 63.6(e)(3)(viii) and (ix) by changing the “Yes” in column 4 to a “No.” The EPA is also proposing to revise 40 CFR 63.2852, which cross-references the requirements of 40 CFR 63.6(e)(3). 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

The EPA is proposing to revise the General Provisions Applicability Table (Table 1 of section 63.2870) entry for 40 CFR 63.6(f)(1) by revising the text in column 4 and removing the text in column 5. The current language in column 4 states that 40 CFR 63.6(f)(1) does not apply and column 5 states that the “Subpart GGGG does not have nonopacity requirements.” This appears to be an error in the final rule, because 40 CFR part 63, subpart GGGG, includes non-opacity requirements. The current language of 40 CFR 63.6(f)(1) exempts sources from non-opacity standards during periods of SSM. As discussed above, the Court in Sierra Club vacated the exemptions contained in this provision and held that the CAA requires that some CAA section 112 standards apply continuously. Consistent with Sierra Club, the EPA is proposing to revise standards in this rule to apply at all times. Therefore, the EPA is revising the text in columns 4 and 5 to clarify that the SSM exemption previously applied but will not apply going forward.

d. 40 CFR 63.2853 Performance Testing

The EPA is proposing to revise the General Provisions Applicability Table (Table 1 of 40 CFR 63.2870) entry for 40 CFR 63.7(e)(1) by changing the “Yes” in column 4 to a “No.” The General Provisions in 40 CFR 63.7(e)(1) describes performance testing requirements. The EPA is instead proposing to add a performance testing requirement at 40 CFR 63.2853(a)(5)(i)(A). The performance testing requirements the EPA is proposing to add differ from the General Provisions performance testing provisions in several respects. The regulatory text does not include the language in 40 CFR 63.7(e)(1) that restated the SSM exemption and language that precluded startup and shutdown periods from being considered “representative” for purposes of performance testing. The proposed performance testing provisions do not allow performance testing during startup or shutdown. As in 40 CFR 63.7(e)(1), performance tests conducted under 40 CFR part 63, subpart GGGG, 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 in 40 CFR 63.2853(a)(5)(i)(A) 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. The General Provisions in 40 CFR 63.7(e) require that the owner or operator make available to the Administrator such records “as may be necessary to determine the condition of the performance test” available to the Administrator upon request, but does not specifically identify 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. 40 CFR 63.2862 Recordkeeping

The EPA is proposing to revise the General Provisions Applicability Table (Table 1 of 40 CFR 63.2870) entry for 40 CFR 63.10(b)(2)(i) by changing the “Yes” in column 4 to a “No.” The requirements of 40 CFR 63.10(b)(2)(i) describe the recordkeeping requirements during startup and shutdown. The EPA is instead proposing to add recordkeeping requirements to 40 CFR 63.2862(f). When a source is subject to a different standard during initial startup, it will be important to know when such initial startup periods begin and end in order to determine compliance with the appropriate standard. Thus, the EPA is proposing to add language to 40 CFR 63.2862(f) requiring that owners or operators of sources subject to a work practice standard during initial startup times must report a description and dates of the initial startup period, the reason it qualifies as an initial startup period, an estimate of the solvent loss in gallons for the duration of the initial startup, and the nominal design rate and operating rate of the extractor or the permitted and actual production rates for the duration of the initial startup period. The EPA is also proposing that sources would be required to record information supporting the work practice standards, including: (1) Measured temperature and pressure for desolventizing and oil distillation units, (2) an indication that the mineral oil absorpotion system was operating at all times, and (3) an indication that the solvent condensers were operating at all times. The proposed records are required to demonstrate that the work practice standards have been met for periods of initial startup.

The EPA is proposing to revise the General Provisions Applicability Table (Table 1 of 40 CFR 63.2870) entry for 40 CFR 63.10(b)(2)(ii) by changing the “Yes” in column 4 to a “No.” The General Provisions in 40 CFR 63.10(b)(2)(ii) describe the recordkeeping requirements during a malfunction. The EPA is proposing to tailor recordkeeping requirements during a malfunction in 40 CFR 63.2862(g). Instead of requiring source owners or operators to create and retain a record of the “occurrence and duration of each malfunction” of process, air pollution control, and monitoring equipment, the rule proposes that this requirement apply to any “failure to meet an applicable standard” (including the work practice standard) and the source owners or operators must record the date, time, and duration of the “failure” rather than the “occurrence.”

