Good Neighbor Environmental Board

Agenda

Tuesday, August 6, 2013

12 p.m. – 4 p.m. (EST)

Call-in:<PHONE_NUMBER>, conference code:<PHONE_NUMBER>

12:00 p.m.	Welcome and Introductions

Mark Joyce, Associate Director

 GNEB Acting Designated Federal Officer

Cynthia Jones-Jackson

U.S. EPA Office of Diversity Advisory Committee Management and Outreach

Diane Austin, Chair

Good Neighbor Environmental Board

Board Members

12:10 – 12:20	Overview of Agenda

Diane Austin, Chair

		Good Neighbor Environmental Board

12:20 – 1:00	Overview of Workgroup Progress

Workgroup #1 – Define Ecological Restoration and Why It’s Important

Greg Eckert, Workgroup Chair

Workgroup #2 - Review of Border Specific Programs and Where Ecological Restoration Resonates, Is Incorporated, Etc.

Cyrus Reed, Workgroup Chair

Workgroup #3 - Review of Ecological Restoration Efforts with Federal Involvement

Steve Niemeyer, Workgroup Chair

Workgroup #4 - Review of Data/Tools/Performance Indicators/Models

Dave Anderson, Workgroup Chair

1:00 – 3:00	Discussion of Advice Letter Priorities and Workgroup Reorganization

3:00 – 3:40	Discussion of GNEB Advice Letter and Report

Timeline

Next steps

3:40 – 3:50 	Other issues

Spanish Translation of 15th Report

3:50 – 4:00	Public Comments

4:00		Adjourn


National Emission Standards for Hazardous Air Pollutant Emissions: Off-Site Waste and Recovery Operations

          Summary of Public Comments and Responses on Proposed Rule
                          (79 FR 37850, July 2, 2014)

                     U.S. Environmental Protection Agency
                 Office of Air Quality Planning and Standards
                     Sector Policies and Programs Division
                       Research Triangle Park, NC 27711

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                               TABLE OF CONTENTS

1.0	Introduction	1
2.0	Risk-Related Assessment and Standards	3
2.1	Risk Assessment Data and Methodology	3
2.2	Consideration of Risks from Entire Facilities, Industrial Clusters, and Other Sources in Risk Assessment	12
2.3	Consideration of Demographics in Risk Assessment	14
2.4	Additional Standards to Address Risks	15
3.0	Startup, Shutdown, and Malfunction Exemption	18
4.0	Electronic Reporting Requirements	24
5.0	Equipment Leak Provisions	26
5.1	Open Ended Line Provisions	26
5.2	Pressure Relief Device Provisions	27
5.3	Compliance with 40 CFR Part 63 Subpart H, Including Connector Monitoring Provisions	29
6.0	Tank Provisions	30
7.0	Control Device, Performance Testing, and Monitoring Provisions	30
8.0	Other Comments	33

                          ACRONYMS AND ABBREVIATIONS

                                   Acronym/
                                 Abbreviation

                                  Definition
   Act or CAA
Clean Air Act
   ACA
American Coatings Association
   ACC
American Chemistry Council
   AEGL
Acute Exposure Guideline Level
   AMOS
Ample Margin of Safety
   BDT
Best Demonstrated Technology
   Cal OEHHA
California Office of Environmental Health Hazard Assessment
   CERCLA
Comprehensive Environmental Response, Compensation, and Liability Act
   CFR
Code of Federal Regulations
   CHIEF
Clearinghouse for Emission Inventories and Emissions Factors
   CRWI
Coalition for Responsible Waste Incineration
   CWA
Clean Water Act
   EJ
Environmental Justice
   EO
Executive Order
   EPA
U.S. Environmental Protection Agency
   EPCRA
Emergency Planning and Community Right-to-Know Act
   ERPG
Emergency Response Planning Guideline
   ERT
Electronic Reporting Tool
   FR
Federal Register
   HAP
Hazardous Air Pollutants
   HEM
Human Exposure Model
   HON
National Emission Standards for Organic Hazardous Air Pollutants From the
Synthetic Organic Chemical Manufacturing Industry
   HQ
Hazard Quotient
   IRIS
Integrated Risk Information System
   LDAR
Leak Detection and Repair
   MACT
Maximum Achievable Control Technology
   MOA
Mode of Action
   NACAA
National Association of Clean Air Agencies
   NAS
National Academy of Sciences
   NATA
National Air Toxics Assessment
   NEI
National Emissions Inventory
   NESHAP
National Emission Standards for Hazardous Air Pollutants
   OECA
Office of Enforcement and Compliance Assurance
   OEL
Open-Ended Line
   OSWRO
Off-Site Waste and Recovery Operations
   PAH
Polycyclic Aromatic Hydrocarbon
   PB
Persistent and Bioaccumulative
   PHA
Process Hazards Analysis
   POM
Polycyclic Organic Matter
   ppm
Parts Per Million
   PRD
Pressure Relief Device
   QA
Quality Assurance
   REL
Reference Exposure Level
   RfC
Reference Concentration
   RfD
Reference Dose
   RQ
Reportable Quantity
   RTR
Risk and Technology Review
   SAB
Science Advisory Board
   SCAQMD
South Coast Air Quality Management District
   SOCMA
Society of Chemical Manufacturers and Affiliates
   SOCMI
Synthetic Organic Chemical Manufacturing Industry
   SSM
Startup, Shutdown, and Malfunction
   TOSHI
Target Organ-Specific Hazard Index
   VOC
Volatile Organic Compound
   VOHAP
Volatile Organic Hazardous Air Pollutant

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1.0	Introduction

      On July 2, 2014 (79 FR 37850), the U.S. Environmental Protection Agency (EPA) proposed to revise the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Off-site Waste and Recovery Operations (OSWRO) under the authority of section 112 of the Clean Air Act (CAA). This document presents summaries of the comments that were submitted in response to this action and our responses to those comments for all comments not discussed in the preamble to the final rule. Within each comment summary, the EPA provides one or more Docket ID numbers for commenters who raised particular issues. However, the list of commenter ID numbers is not meant to be exhaustive. The EPA does not individually identify each and every commenter who made a certain point in all instances, particularly in cases where multiple commenters express essentially identical arguments. Although portions of the preamble to the final rule are paraphrased in this document, to the extent any ambiguity is introduced by paraphrasing, the preamble itself remains the definitive statement of the rationale for the final rule.
      Thirteen comment letters were received from industry representatives, governmental entities, and environmental advocacy groups during the public comment period. In addition, the EPA received one comment letter following the close of the comment period. Although the EPA is not required to consider late comments, to the extent practicable, the EPA often attempts to consider late comments and our responses to the late comment letter are also presented in this document.
      A list of the commenters, their affiliations, and the EPA docket number assigned to their correspondence is presented in Table 1-1. The EPA Docket contains all comment letters submitted and the comments are available for viewing at the EPA Docket Center Reading Room, or electronically through http://www.regulations.gov by searching Docket ID No. EPA-HQ-OAR-2012-0360 by docket number.

TABLE 1-1. LIST OF COMMENTERS ON PROPOSED NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS

                              Document ID[a][,b]
Commenter
Affiliation
                                      57
Donald R. Schregardus
U.S. Department of the Navy (Navy)
                                      58
Russell A. Wozniak
The Dow Chemical Company (Dow)
                                      59
G. Vinson Hellwig and Robert Colby
The National Association of Clean Air Agencies (NACAA)
                                      60
David Darling and Javaneh Nekoomaram
American Coatings Association (ACA)
                                      61
Lorraine Krupa Gershman
American Chemistry Council (ACC)
                                      62
Richard Krock
The Vinyl Institute (VI)
                                      63
Emma Cheuse and Jim
Pew
Sierra Club and California Communities Against Toxics (Sierra)
                                      64
Kevin D. McGrath
Veolia ES Technical Solutions, L.L.C. (Veolia)
                                      65
Melvin E. Keener
Coalition for Responsible Waste Incineration (CRWI)
                                      66
Michel R. Benoit
Cement Kiln Recycling Coalition (CKRC)
                                      67
Scott Kuhn
Clean Harbors
                                      68
John Dege
E. I. DuPont de Nemours (DuPont)
                                      69
Chris L. Manley
Eastman Chemical Company (Eastman)
                                      70
Repeat submission of comment 0063
                                      71
Melvin E. Keener (late comment)
Coalition for Responsible Waste Incineration (CRWI)
                                      72
25 attachments to comment 0063
a Document ID identifies comments found in Docket No. EPA-HQ-OAR-2012-0360 by document number.
[b] Individual comments from the public (and attachments submitted with comments) submitted to the docket are assigned a unique 4-digit docket number that follows the base docket number (i.e., EPA-HQ-OAR-2012-0360-XXXX, where "XXXX" represents the unique 4-digit document docket number). The unique document docket numbers presented in this table and document represent that unique docket number without the preceding 0s. For example, docket number EPA-HQ-OAR-2012-0360-0057 is presented as 57 in this table and within the text of this document.

