National Emission Standards for Hazardous Air Pollutant 

Emissions: Group I Polymers and Resins; Marine Tank Vessel

Loading Operations; Pharmaceuticals Production; and The Printing 

and Publishing Industry 

Summary of Public Comments and Responses
Draft-Do Not Cite or Quote March 28, 2011

ii

(This page is intentionally left blank)
Draft-Do Not Cite or Quote March 28, 2011

iii

TABLE OF CONTENTS

1 Background.............................................................................................................................. 5

2 Summary of Public Comments................................................................................................ 9

2.1 Risk Assessment Data and Methodology......................................................................... 9

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

Risk Assessment............................................................................................................. 15

2.3 Consideration of Demographics in Risk Assessment..................................................... 17

2.4 Additional Standards to Address Risks.......................................................................... 19

2.5 Removal of the SSM Exemption.................................................................................... 20

2.6 Affirmative Defense Provisions..................................................................................... 22

2.7 Source Category Specific Comments............................................................................. 34

2.7.1 Source Category Specific Comment – Pharmaceuticals Production ...................... 34

2.7.2 Source Category Specific Comment – The Printing and Publishing Industry........ 35

2.7.3 Source Category Specific Comments – Group I Polymers and Resins.................. 36

2.7.4 Source Category Specific Comments -- Marine Tank Vessel Loading Operations 38

2.8 Other Comments............................................................................................................. 48
Draft-Do Not Cite or Quote March 28, 2011

iv

(This page is intentionally left blank)
Draft-Do Not Cite or Quote March 28, 2011 

5

1 Background

On October 21, 2010, the U.S. Environmental Protection Agency (EPA or 

Agency) proposed to revise the National Emission Standards for Hazardous Air 

Pollutants (NESHAP) for National Emission Standards for Hard and Decorative 

Chromium Electroplating and Chromium Anodizing Tanks; Group I Polymers and 

Resins; Marine Tank Vessel Loading Operations; Pharmaceuticals Production; The 

Printing and Publishing Industry; and Steel Pickling—HCl Process Facilities and

Hydrochloric Acid Regeneration Plants, under the authority of section 112 of the Clean 

Air Act (CAA). Four of the six MACT included in the proposal are addressed in this 

final action: Group I Polymers and Resins; Marine Tank Vessel Loading Operations; 

Pharmaceuticals Production; and The Printing and Publishing Industry. We summarized 

and responded to numerous comments in the preamble to our final action. This document 

presents summaries of the additional comments that were submitted and our responses to 

those comments. The comments to which we are responding were submitted in 104

letters from industry representatives, governmental entities, environmental advocacy

groups, and citizens during the public comment period. A list of the commenters, their 

affiliations, and the EPA docket number assigned to their correspondence is presented in 

Table 1-1. The comment summaries and responses for the other two MACT rules

included in the October 2010 proposal - Hard and Decorative Chromium Electroplating 

and Chromium Anodizing Tanks and the Steel Pickling—HCl Process Facilities and

Hydrochloric Acid Regeneration Plants - will be included in a separate response to 

comments document made available at the time we take final action on those two source 

categories. 
Draft-Do Not Cite or Quote March 28, 2011 

6

TABLE 1-1. LIST OF COMMENTERS ON PROPOSED NATIONAL EMISSIONS 

STANDARDS FOR HAZARDOUS AIR POLLUTANTS 

Docket Number a b Commenter and Affiliation

256, 265 Robert J. Morehouse, ExxonMobil Refining & 

Supply Company

257, 262 James L. McGraw, Managing Director & 

CEO, International Institute of Synthetic 

Rubber Producers, Inc (IISRP)

258, 359 Matthew Todd, American Petroleum Institute 

(API)

259 James R. Thorton, Sector Director, 

Environmental, Health, and Safety, Northrop 

Grumman Shipbuilding, Inc. (NGSB)

260 Donald R. Schregardus, Deputy Assistant 

Secretary of the Navy, Department of the 

Navy

261 Jeffrey K. Francer, Assistant General Counsel, 

Pharmaceutical Research and Manufacturers 

of America (PhRMA)

263 Ram Singhal, VP Technology and 

Environmental Strategy, Flexible Packaging 

Association (FPA)

264 Russell Wozniak, EH&S Global Regulatory

Affairs, The Dow Chemical Company

272 John Paul, Administrator, Regional Air 

Pollution Control Agency (RAPCA)

273 Melvin Keener, Executive Director, Coalition 

for Responsible Waste Incineration (CRWI)

274 David J. Shaw, Director, Division of Air 

Resources, New York State Department of 

Environmental Conservation
Draft-Do Not Cite or Quote March 28, 2011 

7

275 Vinson Hellwig and Robert Colby, Co-Chairs, 

National Association of Clean Air Agencies 

(NACAA)

276 Kyle Beall, Kean Miller on behalf of the 

Louisiana Chemical Association (LCA)

278 Sheila Holman, North Carolina Department of 

Environment and Natural Resources, Division 

of Air Quality (NCDAQ)

279 Lorraine Krupa Gershman, Director, American 

Chemistry Council (ACC)

280 Christopher S. Colman, Counsel, HOVENSA

281 Christina Harris, Kinder Morgan Liquids 

Terminals LLC

283,301 Jennifer Carpenter, The American Waterways 

Operators

284 NEDA/CAP

286 Peter Pagano, Vice President, Environment, 

American Iron and Steel Institute,

287 Matt Todd, Chair, The Residual Risk Coalition

288 John Dege, Leader – Air Competency, DuPont

289 SSM Coalition

290 Earthjustice, Sierra Club, California 

Communities Against Toxics, Natural 

Resource Defense Council

291 Shannon Broome, Executive Director, Air 

Permitting Forum

293 Robert Barlow, VP of Manufacturing and 

Operations, Zeon Chemicals, L.P.

294 Jim Wilson, Vice President and Chief Legal 

Counsel, Legal and Environmental Services, 
Draft-Do Not Cite or Quote March 28, 2011 

8

Roche Colorado Corporation

295 Eric Hiser, Counsel, Nucor Corporation

297 Jesse N. Marquez, Executive Director, 

Coalition For A Safe Environment

298 Linda Farrington, Eli Lilly

300 Marise Lada Textor, Corporate DirectorRegulatory Affairs, TPC Group (formerly 

Texas Petrochemicals LLC)

270, 302-349, 351-358 Comment Campaign Organized by

EarthJustice, includes submissions from: 

Christopher Lish, Alison Leary, Theophilus 

Griswold, Richard Miller, Laura Jobe, Craig 

Leman, Kathy Shimata, Virginia Harris, Diane 

Aikins, Takeshi Imajo, Alyssa Kay, Bob 

Browning, Gloria Sferra, Katherine Russell, 

John Gau, N. Gladfelter, Peggy La Point, 

Chris Dietrich, Elizabeth Zenker, Matthew 

Reid, Charles Schmalz, Sue Chickman, Salam 

Tims, Robert Bixby, Charlene Woodcock, 

Michael Nola, Ralph Philbrick, Lawrence

Thompson, Hugh Curtler III, Steve and 

Deborah Anthes, Kimberly Rowlett, Sarah 

McKee, David Johnson, C. Morey Jr., George 

and Frances Alderson, Ze Daluz, Jean 

Mortensen, Nancy Brothers, Julie Robinson, 

Duke Briscoe, Ron Rodarte, Jill Harmer, 

Rebecca Ruggles

a Document ID identifies comments found in Docket No. EPA-HQ-OAR-2010-0600 by 

document number.

b Documents submitted to the docket together appear in the docket as multiple documents 

with the same 4-digit "root number" followed by a unique extension. For example, 

comments received via email are generally assigned two numbers. First, the email message 

itself is assigned the root number (e.g., 0019). Second, the attachment comment document 

is assigned an extended number based on the root number (e.g., 0019.1). Additional 

attachments, if any, would follow the same pattern (e.g., 0019.2, 0019.3, etc.). For the 

purposes of this table and comment summary, we listed all related documents under the 

root number but only included the last three digits (e.g., 0200 would be 200). 
Draft-Do Not Cite or Quote March 28, 2011 

9

2 Summary of Public Comments

A total of 104 written comments were received on the proposed standards for the

Group I Polymers and Resins; Marine Tank Vessel Loading Operations; Pharmaceuticals

Production; and The Printing and Publishing Industry NESHAP. Some of these 

comments were part of a mass comment campaign sponsored by Earthjustice. The 

comment reflects some of the same comments as those provided by Earthjustice, 

commenter 290. The following comments were part of the mass campaign: 270, 302-

349, 351-358. Although we did not identify the mass campaign commenters in the 

comment summaries, we responded to each of their comments with the exception of 

comments specifically regarding the chromium electroplating source categories.

Responses to comments specifically regarding the Hard and Decorative Chromium

Electroplating and Chromium Anodizing Tanks NESHAP and the Steel Pickling—HCl 

Process Facilities and Hydrochloric Acid Regeneration Plants NESHAP will be presented 

in a subsequent final rulemaking.

The following sections provide a summary of these comments, as well as the 

Agency’s responses to these comments. For the purpose of orderly presentation, the 

comments have been categorized under the following topics:

• Risk Assessment Data and Methodology

• Consideration of Risks from Entire Facilities, Industrial Clusters, and Other 

Sources in Risk Assessment

• Consideration of Demographics in Risk Assessment

• Additional Standards to Address Risks

• EPA’s Authority Under and Approach to the CAA 112(d)(6) Technology Review

• Removal of the Startup, Shutdown, and Malfunction Exemption

• Affirmative Defense Provisions

• Source Category Specific Comments-

• Pharmaceuticals Production

• Printing and Publishing Industry

• Group I Polymers and Resins

• Marine Tank Vessel Loading Operations (MTVLO)

2.1 Risk Assessment Data and Methodology

Comment 1: Commenters 274 and 275 believe the population cancer risk metrics 

are one of the most transparent ways to make risk management decisions concerning 

acceptability and ample margin of safety determinations under CAA section 112(f). In 

line with EPA’s goals, these commenters and commenter 297 would like to see cancer 

risk from HAPs reduced to below the 1-in-1 million risk level for the majority of the 

population that resides near a facility if it is technologically feasible. Commenter 297 

stated that EJ communities do not accept a risk higher than 1-in-1 million. This 

commenter also noted that risk to EJ communities already exceeds 1-in-1 million at the 

Port of Los Angeles, Port of Long Beach, and at each major petroleum refinery in and 
Draft-Do Not Cite or Quote March 28, 2011 

10

around Wilmington. The commenters believe strengthening the protections for HAP 

sources is essential to demonstrate EPA’s commitment to seeking environmental justice 

for communities overburdened by toxic pollution. In contrast,

Response 1: As stated in the Benzene NESHAP, in determining the need for 

residual risk standards, we strive to limit to no higher than approximately 1-in-10 

thousand the estimated risk that a person living near a plant would have if he or she were 

exposed to the maximum pollutant concentrations for 70 years and, in the ample margin 

of safety decision, to protect the greatest number of persons possible to an individual

lifetime risk level of no higher than approximately 1-in-1 million. However, in 

determining whether to require additional standards, these levels are not considered 

rigid lines, and we weigh the cancer risk values with a series of other health measures 

and factors in both the decision regarding risk acceptability and in the ample margin of 

safety determination. If we determine that the risk is unacceptable, we must impose 

additional requirements to reduce emissions without consideration of cost. However, as 

part of our determination of whether standards protect public health with an ample 

margin of safety, we do not look solely at whether technology is “feasible,” (as urged by 

the commenter) but also consider cost. We also consider cost as part of technology 

review under section 112(d)(6), which we are required to perform periodically. 

Comment 2: Commenters 272, 274 and 275 note that EPA has problems with its 

risk assessments in that it lacks current actual emissions data. As such, the commenters

recommend that periodic emissions testing be included in any MACT standard that 

requires the installation of control equipment and initial emissions testing for compliance 

demonstration purposes. Commenter 272 notes this data would provide greater assurance 

for the public and regulatory community that sources are complying with emission limits 

on an on-going basis. The commenters further note it is often difficult for state or local 

agencies to impose requirements like this if it is not an explicit requirement of the federal 

rule. The commenters say the effect of this is that EPA does not receive information it 

needs voluntarily from these agencies to conduct risk assessments.

Commenter 290 states that EPA should not rely solely on industry-reported, 

unverified emissions data in its residual risk review, which the commenter states, 

includes some of the data in the NEI. The commenter states that where there are 

uncertainties or gaps in the data, EPA needs to complete the section 114 information 

collection process. Commenter 297 stated that EPA has not conducted a detailed 

technical review of HAP emissions data for these source categories and facilities. 

Commenter 297 stated that EPA has failed to validate the marine terminal self 

reported annual emissions used to establish the proposed rule. The commenter requests 

that independent third-party emissions testing be performed at all U.S. marine terminals 

to validate annual emissions reporting and to validate that the proposed rule is adequate 

to protect public health.

Response 2: The data for the four MACT rules were derived from the National 

Emission Inventory (NEI) and directly from industry and states. The source of the data is

documented in the docket. The EPA has greatly improved the NEI for HAPs since the 

1996 NEI. We have worked diligently with state and local agencies and tribes to improve 

their emission inventories over the years and we have instituted a number of QA 

measures to improve data received from state and local agencies since 1996. The 2005 
Draft-Do Not Cite or Quote March 28, 2011 

11

NEI underwent a number of QA steps that were not used in the 1996 NEI. 

Documentation for the 2005 NEI point source emissions inventory is available on EPA's 

CHIEF website, http://www.epa.gov/ttn/chief/net/2005inventory.html. Quality assurance 

and augmentation procedures used for the 2005 NEI point sources are contained in the 

report, EI Quality Assurance and Data Augmentation for Point Sources, posted at: 

http://www.epa.gov/ttn/chief/net/2002inventory.html. The 2005 NEI data have been 

reviewed extensively internally and externally during a 9 month effort as part of the 

development of the 2005 National Air Toxics Assessment (NATA). As part of the 2005 

NATA review, more than one million records for HAPs were revised.

For RTR categories, EPA’s review included an evaluation of 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 

emissions levels typically seen. The EPA often had additional information on the source 

category, and where better data were available, this information was included in the 

proposal datasets. Section IV.A.1 of the October 21, 2010 proposal preamble 

(75FR65068) sets forth a detailed explanation of the review that EPA performed on the 

emissions data for the source categories subject to this final rule.

In addition, as part of the October 21, 2010 proposal, we placed the data sets for 

review using a RTR data review tool in the docket and solicited comments on the data 

sets in the preamble to the proposal. The RTR review of the proposal data sets act as 

another external third party review mechanism in addition to the external 2005 NATA 

review of the RTR data sets. Several opportunities have been provided to review the data 

used in the current proposal during the last 3 years. Through enhanced NEI QA 

procedures, 2005 NATA review, public comment on proposal files, source categoryspecific engineering reviews, and modeling, improvements to the data files have been 

made. We believe that EPA has provided multiple opportunities for third party review of 

data

With regard to the commenters recommendation that periodic emissions testing 

be included in any MACT standard that requires the installation of control equipment 

and initial emissions testing for compliance demonstration purposes, we note that we are 

also requiring the electronic submittal of performance test data to increase the ease and 

efficiency of data submittal and to improve data accessibility. Specifically, owners and 

operators are required to submit electronic copies of applicable reports of performance 

tests to EPA’s WebFIRE database through an electronic emissions test report structure 

called the Electronic Reporting Tool (ERT). Having these data, EPA would be able to 

develop improved emission factors, make fewer information requests, and promulgate 

better regulations.