The EPA is also proposing to add to 40 CFR 63.2862(g) a requirement that source owners or operators keep records that include a statement of the cause of each deviation (including unknown cause, if applicable), 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 when the standard is not met, 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 source owners or operators 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 general duty to minimize emissions was met when an applicable standard was not met.

The EPA is proposing to revise the General Provisions Applicability Table (Table 1 of 40 CFR 63.2870) entry for 40 CFR 63.10(b)(2)(iv) by changing the “Yes” in column 4 to a “No.” When applicable, the provision requires source owners and operators to record actions taken during SSM events when actions were inconsistent with their SSM plan. The requirement would no longer be appropriate because SSM plans are no longer proposed to 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 63.2862(g).

The EPA is proposing to revise the General Provisions Applicability Table (Table 1 of 40 CFR 63.2870) entry for 40 CFR 63.10(b)(2)(v) by changing the “Yes” in column 4 to a “No.” When applicable, the provision requires source owners or operators to record actions taken during SSM events to show that actions taken were consistent with their SSM plan. The requirement would no longer be appropriate because SSM plans would no longer be required.

f. 40 CFR 63.2861 Reporting

The General Provisions Applicability Table (Table 1 of 40 CFR 63.2870) entry for 40 CFR 63.10(d)(5) currently refers to the reporting requirements for startups, shutdowns, and malfunctions in 40 CFR 63.2861(c) and (d), which required periodic or immediate SSM reports according to whether the procedures of the SSM plan were followed, consistent with 40 CFR 63.10(d)(5)(i) and (ii). To replace the SSM reporting requirements, the EPA is first proposing to eliminate the periodic SSM reports in 40 CFR 63.2861(c), which were required to be submitted at the end of each calendar month of an initial startup period or malfunction period. The EPA is also proposing to remove the requirement in 40 CFR 63.2861(d) to submit an immediate report for startups, shutdown, and malfunctions when a source failed to meet an applicable standard but did not follow the SSM plan. We will no longer require owners 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.

The EPA is proposing that source owners or operators that fail to meet an applicable standard at any time must report the information concerning such events in the deviation report already required under this rule. 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 HAP emitted over the emission requirements of 40 CFR 63.2840, 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 general duty to minimize emissions during a failure to meet an applicable standard was met. The EPA is also proposing that source owners or operators that fail to meet the work practice standard during the initial startup period must include a description of the deviation and include the records for the initial startup period in 40 CFR 63.2862(f), as described in section IV.D.1.e of this preamble.

Finally, the EPA is proposing that source owners or operators that choose to operate under an initial startup period according to 40 CFR 63.2850(c)(2) or (d)(2) must also provide an initial startup report. The proposed initial startup report would require a compliance certification indicating whether the source was in compliance with the work practice standard of 40 CFR 63.2840(h). The EPA is proposing that the initial report must be submitted within 30 days of the end of the initial startup period. The proposed initial startup report would only be submitted on a one-time basis, rather than at the end of each calendar month of the initial startup period, but would demonstrate whether a facility operating in an initial startup period met the work practice standard for the duration of the period.

2. Electronic Reporting

Through this action, the EPA is proposing that owners and operators of vegetable oil production facilities submit electronic copies of initial notifications, initial startup reports, annual compliance certifications, deviation reports, and performance test reports through the EPA's Central Data Exchange (CDX) using the Compliance and Emissions Data Reporting Interface (CEDRI). A description of the electronic data submission process is provided in the memorandum, Electronic Reporting Requirements for New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAP) Rules, available in Docket ID No. EPA-HQ-OAR-2019-0208. The proposed rule requires that performance test results collected using test methods that are supported by the EPA's Electronic Reporting Tool (ERT) as listed on the ERT website ^[20] at the time of the test be submitted in the format generated through the use of the ERT and that other performance test results be submitted in portable document format (PDF) using the attachment module of the ERT. For initial notifications, initial startup reports, annual compliance certifications, and deviation reports, the proposed rule requires that owners and operators use the appropriate spreadsheet template to submit information to CEDRI. A draft version of the proposed templates for these reports are included in the docket for this rulemaking.^[21] The EPA specifically requests comment on the content, layout, and overall design of the templates.