      The following sections of this document summarize comments received on the proposed standards for the OSWRO source category, for all comments not discussed in the preamble to the final rule, as well as the EPA's responses to these comments. For the purpose of orderly presentation, the comments have been categorized under the following topics:

      Section 2: Risk-Related Assessment and Standards
      Section 3: Startup, Shutdown, and Malfunction Exemption
      Section 4: Electronic Reporting Requirements
      Section 5: Equipment Leak Provisions
      Section 6: Tank Provisions
      Section 7: Control Device, Performance Testing, and Monitoring Provisions
      Section 8: Other Comments

2.0	Risk-Related Assessment and Standards
2.1	Risk Assessment Data and Methodology

      Comment 2.1.1: Commenter 59 recommends that the EPA consider risk based on potential or allowable emissions because emissions and associated impacts could increase over time, and analyses based on actual emissions may underestimate residual risk. The commenter notes that the thresholds for major source status were based on maximum potential-to-emit, and permits are issued based on potential emissions. Further, the commenter argues that limiting the scope of risk assessments to actual emissions would be inconsistent with the applicability sections of Part 63 rules. While acknowledging that the EPA used allowable emissions in parts of the rulemaking, the commenter encourages the EPA to use allowable emissions also for acute health risks.
      Response 2.1.1: Consistent with previous risk assessments, the EPA considers both allowable and actual emissions in assessing chronic risks under section 112(f)(2). (See, e.g., National Emission Standards for Coke Oven Batteries (70 FR 19998-19999, April 15, 2005); proposed and final National Emission Standards for Organic Hazardous Air Pollutants from the Synthetic Organic Chemical Manufacturing Industry (71 FR 34428, June 14, 2006, and 71 FR 76603, December 21, 2006). This approach is both reasonable and consistent with the flexibility inherent in the Benzene NESHAP framework for assessing acceptable risk and ample margin of safety. As a general matter, modeling allowable emission levels is inherently reasonable since this reflects the maximum level sources could emit and still comply with national emission standards. But it is also reasonable to consider actual emissions, where such data are available, in the acceptable risk and ample margin of safety analyses. See National Emission Standards for Coke Oven Batteries, 70 FR 19992, 19998 (April 15, 2005). The commenter claims that limiting our review to actual emissions would be inconsistent with the applicability section of Part 63 rules. As explained, however, we did not limit our review to actual emissions.
      The commenter also urges the Agency to rely on allowable emissions for the purpose of our acute assessment. The use of allowable emissions was not considered due to the conservative assumptions used to gauge worst-case potential acute health effects. The conservative assumptions built into the acute health risk screening analysis include: (1) use of peak 1-hour emissions that are on average ten times the annual average 1-hour emission rates; (2) that all emission points experience peak emissions concurrently; (3) worst-case meteorology (from 1 year of local meteorology); and (4) that a person is located downwind at the point of maximum impact during this same 1hour period. Thus, performing an acute screen based on allowable emissions would be overly conservative and at best, of questionable utility to decision makers.

      Comment 2.1.2: Commenter 59 states that the use of the census block centroid dilutes the effect of sources' emissions, as the maximum point of impact can be far from the centroid and may be at or near a facility's property line, and suggested that the risks for a source category be based on the risks to the maximally exposed individual.
      Response 2.1.2: As we have noted in the development of previous RTRs, such as the Hazardous Organic NESHAP (HON) RTR (71 FR 76603, December 21, 2006), in a national-scale assessment of lifetime inhalation exposures and health risks from facilities in a source category, it is appropriate to identify exposure locations where it may be reasonably expected that an individual will spend a majority of his or her lifetime. Further, in determining chronic risks, it is appropriate to use census block information on where people actually reside to locate the estimation of exposures and risks to individuals living near such facilities.
      Census blocks are the finest resolution available as part of the nationwide population data (as developed by the US Census Bureau); each is typically comprised of approximately 40 people of about 10 households. In the EPA risk assessments, the geographic centroid of each census block containing at least one person is used to represent the location where all the people in that census block live. The census block centroid with the highest estimated exposure then becomes the location of maximum exposure, and the entire population of that census block is assumed to experience the maximum individual risk. In some cases, because actual residence locations may be closer to or farther from facility emission points, this may result in an overestimate or underestimate of the actual annual concentrations (although there is no systematic bias for average levels). Given the relatively small dimensions of census block in densely-populated areas, there is little uncertainty introduced by using the census block centroids in lieu of actual residence locations. There is the potential for more uncertainty when the census block are larger, although there is still no systematic bias. The EPA concludes that the most appropriate locations at which to estimate chronic exposures and risks are the census block centroids because: 1) census blocks are the finest resolution available in the national census data; 2) facility fence lines do not typically represent locations where chronic exposures are likely (i.e., people do not typically live at the fence line of facilities); and 3) there is no bias introduced into the estimate of the maximum individual risk (MIR) by using census block centroid locations.
      This has been the EPA's approach for estimating chronic maximum individual exposures and risks throughout the RTR program. In addition, in its peer review of the methodologies used to estimate risks as part of the RTR rulemaking efforts, the EPA's Science Advisory Board (SAB) endorsed this approach.
      In addition to the approach described above, the EPA recognizes that where a census block centroid is located on industrial property or is large and the centroid is less likely to be representative of the block's residential locations, the block centroid may not be the appropriate surrogate. For this source category, as described in the risk assessment document available in the docket, in cases where a census block centroid was within 300 meters of any emission source (and therefore possibly on facility property), we viewed aerial images of the facility to determine whether the block centroid was likely located on facility property. Likewise, we examined aerial image of all large census blocks within one kilometer of any emission source. If the block centroid did not represent the residential locations within that block, we relocated it to better represent them and/or we added receptors for residences nearer to the facility than the centroid. For this source category, we added several receptors for census blocks where the centroid location was not representative of the residential locations. Appendix 7 of the risk assessment, entitled "Residual Risk Assessment for the Off-Site Waste and Recovery Operations Source Category" provide additional information on these changes.

      Comment 2.1.3: Commenter 63 states that the EPA cannot assume that hazardous air pollutants (HAP) with no peer-reviewed reference values for cancer or non-cancer effects have zero risk. The commenter states that the EPA must select health protective values based on the information it has or, at a minimum, add an uncertainty factor to the risk estimates. The commenter also requests that the EPA clearly state which HAP emitted by this source category have no health reference values.
      Response 2.1.3: This issue was addressed by the EPA's SAB in its May 7, 2010 response to the EPA Administrator.  In that response, the SAB Panel recommended that, for HAP that do not have dose-response values from the EPA's hierarchy list, the EPA should consider and utilize, as appropriate, additional sources for such values that have undergone adequate and rigorous scientific peer review. The SAB panel further recommended that the inclusion of additional sources of dose-response values into the EPA's hierarchy should be adequately documented in a transparent manner in any residual risk assessment case study. We agree with this approach and have considered other sources of dose-response data when conducting our risk determinations under RTR. However, in some instances no sources of information beyond the EPA's hierarchy are available.
      The EPA notes that we did state which HAP currently have no reference value. In the risk assessment document, Table 3.1-1 lists all the HAP emitted by the source category, and indicates whether there is an available cancer, chronic noncancer and/or acute dose-response value.

	Comment 2.1.4: Commenter 59 states that the use of Acute Exposure Guideline Levels (AEGLs) or Emergency Response Planning Guidelines (ERPGs) in residual risk assessments is not appropriate and does not ensure that public health is adequately protected from the acute impacts of HAP exposure. These limits were developed for accidental release emergency planning and are not appropriate for assessing daily human exposure scenarios. In the December 2002 EPA document, "A Review of the Reference Dose and Reference Concentration Processes," EPA stated that the primary purpose of the Acute Exposure Guideline Level (AEGL) program is to develop guidelines for once-in-a-lifetime, short-term exposures to airborne concentrations of acutely toxic chemicals. They are not meant to evaluate the acute impacts from routine emissions that occur over the life of a facility. Unlike the reference concentrations (RfCs) for chronic exposures, the AEGLs and ERPGs do not include adequate safety and uncertainty factors and cannot be relied upon to protect the public from the adverse effects of exposure to toxic air pollutants. The commenter supports the EPA's increased reliance on the California Reference Exposure Levels (RELs) to address acute exposures in the residual risk assessments, and the commenter continued to urge EPA to use RELs for these assessments.
      Response 2.1.4: The EPA does not rely exclusively upon AEGL or ERPG values for assessment of acute exposures. Rather, the EPA's approach is to consider various acute health effect reference values (see 79 FR 37857), including the California REL, in assessing the potential for risks from acute exposures. To better characterize the potential health risks associated with estimated acute exposures to HAP, and in response to a key recommendation from the SAB's peer review of the EPA's RTR risk assessment methodologies, we generally examine a wider range of available acute health metrics (e.g., RELs, AEGLs) than we do for our chronic risk assessments. This is in response to the SAB's acknowledgement that there are generally more data gaps and inconsistencies in acute reference values than there are in chronic reference values. In some cases, when Reference Value Arrays for HAP have been developed, we consider additional acute values (i.e., occupational and international values) to provide a more complete risk characterization. As discussed in the preamble to the proposed rule (79 FR 37857), the exposure guidelines EPA considers depends on which exposure guidelines are available for the various hazardous air pollutants emitted. The EPA uses AEGL and ERPG values (when available) in conjunction with REL values (again, when available) to characterize potential acute health risks. However, it is often the case that HAP do not have all of these acute reference benchmark values. In these instances, the EPA describes the potential acute health risk in relation to the acute health values that are available. Importantly, when interpreting the results, we are careful to identify the benchmark being used and the health implications associated with any specific benchmark being exceeded.