Comment 3: Commenter 287 stated that EPA cannot lawfully use MACT 

allowable emissions in the proposed risk assessments because the Agency failed to 

provide adequate explanation for the use of these data. This commenter and commenters 

265 and 359 state that considering the conservative assumptions already included in the 

risk assessments, adding another layer of conservatism is unneeded, and actual emission 

should be used. Commenter 265 notes that potential emissions overstate emissions and 

risk because facilities do not operate at the level of their potential emissions in order to 

maintain a compliance margin. This commenter also states that considering allowable 
Draft-Do Not Cite or Quote March 28, 2011 

12

emissions dilutes the more important health measures already examined, which more 

directly assess risk from the regulated source category. Commenter 287 states that EPA 

has also provided no data or analysis to indicate that the use of actual emissions results in 

negative bias or that affected sources actually do emit at levels significantly higher than 

the actual data show for a significant period of time. The commenter states that failure to 

provide a reasoned explanation for the approach or evidence supporting the use of MACT 

allowable emissions renders the proposal insupportable under the law. Commenter 276 

also requests that risks assessments be based on source category actual emissions. 

In contrast, commenter 275 stated, as it has in the past, that the Agency should 

consider risk based on potential or allowable emissions because emissions and associated 

impacts could increase over time, and analyses based on actual emissions underestimate 

residual risk. This commenter noted 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 argued that limiting the scope of risk assessments to 

actual emissions would be inconsistent with the applicability sections of the MACT 

standards. While acknowledging that EPA has relied less on actual emissions than it has 

in the past, the commenter would like to see more reliance on the use of allowable 

emissions.

Response 3: We have discussed the use of both allowable and actual emissions 

in previous actions, including the final Coke Oven Batteries residual risk rule (70 FR 

19998-19999, April 15, 2005) and in the proposed and final Hazardous Organic 

NESHAP (HON) residual risk rules (71 FR 34428, June 14, 2006, and 71 FR 76603, 

December 21, 2006, respectively). In those previous actions, we noted that modeling the 

allowable levels of emissions (i.e., the highest emission levels that could be emitted while 

still complying with the NESHAP requirements) is inherently reasonable since they 

reflect the maximum level sources could emit and still comply with national emission 

standards. But we also explained that it is reasonable to consider actual emissions, 

where such data are available, in both steps of the risk analysis, in accordance with the 

Benzene NESHAP. We also note that our use of allowable emissions levels in the risk 

assessments in this rulemaking did not result in revising the previously established 

standards due to risk concerns.

Comment 4 Commenter 290 states that EPA should include emissions from 

malfunctions in its risk assessments for the source categories at issue in this final rule. 

The commenter references information that suggests emissions during upsets dwarf 

emissions from normal operations. The commenter also states that EPA should include 

emissions information that occur during periods of violation of the MACT standard in the 

risk assessment using actual or estimated data and account for variability in actual 

emission levels.

Response 4: We believe SSM events do not contribute significantly to cancer or 

chronic noncancer risks for the source categories in this rulemaking because SSM events 

are inherently short-term and infrequent relative to annual operations and emissions. The 

commenter did not supply any data to the contrary. 

Comment 5: Commenter 297 requests that EPA identify, quantify, assess and 

mitigate all public health and environmental impacts from HAPs, including impacts from 
Draft-Do Not Cite or Quote March 28, 2011 

13

dermal absorption, aerial deposition onto land and water, and climate change. The 

commenter also stated that EPA’s risk assessment fails to assess bioaccumulative toxins.

Response 5: In our risk assessments, dermal absorption and aerial deposition 

onto land and water are considered for any HAP that are known to be persistent and bioaccumulative in the environment. More information on the approach used for these 

source categories can be found in the residual risk documentation in the docket for this 

action. 

Comment 6: Commenter 297 stated that the EPA has not considered the 

incidence (the number of people estimated to suffer cancer or other health effects due to 

exposure to a pollutant) because it has not conducted a health impact assessment, public 

health survey, or established a public health baseline, so EPA does not know the number 

of people impacted. The commenter requested that EPA conduct these studies to 

determine the impact of its proposed rulemaking.

Response 6: In our risk assessments, we do estimate the incidence of cancer and 

non-cancer health effects and have considered these factors in our decisions regarding 

the need for additional standards to address residual risk. More information about the 

estimated incidence of health effects can be found in the residual risk documentation in 

the docket for this action.

Comment 7: One commenter, 297, stated that the risk factors stated are not 

accurate because they are based on statewide or national averaging and not the actual 

impacts. The commenter noted that risks based on average in an area 50 km from any

source is not acceptable when 90%+ of the impacts occur less than 5 km from the source.

Response 7: The commenter is misinterpreting the risk results. In the risk 

assessments, HAP concentrations and associated risks are estimated at the centroid of 

every census block from the facility fenceline out to a distance of 50 km. This includes all 

areas within 5 km from the facilities. In addition, the results are not averaged over the 

area of the nation or a state, but are estimates of risk precisely at the locations of the 

census block centroids around the facilities. More information about the method of 

modeling and estimating risks can be found in the residual risk documentation in the 

docket for this action. 

Comment 8: Commenter 290 states that EPA should not consider a non-cancer 

TOSHI of 1.0 as an acceptable threshold for a single source category. This approach will 

not limit the TOSHI to 1.0 or less for a whole facility when a facility has multiple source 

categories. The commenter is also unsure why the EPA has chosen to put the threshold at 

1.0 when it considered it to be 0.2 for a single source category in the past.

Response 8: The EPA has not used a TOSHI value of 0.2 as a default upper limit 

for acceptable chronic noncancer risk in RTR rule making. In determining whether to 

require additional standards, non-cancer risks are considered in addition to cancer risks 

and other health measures and factors. A TOSHI of 1.0 is not considered a rigid line for 

acceptability, and we weigh this value with other health measures and factors in both the 

decision regarding risk acceptability and in the ample margin of safety determination. In 

regards to facility-wide risk, if a source category contributes significantly to elevated 

facility-wide non-cancer risks, we may consider whether additional standards should be 
Draft-Do Not Cite or Quote March 28, 2011 

14

required to reduce those risks; however, that situation was not presented for any of the 

source categories in the October 2010 proposal. 

Comment 9: Commenter 291 states that EPA should undertake supplemental 

analyses for all the source categories addressed in the proposal to inform decision makers 

and the public about the degree of the uncertainties in the risk estimates. The commenter 

states it appears EPA performs this type of analysis only when estimated risks for a 

source category approach the upper range of acceptable risks, for the chromium 

electroplating source category in this instance. 

Response 9: As the commenter notes, we performed a supplemental analysis for 

the chromium electroplating source categories but not for the source categories subject 

to this rulemaking. By performing the supplemental analysis for the chromium 

electroplating source categories, we tried to present a more realistic picture of the risk, 

to understand the degree to which the risk might be overstated, and how much weight to 

attach to the conservative analysis in our decisions regarding risk acceptability and 

ample margin of safety. Although the type of chromium electroplating plants used in the 

NEI analysis is based on a variety of reliable sources, including ICR responses for the 

Plating and Polishing NESHAP, trade association data, data from State agencies, and 

information from websites, we were unable to identify the specific chromium 

electroplating plant type for nearly half of the data set. Such was not the case for the 

source categories subject to this rulemaking. Since the emissions data used for these 

source categories were considered to be of high confidence we did not need to perform a 

supplemental analysis. While the data used in the analysis for these source categories 

were the best actual emissions estimates available, the data used for the chromium 

categories contained estimates known to be highly conservative and that likely overstate 

emissions. 

Comment 10: We received comments both in favor of and objecting to the use 

of census block centroids in the analysis of chronic exposure and risk. Two commenters

(275 and 290) argued 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 concentrations at the fenceline and beyond and include risks to the 

maximally exposed individual. In contrast, other commenters felt the use of the census 

block centroids was appropriate for these source categories, and one commenter (265) 

added that using the fenceline as a location to estimate risk is inappropriate in risk 

assessment because people do not generally live at the fenceline, and this approach would 

overstate risk.

Response 10 As we have noted in the development of previous residual risk 

regulations, such as the HON, EPA contends that, 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, EPA asserts that 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 
Draft-Do Not Cite or Quote March 28, 2011 

15

developed by the US Census Bureau); each is typically comprised of approximately 40 

people or about 10 households. In 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 experiences 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 blocks in densely-populated areas, there is little 

uncertainty introduced by using the census block centroids. There is more uncertainty 

when census blocks are larger, although there is still no bias on average.

Comment 11: Commenters 265 and 276 state that EPA should include central 

tendency or most expected probability of risk to better communicate the conservative 

nature of the risk assessments.

Response 11: In most cases, quantitative dose-response estimates representing 

the upper-bound of risk are the only values available, and thus are the ones used in our 

assessments of risk. The upper-bound potency value that is presented in IRIS is routinely

characterized using the standards descriptor for the cancer potency (“upper

bound”), by saying that the upper bound is not likely to underestimate risks, that true 

risks are likely to be less, and that, for some individuals, risk may be zero. In addition, in 

our decisions regarding risk acceptability and ample margin of safety, we take into 

account the distribution of risks across the population and not just the maximally exposed 

individual.

2.2 Consideration of Risks from Entire Facilities, Industrial Clusters, 

and Other Sources in Risk Assessment

Comment 12: Commenter 290 states that EPA did not appropriately measure or 

address aggregate emissions and impacts from clustered or nearby sources in the same 

source category. The commenter suggests EPA perform a cluster analysis similar to that 

of the analysis it did for the synthetic organic chemical manufacturing industry (SOCMI) 

accounting for all facilities in the source category. The commenter states this is 

especially important for the chromium electroplating source categories which likely have 

several clusters of facilities.

Response 12: In our current risk modeling methodology, which has been 

updated since we performed the analyses for SOCMI, overlapping risks for the same 

source category are automatically included in determining the MIR, incidence, etc. Any 

risks from clusters of facilities in the source categories investigated were included in the 

reported results of the analysis for the source category. We will respond to rule-specific 

comments for the Hard and Decorative Chromium Electroplating and Chromium 

Anodizing Tanks NESHAP in the final rule for that NESHAP.

Comment1 13 Commenter 291states that considering facility-wide risks would 

constrain whole facilities to the ample margin of safety level established in the Benzene 
Draft-Do Not Cite or Quote March 28, 2011 

16

Rule decision framework for individual source categories. The commenter also states 

that it will be difficult for the EPA to reconcile aggregated risk results from different 

sources and that it is unlikely EPA would identify any better emission reduction 

opportunities than it would by conducting individual source category analyses. The 

commenter also states that EPA is correct in concluding that facility-wide and 

background risk levels are significantly more uncertain because the data relied on for 

those estimates are more uncertain. The commenter also states that NATA is too blunt 

and inexact to be used for this regulatory purpose, citing the NATA website: “The results 

cannot be used to identify exposures and risks for specific individuals, or even to identify

exposure and risks in small geographic regions such as a specific census block, i.e., 

hotspots.”

Response 13: We examined facility-wide risk to provide additional context to the 

source category risks. In May 2010, the SAB advised us “* * * that RTR assessments 

will be most useful to decision makers and communities if results are presented in the 

broader context of aggregate and cumulative risks, including background concentrations 

and contributions from other sources in the area.” The development of facility-wide risk 

estimates provides additional information about the potential cumulative risks in the 

vicinity of the RTR sources, as one means of informing potential risk-based decisions 

about the RTR source category or categories in question.. In developing facility-wide risk 

estimates, we do not use NATA-derived risk results at the census tract level; rather, we 

develop census block-level risk estimates using NATA-derived facility-wide emissions 

estimates. While we recognize that, because these risk estimates were derived from 

NATA facility-wide emissions estimates which have not generally been subjected to the 

same level of engineering review as the source category emission estimates, they may be 

less certain than our risk estimates for the source categories in question, they remain 

important for providing context, as long as their uncertainty is taken into consideration 

in the process. In the case of the source categories in this rulemaking package, the 

results did not affect the decisions in any way, even taking their uncertainties into 

consideration. We will continue to investigate the use of NATA-derived emissions as well 

as other emission data sources in developing future RTR assessments.

Comment 14: Commenters 274, 275, and 290 are pleased to see that EPA has 

examined facility-wide risks to put the risks posed by the source categories in context. 

However, commenters 274 and 275 would like more description provided about the colocated sources contributing to the facility-wide risks. Commenter 274 adds that a 

verification of the accuracy of other HAP-emitting operations should have been 

conducted in the assessments. Commenter 274 also stated that it is unclear how the 

NATA point source estimates were used in this portion of the assessment, and asks 

whether the maximum point of impact from the other HAP emitting sources were added 

to the results of the portion of the plant in the source category under investigation.

Response 14: When facility-wide risk estimates are significant and significantly 

larger than the source category risk estimates, we determine the key emission sources 

associated with that difference and describe them along with our plans to address them 

via regulation in the preamble. We may also perform additional QA on the facility-wide 

emissions in such cases. In the case of this rulemaking package, the results were not 

significant, and did not change any of the risk-based decisions, so additional follow-up 
Draft-Do Not Cite or Quote March 28, 2011 

17

was not needed or performed. When NATA-based emissions are used to develop facilitywide risk estimates, the dispersion modeling reflects the interaction of source category 

and facility-wide emissions according to the geographical layout of the emission sources 

and the dispersed plumes as a result of hourly windflow patterns; no artificial 

superimposition of plume maxima is performed as suggested by the commenter.

2.3 Consideration of Demographics in Risk Assessment

Comment 15: Commenter 291 supports EPA’s discussed approach to analyzing 

potential demographic risks in which the risks would be analyzed only for the population 

within 5 km expected to have risks greater than 1-in-1 million. The commenter states 

that EPA estimates the 5 km radius would include 90 percent of the population estimated 

to have risks greater than 1-in-1 million, and while EPA apparently plans to extend the 

radius to 50 km in future assessments, this should only be done if it does not reduce the 

accuracy of the resulting information, including the link between source category

emissions and the population at risk.

Response 15: As the commenter notes, we have included the population within a 

5-km radius of facilities in the demographic analyses for these source categories. If we 

determine in the future to broaden the analysis for future risk reviews, the commenters 

will have an opportunity to raise any concerns during the comment period on such 

proposed rules. 