The initial notifications, initial startup reports, annual compliance certifications, deviation reports, and performance test reports are required to be submitted according to the deadlines specified in 40 CFR 63.2861. Additionally, the EPA has identified two broad circumstances in which electronic reporting extensions may be provided. In both circumstances, the decision to accept the claim of needing additional time to report is within the discretion of the Administrator, and reporting should occur as soon as possible. The EPA is providing these potential extensions to protect owners and operators from noncompliance in cases where they cannot successfully submit a report by the reporting deadline for reasons outside of their control. The situation where an extension may be warranted due to outages of the EPA's CDX or CEDRI, which precludes an owner or operator from accessing the system and submitting required reports is addressed in 40 CFR 63.2862(f). The situation where an extension may be warranted due to a force majeure event, which is defined as an event that will be or has been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevents an owner or operator from complying with the requirement to submit a report electronically as required by this rule is addressed in 40 CFR 63.2862(g). Examples of such events are acts of nature, acts of war or terrorism, or equipment failure or safety hazards beyond the control of the facility.

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 and transparency, will further assist in the protection of public health and the environment, will improve compliance by facilitating the ability of regulated facilities to demonstrate compliance with requirements and by facilitating the ability of delegated state, local, tribal, and territorial air agencies and the EPA to assess and determine compliance, and will ultimately reduce burden on regulated facilities, delegated air agencies, and the EPA. Electronic reporting also eliminates paper-based, manual processes, thereby saving time and resources, simplifying data entry, eliminating redundancies, minimizing data reporting errors, and providing data quickly and accurately to the affected facilities, air agencies, the EPA, and the public. Moreover, electronic reporting is consistent with the EPA's plan ^[22] to implement Executive Order 13563 and is in keeping with the EPA's Agency-wide policy ^[23] developed in response to the White House's Digital Government Strategy.^[24] For more information on the benefits of electronic reporting, see the memorandum, Electronic Reporting Requirements for New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAP) Rules, available in Docket ID No. EPA-HQ-OAR-2019-0208.

3. Technical and Editorial Changes

The EPA is proposing several minor technical editorial changes to the rule. The EPA is proposing revisions to several definitions in 40 CFR 63.2872 to harmonize with the proposed removal of the SSM requirements and to clarify existing provisions. Specifically, the EPA is proposing harmonizing changes to the definitions of “Compliance ratio,” “Nonoperating period,” “Normal operating period,” and “Operating month” to clarify where the malfunction period is excluded, because sources would no longer be able to choose the malfunction period as a source operating status. The EPA is also proposing to revise “Normal operating period” to clarify that this definition also applies to “normal operation.”

The EPA is proposing to revise the definition of “Hazardous air pollutant (HAP)” to remove the reference to the date of April 12, 2001. The current definition would continue to include HAP that may have been delisted following the April 2001 date, therefore, removal of the date would more appropriately reference the current list of HAP in section 112(b) of the CAA. Finally, the EPA is adding a definition for “Nonoperating month,” which was not previously defined. A nonoperating month would include any entire calendar or accounting month in which a source processes no agricultural product.

The EPA is proposing minor revisions to 40 CFR 63.2840(a)(1) and (b)(1), 40 CFR 63.2853(a)(2), and 40 CFR 63.2855(a)(3) to remove text that is redundant with the definition of “operating month” in 40 CFR 63.2872. Finally, the EPA is proposing a minor correction to Table 1 of 40 CFR 63.2850 to correct a typographical error in row “(a)” for malfunction periods.

E. What compliance dates are we proposing?

Affected sources that commence construction or reconstruction after June 27, 2019 would comply with all requirements of 40 CFR part 63, subpart GGGG, including the amendments being proposed, no later than the effective date of the final rule or upon startup. All affected facilities would continue to meet the current requirements of the Solvent Extraction for Vegetable Oil Production NESHAP until the applicable compliance date of the amended rule.