      Comment 2.1.5: Commenter 63 states that the EPA must account for the health risk from flares, especially badly performing flares, in its assessment of risk. Where the EPA does not have enough information to assess the actual performance and emissions from flares, default values should be used.
      Response 2.1.5: The EPA disagrees with the commenter that it has failed to adequately assess the risk from the one known flare in this source category. We incorporated reported emissions from all emission points, including this flare in our risk assessment. The commenter has failed to provide the EPA with evidence that the one known flare in this source category is underperforming, that any reported emissions from this flare is not accurate, or data on how such a default factor should be developed. Lacking that information, we do not believe it is appropriate to apply a default factor to this flare. The commenter also has not identified any other flares in this source category.

      Comment 2.1.6: Commenter 63 states that all emissions data the EPA currently has are primarily estimates subject to significant error in the estimation calculations. To improve the available data, the commenter states that the EPA needs to require remote sensing and continuous monitoring to track and measure emissions, with technologies such as differential absorption light detection and ranging, solar occultation flux, CEREX UV Hound, and Accusense. The commenter also states that in addition or as an alternative, the EPA should require continuous emissions monitoring and/or performance tests every year, at a minimum, as it has done for other source categories.

      Response 2.1.6: The emissions data for the risk assessment in the proposed rule were derived from a combination of industry responses to an EPA questionnaire sent under the authority of CAA section 114, the toxics release inventory (TRI) and the National Emissions Inventory (NEI). The sources of the data are documented in the docket. We have worked diligently with state and local agencies and tribes to improve emission inventories over the years, and we have instituted a number of quality assurance (QA) measures to improve data received from state and local agencies for the NEI. Additionally, the online data reporting system for the TRI contains extensive data quality checks and additional QA analyses are performed by EPA staff once the submissions are received. In addition to the broad QA analysis the EPA performed on the questionnaire response data for the dataset as a whole, the EPA also reviewed the facilities contained in the source category, the emissions units expected to be included for the processes in the source category, coordinates and stack parameters, and the HAP compounds and emission levels typically seen. A preliminary data set, containing NEI data, was also reviewed by an industry trade group, individual companies and several state air agencies, and the EPA revised the NEI data where we concluded comments from this review supported such adjustment. The memorandum, Development of the RTR Emissions Dataset for the Off-Site Waste and Recovery Operations Source Category, available in the docket for this action, sets forth a detailed explanation of the emissions data compilation and review that the EPA performed for the OSWRO source category. As part of the proposal, we also made the data set available for review using a RTR data review tool in the docket and solicited comments on the data set. The RTR review of the proposal data sets act as an external third party review mechanism of the RTR data set, and we note that no comments regarding the RTR data set were received during the public comment period for the proposed rulemaking. Several opportunities have been provided to review the data used in the current rulemaking. Through the NEI and TRI QA procedures, QA of industry submitted data, industry, state, and NACAA review, public comment on proposal files, source category-specific engineering reviews, and modeling, improvements to the data files have been made. We believe the data set used in this rulemaking is sufficiently accurate and complete and constitutes the best information the EPA has for conducting the RTR for this source category.

      Comment 2.1.7: Commenter 63 claims the EPA lags behind the best available science to address the real-world health risk for the individual most exposed to OSWRO emissions and must apply this science in the rulemaking under CAA section 112(f)(2). In particular, the commenter believes the EPA should follow the recommendations of the National Academy of Sciences (NAS) and the SAB on the key issues that affect the most-exposed and most vulnerable populations, especially children and environmental justice (EJ) communities. The commenter states the EPA must consider the science and update its risk assessment in, at least, each of the following ways before finalizing the rule:
      * Account for individual-level vulnerability in this risk assessment by better incorporating the vulnerability of children, early-life exposures, and the developing fetus into risk assessment methods.
      * Account for increased susceptibility by using California Office of Environmental Health Hazard Assessment (Cal OEHHA) Cancer Guidelines (Age-Dependent Adjustment Factors) for all carcinogens, not just known mutagens and include pre- natal susceptibility.
      * For chronic non-cancer risk, consult and apply child-specific reference values (such as the Cal OEHHA values), where available.
      * If child-specific reference values are unavailable, consult science on early exposure impacts, and use an additional default factor of at least 10X.
      Response 2.1.7: We disagree with the general comment that the EPA should adopt the Cal OEHHA child-protective scientific approach on cancer. The EPA has an approach for selecting appropriate health benchmark values and in general, this approach places greater weight on the EPA derived health benchmarks than those from other agencies (see http://www.epa.gov/ttn/atw/nata1999/99pdfs/healtheffectsinfo.pdf). Notably, this approach favoring EPA benchmarks (when they exist) over all others has been endorsed by the SAB. Further, the EPA is currently evaluating whether it is appropriate to use the Cal OEHHA child- specific reference doses, and we note that because there are currently no such values for HAP inhalation, their current utility would be limited to persistent and bioaccumulative (PB)-HAP, which may be associated with non-negligible ingestion exposures. That is, before using these child-specific reference doses (RfDs), the EPA would need to evaluate whether they have been appropriately derived.
      We also disagree with the comment that the risk assessment for this source category does not consider the groups that may be most at-risk (e.g., pregnant women). When the EPA derives exposure reference concentrations and unit risk estimates for metal HAP, it also considers the most sensitive populations identified in the available literature, and importantly, these are the values used in our risk assessments (see US EPA. (2002). A review of the reference dose and reference concentration processes. EPA/630/P-02/002F. Risk Assessment Forum, Washington, DC. Available online at http://www.epa.gov/raf/publications/pdfs/rfd-final.pdf. With respect to maternal exposure in utero specifically, we are unaware of literature that would allow for a robust characterization of risk during this stage of development.
      We acknowledge that population subgroups, including children, may have a potential for risk that is greater than the general population due to greater relative exposure and/or greater susceptibility to the toxicant. As explained in previous actions, including the final HON RTR (71 FR 76610-76611), the assessments we undertake to estimate risk account for this potential vulnerability. With respect to exposure, the risk assessments we perform implicitly account for this greater potential for exposure by assuming lifetime exposure, in which populations are conservatively presumed to be exposed to airborne concentrations at their residence continuously, 24 hours per day for a full lifetime, including childhood. With regard to children's potentially greater susceptibility to non-cancer toxicants, the assessments rely on EPA (or comparable) hazard identification and dose-response values which have been developed to be protective for all subgroups of the general population, including children.
      For example, a review of the chronic reference value process concluded that the EPA's reference concentration (RfC) derivation processes adequately considered potential susceptibility of different subgroups with specific consideration of children, such that the resultant RfC values pertain to the full human population "including sensitive subgroups," a phrase which is inclusive of childhood. With respect to cancer, the EPA uses the age-dependent adjustment factor approach referred to by the commenter, but limits the use of those factors only to carcinogenic pollutants that are known to act via mutagenic mode of action, in contrast to the OEHHA approach, which uses them across the board for all carcinogens regardless of mode of action (MOA). In lieu of chemical-specific data on which age or life-stage specific risk estimates or potencies can be determined, default age dependent adjustment factors can be applied when assessing cancer risk for early-life exposures to chemicals which cause cancer through a mutagenic MOA. The estimated risks must also be considered in the context of the full set of assumptions used for this risk assessment. For example, we used a health-protective assumption of a 70-year exposure duration in our risk estimates; however, using the national average residency time of 12 years would reduce the estimate of risk by roughly a factor of 6. Our unit risk estimates for HAP are considered a plausible upper-bound estimate; actual potency is likely to be lower and some of which could be as low as zero. After considering these and other factors, we continue to consider the risks from emissions after application of the revisions to the NESHAP for this source category to provide an ample margin of safety (consistent with the Benzene NESHAP framework).