Comment 16: Commenter 270 states that the current methodology that assesses 

health impacts for a theoretical, healthy adult is insufficient and unrealistic, since the real 

people exposed to toxic pollutants include children, the elderly, and other vulnerable 

populations. The commenter states that EPA has recognized new science that shows the 

impacts of pollution on these people are different from the assumptions in the conceptual 

standard EPA has employed in the past and should be considered in the final rule. The 

commenter further states that EPA’s lifetime exposure metric does not account for greater 

risk of harm during these times of life. The commenter also states that EPA must 

consider whether certain individuals or communities have disproportionate risks in its 

residual risk determinations. Commenter 297 noted that the assessment did not appear to 

take into account all sensitive receptors, such as pregnant women and people with 

preexisting health conditions, or account for EJ community factors such as availability of 

public health facilities, paramedic response availability, the population with little or no 

health care insurance, the population with little disposable income for health care, and the 

inability due to low income to relocate to cleaner communities. This commenter added 

that EJ community residents are predominantly people of color who have more children 

and infants per population than white communities.

Response 16: The health benchmark values used in the acute and chronic noncancer analysis specifically take into consideration susceptible individuals, and because 

the benchmark values used in the chronic cancer assessment are upper-bound estimates 

of increased cancer risk, they effectively consider sensitive subgroups as well. While 

some people that are exposed to HAP may face factors that make it difficult to obtain 

treatment for illnesses, the scope of these risk assessments is only to estimate the 
Draft-Do Not Cite or Quote March 28, 2011 

18

probability of an adverse effect related to exposure, and possible treatment or relocation 

difficulty is beyond the scope of these analyses. 

Comment 17: Commenter 297 stated that the EPA failed to identify and assess 

the cumulative sources of HAPs and impacts in EJ communities. The commenter was 

also unable to find the EPA’s cumulative impact data to determine if all sources had been 

identified and considered, such as co-located facilities, major, and non-major sources, 

and also noted that EPA has never conducted any long term study of multiple HAP 

exposure public health impacts. The commenter requests that EPA determine the actual 

risks of exposure to HAPs for 70 years or more in EJ communities considering these 

factors.

Response 17: As explained in the risk assessment documents and source 

category data files in the docket for this action, we do consider many of the things the 

commenter is concerned about in our assessments. For one, we estimate risks based on 

exposure to HAP emitted from sources within the source category under review for 70 

years in all areas within 50 km of the facilities, regardless of community type or 

demographic distribution of the population. We estimate risks for all the sources in a 

source category together, including any overlap in exposure to emissions from more than 

one facility within the source category. We also examined facility-wide risks in the 

assessments for these source categories. We appreciate that the commenter would prefer 

an even more comprehensive analysis of risk; however, such a review goes beyond that 

mandated under the CAA and we currently lack sufficient data to perform reviews of total 

HAP exposure and risk to populations. EPA does not have the resources to perform such 

a study, as urged by the commenter. 

Comment 18: Commenter 275 commends EPA for considering environmental 

justice issues in this proposal but believes improvements in the analysis are needed. This 

commenter and commenter 274 are unsure why other factors recommended by the EPA 

as presented in the Environmental Justice Strategic Enforcement Assessment Tool 

(EJSEAT) were not considered in the RTR assessment. The commenters note that the 

OTIS database appears to do this already at the facility-specific level and could be 

incorporated into the assessment to more accurately define the number of individuals 

impacted by the emissions and the demographics of the impacted community. 

Response 18: While the EJSEAT and OTIS database are general tools that can 

be used in considering environmental justice issues, the demographic analyses we 

performed for the proposal was superior for purposes of this rulemaking because they 

were more specific to these particular source categories. We 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 19: Commenter 291 states that EPA should not consider 

demographics in its regulatory decisions unless there is evidence that a demographic 

category, or sensitive subpopulation, is more vulnerable to the specific health effects 

caused by the source category beyond mere proximity to the facility. This commenter 

adds that EPA cannot assume that race, income, age, or education is a surrogate for a 

sensitive subpopulation without supporting health evidence. The commenter states that 
Draft-Do Not Cite or Quote March 28, 2011 

19

because EPA failed to produce such evidence for this proposal, it cannot consider race, 

income, age, or education in its regulatory decisions.

Response 19: As stated in the Benzene NESHAP, in determining the need for 

residual risk standards, we strive to limit to no higher than approximately 1-in-10 

thousand (100 in a million) the estimated cancer risk that a person living near a plant 

would have if he or she were exposed to the maximum pollutant concentrations for 70 

years and, in the ample of safety decision, to protect the greatest number of persons 

possible to an individual lifetime risk level of no higher than approximately 1-in-1 

million. These considerations are made for all people regardless of racial or 

socioeconomic status. However, in determining whether to require additional standards, 

these levels are not considered rigid lines, and we weigh the cancer risk values with a 

series of other health measures and factors in both the decision regarding risk 

acceptability and in the ample margin of safety determination. We also consider cost of 

controls in the ample margin of safety determination. While we analyzed the 

demographic makeup of the at-risk populations surrounding the facilities with source 

categories addressed by this rule making and found slightly higher minority populations 

in some cases, we ultimately reaffirmed our initial findings that the risks from each 

source category were acceptable and protected public health with an ample margin of 

safety. Thus, the results of our demographic analyses only served to inform the public 

about the demographic makeup of the populations exposed to each of these source 

categories.

2.4 Additional Standards to Address Risks

Comment 20: Commenter 265 states that EPA should include a low-risk exclusion 

for facilities that are low risk, which do not require additional regulation, when making 

residual risk rules. The rules should include a site-specific determination similar to the 

applicability determinations for other rules. The facility would determine initial 

applicability and later review applicability through a management-of-change process 

related to capital investments and operations changes, and no on-going permitting or 

reporting requirements would apply if the rule is not applicable. The commenter suggests 

the following for this low-risk applicability determination

 Facilities would use any scientifically accepted, peer-reviewed risk assessment 

methodology.

 The applicability threshold would be set at either a risk level that reflects an 

ample margin of safety or at a cancer risk less than or equal to 1-in-1 million and 

a hazard index of less than or equal to 1.

 A notation would be included in the Title V permit or Title V permit application 

that the residual risk standards are not applicable to the facility if it is low-risk.

 Applicability determinations would be available for review by regulatory

authorities but would not require a regulatory approval process, which would be 

burdensome and unwarranted. 

 Facilities would have the on-going obligation to reassess applicability when 

facility changes could potentially impact rule applicability.
Draft-Do Not Cite or Quote March 28, 2011 

20

 Applicability reassessment would not be required for changes outside the facility

or from formal rulemaking processes, such as changes in population and census 

track data, changes in health benchmarks, improvements and changes in 

dispersion models.

 The analysis and modeling would be consistent with the health concerns in the 

source category, for example, if cancer is the concern, modeling for acute effects 

would not be required.

 If EPA determines there are no adverse environmental risks for a source category, 

there would not be a requirement to demonstrate no adverse environmental risks.

 The applicability determination would be completed before the first major 

compliance date after the rule.

Response 20: No new requirements are included in the final rules for these

source categories to address or reduce residual risk, so these comments are not 

germane. To the extent the commenter has concerns with actions taken in future 

residual risk reviews, those concerns should be raised at that time.

Comment 21: Commenter 265 states that in calculating cost effectiveness, EPA 

should evaluate costs on a risk reduction basis rather than a cost per ton of HAP reduced 

basis, which would tie in better with the goals of the residual risk program.

Response 21: Our residual risk decisions are based on the approach in the 1989 

benzene decision framework. In that decision, we stated that the level of the MIR, 

distribution of risk in exposed population, incidence, science policy assumptions, and 

uncertainties associated with risk measures, and weight of evidence that a pollutant is 

harmful to health are all important factors which may be considered in the acceptability 

judgment (first step). In the second step, we again consider all of the health risk and 

other health information considered in the first step. Beyond that information, additional 

factors relating to the appropriate level of control will also be considered, including 

costs and economic impacts of controls, technological feasibility, uncertainties, and any 

other relevant factors. As part of the ample margin of safety analysis, we examined HAP 

emissions control options, the emissions and risk reductions that would be realized with 

those controls, and the costs associated with the controls. This information was 

presented in the October 10, 2008 RTR proposal (73 FR 60432) for the Group I Polymers 

and Resins, Marine Tank Vessel Loading Operations, Pharmaceuticals Production, and 

the Printing and Publishing MACT standards. While the cost effectiveness information 

was not presented on a cost per risk reduction basis, the capital and annualized costs of 

the risk reduction associated with reduced emissions due to controls were considered and 

presented in that proposal. 

2.5 Removal of the SSM Exemption

Comment 22: Commenters 270 and 275 support the removal of the malfunction 

exemption. Commenters 265 and 359 support EPA’s edits to render the SSM references 

in the General Provisions not applicable to the MTVLO MACT, given that the existing 

rule does not require a SSM plan and the SSM exemption has be vacated by the courts.

Response 22: EPA thanks the commenter for its support.
Draft-Do Not Cite or Quote March 28, 2011 

21

Comment 23: Commenter 265 supports EPA’s proposal to address malfunctions 

as distinct from routine operating conditions but objects to the manner in which EPA 

proposes to do so. Commenter 288 states that EPA contends that SSM periods should not 

be considered distinct operating modes without providing data or soliciting information 

to support this claim. Commenter 284 states that EPA has a burden under the CAA to 

show that compliance is achievable at all times, but it has not demonstrated this for 

periods of startup and shutdown. The commenter suggests that in lieu of establishing 

alternative numerical emissions standards for these events, the Agency should pursue 

other options. One suggestion the commenter had would be to not require compliance 

with the emission limits for a short period of time during these events because the 

facilities are not operating under normal conditions. Another suggestion the commenter 

presents is to establish an affirmative defense work practice standard in each MACT that 

would be based on minimizing emissions according to a source’s SSM plan. As part of 

this option could be the requirement to conduct further analyses to determine whether 

emissions from startups and shutdowns are preventable in the future.

Response 23: As explained in more detail in the response to comments section of 

the preamble to the final rule, EPA’s approach to malfunctions is consistent with section 

112 and is a reasonable interpretation of the statute. Based on the information available 

at the time of proposal, EPA determined that for each of the source categories subject to 

this final rule, sources could meet the underlying limit during periods of startup and 

shutdown. For all source categories, with two exceptions, we did not receive any specific 

information indicating that sources could not meet the applicable emissions limitations 

during periods of startup and shutdown that would justify setting alternative limits for 

such periods. 

We did receive a comment for the Group I Polymers and Resins MACT standards

that compliance with the standards for 98 percent organic HAP destruction during 

periods of shutdown for front-end vents in the Butyl Rubber and Ethylene Propylene 

Rubber source categories would not be possible for certain equipment (i.e., flares). The 

commenter stated that they may not always be able to route these process vents to a flare 

during periods of shutdown due to the low pressure or low heating value in the process 

vent. EPA agrees with the commenter that it is not possible to comply with the current 

standard during periods of shutdown. Therefore, we are promulgating an alternative 

standard for front-end vents in these categories for these shutdown periods.

Comment 24: Commenter 297 states that in its experience with and research 

into petroleum refineries, many past malfunctions were preventable, caused by a failure 

to conduct more frequent inspections and testing and replacement of systems, equipment 

and parts. The commenter also states that not having emergency back-up power also 

contributed to numerous and regular malfunctions. The commenter requests that 

emissions from these malfunctions be included in the development of the MACT 

standards.

Response 24: EPA agrees that some equipment or air pollution control failures 

are preventable. Today’s final rules remove the SSM exemption and facilities will now 

be required to comply with the established standards at all times, including periods of 

malfunction. As any malfunction resulting in emissions that exceed the established 
Draft-Do Not Cite or Quote March 28, 2011 

22

standards will cause a violation of the standard, we expect a significant decrease in the 

occurrence of preventable malfunctions. 

2.6 Affirmative Defense Provisions

Comment 25: One commenter (263) supports EPA’s proposal to provide an 

affirmative defense against civil penalties and the proposal to set criteria for establishing 

the affirmative defense, but has concerns regarding the specific criteria included in the 

provisions.

Response 25: EPA thanks the commenter for its support. Comments concerning 

the affirmative defense criteria are addressed below. 

Comment 26: Commenter 295 objects to EPA’s adoption of the “enforcement 

discretion” policy as it applies to periods of SSM. The commenter notes that EPA quotes 

with approval the D.C. Circuit’s decision in Weyerhaeuser v. Costle, 590 F.2d 1011, 

1058 (D.C. Cir. 1978) that says the Agency is not bound to anticipate all upset situations 

and may deal with them by “enforcement discretion.” The EPA should account for why

it is entitled to exercise enforcement discretion, which is unbridled discretion in the hands 

of the government on whether to enforce or not, when this prerogative is denied to every

other agency and instrumentality of government in the United States.

Response 26: The preamble discussion the commenter appears to be referring to 

relates to EPA’s approach to periods of malfunction, not to periods of startup and 

shutdown. As explained in more detail elsewhere in this response to comment document, 

EPA’s approach to malfunctions is consistent with section 112 and is a reasonable 

interpretation of the statute. Moreover, EPA disagrees with commenter’s statements 

concerning enforcement discretion. All government agencies, including EPA, can and 

must prioritize in determining how to allocate limited agency resources, including 

enforcement resources. 

Comment 27: Commenters 265, 286, 287, 288, 289, and 291 state that the 

affirmative defense provisions do not cure EPA’s failure to set emission standards that 

are achievable during SSM events and are not a substitute for setting emissions standards 

for these periods. Commenter 288 states that the affirmative defense provisions are 

inappropriate for regulations that are required to be achievable, clear, and that a source 

can comply with as specific in President Clinton’s E.O. 12866. The commenters further 

state that the proposed standards with the affirmative defense do not represent emission 

limitations achieved by the best-performing existing sources, nor do they meet the criteria 

for establishing beyond-the-floor emission standards. Commenters 287 and 291 state 

that the affirmative defense is not a permissible substitute for setting standards for 

periods of malfunction and is insufficient to meet EPA’s obligations under CAA §112. 

Commenter 287 requests EPA set aside the proposed affirmative defense for periods of 

malfunction and establish a work practice standard for these periods.

Response 27: The affirmative defense is not intended as a substitute for 

standards under section 112. The affirmative defense applies to malfunction events and 

not to periods of startup and shutdown. EPA explained the basis for its approach in the 
Draft-Do Not Cite or Quote March 28, 2011 

23

preamble and elsewhere in this response to comment document. Comments concerning 

the affirmative defense criteria are addressed below. 

Comment 28: Commenter 291 states that EPA has previously found a case-bycase basis consideration of potential enforcement to be a less desirable route to address 

malfunctions. 37 Fed. Reg. 17,214, 17,214 (Aug. 25, 1972). As the Supreme Court has 

found, “a reasoned explanation is needed for disregarding facts and circumstances that 

underlay or were engendered by the prior policy.” FCC v. Fox Television Stations, Inc., 

129 S. Ct. 1800, 1811 (2009) (citation omitted). EPA failed to provide any explanation 

as to why it now believes a case-by-case affirmative defense is a more appropriate route. 

Commenter 265 also points out that the determinations in a citizen suit would be made by 

a lay judge rather than environmental experts at EPA.