Existing affected sources and affected sources that commenced construction or reconstruction on or before June 27, 2019 would comply with the amendments no later than 180 days after the effective date of the final rule. Affected sources that commence construction or reconstruction after June 27, 2019 would comply with all requirements of 40 CFR part 63, subpart GGGG, including the amendments being proposed, no later than the effective date of the final rule or upon startup, whichever is later. The final action is not expected to be a “major rule” as defined by 5 U.S.C. 804(2), so the effective date of the final rule will be the promulgation date as specified in CAA section 112(d)(10). For existing sources, the EPA is proposing three changes that would affect ongoing compliance requirements for the Solvent Extraction for Vegetable Oil Production NESHAP. As discussed elsewhere in this preamble, the EPA is proposing to add a requirement that initial notifications, initial startup reports, annual compliance certifications, deviation reports, and performance test results be electronically submitted. The EPA is proposing to change the requirements for SSM by removing the exemption from the requirements to meet the standard during SSM periods, and the EPA is proposing an option for facilities to follow new work practice standards for periods of initial startup. Our experience with similar industries shows that a minimum of 90 days, and, more typically, 180 days is generally necessary to successfully convert to electronic reporting. Facilities must install necessary hardware and software, become familiar with the process of submitting initial notifications, initial startup reports, annual compliance certifications, deviation reports, and performance test results electronically through the EPA's CEDRI, test these new electronic submission capabilities, and reliably employ electronic reporting and to convert logistics of reporting processes to different time-reporting parameters. Our experience with similar industries further shows that this sort of regulated facility generally requires a time period of 180 days to read and understand the amended rule requirements; to evaluate their operations to ensure that they can meet the standards during periods of startup, including the revised standards for initial startup periods, as defined in the rule and make any necessary adjustments; and to update their operation, maintenance, and monitoring plan to reflect the revised requirements. The EPA recognizes the confusion that multiple different compliance dates for individual requirements would create and the additional burden such an assortment of dates would impose. From our assessment of the timeframe needed for compliance with the entirety of the revised requirements, the EPA considers a period of 180 days to be the most expeditious compliance period practicable and, thus, is proposing that existing affected sources be in compliance with the revised requirements within 180 days of the regulation's effective date.

We solicit comment on these proposed compliance periods, and we specifically request submission of information from sources in this source category regarding specific actions that would need to be undertaken to comply with the proposed amended requirements and the time needed to make the adjustments for compliance with any of the revised requirements. We note that information provided may result in changes to the proposed compliance periods.

V. Summary of Cost, Environmental, and Economic Impacts

A. What are the affected sources?

The EPA estimates that there are 89 vegetable oil production facilities that are currently subject to the Solvent Extraction for Vegetable Oil Production NESHAP and would be affected by the proposed amendments. The bases of our estimate of affected facilities are provided in the memorandum, Residual Risk Modeling File Documentation for the Solvent Extraction for Vegetable Oil Production Source Category, which is available in the docket for this action. The EPA is aware of one potential new or reconstructed vegetable oil production facility that is subject to the standards.

B. What are the air quality impacts?

The EPA estimates that annual HAP emissions from the vegetable oil production facilities that are subject to the NESHAP are approximately 13,500 tpy.^[25] Because the EPA is not proposing revisions to the emission limits, we do not anticipate any quantifiable air quality impacts as a result of the proposed amendments. However, we anticipate that the proposed requirements, including the work practice standards for the optional initial startup period, are at least as stringent as the current rule requirements.

C. What are the cost impacts?

The 89 vegetable oil production facilities that would be subject to the proposed amendments would incur minimal net costs to meet revised recordkeeping and reporting requirements, some estimated to have costs and some estimated to have cost savings. Nationwide annual costs associated with the proposed requirements are estimated to be $29,623 over the 3 years following promulgation of amendments (or $9,874 per year). The EPA believes that the vegetable oil production facilities which are known to be subject to the NESHAP can meet the proposed requirements without incurring additional capital or operational costs. Therefore, the only costs associated with the proposed amendments are related to recordkeeping and reporting labor costs. For further information on the requirements being proposed, see section IV of this preamble. For further information on the costs and cost savings associated with the requirements being proposed, see the memorandum, Cost for the Solvent Extraction for Vegetable Oil Production Source Category Risk and Technology Review—Proposed Amendments, and the document, Supporting Statement for NESHAP for Solvent Extraction for Vegetable Oil Production, which are both available in the docket for this action. We solicit comment on these estimated cost impacts.

D. What are the economic impacts?

Economic impact analyses focus on changes in market prices and output levels. If changes in market prices and output levels in the primary markets are significant enough, impacts on other markets may also be examined. Both the magnitude of costs needed to comply with a proposed rule and the distribution of these costs among affected facilities can have a role in determining how the market will change in response to a proposed rule. The total costs associated with reviewing the final rule are estimated to be $29,623 (or $9,874 per year) for the 3 years following the final rule. This is an estimated cost of $333 per facility. These costs are not expected to result in a significant market impact, regardless of whether they are passed on to the purchaser or absorbed by the firms.