      Comment 2.1.8: Commenter 63 states that the EPA failed to perform an adequate multipathway risk assessment. One reason the commenter states the assessment is inadequate is that it does not account for all the PB-HAP pollutants. The commenter asserts that the EPA's choice to restrict the multipathway screening assessment to only HAP that bioaccumulate is not supported by the 2003 Risk Assessment Guidance because it ignores other HAP that persist and accumulate in soils. In addition, the commenter states that the EPA should include all metals in the multipathway risk assessment, as recommended by California's OEHHA and also recommends that naphthalene, a polycyclic aromatic hydrocarbon (PAH), be considered a polycyclic organic matter (POM), which is listed as a PB-HAP. In addition, the commenter notes that the EPA did not assess all exposure routes, did not use the information from the multipathway analysis in the overall risk analysis, and did not add the multipathway risk found to the inhalation risk. The commenter asserts that the EPA may not assume that emissions under the multipathway screening levels are not significant enough to require a full analysis. The commenter opines that the EPA should update the incidental soil ingestion factors it uses in its multipathway risk assessments to fully account for the greater multipathway exposure and risk for children.
      Response 2.1.8: We believe our multipathway assessment is a reasonable technical analysis of risk to human health from OSWRO emissions of HAP via non-inhalation pathways based on the information and analytical tools currently available to the EPA. In the Air Toxics Risk Assessment Reference Library, we developed the current PB-HAP list considering all of the available information on persistence and bioaccumulation (see http://www2.epa.gov/fera/air-toxics-risk-assessment-reference-library-volumes-1-3), specifically Volume 1 Appendix D). (The Air Toxics Risk Assessment Reference Library provides information on the fundamental principles of risk-based assessment for air toxics and how to apply those principles in different settings (e.g., facility-specific) as well as strategies for reducing risk at the local level.) This list considered HAP identified as PB-HAP by other EPA Program Offices (e.g., the Great Waters Program), as well as information from the persistent, bioaccumulative and toxic (PBT) profiler (see http://www.pbtprofiler.net). This list was peer-reviewed by the SAB and found to be acceptable, and therefore we consider it to be reasonable for use in the RTR program. Based on these sources and the limited available information on the persistence and bioaccumulation of other HAP, we do not believe that the potential for multipathway risk from other HAP rises to the level of the PB-HAP currently on the list.
      Naphthalene is not treated as a POM chemical in the multipathway analyses. Naphthalene is listed individually as a HAP under Section 112(b) of the Clean Air Act. POM also is listed as a HAP under Section 112(b) and is defined as organic compounds with more than one benzene ring and a boiling point greater than or equal to 100 degrees Celsius. This definition potentially could include naphthalene. However, naphthalene is short-lived in environmental media due to its tendency to volatilize and biodegrade and, consequently, will not build up in environmental media over time. It has a moderate affinity for lipids and will undergo short-term bioaccumulation is tissues; however, biochemical processes lead to its biodegradation and elimination. Because it is neither persistent nor bioaccumulative, we do not consider it a PB-HAP in our multipathway risk analyses and believe that its inclusion as a PB-HAP would result in less accurate and less meaningful estimates of media concentrations and multipathway risk.
       We did not combine the inhalation and multipathway risk assessment results for each pollutant because it is inappropriate to do so. The multipathway risk assessment conducted for proposal was a screening-level assessment (i.e., Tier 1). It used highly conservative assumptions designed to ensure that facilities with results below the screening threshold values did not have the potential for multipathway impacts of concern. The screening scenario is a hypothetical scenario. It is inappropriate to combine the results of a refined inhalation assessment, which produces a quantitative result, with a screening-level multipathway assessment, which produces a "yes/no" result. In situations where we have previously summed the inhalation and multipathway assessment results (e.g., secondary lead smelters), it was for two refined assessments, and still serves as an overestimate of potential risks given that it is highly unlikely that the same receptor has the maximum results in both assessments.
      We further note that we generally draw no bright lines of acceptability regarding cancer or noncancer risks from source category HAP emissions, and that it is always important to consider the specific uncertainties of the emissions and health effects information regarding the source category in question when deciding exactly what level of cancer and noncancer risk should be considered acceptable. In addition, the source category-specific decision of what constitutes an acceptable level of risk should be a holistic one; that is, it should simultaneously consider all potential health impacts -- chronic and acute, cancer and noncancer, and multipathway -- along with their uncertainties, when determining the acceptable level of source category risk. In other words, we look at the risk numbers within the context of uncertainty associated with emissions and health benchmark values. The Benzene NESHAP decision framework of 1989 acknowledged this; in today's world, such flexibility is even more imperative, because new information relevant to the question of risk acceptability is being developed all the time, and the accuracy and uncertainty of each piece of information must be considered in a weight-of- evidence approach for each decision. This relevant body of information is growing fast (and will continue to grow even faster), necessitating a flexible weight-of-evidence approach that acknowledges both complexity and uncertainty in the simplest and most transparent way possible. While this challenge is formidable, it is nonetheless the goal of the EPA's RTR decision-making, and it is the goal of the risk assessment to provide the information to support the decision-making process.
      Regarding incidental soil contamination, the EPA has estimated risks from both direct and indirect pathways. Direct routes of exposure include direct ingestion of soil and exposure through dermal contact. However, because it has been demonstrated in past analyses that exposure levels associated with dermal contact are but a small fraction of exposure levels associated with ingestion and inhalation pathways, dermal exposures were not assessed for this source category.

      Comment 2.1.9: Commenter 63 states that the EPA has not used a high enough emissions factor to account for acute risks. The commenter states the EPA used an emissions factor of 1 that fails to adequately account for additional health risk from malfunctions, considering that a facility could emit 100 times more than its usual emissions during a control equipment failure if it usually controls 99% of emissions.
      Response 2.1.9: The acute risk assessment methodology uses a tiered, iterative approach that begins with an assessment of an approximation of a worst-case exposure. To this end, we assumed that peak 1-hour emissions are equal to 10 times the average 1-hour emissions rate (rather than a factor of 1 as stated by the commenter), which is only one of the worst-case assumptions that we made in our acute health risk screening analysis. Other worst-case assumptions included:
                        *       For facilities with multiple emission points, peak 1-hour emissions were assumed to occur at all emission points at the same time.
                        *       For facilities with multiple emission points, 1-hour concentrations at each receptor were assumed to be the sum of the maximum concentrations due to each emission point, regardless of whether those maximum concentrations occurred during the same hour.
                        *       Worst-case meteorology (from one year of local meteorology) was assumed to occur at the same time the peak emission rates occur. The recommended EPA local-scale dispersion model, AERMOD, is used for simulating atmospheric dispersion.
                        *       A person was assumed to be located downwind at the point of maximum impact during this same 1-hour period, but no nearer to the source than 100 meters.
                        *       The maximum impact was compared to multiple short-term health benchmarks for the chemical being assessed to determine if a possible acute health risk might exist.

      With regards to the failure of a control device, this would constitute a violation of the emission standard. The acute risk emissions factor is designed to account for fluctuations in emissions for facilities complying with the standards, not for facilities in non-compliance. Therefore, it would be inappropriate to use the emissions factor suggested by the commenter for purposes of determining whether the NESHAP's current requirements are in need of revision under section 112(f)(2).

      Comment 2.1.10: Commenter 63 states that the EPA should analyze risk including emissions that may occur above the existing MACT standards, considering malfunctions and violations. The commenter states that the EPA must assess public health risk based on the likelihood of such events and suggests that the EPA develop and apply a factor to the risk results based on available malfunction and violation data.
      Response 2.1.10: We disagree with the commenter that emissions that exceed standards and are violations, whether or not they are caused by malfunction events, should be considered as part of the risk analysis for purposes of determining the sufficiency of pre-existing standards, particularly when we are revising the standards to eliminate any excused periods of non-compliance during upset periods. The purpose of the risk review is to evaluate whether the emission limits -- the "standards promulgated pursuant to subsection (d)," not the non- compliance with those standards (section 112(f)(2)(A)) -- should be made more stringent to reduce the risk posed after compliance with the underlying MACT standard. To the extent that a source is violating the underlying MACT standard, no tightening of the emission standard under the residual risk rule will avoid or militate against such violations. In other words, a source that is violating the emission standard promulgated under section 112(d) would not be any more likely to be able to avoid such violations and comply with a different presumably more stringent standard promulgated under section 112(f). Such events are violations and subject to enforcement by the EPA, the states or citizens, and an action for injunctive relief is the most effective means to address violations, whether or not they are caused by malfunctions, if an emissions event poses a significant health or environmental risk.
      Furthermore, the conservative estimates built into the acute risk assessment are sufficient to gauge worst-case potential acute health effects. The conservative estimates built into the assessment include worst-case meteorology, emissions at ten times the maximum peak emission rate from all point sources simultaneously, and the sum of the maximum impact of each emission source, regardless of receptor location. Thus, even if we were to consider emissions that are in violation of the standard, we do not believe that they would result in any different level of control than we are promulgating here.

      Comment 2.1.11: Commenter 67 questions why the EPA used NEI data from 2005 instead of the newer 2011 NEI data for the risk analysis.
      Response 2.1.11: As noted in the preamble to the proposed rule and the emissions data documentation available in the docket for this action, Development of the RTR Emissions Dataset for the Off-Site Waste and Recovery Operations Source Category, we used the best data available to us in the risk assessment. Of the 38 facilities modeled in the risk assessment, data from industry gathered under CAA section 114 was used for 19 facilities. For the remaining facilities where this data was not available, we used a combination of NEI, toxics release inventory (TRI) and emissions inventory system (EIS) data. In an effort to ensure emissions were assigned to the OSWRO source category wherever possible, an emissions summary was developed by HAP category name at the facility level for side by side comparison of emissions data from the 2005 NEI, 2008 EIS, and 2008, 2009, and 2010 TRI. When this data was compiled and modeled in the summer of 2013, the 2011 NEI data was not yet available and was not considered. As the 2010 TRI contained the most recent data available, these data were generally used to fill gaps in or replace the 2005 NEI data, which represented the most complete data available, including data for specific emissions points, emissions point type identifiers, HAP emitted, and emissions release parameters.