Response 28: The Federal Register notice cited by commenters is almost four 

decades old and does not reflect subsequent amendments to the Clean Air Act and court

decisions. In any event, the Federal Register notice merely states EPA’s preference at 

that time for adopting regulations in order to formalize an approach to excess emissions 

caused by malfunctions. EPA explained its view that such an approach was preferable to 

an informal enforcement discretion approach for the following reasons: “First, the 

existence of a formal process better informs the public of the policy and factual issues 

which will underlie enforcement of the standards. Second, affected industries which are 

making good-faith efforts to meet the standards will on the whole welcome a regularized 

means of informing the Agency in detail of the circumstances surrounding unavoidable 

emission excesses. Third, the Agency expects to benefit substantially from the information 

it will gain about the operation of the processes in question, for both future enforcement 

and standard setting.” 37 Fed. Reg. 17,214, 17,214-15 (Aug. 25, 1972). The affirmative 

defense is not an informal enforcement discretion approach of the type that EPA rejected 

in 1972 and provides the benefits associated with the formalized approach that EPA 

identified in its 1972 proposal. 

Further, EPA believes that courts are well equipped and often do evaluate and 

apply the type of criteria set forth is the affirmative defense. Many of the conditions were 

modeled after the conditions of the affirmative defense in EPA’s SIP SSM policy, which 

several states have adopted into their SIPs. (See, e.g., State Implementation Plans: Policy 

Regarding Excessive Emissions During Malfunctions, Startup, and Shutdown (Sept. 20, 

1999); Policy on Excess Emissions During Startup, Shutdown, Maintenance, and 

Malfunctions (Feb. 15, 1983)). We do not have any indication that parties to enforcement 

proceedings have had any significant difficulties applying the terms of these SIP 

affirmative defenses. 

Comment 29: While commenters 270 and 290 support EPA’s removal of the 

malfunction exemption, the commenters do not support the inclusion of the affirmative 

defense provisions. These commenters feel the proposed affirmative defense approach 

reduces the disincentive to emit pollutants, diminishes the value of the standard, and may 

affect the ability of citizens to seek civil penalties from violators of standards under the 

Clean Air Act. For these reasons, the commenters urge EPA not to establish the 

affirmative defense provisions and to ensure full public reporting when malfunctions do 

occur. Commenter 290 adds that the provisions will reduce the civil enforcement 
Draft-Do Not Cite or Quote March 28, 2011 

24

mechanisms available to citizens, which is contrary to Congress’s intent when 

establishing the CAA, and it is outside of EPA’s authority to decide when civil penalties 

will not be allowed. The commenter states that if EPA did have the authority to 

promulgate affirmative defense provisions, the following provisions should be added: 

 A specific amount of compensatory damages that will apply to each 

reported malfunction, the funds of which would be dedicated to 

enforcement, inspections, and monitoring in the area around the specific 

facility to create greater assurance that the malfunction will not recur.

 A provision that the affirmative defense can only be used once by a 

specific company or facility within a certain period of time, such as 10 

years.

 Specific public reporting and notification requirements for malfunctions or 

any emissions exceedance of which the operator is aware, including a 

requirement that any notification of a malfunction or emissions 

exceedance provided to EPA should be made public on EPA’s website 

within 14 days. Also, when these notifications are made, the facility must 

also provide community notification within 2 business days through an 

appropriate public forum, such as notices on the facility’s website, a 

written notice to the local municipality and school district, and/or a press 

release to the local newspaper, radio and TV news station.

Response 29: EPA disagrees with the commenters who alleged that the 

affirmative defense provision for malfunctions is inconsistent with sections 113(e) and 

304 of the Act. Section 304 gives district courts jurisdiction “to apply appropriate civil 

penalties.” Section 113(e)(1) identifies the factors that the Administrator or a court shall 

take into consideration in determining the amount of a penalty to be assessed, once it has 

been determined that a penalty is appropriate. The affirmative defense regulatory 

provision is not relevant to the amount of any penalty to be assessed. If a court 

determines that the affirmative defense elements have been established, then a penalty is 

not appropriate and penalty assessment pursuant to the section 113(e)(1) factors does not 

occur. 

EPA also disagrees that the affirmative defense provision will hamper citizen 

enforcement. First, injunctive relief is still available and the threat of penalties would 

not deter violations in cases where all of the conditions of the affirmative defense have 

been satisfied because the affirmative defense criteria ensure that all reasonable steps 

were taken to prevent a malfunction that causes excess emissions. Further, litigating 

whether a source has met the affirmative defense will not burden citizen group any more 

or less than would litigating the appropriate penalty amount in the penalty assessment 

stage of a citizen suit enforcement action, because the 113(e) penalty assessment criteria 

and the affirmative defense criteria are similar and in fact overlap. For example, the 

requirement that the Administrator or the court consider “good faith efforts to comply” 

is bound to generate the type of fact-intensive disputes that the commenter complains of. 

In addition, several of the affirmative defense criteria are exactly the type of criteria the 

Administrator or Court might consider in determining whether a source made “good 

faith efforts to comply.” For example, to take advantage of the affirmative defense, the 

source must prove by a preponderance of the evidence that, among other things, the 

excess emissions “were caused by an unavoidable failure of air pollution control and 
Draft-Do Not Cite or Quote March 28, 2011 

25

monitoring equipment, process equipment, or a process to operate in a normal or usual 

manner” and “could not have been prevented through careful planning, proper design or 

better operation and maintenance practices” and “did not stem from any activity or 

event that could have been foreseen and avoided, or planned for.” 

Thus, EPA does not expect the affirmative defense provision to significantly alter 

the burden of bringing a citizen enforcement action. For those cases that do proceed to 

trial, even in the absence of this affirmative defense, sources generally raise equitable 

arguments to argue for a low penalty and citizens often rebut such arguments. Therefore, 

as a practical matter, EPA does not expect the affirmative defense provision to materially 

affect the practice of Clean Air Act enforcement.

Additionally, the affirmative defense is reasonable. EPA’s judgment is that the 

affirmative defense criteria capture the appropriate considerations in determining 

whether penalties are appropriate when a violation occurs as the result of a malfunction. 

As noted above, the affirmative defense criteria overlap to some extent with the penalty 

assessment criteria set forth in section 113(e), but are not identical. For example, size of 

business is one of the factors listed in section 113(e), but is not reflected in EPA’s 

affirmative defense. This reflects EPA’s view that when a violation is caused by a 

malfunction, the size of the business is not relevant to whether penalties should be 

excused. If the violation was unavoidable and could not have been prevented, EPA’s 

view is that it would be unfair to impose a penalty no matter the size of the business. 

EPA is not adopting commenters’ suggestion with respect to compensatory 

damages or limits on the frequency of use of the affirmative defense. It is not clear that 

EPA has authority to require the automatic imposition of compensatory damages and 

even if such authority exists, EPA does not think automatic imposition of damages is 

appropriate. Ensuring that malfunctions do not recur can be handled through imposition 

of appropriate injunctive relief. In addition, EPA’s view is that it would not be 

appropriate to limit a source’s ability to take advantage of the affirmative defense to one 

time over a specified period of time such as ten years given that the affirmative defense is 

only available when the source could not have prevented the excess emissions. With 

respect to commenters’ suggested reporting requirements, the reporting requirements in 

the rules promulgated today already require malfunction reporting and the affirmative 

defense provisions require that parties choosing to assert the affirmative defense meet 

additional malfunction reporting requirements. Any such reports submitted to EPA are 

publicly available pursuant to CAA section 114. 

Comment 30: Commenters 263, 265, 284, 286, 289, and 295 stated that EPA 

should provide that the affirmative defense apply to injunctive relief. Commenters 262 

and 265 state that injunctive relief is not an efficient means to address malfunctions since 

the affirmative defense is only available to malfunctions that could not have been 

prevented anyway. Commenter 262 adds that through injunctive relief, it appears that 

there is no cost ceiling that would prevent the EPA from demanding that changes be 

made to a facility to prevent all malfunctions that result in an emissions exceedance. 

Commenters 263, 265, 284, 286, and 289 added that it should also apply to civil 

penalties, civil administrative penalties, noncompliance penalties, and to actions brought 

by citizens and state and local permit authorities. Commenter 284 added that it should 

protect from criminal enforcement under §113(e), (c)(1), and (c)(5)(A). Commenters 286 
Draft-Do Not Cite or Quote March 28, 2011 

26

and 289 stated that the affirmative defense is inadequate to meet the purported purpose of 

the provisions, which is to provide relief from emission limitation that cannot be met at 

times even with equipment that is properly designed and maintained, unless it covers 

these other types of claims and penalties.

Response 30: The affirmative defense applies to civil penalties, including civil 

administrative penalties and penalties under section 120, but does not apply to injunctive 

relief or criminal penalties. The affirmative defense is available in any civil action to 

enforce the standards set forth in this rule, whether such action is brought by EPA, a 

state or local authority or a citizen. EPA agrees that in some cases, injunctive relief may 

not be appropriate if all the criteria of the affirmative defense have been satisfied. In 

such cases, liability for attorney’s fees is not a real issue. However, some form of 

injunctive relief may be appropriate. The Sierra Club v. Otter Tail Power Co case cited 

by commenters is not on point and does not undermine EPA’s ability to limit the 

affirmative defense to penalty claims. The concurrent remedy doctrine provides that 

where a party's legal remedies are time-barred a party's concurrent equitable claims 

generally are barred. The affirmative defense is not a time-bar to civil penalties. EPA 

does not intend to provide an affirmative defense to criminal charges as the very nature 

of criminal charges is that there is alleged to be a knowing violation (CAA Section 

113(c)(1-3), or a knowing or negligence release that threatens imminent danger to 

persons (CAA Section 113(c)(4)and (5)). In these circumstances, it is likely that the 

source did not do all that could be done to prevent the excess emissions. However, if 

there are circumstances that justify a knowing release as is suggested by the commenter, 

such circumstances can be raised in any enforcement action and may be the basis for a 

defense.

Comment 31: Commenter 263, 265, 284, 286, 289, 291, and 295 believe the 

affirmative defense provisions should apply to the potential violation of emission limits 

during a startup or shutdown event as well as during malfunctions, if EPA is to use such 

affirmative defense.

Response 31: EPA is promulgating the affirmative defense for malfunctions 

only, not for periods of startup and shutdown. EPA believes that malfunction events 

should be treated differently than periods of startup and shutdown, which are predictable 

and routine aspects of a source’s operations. In contrast, EPA has determined that CAA 

section 112 does not require that emissions that occur during malfunctions be factored 

into development of CAA section 112 standards. Because startup and shutdown periods 

are part of a source’s normal operations, the same approach to compliance with, and 

enforcement of, applicable emissions standards during those periods should apply as 

otherwise applies during a source’s operations. Further, as explained above, periods of 

startup and shutdown – but not malfunctions -- are taken into account when establishing 

section 112 emissions standards. For these reasons, EPA does not believe it is 

appropriate to apply the affirmative defense provision to startup and shutdown periods.

Comment 32: Commenter 291 states that it is unclear why EPA has not followed 

the long-standing upset defense at 40 CFR 122.41(n) promulgated under the Clean Water 

Act, which provides that an upset constitutes an affirmative defense and establishes 

criteria for the defense. These criteria include:
Draft-Do Not Cite or Quote March 28, 2011 

27

 An upset occurred and the permittee can identify the cause(s) of the upset;

 The permitted facility was at the time being properly operated;

 The permitted facility submitted notice of the upset (required within 24 

hours);

 The permittee took all reasonable steps to minimize or prevent the 

violation.

The commenter suggests that if an affirmative defense is to be used, EPA should 

eliminate the criteria in the proposal and require the regulated entity to establish that a 

malfunction occurred using the definition in 40 CFR 63.2. Alternatively, the commenter 

suggests using the Clean Water Act criteria as a model for the affirmative defense 

requirements, rather than the 1983 and 1999 EPA memoranda on excess emissions, 

which do not adequately address the treatment of SSM events in technology-based 

standards. 

Commenters 262, 264, 265, 284, and 291 noted that the proposed affirmative 

defense language is not consistent with the definition of malfunction in 40 CFR 63.2 or 

those specified in specific subparts, and they believe EPA should revise the affirmative 

defense language to conform with the longstanding definition of “malfunction.” For 

instance, commenter 264 noted that in the proposed affirmative defense language in 

§63.1250(g)(4)(i)(A), excess emissions must be caused by an event that, among other 

things, is short in duration. The commenter points out that the definition of malfunction 

in §63.1251 does not specify the duration of the malfunction event. To conform to the 

definition of malfunction, commenter 265 suggests the following language for the 

standards in equivalent paragraphs to §63.480(j)(4)(i)(A):

The excess emissions were caused by a sudden, infrequent, and not reasonably 

preventable failure of air pollution control and monitoring equipment, or a process 

to operate in a normal and usual manner; and that the failure was not caused in 

part by poor maintenance or careless operation.

Commenter 262 noted that the affirmative defense provisions essentially require 

an owner or operator to design, operate and maintain a facility without the benefit of 

hindsight that comes after a malfunction occurs. The commenter states that this is a 

fundamental flaw in the affirmative defense approach.

Commenters 262, 273, 286 and 289 state that if EPA retains the affirmative 

defense, the Agency must modify it substantially so that it does not require the source to 

prove its innocence (before it is even charged). The commenters are concerned that the 

affirmative defense provisions imply the facility is guilty until proven innocent and put 

the burden of proof on the facility rather than the Agency. Commenter 273 suggests EPA 

establish a rebuttable presumption rather than an affirmative defense where it is presumed 

the facility did everything in its power to minimize emissions during SSM events unless 

the Agency proves certain facts to show that it did not take reasonable actions to 

minimize emissions. Commenters 286 and 289 state that EPA has not provided any 

statutory authority or real justification for requiring a source to prove its innocence, 

producing all documentation within 30 days of the event, without ever being charged. 

The commenters state that the ordinary default rule is that plaintiffs bear the risk of 

failing to prove their claims; however, these provisions require a facility to prove its 

innocence rather than requiring an enforcement authority to prove a violation of the 

CAA. The commenters suggest that if EPA adopts an affirmative defense approach, it 
Draft-Do Not Cite or Quote March 28, 2011 

28

should allow that once a source has claimed its excess emissions were related to a 

malfunction, it will not be considered to be in violation of the standards unless the 

enforcement authority demonstrates that the source is not entitled to claim the 

malfunction. These commenters and commenter 265 suggest that the provisions state 

that a source “will not be deemed in violation of” the MACT standards for excess 

emissions associated with SSM, unless the event, and the source’s response to the event, 

do not meet the criteria spelled out in the regulations. The commenters suggest with 

these changes, the affirmative defense provisions could then be referred to as an 

“alternative standard for SSM events.” The commenters also suggest that with this 

change, it may be unnecessary to state also that the affirmative defense relieves the 

source from liability for all types of penalties and injunctive relief (save criminal 

penalties).