E. What are the benefits?

Although the EPA does not anticipate reductions in HAP emissions as a result of the proposed amendments, we believe that the action, if finalized as proposed, would result in improvements to the rule. Specifically, the proposed amendments revise the standards such that they apply at all times. For facilities who choose to operate under an initial startup period, the EPA is proposing an alternative work practice standard that will ensure that facilities are minimizing emissions while the source operates under non-steady state production, which will protect public health and the environment. Additionally, the proposed amendments requiring electronic submittal of initial notifications, initial startup reports, annual compliance certifications, deviation reports, and performance test results will increase the usefulness of the data, is in keeping with current trends of 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. See section IV.D.2 of this preamble for more information.

VI. Request for Comments

We solicit comments on this proposed action. In addition to general comments on this proposed action, the EPA is also interested in additional data that may improve the risk assessments and other analyses. The EPA is 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.

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 website at https://www3.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 website, 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® Access format and all accompanying documentation to Docket ID No. EPA-HQ-OAR-2019-0208 (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 (or facilities). We request that all data revision comments be submitted in the form of updated Microsoft® Excel files that are generated by the Microsoft® Access file. These files are provided on the RTR website at https://www3.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. Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs

This action is not expected to be an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866.

C. Paperwork Reduction Act (PRA)

The information collection activities in this proposed rule have been submitted for approval to the OMB under the PRA. The Information Collection Request (ICR) document that the EPA prepared has been assigned EPA ICR number 1947.08. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here.

The EPA is proposing amendments that revise provisions pertaining to emissions during periods of SSM; add requirements for electronic reporting of certain notifications, reports, and performance test results; and make other minor clarifications and corrections. This information would be collected to assure compliance with the Solvent Extraction for Vegetable Oil Production NESHAP.

Respondents/affected entities: Owners or operators of vegetable oil production processes.

Respondent's obligation to respond: Mandatory (40 CFR part 63, subpart GGGG).

Estimated number of respondents: 90 (assumes one new respondent over the next 3 years).

Frequency of response: Initially, occasionally, and annually.

Total estimated burden: The annual recordkeeping and reporting burden for responding facilities to comply with all of the requirements in the NESHAP, averaged over the 3 years of this ICR, is estimated to be 33,000 hours. Of these, 241 hours (per year) is the incremental burden to comply with the proposed rule amendments. Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: The annual recordkeeping and reporting cost for responding facilities to comply with all of the requirements in the NESHAP, averaged over the 3 years of this ICR, is estimated to be $3,380,000 (per year), including $0 annualized capital or operation and maintenance costs. Of the total, $9,874 (per year) is the incremental cost to comply with the proposed amendments to the rule, or approximately $111 per facility.

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 to comply with all of the requirements in the NESHAP or the proposed amendments, 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 July 29, 2019. The EPA will respond to any ICR-related comments in the final rule.

D. Regulatory Flexibility Act (RFA)

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action are small vegetable oil production facilities. The Agency has determined that up to 12 small entities, representing approximately 13 percent of the total number of entities subject to the proposal, may experience an impact of less than 0.1 percent of revenues.

E. Unfunded Mandates Reform Act (UMRA)

This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, or tribal governments or the private sector.

F. Executive Order 13132: Federalism

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

This action does not have tribal implications as specified in Executive Order 13175. No tribal facilities are known to be engaged in the vegetable oil production industry that would be affected by this action. Thus, Executive Order 13175 does not apply to this action.

H. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This action's health and risk assessments are contained in sections III and IV of this preamble and further documented in the risk report titled Residual Risk Assessment for the Solvent Extraction for Vegetable Oil Production Source Category in Support of the 2019 Risk and Technology Review Proposed Rule, in the docket for this action.