2.2	Consideration of Risks from Entire Facilities, Industrial Clusters, and Other Sources in Risk Assessment

      Comment 2.2.1: Commenter 63 states that the EPA should assess the cumulative burden of exposures to multiple pollutants and sources via multiple pathways. To do this, the commenter suggests that the EPA aggregate inhalation and non-inhalation-based cancer risks; include the interaction of multiple pollutants; and account for exposure to multiple emissions sources including other emissions sources at the facilities and from other sources of toxic air pollutants in the area. The commenter states that until the EPA has a specific mechanism for estimating total exposures, use of a default factor of at least 10X should be incorporated in the risk assessments.
      Response 2.2.1: We have combined risk assessment results to the extent that it is appropriate to do so. We consider the effect of mixtures of carcinogens and use a target organ-specific hazard index (TOSHI) approach for our chronic noncancer assessments. We do not use a TOSHI approach for our acute analyses nor do we combine the results of our inhalation and multipathway assessments.
      For the OSWRO source category, the EPA conducted an assessment of the cumulative cancer risks from emitted carcinogens and the cumulative noncancer hazard indices from all emitted non-carcinogens affecting the same target organ system for both the source category emissions and the facility-wide emissions. While the incorporation of additional background concentrations from the environment in our risk assessments (including those from mobile sources and other industrial and area sources) could be technically challenging, they are neither mandated nor barred from our analysis. In developing the decision framework in the Benzene NESHAP currently used for making residual risk decisions, the EPA rejected approaches that would have mandated consideration of background levels of pollution in assessing the acceptability of risk, concluding that comparison of acceptable risk should not be associated with levels in polluted urban air (54 FR 38044, 38061, September 14, 1989). Background levels (including natural background) are not barred from the EPA's ample margin of safety (AMOS) analysis, and the EPA may consider them, as appropriate and as available, along with other factors, such as cost and technical feasibility, in the second step of its section 112(f) analysis. This assessment excludes background contributions because the available data are of insufficient quality upon which to base a meaningful analysis.
      We disagree with the comment that we failed to consider or account for cumulative risk. The EPA modeled whole-facility risks for both chronic cancer and non-cancer impacts to understand the risk contribution of the sources within the OSWRO source category. The individual cancer risks for the source category were aggregated for all carcinogens. In assessing noncancer hazard from chronic exposures for pollutants that have similar modes of action or (where this information is absent) that affect the same target organ, we aggregated the hazard quotients (HQ). This process creates, for each target organ, a TOSHI, defined as the sum of hazard quotients for individual HAP that affect the same organ or organ system. All TOSHI calculations presented here were based exclusively on effects occurring at the "critical dose" (i.e., the lowest dose that produces adverse health effects). Whole facility risks were estimated utilizing the 2005 NEI, with updated facility-wide and source category data files developed by the EPA through emission data updates from industry, states, and NACAA. We also disagree with the commenter's assertion that additional quantitative assessment of risks from sources outside the source category is required under the statute. The statute requires the EPA to provide the quantitative risk information necessary to inform RTR regulatory decisions, and to this end, the EPA conducts a comprehensive assessment of the risks associated with exposure to the HAP emitted by the source category and supplements that with additional information that is available about other possible concurrent and relevant risks.
      As described in the risk assessment report (available in the docket for this action), we do not sum results of the acute noncancer inhalation assessment to create a combined acute risk number that would represent the total acute risk for all pollutants that act in a similar way on the same organ system or systems (similar to the chronic TOSHI). As noted in previous responses, the worst-case acute screen is already a conservative scenario. That is, the acute screening scenario assumes worst-case meteorology, peak emissions for all emission points occurring concurrently and an individual being located at the site of maximum concentration for an hour. Thus, as noted in section 2.7.2 of the Draft Residual Risk Assessment for the Off-Site Waste and Recovery Operations Source Category (Docket Item No. EPA-HQ-OAR-2012-0360-0003), "because of the conservative nature of the acute inhalation screening and the variable nature of emissions and potential exposures, acute impacts were screened on an individual pollutant basis, not using the TOSHI approach."
      We did not combine the inhalation and multipathway risk assessment results for each pollutant because it is inappropriate to do so. The multipathway risk assessment conducted for proposal was a screening-level assessment (i.e., Tier 1). It used highly conservative assumptions designed to ensure that facilities with results below the screening threshold values did not have the potential for multipathway impacts of concern. The screening scenario is a hypothetical scenario, and due to the theoretical construct of the screening model, exceedances of the thresholds are not directly translatable into estimates of risk or hazard quotients for these facilities. In situations where we have previously summed the inhalation and multipathway assessment results (e.g., secondary lead smelters), it was for two refined assessments, and still serves as a conservative overestimate of potential risks given that it is highly unlikely that the same receptor has the maximum results in both assessments.

2.3	Consideration of Demographics in Risk Assessment

      Comment 2.3.1: Commenter 59 commends the EPA for considering EJ issues in this proposal. However, the commenter suggests the EPA rule writers work with the EPA's Office of Environmental Justice to develop specific criteria and guidance on how to interpret and apply the outcomes of EJ analyses in the rulemaking process. The commenter also specifically suggests that the EPA use a 5-kilometer radius rather than 3-mile radius in its demographic analyses; that the EPA conduct the demographic analysis for all people projected to experience risk greater than 1-in-1 million for cancer or an HQ above one, consistent with the approach used for the Hard and Decorative Chromium Electroplating and Chromium Anodizing Tanks source category; and that the analysis be conducted using maximum allowable emissions..
      Response 2.3.1: The commenter is correct that we performed the demographic analyses for the OSWRO source category differently than we did for the October 2010 proposed RTR for the chrome source categories. We performed the demographic analyses for the chrome source categories using two approaches as examples of how such analyses might be developed, and invited public comment on the approaches used and the interpretations made from the results. In the first approach, we focused the analysis on the total populations residing within 5 km of each facility, regardless of their estimated risks, and examined the distributions across various demographic groups within those 5 km circles. That analysis was a "proximity" analysis in that it considered only the distance from the emission sources to surrounding populations, and not the estimated risks to those populations
      In the second approach, we focused the analysis on the populations within 5 km of any facility estimated to have exposures to HAP which result in cancer risks of 1-in-1 million or greater or non-cancer hazard indices of 1 or greater. We examined the distributions of those risks across various demographic groups. In each approach, we compared the percentages of particular demographic groups to the total number of people in those demographic groups nationwide. We stated in the proposed rule for the chrome source categories that in future rules we planned to extend the analyses to cover the entire modeled domain for a facility (50 km radius) to capture all individuals with risks above 1-in-1 million or greater or non-cancer hazard indices of 1 or greater. We also stated that generally we have found that using a 5 km radius in the analysis will capture more than 90 percent of the individuals with cancer risks above 1-in-1 million.
      In the February 2012 supplemental proposal for the RTR for the chrome source categories, our demographic analyses included populations within 50 km of each source (including those very near the sources) with risks of 1-in-1 million or greater or non-cancer hazard indices of 1 or greater (77 FR 6628, Feb. 8, 2012). We did not include analyses using a 5 km radius in that supplemental proposal nor in the RTR proposal for the OSWRO source category. We believe that, where a risk assessment has been performed, it is more informative to consider the demographics of all populations (including those beyond 5 km) with elevated risks than to limit the demographics analysis to populations located within 5 km of a facility. Where a risk assessment has been performed, these populations are identified, and the source parameters (like the low release height mentioned by the commenter) are taken into account. As discussed above, we have found that most exposure locations with the highest estimated risks are within 5 km of a facility, so extending the radius to 50 km has little impact on an analysis based on risks, but makes more sense because 50 km corresponds to the risk modeling radius and includes all populations with elevated risk estimates. We also note that we are working with the Office of Environmental Justice in an ongoing effort to develop new tools for considering environmental justice in rulemakings.

      Comment 2.3.2: Commenter 63 states that the EPA should assess and account for increased vulnerability due to socioeconomic status and baseline overall health status in its risk assessment, which could be accomplished by adding a default factor to account for socioeconomic and other community-based stressors.
      Response 2.3.2: We are not able to determine the baseline health status of individuals or communities in a national rulemaking. Individual privacy issues as they relate to health records and the costs that would be associated with such an analysis make the analysis infeasible. Through the EPA's interim guidance on EJ and the Action Development Process, the agency is encouraging rule writers and policy makers to look at the whole range of factors that impact communities and population groups when crafting rules. The EPA is continuing to discuss and pilot approaches that are consistent with the agency's responsibilities regarding EJ as outlined in EO 12898. In determining the need for tighter residual risk standards, the EPA strives to limit to no higher than 100-in-1 million the estimated cancer risk for persons living near a plant if exposed to the maximum pollutant concentration for 70 years and to protect the greatest number of persons to an individual lifetime risk of no higher than 1-in-1 million. Considerations are made for all people regardless of racial or socioeconomic status, and the EPA does not believe it is necessary to establish a default factor to account for socioeconomic and other community-based stressors.