Commenter 284 states that the affirmative defense provisions should be amended 

because they do not meet the Agency’s burden to demonstrate that compliance with a 

MACT standard is continuously achievable. The commenter states that in lieu of being 

able to establish an emission limitation, EPA should clarify that the affirmative defense 

provisions are work practices that are part of the standard itself. Commenters 265 and 

359 also suggest that the affirmative defense provisions should be specified as work 

practice standards. These commenters also suggest EPA provide an allowance for a 

reasonable period of routine maintenance for the control device.

Several commenters (262, 264, 265, 273, 284, 286, 288, 289, 291, and 295) stated 

that some of the affirmative defense requirements are unreasonable, difficult to prove, 

and subject to varying interpretation. Several commenters requested that the term 

“infrequent” be removed from the regulatory text, as it could be subject to different 

interpretations by regulatory agencies, and it should be evaluated on a case-by-case basis. 

Another suggestion is that the sentence regarding the use of “off-shift and overtime 

labor” be deleted to allow facilities the flexibility to respond to the matter in the most 

appropriate manner. Other suggestions offered were to delete the word “severe” in the 

descriptions of personal injury and property damage, as the word is subjective and open 

to a wide range of interpretations; and further define “facility” in the context of the 

Affirmative Defense requirements. Further suggestions include the removal of terms 

such as “careful,” “proper,” and “better,” in §63.342(b)(1)(i)(A), which are not defined 

and would make it difficult to determine whether the criteria have been met. Several 

commenters also suggest removing references to “any” activity and “all” in the 

affirmative defense language, which would make it difficult to ever satisfy the 

affirmative defense. Several commenters suggest EPA reword the affirmative defense to 

state that a source is “not in violation” if it meets the requirements of the affirmative 

defense. Commenter 284 suggests that instead of requiring that excess emissions “did 

not stem from any activity or event that could have been foreseen and avoided” it should 

read as the definition of malfunction and rely on whether the event was caused by “poor 

maintenance” or “careless operation.” This and other commenters also suggest the 

phrase “expeditiously as possible” be replaced by the phrase “expeditiously as 

practicable” or “in an expeditious manner” and that the phrase “if at all possible” be 

replaced by “to the maximum extent practicable.” Commenters 286 and 289 requested 

the removal of the phrase “if at all possible.” Commenter 284 also requests the provisions 

not include the requirements that a bypass was unavoidable to “prevent loss of life, 
Draft-Do Not Cite or Quote March 28, 2011 

29

severe personal injury, or severe property damage” as this is an evidentiary consideration 

for purposes of prosecution and is not proper to include as a recordkeeping and reporting 

requirement. However, if this phrase remains in the rule, the commenter requests it also 

include “severe economic loss.” Commenters 262, 264, 286 and 289 recommended the 

removal of the term “short.” Commenters 264, 286, and 289 recommended that EPA 

clarify that the “affected source” rather than the “facility” was operated in a manner 

consistent with good practices for minimizing emissions. Commenter 262 objects to 

using the term “unavoidable” and suggests using “not reasonably preventable.” 

Commenter 262 adds that these provisions regarding when it is appropriate to bypass 

emissions inappropriately favors reducing emissions over preventing human injury and 

suggests that if a limitation on what constitutes an injury is needed, EPA should utilize 

the OSHA for a “serious” rather than “severe” injury. Commenter 265, citing issues with 

the phrasing of the language of §63.480(j)(4)(i)(B) and the same language in the other 

standards, the commenter recommended this paragraph not be finalized and that the 

proposed §63.480(j)(4)(i)(C) remain as the basis for demonstrating an appropriate 

response to the malfunction. This commenter also recommended that §63.480(j)(4)(i)(E) 

be removed because it is impossible to demonstrate that “all possible steps” were taken to 

minimize impacts of emissions.

Commenters 265 and 284 state that the affirmative defense provision to document 

excess emissions activities in “properly signed, contemporaneous operating logs,” should 

be deleted. The commenters state that during a malfunction engineers have little or no 

time to keep contemporaneous records, a source should be allowed to prove its 

entitlement to an affirmative defense using any credible evidence which would otherwise 

be admissible in court, sources should not be required to maintain an operating log which 

is not required by the underlying NESHAP, and sources should be directing resources to 

minimize excess emissions and correct malfunctions rather than documenting its actions. 

In addition, the commenter states that the term “properly signed” lacks a definition and 

should be removed if this provision is retained. Commenter 265 recommends the 

following language be used in place of this requirement in 63.480(j)(4)(i)(G):

Records are maintained documenting the event, including actions taken to 

minimize emissions and the calculation of the amount of excess emissions.

Commenters 265 and 284 state that the provision, “At all times, the facility was 

operated in a manner consistent with good practices for minimizing emissions,” should 

be deleted. The commenters state that the definition of malfunction itself already

excludes situations that are caused by careless operation. Commenter 284 states that, at a 

minimum, EPA should clarify that this requirement only applies during times of 

malfunction and that the duty to minimize emissions does not require emissions to be 

reduced to below the applicable emissions standard. Commenter 265 states that this 

requirement is duplicative of the general duty to minimize emissions, which is not 

included in the individual standards proposed, and deals with the entire facility rather 

than just the malfunctioning equipment.

Commenters 264 and 265 recommend that 2-day initial requirement be deleted 

and leave only a 180-day written demonstration requirement. Commenter 265 

recommends the following language for the notification requirement (taken from the 

Polymers and Resins I MACT language):
Draft-Do Not Cite or Quote March 28, 2011 

30

(ii) Notification. The owner or operator seeking to assert an affirmative defense 

shall submit a written report to the Administrator within 180 days of determining 

that an exceedance has occurred to demonstrate, with all necessary supporting 

documentation, that it has met the requirements set forth in paragraph (4)(i) of this 

subsection.

Commenter 273 suggested the following language that would apply to all MACT 

standards subject to this final rule to incorporate its comments regarding a rebuttable 

presumption, ambiguous terms, root cause analyses, and communicating electronically in 

§ 63.342(b)(1)(i):

To establish a rebuttable presumption in any action to enforce such a limit, the 

owners or operators of facilities must timely meet the notification requirements of 

paragraph (b)(1)(ii) of this section. The Administrator must prove by a preponderance of 

evidence that:

(A) The excess emissions were not caused by a sudden, short; infrequent, and 

unavoidable failure of air pollution control and monitoring equipment, or of a process to 

operate in a normal and usual manner; and could not have been reasonably prevented 

through careful planning, proper design or better operation and maintenance practices; 

and stemmed from any activity or event that could have been reasonably foreseen and 

avoided, or planned

for; and were part of a recurring pattern indicative of inadequate design, operation, or 

maintenance; and 

(B) If the applicable emission limits were exceeded, repairs were not made as 

expeditiously as possible, including using off-shift and overtime labor to the extent 

practicable; and 

(C) The frequency, amount and duration of the excess emissions (including any

bypass) were not minimized to the maximum extent practicable during periods of such 

emissions; and

(D) If the excess emissions resulted from a bypass of control equipment or a 

process, then the bypass was not needed to prevent loss of life, severe personal injury, or 

severe property damage; and

(E) Reasonable steps were not taken to minimize the impact of the excess 

emissions on ambient air quality, the environment, and human health; and

(F) Emissions monitoring and control systems were not kept in operation if 

possible; and

(G) Your actions in response to the excess emissions were documented by 

properly signed, operating logs; and

(H) The facility was not operated in a manner consistent with good practices for 

minimizing emissions; and

(l) The owner or operator has prepared a written report to determine and mitigate 

the primary causes of the malfunction and the excess emissions resulting from the 

malfunction event at issue. A root cause analysis may be required only if the cause of the 

malfunction is difficult to determine or if the serious nature of the event indicates one is 

needed. Facility personnel will have the discretion to make this determination. The

analysis shall also specify, using the best monitoring methods and engineering judgment, 

the amount of excess emissions that were the result of the malfunction.

(ii) Notification. The owner or operator of the facility experiencing an exceedance
Draft-Do Not Cite or Quote March 28, 2011 

31

of its emission limit(s) during a malfunction shall notify the Administrator by telephone, 

facsimile (FAX) transmission, or electronic means as soon as possible, but no later than 

two business days after the initial occurrence of the malfunction, if it wishes to avail itself 

of the rebuttable presumption to civil penalties for that malfunction. The owner or 

operator seeking to assert an affirmative defense shall also submit a written report to the 

Administrator within 30 days of the initial occurrence of the exceedance of the standard 

in this subpart to demonstrate, with all necessary supporting documentation, that it has 

met the requirements set forth in paragraph (b)(1)(i) of this section. If the report requires 

a root cause analysis, the report must be submitted within 90 days of the initial 

occurrence of the event.

Response 32: Many of the conditions in the affirmative defense are modeled 

after the affirmative defense in EPA’s SIP SSM policy, See, e.g., State Implementation 

Plans: Policy Regarding Excessive Emissions During Malfunctions, Startup, and 

Shutdown (Sept. 20, 1999); Other conditions are modeled after a Federal Implementation 

Plan promulgated by EPA. (40 C.F.R. 50.1312). EPA’s view is that use of consistent 

terms in establishing affirmative defense regulations and policies across various CAA 

programs will promote consistent implementation of those rules and policies. The 

commenter does not explain its view that the terms of the SIP policy are not appropriate 

to address malfunctions in the CAA section 112 context. The affirmative defense does not 

“require a facility to prove its innocence rather than requiring an enforcement authority 

to prove a violation of the CAA” or change the burden of proof with respect to 

establishing a violation. The affirmative defense applies only where a violation has been 

established. The burden of proof that a violation occurred remains with the plaintiff in 

an enforcement action. See, e.g., 40 C.F.R. 22.24. If a violation has been established 

and a source wishes to assert the affirmative defense with respect to penalties, the source 

does bear the burden of establishing that the elements of the affirmative defense have 

been met. This burden-shifting is appropriate because the source is in a better position 

to determine the facts required to establish the defense. See, e.g., Arizona Pub. Serv. Co. 

v. EPA, 562 F.3d 1116, 1120, 1129-30 (10th Cir. 2009) (rejecting industry challenge to 

EPA’s use of an affirmative defense to address excess emissions during malfunction 

events.). The notification and reporting requirements are not unreasonable and are 

consistent with other malfunction reporting and notification requirements that have been 

applied without significant difficulty. (See, e.g. 40 CFR 63.6(e)(3)(iv) and 

63.10(d)(5)(ii)). Section 114 of the CAA clearly provides authority to require such 

reports. 

EPA does not agree that the affirmative defense criteria are overly vague and will 

result in varying interpretations. Courts are well equipped and often do evaluate and 

apply criteria that are subject to differing interpretations. As noted above, many of the 

conditions were modeled after the conditions of the affirmative defense in EPA’s SIP 

SSM policy, which several states have adopted into their SIPs. We do not have any 

indication that parties to enforcement proceedings have had any significant difficulties 

applying the terms of these SIP affirmative defenses. However, EPA agrees that some of 

the terms or phrases in the regulatory text establishing the affirmative can be revised or 

streamlined to some extent. EPA is revising the affirmative defense language to delete 

“short” from §63.820(c)(1)(i), because other criteria in the affirmative defense require 

that the source assure that the duration of the excess emissions “were minimized to the 
Draft-Do Not Cite or Quote March 28, 2011 

32

maximum extent practicable.” In addition, EPA is revising §63.820(c)(1)(vi) and 

§63.562(e)(7)(i)(H) to add “consistent with good air pollution control practice for 

minimizing emissions” and “consistent with safety and good air pollution control 

practices” as suggested by the commenter. We are also deleting the term “severe” in the 

phrase “severe personal injury” in §63.820(c)(1)(iv) because we do not think it is 

appropriate to make the affirmative defense available only when bypass was unavoidable 

to prevent severe personal injury. We have revised sections 63.823, 63.829(g), and 

63.829(h)to refer to the “affected source” which is defined in §63.2. EPA disagrees that 

other terms and conditions of the affirmative defense are overly subjective or extreme or 

need further qualification. EPA acknowledges that some of the criteria may overlap to 

some extent and under some circumstances, but does not believe it is necessary to change 

the requirements. To the extent there is overlap, the same information can be used to 

meet the provisions in question. Finally, EPA is not eliminating the word “infrequent” 

from §63.820(c)(1)(i), because that term appears in the definition of malfunction in 63.2. 

With respect to the comment that the affirmative defense should be stated instead 

in terms that, once a source has claimed that its excess emissions were related to a 

malfunction, it will not be considered to be in violation of the standards unless the 

enforcement authority demonstrates that the source is not entitled to claim the 

malfunction, EPA’s does not agree that the affirmative defense should operate as the 

commenter suggests. The commenter improperly seeks to shift the burden of proof from 

the source to EPA. It is the source, not EPA, that has the information relevant to assess 

whether a particular event qualifies as a malfunction and meets the affirmative defense. 

Furthermore, commenter’s suggested approach appears to be similar to the scheme that 

the court vacated in the Sierra Club case, in that there would be no violation unless the 

enforcing party (EPA or a citizen), established that the event in question was not a 

malfunction. EPA also disagrees with the comments suggesting that the affirmative 

defense provisions should be specified as work practice standards. As is explained 

elsewhere is the response to comment document, EPA is not taking malfunctions into 

account in setting section 112 standards. 

With respect to the comment concerning operating logs, EPA believes that log 

entries should be made contemporaneously, which does not mean, at the exact time that 

the engineers are taking actions to address the malfunction, but rather immediately 

thereafter. That way, more accurate records of the malfunction can be expected, as 

opposed to records reconstructed long after the malfunction. “Properly signed” means 

that the records should be signed by an engineer or other employee with knowledge of 

the situation, in a legible manner so that enforcement officials can tell who made the 

record and what their responsibilities were. 

Comment 33: Commenter 284 requests clarification whether or not a facility

would be required to shut down an emission unit until repairs could be made and under 

what circumstances a source could continue to operate the unit, given the affirmative 

defense provision that the “frequency, amount and duration of the excess emissions 

(including any bypass) were minimized to the maximum extent practicable during 

periods of such emissions.”

Response 33: EPA is unable to give specific guidance as to how the criteria 

would apply in the abstract. However, as noted above, we do not believe that courts will 
Draft-Do Not Cite or Quote March 28, 2011 

33

have significant difficulty applying these criteria when presented with the specific facts 

and circumstances of a malfunction event.