I. 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.

J. National Technology Transfer and Advancement Act (NTTAA)

This action involves technical standards. Therefore, the EPA conducted searches for the Solvent Extraction for Vegetable Oil Production sector RTR through the Enhanced National Standards Systems Network Database managed by the American National Standards Institute. We also contacted voluntary consensus standards (VCS) organizations and accessed and searched their databases. We conducted searches for EPA Method 311 of 40 CFR part 63, appendix A. No applicable VCS were identified for EPA Method 311. The search identified two VCS that were potentially applicable for this rule in lieu of EPA reference methods. After reviewing the available standards, the EPA determined that the two candidate VCS (ASTM Method D6438 (1999), Standard Test Method for Acetone, Methyl Acetate, and Parachlorobenzotrifluoride Content of Paints and Coatings by Solid Phase Microextraction-Gas Chromatography, and CARB Method 310, Determination of Volatile Organic Compounds in Consumer Products and Reactive Organic Compounds in Aerosol Coating Products, identified for measuring emissions of pollutants or their surrogates subject to emissions standards in the rule would not be practical due to lack of equivalency, documentation, validation data, and other important technical and policy considerations.

A thorough summary of the search conducted and results are included in the memorandum, Voluntary Consensus Standard Results for National Emission Standards for Hazardous Air Pollutants for Solvent Extraction for Vegetable Oil Production, which is available in the docket for this action.

K. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low income populations, and/or indigenous peoples, as specified in Executive Order 12898 (58 FR 7629, February 16, 1994). The documentation for this decision is contained in section IV.A of this preamble and the technical report titled Risk and Technology Review—Analysis of Demographic Factors for Populations Living Near Vegetable Oil Production Facilities, 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 noncancer hazards from the vegetable oil production processes across different social, demographic, and economic groups within the populations living near operations identified as having the highest risks.

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 1-in-1 million); we estimate that none of the population is exposed to risks greater than 1-in-1 million; 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
• Reporting and recordkeeping requirements

For the reasons set forth in the preamble, the EPA proposes to amend 40 CFR part 63 as follows:

PART 63—NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES

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

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

Subpart GGGG—National Emission Standards for Hazardous Air Pollutants: Solvent Extraction for Vegetable Oil Production

2. Section 63.2834 is amended by revising Table 1 of § 63.2834 to read as follows:

3. Section 63.2840 is amended by:

a. Revising the introductory text, paragraphs (a)(1) introductory text, (b) introductory text, and (b)(3) through (5);

b. Removing and reserving paragraph (b)(1); and

c. Adding paragraphs (g) and (h).

The revisions and additions read as follows:

4. Section 63.2850 is amended by:

a. Revising paragraphs (a)(3) and (a)(5) introductory text;

b. Adding paragraph (a)(5)(iv);

b. Revising paragraphs (b), (c)(1) and (2);

c. Revising paragraphs (d)(1) and (2), (e) introductory text, and (e)(2); and

d. Revising Table 1 of § 63.2850.

The revisions and addition read as follows:

5. Section 63.2851 is amended by revising paragraph (a) introductory text and adding paragraph (a)(8) to read as follows:

6. Section 63.2852 is revised to read as follows:

7. Section 63.2853 is amended by:

a. Revising paragraph (a)(2) introductory text and the heading to Table 1 of § 63.2853;

b. Adding Table 2 of § 63.2853 in paragraph (a)(2); and

c. Revising paragraphs (a)(3) and (a)(5)(i), (c)(1), (3), and (4).

The revisions and addition read as follows:

8. Section 63.2855 is amended by revising paragraphs (a)(3), (a)(5)(i), and (c)(3) to read as follows:

9. Section 63.2861 is amended by:

a. Revising paragraph (b) introductory text;

b. Adding paragraphs (b)(5) through (8);

c. Revising paragraphs (c) introductory text and (d) introductory text; and

d. Adding paragraphs (e) through (i).

The revisions and additions read as follows:

10. Section 63.2862 is amended by:

a. Revising paragraphs (b) and (c) introductory text;

b. Revising paragraphs (c)(3)(ii), (d) introductory text, and (e) introductory text; and

c. Adding paragraphs (f) through (h).

The revisions and additions read as follows:

11. Section 63.2870 is amended by revising Table 1 to § 63.2870 to read as follows:

12. Section 63.2872 is amended by:

a. Revising the definitions for “Compliance ratio”, “Hazardous air pollutant (HAP)”, “Initial startup period” and “Malfunction period”;

b. Adding a definition for “Nonoperating month”; and

c. Revising the definitions for “Nonoperating period”, “Normal operating period” and “Operating month”.

The revisions and addition read as follows:

Footnotes