2.4	Additional Standards to Address Risks

	Comment 2.4.1: Commenter 64 states that the EPA's risk analysis demonstrates that current regulations adequately address HAP emissions from OSWRO facilities, and the proposed emissions controls would not significantly decrease the health risk to the public and would be costly. The commenter notes the EPA's assessment of the acceptability of risks and argues that a margin of safety analysis and associated emission controls are not warranted.
      Response 2.4.1:  For the OSWRO NESHAP, we are revising emissions controls for equipment leaks and certain tanks concurrently under both the CAA section 112(d)(6) technology review and the CAA section 112(f)(2) risk review.  As noted in the preamble to the proposed rule (79 FR 37853-37854), in keeping with the Benzene NESHAP two-step process for developing residual risk standards, in the risk review the EPA first examines risk acceptability and then considers whether the existing standards provide for an "ample margin of safety." The two-step process does not conclude with a decision of acceptability. In the second step, the EPA determines whether the emissions standards provide an ample margin of safety, considering all of the health risks and other health information considered in the acceptability determination, as well as other relevant factors. While we proposed that the risks from the OSWRO source category are acceptable, we also found that the cancer risk estimates for 210,000 individuals in the exposed population were above 1-in-1 million, with an MIR of up to 9-in-1 million, based on actual emissions. We then proceeded to the ample margin of safety analysis. For this source category, several options for tanks, equipment leaks and process vents were identified. Finding that the revised requirements would reduce cancer and non-cancer risks and considering the associated costs, economic impacts, and technological feasibility among other information, we proposed to revise the standards for these emissions sources under CAA section 112(f).  The commenter has identified no flaw in our reasons or analysis under either section 112(d)(6) or 112(f)(2) for adopting the revised requirements.

      Comment 2.4.2: Commenter 63 supports the proposed strengthening of emission standards in certain ways for leaks and tanks but states that the EPA also refused to strengthen the existing standards for parts of the source category, including tanks and process vents, based purely on its cost-benefit analysis. The commenter states that EPA used cost as a metric to develop revised standards, but that CAA section 112(d)(6) does not mention cost. The commenter states that if the EPA is going to use a "cost-effectiveness" metric, it should at least assess the cost-per-pound of emission reductions, rather than cost-per-ton, consistent with the EPA's chrome plating rule.
      The commenter also states that the EPA failed to explain the rationale for determining why some costs were too high and why other costs were acceptable in the determination of additional standards. In addition, the commenter states that the EPA's approach considered only the cost per ton of HAP emission reduction, without assessing relevant factors such as: the individual HAPs emitted and the impact those HAPs can have at a level below 1 ton; how many people would be affected by the potential emission reductions; where they live and if they are in a community containing multiple HAP sources, or whether they face a longstanding environmental justice impact. The commenter states that the EPA also did not consider or address whether the standards would provide any "margin of safety" to protect public health, much less whether the margin is "ample." Thus, the commenter claims the EPA ignored and violated CAA section 112(f)(2).
Response 2.4.2: The EPA disagrees with the commenter's assertion that the decision not to propose more stringent standards other than those for leaks and tanks was based entirely on a cost-benefit analysis. To address the requirements of CAA section 112(f)(2) for the OSWRO source category, we performed a risk assessment, and based on the results of that assessment, made a determination that emissions remaining from the OSWRO source category after implementation of the existing standards result in risks that are acceptable. We did not consider costs as part of that analysis. For purposes of determining whether the existing standards provide an ample margin of safety to protect public health, we assessed the additional risk reductions that would result from tightening the standards (see 79 FR 37868 - 37870). Specifically, we investigated the possibility of requiring additional emissions controls for leaks, tanks and process vents. We proposed revised requirements for leaks and certain tanks, as noted in the comment. In our analysis of the control options for process vents and one of the options for tanks, we estimated reductions in levels of emissions and maximum individual cancer risks and other risk metrics, as well as costs (see 79 FR 37869 - 37870). Based on this analysis, we proposed (and are determining in the final rule) that revisions to the existing standards, beyond those proposed and finalized for leaks and certain tanks, are unnecessary to provide an ample margin of safety.
We note that when assessing the cost-effectiveness of more stringent standards under consideration, we have discretion to express emission reductions that would result from such standards in any reasonable format, such as costs-per-ton of emissions reduced. We also note that changing units used to express emissions reductions makes no substantive difference, e.g., $4,000 per ton reduced is equivalent to $2 per lb reduced. Presenting costs in terms of costs-per-pound of emissions reduction was appropriate for the chromium electroplating rulemaking, where total emissions and emissions reductions of chromium compounds were below one ton.
      Further, the EPA disagrees with the commenter that we did not assess the individual HAP emitted or the impact those HAP can have at a level below 1 tpy. As noted at proposal (see 79 FR 37855-37856) and in the risk assessment documentation, we assessed the risks considering all individual HAP emissions, regardless of emission level, from the OSWRO source category. We also assessed the impact that the potential emission control options would have on the level of emissions of the individual HAP and on the risks associated with those emissions, as documented in the memorandum, Estimated Risks and Risk Reductions Associated with the Emissions Controls Options Considered in the Ample Margin of Safety Analysis for the Off-Site Waste and Recovery Operations Source Category, available in the docket for this action.
      Regarding the comment that the EPA should consider whether people live in a community containing multiple HAP sources, we note that background risks and contributions to risk from sources outside the facilities under review were not considered in the ample margin of safety determination for this source category, mainly because of the significant uncertainties associated with emissions estimates for such sources (see 79 FR 37866). Our approach here is consistent with the approach we took regarding this issue in the Hazardous Organic NESHAP (HON) RTR, which the court upheld in the face of claims that the EPA had not adequately considered background (NRDC v. EPA, 529 F.3d 1077 (D.C. Cir. 2008)). With regard to the comment concerning longstanding environmental justice impacts, we refer to the preamble of the proposed rule regarding how we examine environmental justice concerns generally, as well as in this specific rulemaking.

      Comment 2.4.3: Commenter 63 states that the EPA should revisit or update its presumed acceptable level of cancer risk considering information learned about children's and overburdened community's vulnerability and considering new information on ways to analyze and control the impacts of pollutants on human health. The commenter believes that 100-in-1 million lifetime cancer risk cannot be considered safe or "acceptable." The commenter also states that the EPA should factor in uncertainties and vulnerability factors to adjust the level of non-cancer risk considered acceptable for both chronic and acute exposure.
      Response 2.4.3: In 1990, Congress codified in section 112(f) of the CAA the approach we use for our residual risk analyses (i.e., the Benzene NESHAP, 54 FR 38044). Under that approach, there is no single bright line (e.g., a 100-in-1 million cancer risk) that indicates that risk is "acceptable." Rather, multiple health metrics, including the cancer risk, are considered to determine whether the risk is acceptable. Costs cannot be considered at this stage of the analysis. However, the analysis of whether risk is acceptable is not the endpoint. Once we determine that the existing MACT standards or identify what additional controls are sufficient to ensure risk is acceptable, we again review the health metrics in conjunction with considering the costs of controls to determine whether further additional controls should be required to provide an ample margin of safety to protect public health. The commenter does not explain how science has evolved in a way that would undermine the codified framework for determining acceptability.
3.0	Startup, Shutdown, and Malfunction Exemption

      Comment 3.1: Commenter 58 requests that the EPA provide a six month transition period to comply with the revised start-up, shutdown, and malfunction provisions. The commenter notes that additional time is needed to review the final amendments and implement changes, including physical or operations changes, update internal guidance and perform personnel training.
      Response 3.1:  We disagree that additional time should be provided to comply with the revised SSM provisions. The court decision which vacated the SSM exemptions in the General Provisions was decided in 2008 (Sierra Club v. EPA, 551 F. 3d 1019 (D.C. Cir. 2008)). In addition, OSWRO facilities have been on notice of EPA's amendments at least since the proposed rule was published on July 2, 2014.Regarding the malfunction reporting and recordkeeping requirements, facilities should be able to immediately implement these upon the next occurrence of a malfunction.