Comment 34: Several commenters (264 and 273) stated that there should be 

more flexibility in the affirmative defense requirements regarding when a root cause

analysis is required. These commenters both believed a formal root cause analysis for 

smaller excess emissions events should not be required and that this step should only be 

required when there is a very significant or repeat event or when other reasonable 

methods fail to show what caused the malfunction. Commenters 262, 265, and 273 

added that it is reasonable to develop a simple report of the cause of a malfunction and 

the corrective action taken within 30 days, but it may not be possible to complete a root 

cause analysis in 30 days, and more time, such as 90 days may be needed or 180 days for 

more complicated situations. Commenters 286 and 289 state that the root cause analysis 

requirement may make the affirmative defense unavailable if the source is not able to 

determine the primary cause of the malfunction. The commenters state that it should be 

expected that in many causes the primary cause will not be ascertainable or that it will not 

be possible to identify a way to ensure the malfunction will not recur. Commenter 265 

added that it should be clarified that the root cause analysis requirement does not require 

corrective actions within the demonstration period, because long-term corrective action 

could require facility modifications that could take years to design and implement. The 

commenters also state that requiring the facility to eliminate the primary cause of the 

malfunction without regard to the costs and impacts of this elimination is unreasonable 

and inconsistent with the criteria for standards established under CAA section 

112(d).Commenters 286 and 289 also stated that 90 days or more should allowed unless 

EPA substantially streamlines the criteria for the affirmative defense. Commenter 262 

suggested that the root cause analysis be submitted as soon as practical after determining 

that there was an exceedance due to a malfunction.

Response 34: EPA is revising this requirement to clarify that the purpose of the 

root cause analysis is to determine, correct, and eliminate the primary cause of the 

malfunction and that the root cause analysis itself does not necessarily require that the 

cause be determined, corrected or eliminated. However, in most cases, EPA believes that 

a properly conducted root cause analysis will have such results. EPA is also revising this 

requirement to state that a written report must be submitted within 45 days of the initial 

occurrence of the malfunction. We further revised this provision to allow the source to 

seek an extension of up to an additional 30 days. 

Comment 35: Commenters 265, 264, and 273 requested that the affirmative 

defense provisions allow for actions taken in response to excess emissions be 

documented and submitted in an electronic format.

Response 35: EPA accepts documents in electronic format, as long as the format 

is compatible with the requirements of the standards. For the affirmative defense 

provisions, the owner or operator of a facility experiencing an exceedance of its emission 

limit(s) during a malfunction must notify the Administrator by telephone or facsimile 

(FAX) transmission of the exceedance. However, the written reports required to 

demonstrate that the affirmative defense provisions have been met and requests for an 

extension of the deadline for these reports may be submitted electronically. 
Draft-Do Not Cite or Quote March 28, 2011 

34

Comment 36: Commenters 262, 265, and 359 state that the notifications and 

reports required in the affirmative defense provisions are arbitrary, unrealistic, and 

unwarranted. The commenters state that in many cases facilities would not be able to 

complete the determination of whether a given malfunction event qualifies for the 

affirmative defense within 2 days following the event and would most likely routinely 

submit the notification to preserve the potential for an affirmative defense. Commenters 

286 and 289 state that with the short malfunction or deviation report sources currently

submit under many air programs, the enforcement authority can determine in many cases 

whether an exceedance of standards resulted from an unforeseen and unavoidable 

equipment failure or process upset. The commenters also state that it is inefficient and 

burdensome for both sources and regulators to require a complete justification of the 

affirmative defense before the enforcement authority has indicated need for further 

investigation. The commenters say this would create unnecessary burden to the facility

and regulatory agency with no associated environmental benefit. Commenter 264 claims 

the immediate notifications will also be duplicative of emergency response reporting 

procedures under SARA/CERCLA/EPCRA and many State regulations for larger 

emission events and will contradict many existing reporting rules by requiring the 

reporting of very small excess emissions below those of CERCLA/SARA and State 

Agencies. The commenters also say that malfunction reports should be submitted with 

semi-annual reports rather than within 30 days of the event. The commenters note that 

facilities are already required to submit reports of excess emissions and continuous 

monitoring system performance and summary reports on a semi-annual basis. The 

commenters further note that EPA promulgated the Recordkeeping and Reporting Burden 

Reduction Rule expressly to simplify and unify reporting schedules, and a semi-annual 

reporting frequency was chosen. Commenter 264 notes that the provisions encourage 

reporting even if the owner/operator is unsure whether excess emissions occurred for fear 

of not being able to claim the affirmative defense, and the provisions are unclear as to 

who should receive the reports. 

Response 36: The general provisions regulations specify where reports are to be 

submitted (40 C.F.R. 63.14). Further , 40 C.F.R. 63.9(i) contains provisions for 

adjustments of reporting deadlines that can be utilized in appropriate circumstances. 

The requirement to notify the Administrator of an exceedance during a malfunction is 

reasonable and consistent with many other upset and malfunction notification 

requirements that have been applied without significant difficulty. (See, e.g. 40 CFR 

63.6(e)(3)(iv) and 63.10(d)(5)(ii)). 

2.7 Source Category Specific Comments

2.7.1 Source Category Specific Comment – Pharmaceuticals Production

Comment 37: Commenter 264 stated that the proposed rule language related to 

performance testing is too vague and seemed to indicate that EPA intends to write the test 

plans for the facilities. The commenter adds that EPA or a delegated authority is already

required to approve the test plans, and another layer of oversight is not needed.
Draft-Do Not Cite or Quote March 28, 2011 

35

Response 37: We have revised the language of §63.1257(a). Performance tests 

shall be conducted under conditions representative of performance of the affected source 

for the period being tested.

Comment 38: Commenter 262 points out that a malfunction of emissions 

monitoring equipment could lead to a theoretical exceedance because there would be an 

absence of monitoring data to demonstrate what the emissions were during that time. 

The commenter suggests EPA modify the SSM provisions to explicitly preclude 

monitoring failures from resulting in assumed emission exceedances.

Response 38: EPA recognizes that monitoring system malfunctions do not 

necessarily result in emission greater than allowed by the standard. The provisions of 

§63.505(g) allow that monitoring system breakdowns, repairs, calibration checks, and 

zero (low-level) and high level adjustments are not required to be included in the 

calculations to determine whether there has been sufficient monitoring data collected.

Comment 39: Commenter 298 concurs with the EPA’s determination that the 

current MACT standards for Pharmaceuticals Production provide an ample margin of 

safety to protect public health and prevent adverse environmental effects and agrees with 

the EPA’s proposal to re-adopt the existing MACT standards to satisfy Section 112(f) of 

the CAA.

Response 39: We thank the commenter for this feedback.

2.7.2 Source Category Specific Comment – The Printing and Publishing Industry

Comment 40: Commenter 263 noted that most of the risk discussions in the 

proposal concern pollutants common to the publishing industry but not the flexible 

packaging industry, and it might be helpful in the future to discuss the 40 CFR part 63, 

subpart KK subcategories separately.

Response 40: We appreciate this feedback and will consider this suggestion as 

we move forward with other RTR rulemakings.

Comment 41: Commenter 263 said that its members reviewed the facility 

information for flexible package plants and did not find data that were of potential 

concern. The commenter also noted that its members agreed that mandating permanent 

total enclosures would be costly for the industry and not warranted by the identified risks.

Response 41: We thank the commenter for carefully reviewing the data and 

confirming our analysis.

Comment 42: Commenter 272 recommended that EPA clarify the rule 

applicability and initial compliance dates in §63.820 to state that area source status must 

be established prior to the compliance dates specified in §63.826 to avoid “once-inalways-in” policy interpretation conflicts.

Response 42: This comment is not germane to this rulemaking. However, we 

note that the commenter is correct that area source status is established prior to the 

compliance dates specified in §63.826.
Draft-Do Not Cite or Quote March 28, 2011 

36

Comment 43: Commenter 278 reviewed the data and the estimated cancer and 

non-cancer risks for the facilities in its jurisdiction and determined there were no 

additional risks from the Printing and Publishing Industry for facilities located in North 

Carolina.

Response 43: We thank the commenter for carefully reviewing the data 

regarding facilities in North Carolina.

2.7.3 Source Category Specific Comments – Group I Polymers and Resins

Comment 44: Commenters 265 and 276 support EPA’s conclusion that no 

further residual risk or technology review is required for the Butyl Rubber or Ethylene 

Propylene Rubber source categories, noting that EPA’s previously finalized analysis 

reached the appropriate conclusion.

Response 44: We appreciate the commenters’ support of EPA’s risk and 

technology review conclusions.

Comment 45: Commenters 265 and 276 state that since there is no consent 

decree for the Butyl Rubber and Ethylene Propylene Rubber source categories, EPA 

should take the appropriate amount of time to thoroughly review the comments received 

and reassess the cost-effectiveness determination for the proposed controls for these 

source categories.

Response 45: We believe that we have taken the appropriate amount of time to 

thoroughly review the comments on these source categories and have reassessed our 

control requirements and cost estimates accordingly. We do not believe it is necessary to 

delay final action on the proposed controls, or the amendments thereto that we are 

promulgating today.

Comment 46: Commenter 288 supports EPA’s conclusion that the MACT floor 

should be based on current emission rates and that the beyond-the-floor option for backend process vents is not cost effective for the neoprene source category.

Response 46: We appreciate the commenter’s support of EPA’s conclusions for 

the neoprene source category.

Comment 47: Commenter 293 agrees with and incorporates the comments by

IISRP by reference.

Response 47: We have addressed all of the comments from the IISRP.

Comment 48: Commenter 265 states that on the 40th anniversary of the Clean 

Air Act, Administrator Lisa Jackson remarked that EPA would set standards that make 

the most sense, focusing on getting the most meaningful results through the most costeffective measures. The commenter states that the proposed controls for the Butyl

Rubber and Ethylene Propylene Rubber source categories are inconsistent with this 

statement, as they are not cost effective, produce no substantive environmental benefit, 

and reduce the competitiveness of U.S. manufacturing.
Draft-Do Not Cite or Quote March 28, 2011 

37

Response 48: We have reanalyzed the Butyl Rubber and Ethylene Propylene 

Rubber source categories. As a result, we are promulgating standards at the MACT floor 

level of control, which we believe comply with our CAA section 112 authority and are 

cost-effective, without reducing the competitiveness of U.S. manufacturing.

Comment 49: Commenter 265 notes that it is unclear what the cost-effectiveness 

criterion is for decision making to require beyond-the-floor controls but it appears to be 

$10,000/ton, also noting that for the Butyl Rubber and Ethylene Propylene Rubber source 

categories there are few if any co-pollutant reduction benefits.

Response 49: EPA does not have a set criterion in beyond-the-floor analyses for 

determining whether or not a control option is cost effective. Rather, control options are 

assessed based on a number of factors, including but not limited to cost-per-ton of HAP 

reduction and co-pollutant reduction, energy impacts, and non-air quality impacts of 

controls, as appropriate under CAA section 112(d)(2).

Comment 50: Commenter 265 notes that there is increasing competitiveness in 

the polymers markets driven by demand for the products in Asia and keeping costs low is 

important to remaining competitive in a global market.

Response 50: We understand that the polymers market is a global business and 

it is important for United States manufacturers to remain competitive. We believe that 

the promulgated standards will result in no major additional burden to the affected 

facilities, and should have no impact on their ability to remain competitive in a global 

market.

Comment 51: Commenter 265 states that there are no data in the record to 

support the supposition that dioxins and furans are formed when chlorinated 

hydrocarbons are burned in a flare or that, if this were true, less of these compounds 

would be formed in a thermal oxidizer/scrubber system, which EPA proposes to require 

instead of a flare. The commenter states that the basis for the proposed controls is HCl 

generation and there is no basis to suggest any benefit related to dioxins and furans. The 

commenter states that the preamble statement regarding dioxins and furans should be 

withdrawn in the final rule preamble.

Response 51: Dioxins and furans can be formed as combustion by-products when 

chlorinated organic materials are burned. However, the commenter is correct in that we 

have no data to indicate that these compounds are being formed specifically at the 

affected facilities in the Butyl Rubber and Ethylene Propylene Rubber source categories.

Comment 52: Commenter 265 notes that EPA did not indicate the compliance 

date related to the removal of the SSM provisions in the Group 1 Polymers and Resins 

MACT standards and requests four years for compliance so that facilities can invest in 

equipment, develop work practices, test the work practices and train personnel. The 

commenter notes that startups and shutdowns occur infrequently, so it will take an 

extended time to develop and test the work practices. The commenter further notes that

EPA should provide four years to comply with emission limits that require capital 

investment to install controls due to the current widespread demand for combustion 

controls, combustion engineers, company resources, materials, and construction resources 
Draft-Do Not Cite or Quote March 28, 2011 

38

to meet the compliance deadlines from other EPA rulemakings related to the 

boiler/process heater MACT, utility air rules, and other air toxics rules. The commenter 

notes that the one-year extension of the three-year period allowed for compliance is 

provided for in CAA section 112(i)(3)(B). The commenters also requested four years for 

compliance even for the MACT emission limits that are set at the floor level of control 

based on current operations. The commenters stated that the additional time would be 

needed due to additional capital investments they would need to make because the 

proposed emission limits did not take into account variability in operations, startup and 

shutdown, and maintenance on the existing RTOs. 

Response 52: These comments were made in regard to our proposal to go beyondthe-floor for certain front-end and back-end process vents in the Butyl Rubber and 

Ethylene Propylene Rubber source categories. However, we have decided to promulgate 

standards at the MACT floor level of control for these source categories, which will not 

require the installation of any new control equipment. Therefore, we do not believe that 

it is appropriate to allow four years to comply with a standard that requires no capital 

expenditure. Additionally, we have set the first compliance demonstration for these 

MACT floor levels of control to be two years following the date of the final rule. As such, 

we believe that the affected facilities have an ample amount of time to comply with the 

new standards. Regarding the compliance time for the removal of the SSM provisions, 

we have established a separate standard for certain front-end process vents during 

periods of shutdown for existing sources in the Butyl Rubber and Ethylene Propylene 

Rubber source categories. This standard requires no additional control equipment or 

capital expenditure, so we do not believe that four years is necessary to comply either. 

We believe that all other affected emission points are already complying with the current 

MACT standards during periods of startup and shutdown, and so four years is not needed 

to comply. Facilities have also had practices in place to minimize emissions during 

malfunctions at least since the compliance date of the MACT standards, and since the 

affirmative defense against civil penalties for exceedances of emission limits that are 

caused by malfunctions is available immediately, we believe facilities will either be able 

to meet the emission standards during malfunctions or will be able to use the affirmative 

defense upon the effective date of this rule

2.7.4 Source Category Specific Comments -- Marine Tank Vessel Loading 

Operations

Comment 53: Commenter 297 states that EPA failed to assess simultaneous 

multiple loading and unloading and other nearby facilities in its risk assessment for 

marine terminals and requests that EPA do so.

Response 53: In the acute analysis, we include a factor to estimate the 

approximate maximum short-term emissions. This factor would account for times of 

loading and unloading at the facility. While there may be HAP emitted by other sources 

at the same time as these peak emissions, we are concerned about the uncertainties of 

including estimates of cumulative risks in our assessments because we have not 

conducted a detailed technical review of HAP emissions data for sources contributing to 
Draft-Do Not Cite or Quote March 28, 2011 

39

background concentrations or facilities that have not previously or are currently 

undergoing a RTR. 

Comment 54: Commenter 290 states that EPA ignores the unacceptable facilitywide risk at some facilities where MTVLO occur in the current proposal. The 

commenter further states that it is necessary for EPA to adopt additional control measures 

to address the risks of MTVLO or at least commit to reopening and revising the MTVLO 

standard within a specific timeframe as necessary to address facility-wide risks.