      Comment 3.2: Commenters 65 and 61 argue that standards developed using data generated during steady-state conditions should not apply during malfunctions. Specifically, the commenters do not agree that the EPA is not required to take malfunctions into account when developing emissions standards. The commenters assert that under the proposed amendments, the OSWRO standards are not achievable at all times and do not reflect what is achieved by the best performing sources because emission limits were developed under steady-state (i.e., normal) conditions, and the EPA is now requiring that they also apply during non-steady-state operations (i.e., malfunctions). Commenter 65 asserts that standards developed under steady-state conditions cannot incorporate the variability that occurs during malfunctions, and the EPA cannot predict what emission limits a facility can meet "every day under all operating conditions" if those operating conditions now include malfunctions. In reference to CAA section 112(d)(2) and (3), the commenter states that emission limitations must be "achieved in practice," which means that the EPA must show that at least one facility can meet the emissions limitations being promulgated (for new sources) and that a similar showing is required for existing sources. The commenter asserts that the EPA has failed to develop standards that are "achieved in practice" if even the best performing existing sources are expected to have malfunctions, and those malfunctions result in emissions that exceed the standard. In response to EPA's statement that the goal of a best controlled source is to operate in such a way as to avoid malfunctions and accounting for malfunctions could lead to less stringent standards than levels achieved by a non-malfunctioning source, the commenter states that congress did not authorize the EPA to set goals but to set emission limitations based on what is achievable.
      Commenter 65 asserts that the EPA inappropriately relies on the Clean Water Act (CWA) case Weyerhaeuser v. Costle, 590 F.2d 1011, 1058 (D.C. Cir. 1978) in its justification that the EPA is not required to factor malfunctions into its standards, because that decision addressed a CWA requirement that, unlike the MACT Floor, was intended to require the development of new control technology. In response to the EPA's claim that accounting for malfunctions in setting emission standards would be difficult, if not impossible, both commenters state that this does not relieve the EPA from complying with the law, and cite Cement Kiln Recycling Coalition v. EPA, 255 F.3d 855, 865 (D.C. Cir. 2001); "Even accepting the proposition that factors affecting source performance ... are difficult to quantify....If EPA cannot meet this requirement using the MACT methodology, it must devise a different approach capable of producing floors that satisfy the Clean Air Act."
      Response 3.2: Commenters assert that the EPA must account for malfunctions when determining the emissions level achieved by the best performing sources, but this view is neither reasonable nor supported by the text of the CAA. A malfunction is defined as a "sudden, infrequent, and not reasonably preventable failure of air pollution control and monitoring equipment, process equipment or a process to operate in a normal or usual manner * * *" (40 CFR 63.2). The EPA interprets CAA section 112 as not requiring emissions that occur during periods of malfunction to be factored into development of CAA section 112 standards. Under CAA section 112, emissions standards for new sources must be no less stringent than the level "achieved" by the best controlled similar source and for existing sources generally must be no less stringent than the average emission limitation "achieved" by the best performing 12 percent of sources in the category. There is nothing in section 112 that directs the Agency to consider malfunctions in determining the level "achieved" by the best performing sources when setting emission standards. As the D.C. Circuit has recognized, the phrase "average emissions limitation achieved by the best performing 12 percent of" sources "says nothing about how the performance of the best units is to be calculated." Nat'l Ass'n of Clean Water Agencies v. EPA, 734 F.3d 1115, 1141 (D.C. Cir. 2013). As discussed above, nothing in section 112 requires the Agency to consider malfunctions as part of that analysis, accounting for malfunctions in setting emission standards would be difficult, if not impossible, and could lead to standards that are not reflective of levels achieved by a well-performing non-malfunctioning source. Accordingly, the EPA's approach to malfunctions is a reasonable interpretation of the statute. And in the event that a source fails to comply with the applicable CAA section 112 standards as a result of a malfunction event, as discussed above, the EPA would determine an appropriate response, and the source can raise any and all defenses in any enforcement action that may be filed.
      The CAA also requires those standards to apply on a continuous basis, which the D.C. Circuit has interpreted to include periods of start-up, shut-down, and malfunction. See Sierra Club v. EPA, 551 F.3d at 1027-28 (striking down a general provision that exempted start-up, shut-down, and malfunction periods). The EPA's approach both accounts for variability associated with a reasonably foreseeable range of operating conditions and recognizes that enforcement mechanisms can address emission exceedances due to unpreventable equipment or process failures. While commenters seek greater accommodation for malfunctions, such accommodation is not compelled by the statutory text and the EPA believes our approach is reasonable.
      Unlike start-up and shut-down, which are foreseeable operations, no one can predict the nature, scope, severity, timing, length, number or likely recurrences of malfunctions a source may  -  or may not  -  experience. Although EPA bases emission standards on different manners of operations and circumstances, EPA only takes into account conditions that are "foreseeable" and "which can reasonably be expected to recur." Sierra Club, 167 F.3d at 665; see also Nat. Lime, 627 F.2d. at 431, n.46. Virtually no malfunction is foreseeable in terms of its nature, timing or effect on emission levels and no operator knows if or when a malfunction could recur.
      Commenters identify no language in the statute that even implies that EPA must factor into MACT emission standards the emission levels that occur during malfunctions. Yet, they assert that CAA section 112 mandates that EPA account for malfunctions in establishing every single MACT floor standard or set a separate MACT floor standard for malfunctions, so that they reflect higher emission levels that might occur during undefined, unidentified malfunction events. Commenters appear to rely on the silence of section 112, which does not speak directly to how malfunctions are to be treated to support their view, filling the void with their own judgments of how EPA must address such uncertain and undefined events.
      Where a statute is ambiguous or leaves a gap as to its application, the Court must defer to the agency's interpretation so long as it is "based on a permissible construction of the statute," Chevron, 467 U.S. at 842-43, and in making this determination under the regulatory HAPs program administered by EPA, the Agency is accorded substantial deference.  Although EPA may have authority to address malfunctions through different mechanisms  -  albeit limited by the Court in Sierra Club v. EPA (striking down exemptions for malfunctions) and NRDC v. EPA (striking down an affirmative defense for malfunctions)  -  EPA's interpretation that it is not required by section 112 to address malfunction emissions by resetting MACT numeric standards is a rational application of section 112.
      EPA has accounted for variability among the best performing sources' emissions over the range of foreseeable operating conditions. But, as EPA determined, it would be impracticable for EPA to factor unforeseeable, random malfunction incidents into emission standards, and commenters offer no roadmap for doing so.
      In any event, there is no statutory basis for requiring EPA to take such action. Commenters assert that section 112 mandates that EPA establish MACT floor standards so that they reflect higher emission levels that might occur during unidentified, unmeasured malfunction events. To support their argument, the commenter states that emission limitations must be "achieved in practice," which means that the EPA must show that at least one facility can meet the emissions limitations being promulgated (for new sources) and that a similar showing is required for existing sources. The commenter asserts that the EPA has failed to develop standards that are "achieved in practice" if even the best performing existing sources are expected to have malfunctions, and those malfunctions result in emissions that exceed the standard.  But a source that suffers worker malfeasance or experiences a hurricane or a terrorist event, may also exceed emission standards at certain times. These events, like malfunctions, do not transform standards based on emission levels that actually have been achieved into unachievable standards. Indeed, under commenter's reasoning, every MACT floor is forever invalid because it does not reflect emission levels that will occur during the next malfunction, act of God, strike, malfeasance or other unpredictable event.
      Hurricanes and malfeasance can also occur at well-maintained and well-managed sources, but this does not warrant factoring such unpredictable events into emission standards. Even if malfunctions were inevitable for all sources, including the best-performing sources, that does not make it possible to take them into account when establishing MACT emission standards, because they are still unknown in frequency, length, magnitude and, most importantly, effect on emission levels.
      The commenter (65) asserts that the EPA inappropriately relies on the CWA case Weyerhaeuser Co. v. Costle, 590 F.2d 1011, 1058 (D.C. Cir. 1978) because the Weyerhaeuser court based its holding on the fact that the standards at issue there were technology-forcing. While the Court did address this point, it went on to uphold EPA's case-by-case enforcement discretion approach to addressing malfunctions because interjecting factors dependent on "murky determinations concerning the sequence of events in the plant, whether those events would have been avoidable" and similar factors, is inconsistent with the intent of Congress to require numeric emission standards that are measurable and easily enforceable. 590 F.2d at 1057-58.
      The commenters also offer the decision in Cement Kiln Recycling Coalition v. EPA as further proof that malfunctions must be considered in developing emissions standards. However, nothing in Cement Kiln even implies that EPA has a duty to reflect in its emission standards emission levels that might occur during unpredictable malfunction events. To the contrary, Cement Kiln cuts to the heart of commenters' argument. The fundamental principle of commenters' argument is that due to malfunctions, the MACT emission standards, which undeniably have been achieved by OSWRO facilities, may be "unachievable" if specific sources experience a malfunction. The Court in Cement Kiln, however, rejected the notion that because a MACT standard may not be achievable by some sources, it is invalid. Cement Kiln, 255 F.3d at 861 ("EPA may not deviate from section 7412(d)(3)'s requirement that floors reflect what the best performers actually achieve by claiming that floors must be achievable by all sources using MACT technology."). See also Sierra Club v. EPA, 479 F.3d at 878; NACWA, 734 F.3d at 1150 (explaining that the argument that a MACT standard is invalid because it is not achievable by all sources at all times has been "roundly rejected" by the Court).

      Comment 3.3: Commenter 65 urges the EPA to establish work practice standards for malfunctions as allowed in CAA section 112(h), in part because it is infeasible to gather data during malfunctions due to the lack of EPA approved test methods for non-steady-state conditions. The commenter notes that in the 2008 SSM decision, the court stated that the inclusion of "continuous" in the CAA definition of emission standard means that some standards apply at all times but does not mean that the same standard must apply at all times, and specifically noted the potential for the EPA to address malfunctions through work practice standards. As an example, the commenter suggests a requirement to implement a malfunction plan that would detail a facility's response to malfunctions and that would outline a method to expeditiously return to allowable operating conditions. Commenter 61 suggests an approach where the EPA would gather data from the best performing sources on best practices used to mitigate excess emissions during malfunctions. The commenter also suggests that the EPA could create an emission standard that combines emission limits with work practice standards.
      Response 3.3: The EPA's rationale for its approach to malfunctions is discussed in the preambles to the proposed rule and this final action. The EPA has determined that CAA section 112 does not require that emissions that occur during periods of malfunction be factored into development of CAA section 112 standards. CAA section 112 uses the concept of "best controlled" or "best performing" unit in defining the level of stringency that CAA section 112 standards must meet. Applying the concept of "best controlled" or "best performing" to a unit that is malfunctioning presents significant difficulties, as malfunctions are sudden and unexpected events. Accounting for malfunctions would be difficult, if not impossible, given the myriad different types of malfunctions that can occur across all sources in the source category and given the difficulties associated with predicting or accounting for the frequency, degree, and duration of various malfunctions that might occur. Setting work practice standards under CAA section 112(h) for malfunctions  -  as opposed to startup or shutdown periods  -  presents the same issues as setting numerical emission limits given the varied nature of malfunctions.
      The decision to use a work practice standard is wholly within the discretion of EPA. CAA section 112(h) ("[T]he Administrator may, in lieu [of a numeric standard], promulgate a design, equipment, work practice, or operational standard, or combination thereof."). In exercising the option to establish a work practice standard, that standard must "in the Administrator's judgment [be] consistent with the provisions of subsection (d) or (f)." CAA section 112(h)(1) (emphasis added). These subsections make clear that EPA is to base emission standards on the emission levels already achieved by the best performing sources and to ensure that public health is protected, as applicable. This means that work practice standards, although written in non-numeric form, must still satisfy statutory requirements such as those applicable to MACT standards, including the requirement to be no less stringent than the MACT floor.
      It is just as difficult to establish a work practice standard for malfunctions that can approximate the level of emission reduction achieved by the best performing sources during malfunctions as it would be to factor emission levels that occur during malfunctions into the numeric standards, as discussed above. EPA would have to design a single work practice standard that applies equally to a tank explosion as it does to innumerable types of operator error, computer glitches or a myriad of other unknown events, or alternatively create innumerable work practice standards.
      The commenter's generic suggestion to create a work practice standard that merely directs sources to have plans to respond to malfunctions and expeditiously return to compliant operating conditions does not present a viable solution. The commenter has not provided any evidence that a mere requirement to have such a plan is consistent with EPA's obligation under section 112(h) to establish a work practice standard only if, in the Administrator's judgment, it is consistent with section 112(d) including the MACT floor requirement. In sum, EPA believes that based on this rulemaking record it would be clearly inappropriate to set a work practice standard for malfunctions in lieu of the otherwise applicable numerical emission limit.  We also note that we would consider any response to violations caused by a malfunction on a case-by-case basis through the exercise of enforcement discretion.

      Comment 3.4: Commenter 63 states that the past history of the SSM exemption and compliance problems for the source category demonstrates a need for strong and more frequent monitoring, testing, and reporting requirements and enforcement provisions. The commenter declares that the EPA must implement enforcement provisions that prevent and remedy emission spikes, malfunctions, and other violations in a way that will be enforceable by citizens in the Title V permits for this source category. The commenter further states that the EPA should review the proposed monitoring requirements and ensure they are stringent enough to enable easy assessment of whether a facility is in full compliance with the standards within a short period of time of any violation.
      Response 3.4: We believe that the removal of the SSM exemption will reduce compliance problems that may have been associated with the exemption and excess emission spikes, as facilities have an incentive to avoid the related violations and penalties, without the need to institute more frequent monitoring, testing, and reporting requirements. We further believe that the monitoring requirements included in these rules are sufficient to ensure compliance with the standards regardless of whether or when a violation occurs. Under the provisions of 40 CFR 63.15, the public can request access to reports submitted to the regulatory agency whenever they choose, with the exception of information protected through 40 CFR part 2 (e.g., confidential business information). In addition, as discussed in section 4.0 below, we are promulgating requirements for electronic reporting of emissions test data that will improve public access to emissions information.

      Comment 3.5: Commenter 63 states that additional requirements are needed for times of malfunctions, including requirements for automatic shut-off of malfunctioning equipment, requirements to assign responsibility to the plant manager or high-up staff member which allows only that person to restart the equipment, and requirements that corrective actions be taken immediately. The commenter also states that for a facility that has had one or more malfunction, exceedance, or other violation in the prior month, the facility must obtain written authorization from the EPA to restart the equipment, and the EPA should only authorize the restart after making a public determination that the facility has instituted the corrective measures the EPA requires. The commenter further asserts that for a facility with more than 4 exceedances or malfunctions in the same quarter, the EPA must require automatic shutdown of the operation for a period of time to conduct and publish a full investigation and ensure correction of the problem(s).
      Response 3.5: We disagree with the commenter that the suggested additional requirements regarding malfunctions or violations are necessary. The EPA believes that the monitoring requirements of the final rule are sufficient to ensure compliance with the emission standards, and that it is not necessary to prescribe when or who may restart equipment that has malfunctioned.

      Comment 3.6: Commenter 63 supports EPA's proposal to require specific public reporting of malfunctions, but expresses concern that EPA proposes to require malfunction reporting as part of a periodic compliance report. The commenter states that the EPA should require safety-related reports and notification much sooner to protect populations living near the facility. Specifically, the commenter declares that the EPA must require telephone reporting by the facility 24 hours of a malfunction or exceedance and make a notice available publicly through the EPA's website and through ECHO within 24 hours. The commenter also asserts that within 24 hours of receiving this notification, the EPA should provide this information to the appropriate EPA Regional Office and direct the Regional Office to notify the local community of the event on the Internet, direct communication, and through all available means. The commenter states that the EPA should further require the facility to provide notification to the community through an appropriate public forum, including the company website, written notice to the local municipality and local school district, and press release to the local newspaper, radio and TV news station, within 24 hours, that contains any information community members may need to try to protect themselves and their families from the additional air pollution. The commenter further declares a written report should be required within 7 days and distributed to the public using the same distribution method as the earlier notification and that this report should include the nature of the event, the duration of the event, estimate of emissions released during the event, and a description and time of corrective actions taken and planned to be taken.
      Response 3.6: As noted by the commenter, the final rule requires malfunction recordkeeping and reporting, including for each failure to meet a standard, the date, time, and duration, a list of the affected sources or equipment, an estimate of the volume of each regulated pollutant emitted over the standard, a description of the method used to estimate such emissions, and actions taken to minimize emissions and any corrective actions taken. Any reports submitted to the EPA are publicly available subject to the requirements of CAA section 114(c).  We do not agree with the commenter that the suggested additional notification and reporting requirements are necessary, as they would be duplicative of the immediate notification requirements of SARA/CERCLA/EPCRA, would be burdensome for both facilities and agencies to review, and would not enhance compliance beyond that of the requirements in the rule for reporting violations of emission limits.

      Comment 3.7: Commenter 63 states that the EPA is legally required to remove all unlawful exemptions from the emission standards that have previously existed for startup, shutdown, and malfunction (SSM) periods, and not to set any new such exemptions. The commenter claims that equipment leaks are a kind of equipment malfunction and that EPA may not authorize any such leaks, because to do so would be in violation of CAA section 302(k) and D.C. Circuit precedent in the Sierra Club v. EPA decision. The commenter also stated that EPA's proposal to not update the leak detection and repair (LDAR) requirements is an unlawful authorization of a malfunction exemption.
      Response 3.7: We disagree with the commenter's claim that the types of equipment leaks addressed in the OSWRO NESHAP are "malfunctions." Equipment leaks typically occur from equipment such as pumps, compressors, agitators, pressure relief devices, sampling collection systems, open-ended valves or lines, valves, and connectors. 40 CFR 63.691; See also 61 FR 34147 (July 1, 1996). At the time we developed the MACT standards for this source category, we recognized that these emission points regularly emit small quantities of HAP, and we promulgated standards regulating equipment leaks from these components at 40 CFR 63.691. These provisions require OSWRO facilities to monitor for leaks and to repair any detected leaks. These requirements do not establish any exemption, and the commenter's suggestion that leaks are "exempt" from regulation or that they are "authorized" is not supported. While any specific equipment leak is not predictable, the types of equipment leaks addressed by the regulations at 40 CFR 63.691 are fairly routine emissions from sources and are not the type of unpredictable or infrequent event for which we cannot anticipate when, where or how they may occur and that we generally consider to be malfunctions.
4.0	Electronic Reporting Requirements
      Comment 4.1: Commenter 58 states that the EPA should address technical issues with the Electronic Reporting Tool (ERT) before requiring submittal of performance test information using the ERT. Based on their experience, the commenter provided examples of technical issues with the ERT primarily related to the need to submit "default/fake" data in order to make the system work.
      Response 4.1: We thank the commenter for the input about situations in which the ERT may require some revisions and the commenter's experience working with EPA contacts regarding data submission. We believe the benefits of the system articulated in the proposal preamble outweigh the minor technical issues that may arise during its use, and that a delay in the implementation of the system for these issues is not warranted. We note that we are working to continually update and improve the system to address technical issues such as those noted by the commenter.

      Comment 4.2: Commenter 61 comments that the proposal to require the use of the ERT is not appropriate as the costs and burdens imposed cannot yet be determined. Also, the regulated community cannot fully comment on the cost of duplicating reports using the ERT for Method 18 and other methods not currently supported by the ERT. The commenter states that the EPA should ensure the ERT includes the ability to accommodate all of the required test data, including Method 18, which can be quite voluminous.
      Response 4.2: The rule only requires that test methods supported by the ERT be reported using the ERT. The EPA believes that the costs and burdens of using the ERT are not significant for several reasons. The electronic reporting requirement does not add any additional testing and it does not change the timing of when test reports are due: the requirement only states that reports be submitted electronically. The ERT is fully functional, has been used successfully by industry for several years, was designed to capture all of the information which is submitted in a typical test report, and was also designed with input from States and the stack testing industry.

      Comment 4.3: Commenter 61 notes that without a formal notice that changes are being made to the ERT, facilities are at risk of noncompliance with the ERT requirements because they have no way to know which test methods must be submitted to ERT unless they actively monitor the EPA's web site.