Response 54: We performed the facility-wide analysis to put the source category 

risks in context and to provide us with information to help inform our decision on 

whether it is necessary to revise the MACT standards under CAA section 112(f)(2). At 

proposal, we identified two facilities with facility-wide MIRs greater than 100–in-1 

million (each with values of 200). Using new data obtained since proposal, we corrected 

the errors noted by the commenters for both MTVLO emission sources and other 

emission sources at the facilities. We found incorrect latitudes and longitudes for some 

emission sources, incorrect emissions reported for some sources, or incorrectly identified 

HAP. We updated the 2005 NEI data sets for each facility with corrected data and 

conducted a reanalysis of the risk using the corrected data set. The revised risk 

assessment results show no facilities with MTVLO have a facility-wide risk of greater 

than 100-in-1 million

Comment 55: Commenter 290 states that EPA must address risk at the facilitylevel for MTVLO at refineries, and it is unlawful for EPA to defer its residual risk 

making duties for this source category by dividing the source category into different 

segments. The commenter states that EPA may address MTVLO at refineries in the 

petroleum refinery rulemaking also since the refineries standards incorporate the 

MTVLO standards by reference, but not as a replacement for satisfying its legal duties 

regarding MTVLO now.

Response 55: We perform and make our decisions from the risk and technology 

reviews on a source category or subcategory basis. The MTVLO that occur at petroleum 

refineries are not included in the MTVLO source category but are included in the 

Petroleum Refinery source category and are regulated under 40 CFR 63 subpart CC. 

These MTVLO will be evaluated along with the other HAP emissions sources at 

petroleum refineries when that source category is reviewed. 

Comment 56: Commenter 297 requests that a specific amount of HAP that 

represents a low risk level be established in a format such as parts per million per cubic 

meter, rather than a percentage by which HAP emissions must be reduced. The 

commenter notes that there is a large difference between being exposed to 3% of 1 ton of 

emissions and 3% of 200 tons of emissions. The commenter also states that the 97% 

control requirement also does not identify and prioritize HAP that are more toxic or 

carcinogenic compared with those that are only irritants and notes that the cumulative 

impact of exposure to multiple marine terminals releasing the same HAP should be 

considered. 

Response 56: In our risk analyses, risks are estimated by analyzing the amount 

of each HAP people are exposed to, the toxicity of each HAP at these exposure levels,
Draft-Do Not Cite or Quote March 28, 2011 

40

and the aggregate risk from exposure to all of these HAP emitted by facilities in the 

source category. By including toxicity information for each HAP, the analysis does 

consider the relative toxicity or carcinogenicity of the HAP. Also, exposure to all HAP 

from all facilities in the source category are considered in estimating risk, which includes 

possible overlap in exposure to HAP from multiple facilities in the source category. 

These estimated risks represent conditions after implementation of the MACT standards. 

If the risks are low, then the control requirements of the MACT are effective and do not 

need to be revised to reduce risks, regardless of the form of the standard or the amount of 

emissions that are still released under that standard. If the risks are not low after 

implementation of the MACT, risks under additional regulatory requirements are 

estimated. In these additional analyses, risks remaining after the additional control are 

estimated including all the emissions remaining after additional control is instituted. 

Additional requirements are selected to reduce risk to acceptable levels and to provide 

an ample margin of safety to protect public health. The format of the standard is not 

relevant as long as it provides that these goals are met. However, priority is placed on 

the format for which it is easiest and most cost effective to ensure and demonstrate 

compliance. For these reasons, a percentage by which HAP emissions must be reduced 

is often preferable to a format such as HAP parts per million allowed per cubic meter.

Comment 57: One commenter (2801) stated their petroleum refinery operates an 

“Offshore Loading Terminal” and it is not clear if the proposed changes to subpart Y for 

offshore loading terminals are required for refineries. The commenter recommended rule 

text changes for §63.560(d)(6). 

Response 57: The current rule excludes offshore loading facilities from controls 

in §63.560(d)(6). This final rule will add a requirement for submerged fill for the 

offshore loading subcategory and for the existing sources with MTVLO emissions less 

than 10/25 tpy subcategory. The current rule in §63.561 defines Offshore loading 

terminal as “a location that has at least one loading berth that is 0.81 km (0.5 miles) or 

more from the shore that is used for mooring a marine tank vessel and loading liquids 

from shore.” The definition does not specify the connected facility. Additionally, the 

petroleum refinery MACT exclusion under §63.560(d)(3) specifies the exclusion from 

§63.562(b)(2), (3), and (4), but not the existing source offshore exclusion from 

§63.560(d)(6). Thus, there is no apparent connection of refineries and the definition of 

offshore facilities. In the proposal preamble, we stated that petroleum refineries would 

be excluded from the additional controls (75 FR 65112/c2). Thus, we are adding to the 

final rule in §63.560(a)(4) that submerged fill is not required at petroleum refineries. 

Comment 58: Since every petroleum-based product has HAP, one commenter 

(297) requested that this rulemaking include public health protection from exposure to 

cover all liquid fuels (gasoline blends, diesel fuel blends, jet fuel blends, bunker/marine 

fuel blends, and partially refined fuels), all gas fuels (LNG, methane, propane, butane, 

and ethane), solvents (kerosene and turpentine), crude oil and petroleum based chemicals 

and plastics. 

 

1

 This number refers to the commenters listed on Table 1. Some of the comments appear to be posted in 

the docket twice; their comments are subsequently referred to by the first posting number assigned to the 

comments. Table 1 includes the secondary docket number when the comments were posted twice.
Draft-Do Not Cite or Quote March 28, 2011 

41

Response 58: We used the 2005 NEI/NATA database to identify emissions 

information for marine loading of all products in the inventory and conducted a risk 

analysis. Using that database, we found that the current MACT-based standards provide 

an ample margin of safety to protect public health and the environment, and therefore did 

not make any changes to the existing standards due to the residual risk. However, we 

proposed and are making final a rule requirement for all products that are subject to the 

current rule to be loaded by submerged fill. We proposed vapor controls for MTVLO for 

gasoline based on the fact that it is the highest-quantity commodity loaded in MTVLO in 

the U.S. In addition, gasoline has a relatively high vapor pressure compared to other 

fuels and chemicals, higher emissions, and therefore would provide the best case for cost 

effectiveness when applying add-on control devices. However, as discussed in the soon 

to be published FR preamble, we are not requiring additional vapor recovery. 

Comment 59: Two commenters (264, 301) provided input on the reference to 

Coast Guard regulations 46 CFR 153.282. 

One commenter (0301) noted that splash loading is used for certain cargoes, 

particularly cargoes that require heating to ensure liquid flow. The commenter believed 

the language in 40 CFR 63.560, that exempts commodities with vapor pressures less than 

10.3 kilopascals (kPa) (1.5 psia) from the submerged fill requirement, is appropriate.

One commenter (301) noted that the EPA and Coast Guard regulations governing 

tank vessel loading should be consistent with one another and supported crossreferencing to Coast Guard regulations. The commenter encouraged EPA to make this 

point explicit in the final rule or the preamble to the final rule. This consistency should 

continue for any future possible changes to EPA or Coast Guard regulations.

One commenter (264) suggested that instead of referencing 46 CFR §153.282 in 

§§63.560(d)(6)(i) and 63.560(f)(1), EPA should directly cite the actual specification for 

the submerged fill line. The commenter noted that this is necessary because 46 CFR 

§153.282 is strictly a regulation governing tank ships and is not applicable to tank barges 

and because referencing the Coast Guard rules could cause issues if that particular section 

(§153.282) is later revised.

Response 59: We appreciate the input on use of cross-referencing to the Coast 

Guard regulations. The Coast Guard regulations ensure safety for MTVLO, and as one 

commenter notes, submerged fill is a safety consideration from the Coast Guard 

perspective, to reduce static charge, and submerged fill also provides emission 

reductions. We believe that cross-referencing to submerged fill requirements is the 

appropriate approach, since we want to be consistent with Coast Guard requirements 

and their safety considerations.

The applicability provisions are provided in subpart Y rule text (e.g., for tank 

barges and tank ships, for commodities with vapor pressure greater than 1.5 psia) and 

the requirements for submerged fill are contained within 46 CFR §153.282. In 

discussions with a Coast Guard representative, we understand that similar submerged fill 

requirements are included under 46 CFR parts 151 (Barges Carrying Bulk Liquid 

Hazardous Material Cargoes) and 153 (Ships Carrying Bulk Liquid, Liquefied Gas, or 

Compressed Gas Hazardous Materials) for hazardous cargo rules and under 46 CFR 

part 32 (Pumps, Piping, and Hoses for Cargo Handling, under subchapter D for Tank 

Vessels) for less combustible cargo rules. While parts 151 and 153 refer to barges and 
Draft-Do Not Cite or Quote March 28, 2011 

42

ships, respectively, the Coast Guard representative indicated that the requirements for 

submerged fill are essentially the same, and that the cited section (§153.282) is more 

explicit. As a practical matter the Coast Guard representative believes that all barges 

and ships are conducting submerged fill that meet the §153.282 requirements, and no 

additional retrofit for fill pipe in these vessels would be needed. We have therefore 

retained the cite to 46 CFR 153.282 to be required for loading into barges and ships.

Comment 60: Commenter 280 stated that EPA concluded that there were no 

technology changes that would affect the 1995 MTVLO MACT determinations for 

MTVLO or offshore loading. Commenter 291 stated that EPA found that there were no 

developments in practices, processes, and control technologies.

Response 60: In the 2008 proposal, under section 112(d)(6), we had not 

identified any developments in practices, processes and control technologies (the socalled technology review) for MTVLO. For the 2010 proposal, we conducted a further 

technology review and identified the possibility of cost effective vapor recovery for 

gasoline loading at lower thresholds than the current standard. In addition, as discussed 

in the soon to be published Federal Register preamble to the final rule, we are not 

requiring these additional vapor recovery controls proposed in 2010. However, as 

presented in the soon to be published Federal Register preamble, the final rule does 

require submerged fill for the two subcategories of offshore loading and existing sources 

with MTVLO emissions less than 10/25 tpy HAP, as this is the MACT floor. 

Comment 61: One commenter (280) incorporated by reference their 1995 

MTVLO NESHAP comments as they regard to the applicability of sections 183 and 112 

to the refinery. The commenter cited from their previous public comments on the 1995 

MTVLO NESHAP the following reasons EPA should refrain from requiring the controls: 

EPA lacks authority under 183(f) to apply controls in attainment areas; EPA must make a 

source-specific assessment; a source-specific assessment of their facility would show 

that features of the facility combine to reduce exposure to emissions and ozone formation 

(i.e., not reasonably anticipated to endanger public health and welfare); compliance costs 

would exceed EPA’s cost-effectiveness cutoff due to the additional costs and lower 

emissions for ships and barges; EPA lacks authority to regulate under section 112 since 

authority is under section 183(f) only; EPA should create a separate source category for 

offshore facilities because of unique circumstances.

Response 61: We responded to similar public comments on MACT and RACT in 

the 1995 MTVLO NESHAP2in the Technical Support Document for Final Standards: 

Summary of Public Comments and Responses.3 In summary, we concluded that the 

 

2

 The public comment period for the MTVLO MACT proposal was from May 13 to July 18, 1994; was 

reopened from August 31 to September 30, 1994 for specific comments (amending the Petroleum Refinery 

source category) (59 FR 44955); and was reopened from March 8 to April 7, 1995 for specific comments 

(extending the compliance dates) (60 FR 12703). The Amerada Hess public comment letter (Docket No. 

A-90-44, item IV-D-143) was dated June 6, 1995 and was marked as received on August 26, 1997 

[assumed this was received in June 1995]. A June 1995 letter was received past the closing date of all 

public comment periods and was not summarized or included in the 1995 Technical Support Document for 

Final Standards: Summary of Public Comments and Responses for MTVLO.

3

 See sections 2.1.3, Titles I and III and 2.3.2, Offshore Terminals/Offshore Production of the Technical 

Support Document for Final Standards. (Federal Standards for Marine Tank Vessel Loading Operations 
Draft-Do Not Cite or Quote March 28, 2011 

43

Agency has authority to regulate MTVLO under section 183(f) and section 112; both 

VOC and HAP emissions from MTVLO may be reasonably anticipated to endanger 

human health and welfare; the Agency does not need to show that emissions from each 

facility causes or contributes to pollution; and the title of an Act (Ozone Nonattainment 

Areas) does not demonstrate that section 183(f) applies only in nonattainment areas 

(section 2.1.3). We established a separate subcategory for offshore loading (section 

2.3.2). We believe the 1995 complete responses are appropriate.

Comment 62: Commenter 359 noted that application of beyond-the-floor 

controls to offshore facilities is not justified and EPA did not consider offshore cost 

impacts. Commenter 359 stated that offshore facilities are large facilities, typically

distribute product by ships rather than barges, and have loading berths on very long piers 

farther from shore. Commenter 359 noted issues with the cost evaluation, including that 

it used a fixed assumption for installation costs and is based on a technology not in use at 

offshore facilities. Commenter 359 noted that capital costs are higher for offshore 

loading due to need for additional platform structure and for piping to carry vapors. 

 One commenter 280 stated that capital costs for island facilities are 1.3 to 2.3 

times higher on average. One commenter 280 stated that island facilities transport almost 

all products by marine vessels, have large MTVLO, must build and operate their own 

utilities, do not have access to natural gas, and secondary emissions are higher.

Commenter 280 noted that EPA created the offshore loading terminal subcategory

in 1995 because of these differences and the extreme costs. The commenter reiterated 

their comments submitted for the 1995 MACT and noted the comments are accurate 

today.

2

 Commenters 280, 359 stated that nothing has changed since 1995 to justify the 

changed conclusion on costs and cost effectiveness.

Response 62: As discussed in the soon to be published Federal Register notice 

preamble, the final rule does not include the proposed vapor recovery requirements. We 

have reviewed the comments on the beyond-the-floor costs for offshore loading, and we 

agree that capital costs for offshore loading are likely higher than those for onshore 

MTVLO terminals, but we do not have any other information than that supplied by the 

commenters. We agree that offshore loading should be considered separately based on 

higher costs and have costed them separately. We included emission levels at offshore 

loading facilities based on the emission factor for ship loading, because MTVLO at 

offshore facilities are more likely to load ships than barges, and the emission rate would 

be lower. See additional cost analysis discussion for offshore loading in the cost 

memorandum. 

In regards to island facilities, we did not analyze this. The commenter expressed 

concerns that island facilities have higher costs. Island or remote facilities likely have 

similar, but possibly somewhat less, logistic and cost issues as offshore facilities that we 

considered above.

 

and National Emission Standards for Hazardous Air Pollutants for Marine Tank Vessel Loading 

Operations, Technical Support Document for Final Standards: Summary of Public Comments and 

Responses. U.S. Environmental Protection Agency. EPA Publication No. EPA-453/R-95-014. July 1995. 

See Docket No. A-90-44, item no. V-B-01.)
Draft-Do Not Cite or Quote March 28, 2011 

44

Comment 63: Commenter 359 noted that EPA did not demonstrate any benefit 

from applying control requirements to offshore facilities, and EPA did not assess the 

nature and fate of the emission to determine if emissions would reasonably be anticipated 

to endanger public health or contribute to ozone non-attainment status.

Response 63: The final submerged fill requirements are for previously 

unregulated emission sources and thus we are required to set technology standards under 

CAA section 112(d) (3) standards. The CAA section 112(d)(3) requires that the MACT 

floor for existing sources not be less stringent than “the average emission limitation 

achieved by the best performing 12 percent of the existing sources.” Submerged fill is 

the MACT floor for two subcategories, as discussed in the October 21, 2010 proposal 

preamble.

Comment 64: One commenter 280 provided updated cost information for a 

vapor combustion unit [for 54 million bbl/yr island loading facility] of $67 million in TCI

and $15 million in TAC for a MTVLO with an annual gasoline throughput of 54 million 

bbl/yr. The commenter estimated the cost effectiveness of HAP reductions as 

$106,000/ton HAP and VOC reductions as $7,700 per ton VOC, and noted the cost 

effectiveness could be higher. Commenter 280 noted the beyond-the-floor option for 

offshore loading is not cost effective. The commenter 280 does not agree that MACT 

beyond-the-floor controls should be judged by a criteria pollutant, and noted that 

secondary emission impacts from operation of the control device and associated utilities 

should also be considered.

The commenter states that if additional controls were cost justified for offshore 

loading terminals based on emissions reductions, the $67 million capital cost is 

economically infeasible and thus qualifies for treatment under section 112(h). This 

approach is similar to that included in the rule preamble for Gas 1 Boiler MACT units.

Commenter 280 noted that a vapor recovery system would be 2.5 to 3 times more 

costly to build [than a combustion system]. A vapor recovery system would have a VOC 

cost effectiveness over $13,000/ton VOC and a HAP cost effectiveness of over 

$177,000/ton HAP. 

Response 64: We appreciate the input on capital and annualized costs for 

combustion units for offshore loading. We do not require that a particular control 

technology be installed, so a facility would install any control technology that meets a 

MACT requirement. We costed a lean oil absorption system as an appropriate, 

applicable control technology (see Technical Issues below) and that is lower cost. As 

discussed in the soon to be published Federal Register preamble, we are not requiring 

this proposed additional vapor recovery option.

Comment 65: Commenter 274 noted that many Ozone Transport Commission 

(OTC) states have lowered the threshold for control of emissions from gasoline loading 

and have adopted VOC reduction requirements, and the commenter provided a summary

of regulations in an attachment to their comment letter. The thresholds in OTC rules 

varied from 15,000 gal/day to 6,000,000 gal/day loading (one was 60,000 gal/day in 

ozone season), control efficiencies varied from 90 to 98 percent VOC reductions, and 

some rule limited emissions to 2 lb VOC/1000 bbl loaded. The commenter 

recommended EPA conduct a review of other state regulations in consideration of 
Draft-Do Not Cite or Quote March 28, 2011 

45

strategies to reduce ozone levels. The commenter further suggested a lowering of the 

gasoline loading threshold below the proposed 1 million bbl/yr threshold.

One commenter 297 stated that the proposed rule of 97 percent control is not the 

best MACT standard that is currently feasible, cost-effective, and available. The 

commenter stated that EPA failed to require technologies that eliminate 100 percent of 

emissions, such as several off-the-shelf Zero Emission Technologies, and failed to 

require technologies that are 99+ percent effective in capturing emissions and fugitives 

for ship and land storage tanks, conveyance systems, and connection nozzles. The 

commenter requested that EPA research, identify, ascertain and establish a list of 

available Zero Emission Technologies and MACT Vapor Recovery Systems that could 

be used for compliance to this proposed ruling.

The commenter noted that EPA failed to require a secondary enclosure or 

encasement device to prevent fugitive emissions from escaping from leaking valve 

connections.

One commenter 297 recommended that EPA adopt work practices and procedures 

that would identify, track and require mandatory periodic replacement of frequent 

equipment, systems, and parts failures, because it is common petroleum industry practice 

to wait for something to break. Equipment is subject to metal fatigue, embrittlement, and 

breakdown.

Response 65: We appreciate the information regarding additional rules that 

support our determination of controlled HAP emissions from gasoline loading at 1 

million bbl/yr or less. The commenter did not provide the data to support those vapor 

recovery rules. We believed they are based on VOC reductions and cost effectiveness. 

From our analysis, we do not believe additional vapor controls are cost effective for HAP 

reductions beyond the current standard. 

While we have conducted searches to identify zero emission technologies for 

control of HAP emissions from MTVLO, the searches revealed mostly zero emission 

technologies related to combustion emission sources, and not for MTVLO. Thus, we do 

not have, nor did the commenter provide, any specific technologies and environmental 

benefits and costs to assess these technologies for MTVLO. While one commenter 

recommended work practices that require mandatory replacement of equipment, the 

commenter did not provide data on failure frequencies or rates, costs, or environmental 

impacts on which to evaluate the commenter’s suggestion. Additionally, current Coast 

Guard rules include safe handling practices and operations that may address these 

issues. See 92 FR 25005; May 13, 1994, Background and History for Proposal of the 

Coast Guard and EPA Standards.

Comment 66: Two commenters (359, 264) indicated that §63.560(f) needs 

corrections related to submerged fill requirements.

One commenter (359) noted that EPA indicated that the submerged fill 

requirement would be applied to existing facilities below the 10/25 tpy threshold by a 

new paragraph §63.560(f), however, in the actual rule language submerged fill is 

proposed only for offshore facilities. Commenter (359) noted that proposed edits to 

§63.560(a)(1), (2), and (3) refer to a paragraph (f) “of this section” but paragraph (f) does 

not exist.
Draft-Do Not Cite or Quote March 28, 2011 

46

Commenter (264) stated that a correction is needed in the proposed language of 

subpart Y to add a new paragraph §63.560(f) concerning the submerged loading 

requirement for 2 subcategories (i.e., those facilities emitting less than 10/25 TPY of 

HAP and those facilities located more than 0.5 miles from shore) and to reference the 

new provisions in §63.562(f)(1) or (f)(2) for marine terminals that load more than 1 

million bbl/yr of gasoline.

Response 66: We appreciate the commenters pointing out the omission of 

§63.560(f) in the proposed rule text. We mistakenly omitted this paragraph but did 

include the text in the docket (see Docket item EPA-HQ-OAR-2010-0600-0253). In the 

final rule, we are adding the submerged fill requirement to a new subparagraph 

§63.560(a)(4) for sources with MTVLO emissions less than 10/25 tpy HAP. (The same 

submerged fill requirements are also included in the final rule for offshore loading in 

§63.560(d)(6).) No new paragraph §63.560(f) will be added to the rule.

Comment 67: One commenter (359) noted that the proposed edits to 

§63.562(b)(1)(i) should read "1 million bbl/yr of gasoline" rather than "1 M barrels of 

gasoline," so as to read correctly and to be consistent with proposed edits to 

§63.562(b)(1)(ii) and (iii).

One commenter (359) stated that while proposed edits to §63.562(b)(1) would 

apply the vapor collection and vapor-tightness requirements to facilities that load at least 

1 M bbl/yr of gasoline, the control standard for these facilities is specified separately in a 

proposed new paragraph §63.562(f). The commenter explained that the manner in which 

this is done results in the following provisions not being applicable to the new 

subcategory:

(1) §63.562(b)(5) Prevention of carbon adsorber emissions during regeneration.

(2) §63.562(b)(6) Maintenance allowed for loading berths. 

(3) §63.563(b) Compliance determination for affected sources (initial 

performance test). 

The commenter explained that it is not apparent whether EPA intended for these 

provisions to not apply to the new subcategory of facilities that load at least 1 M bbl/yr of 

gasoline.

Response 67: We appreciate the commenter’s questions on certain rule 

provisions being applicable to existing sources with MTVLO emissions less than 10/25 

tpy and loading 1 million bbl/yr of gasoline, however, the final rule does not include the 

vapor recovery requirements. The proposed vapor recovery requirements paragraph in 

§63.562(f), and the proposed changes to §63.562(b)(1) are not in the final rule. 

Comment 68: One commenter (359) noted that the proposed edits to Table 1, at 

§63.10(c)(10) and (11), include a reference to §63.657(m)(1) for reporting malfunctions 

but no paragraph §63.657(m) exists.

Response 68: We appreciate the commenters pointing out the omission of 

§63.567(m) in the proposed rule text. We mistakenly omitted this paragraph. In the final

rule, we are adding a new paragraph in §63.567(m) for reporting malfunctions. This 

paragraph is similar to malfunction paragraphs in other rules included in the proposal 

(e.g., in subpart KK, §63.829(b)(6)(v); and in subpart CCC, §63.1164(c)). 
Draft-Do Not Cite or Quote March 28, 2011 

47

Comment 69: Commenter (264) recommended that EPA clarify that §63.562(e) 

does not apply to existing sources with emissions less than 10 and 25 tons (since the 

emission limits do not apply) and that only §§63.560(f)(1) [new section], 63.567(j)(4) 

and 63.565(l) apply as per §63.560(a)(3). As proposed, §63.56[0](a)(2) states that 

existing sources with emissions less than 10 and 25 tons are not subject to the emission 

standards in §63.562(b) and (d), except as specified in paragraph (f) [submerged fill]. 

The commenter noted §63.56[0](a)(3) implies that only the recordkeeping requirements 

in §63.567(j)(4) and the emission estimation requirements in §63.565(l) apply to these 

sources, except as specified in paragraph (f) [submerged fill]. Commenter (0264) noted 

that the way §63.560(a)(2) is worded, one might conclude that §63.562(e) applies to 

existing sources with emissions less than 10 and 25 tons. However, §63.560(a)(3) could 

again lead one to conclude that only those citations mentioned are applicable to sources 

with emissions less than 10 and 25 tons.

Because the emission standards do not apply to existing sources with emissions 

less than 10 and 25 tons, the commenter suggested that one could conclude the operation 

and maintenance requirements in §63.562(e) for air pollution control equipment and 

monitoring equipment do not apply either. 

Commenter (264) noted that the proposed changes to the Marine MACT include 

adding paragraph (7) to §63.562(e) to address recordkeeping and reporting requirements 

during periods of malfunction. The rule also is proposing an affirmative defense against 

civil penalties for exceedances of emission standards caused by malfunctions, as well as 

the criteria for establishing the affirmative defense. Because §63.560(a)(2) specifically

states that the emission standards in §63.562(b) and (d) do not apply to existing sources 

with emissions less than 10 and 25 tons, then the affirmative defense requirements 

proposed in §63.562(e)(7) for exceedances of the emission standards caused by

malfunctions should not apply either. The commenter recommended that the language in 

§63.560(a)(3) be revised: 

(a)(3) Only the recordkeeping requirements in §63.567(j)(4) and the emission 

estimation requirements of §63.565(l) apply to existing sources with emissions less than 

10 and 25 tons, except as specified in paragraph (f) of this section. No other requirements 

in this subpart apply to existing sources with emissions less than 10 and 25 tons.

Response 69: We have reviewed the comments and we believe that the current 

and final §63.562(e) “operation and maintenance requirements for air pollution control 

equipment and monitoring equipment for affected sources” are applicable to existing 

sources with MTVLO emissions less than 10/25 tpy and are now subject to submerged fill 

requirements. The proposed and the current language of §63.562(e) provides “owner 

and operators of affected sources shall operate and maintain a source, including 

associated air pollution control equipment, in a manner consistent with safety and good 

air pollution control practices for minimizing emissions”. Additionally, submerged fill 

reduces the generation of vapor emissions, so it is considered air pollution control 

equipment as well as process equipment. Thus, it applies to both “control equipment” 

and the “source” and is not limited to, as the commenter says, to “emission limits” and 

“air pollution control equipment.” Additionally, we believe the added subparagraph 

(§63.562(e)(7)) for malfunctions is applicable for the same reasons stated above.

We do not believe §63.560(a)(2) and (3) specify requirements for emission 

estimation and recordkeeping as the “only” requirements since the current rule text does 
Draft-Do Not Cite or Quote March 28, 2011 

48

not use “only.” However, for clarity, instead of revising the subparagraphs to add the 

submerged fill requirement as we did in the proposal rule text, we are adding the 

submerged fill requirement as a new subparagraph §63.560(a)(4) in the final rule.

Comment 70: One commenter (264) requested that in the emission estimation 

procedures under §63.565(l), EPA clarify that the exclusion for "Commodities Exempted 

by §63.560(d)" was intended to mean that annual HAP emissions do not need to be 

estimated from marine tank vessel loading operations that meet any of the exemptions 

provided in §63.560(d). The commenter believes that, in addition to excluding 

“commodities,” other exemptions in §63.560(d) that should be excluded from the annual 

emission estimation requirement in §63.565(l) include §63.560(d)(2) thru (7).

The commenter stated EPA could improve the language in §63.565(l) by rewording it 

as follows:

(l) Emission estimation procedures. For sources with emissions less than 10 or 25 

tons and sources with emissions of 10 or 25 tons, the owner or operator shall calculate an 

annual estimate of HAP emissions, excluding commodities emissions from marine tank 

vessel loading operations exempted by §63.560(d), from marine tank vessel loading 

operations.

Response 70: We appreciate the commenter requesting clarification to 

§63.565(l); however, the commenter’s proposed changes to the rule text would not 

change this paragraph, and the impacts are unknown. Therefore, we are not adopting 

the suggested language in this final action.

2.8 Other Comments

Comment 71: Commenter 297 stated that EPA failed to provide adequate public 

notice and meetings to the public and Environmental Justice Communities that would be 

most impacted by this rulemaking. The commenter noted that EPA provided the 

minimum public notice required by law, but made no effort to identify EJ advocacy

organizations that traditionally participate in EPA rulemakings or those located in US 

port areas where Marine Tank Vessel Loading Operations are located, noting that most of 

these groups do not subscribe to the Federal Register. The commenter stated that EPA 

could have worked with their Regional Offices to identify EJ advocacy organizations.

The commenter requested that EPA conduct public hearings in Environmental Justice 

Communities that would be most impacted by this new rulemaking, including areas 

where Ports and Marine Fuel Terminals are located.

Response 71: EPA followed the Clean Air Act provisions of section 307(d) in 

providing public notice of its actions and generally does not provide special notice to any 

individual parties. These EJ organizations may also use the free website 

http://www.federalregister.gov/environment to help identify Federal Register notices 

related to environmental topics that may be of interest. 

Comment 72: Commenter 265 supports EPA’s efforts to conduct the residual 

risk and technology reviews concurrently, which provides for efficiency, avoids potential 
Draft-Do Not Cite or Quote March 28, 2011 

49

inconsistency between standards, and allows for the results of the residual risk 

assessment to inform the technology review determination.

Response 72 We agree with the commenter about the benefits of conducting 

these reviews concurrently, where the statutory residual risk and technology review 

deadlines make this practicable.