# National Emissions Standar ds for Hazardous Air

Pollutant s : Flexible Polyurethane Foam Production

Summary of Public Comments and Responses on Proposed Rule

(78 FR 661 0 8, November 4, 2013)

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

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## T able of Contents

Page

Table of Contents

................................ ................................ ................................ ................................ ........... i

List of Acronyms and Units of Measure

................................ ................................ ................................ ....... ii

1. Introduction

................................ ................................ ................................ ................................ ............... 1

2. Summary of Public Comments

................................ ................................ ................................ ................ 2

2.1. Risk Assessment

................................ ................................ ................................ ................................ 3

2.2. Startup, Shutdown and Malfunction

................................ ................................ ................................ .. 8

2.3. Miscellaneous Comments

................................ ................................ ................................ .................. 9DRAFT

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ii 

## List of Acronyms and Units of Measure

ABA auxiliary blowing agent

AEGL acute exposure guideline levels

ATSDR A gency for Toxic Substances and Disease Registry

CAA Clean Air Act

CEM continuous emissions monitor

CFR Code of Federal Regulations

CRWI Coalition for Responsible Waste Incineration

EPA Environmental Protection Agency

EJ environmental justice

EO executive order

ERPG Emergency Response Planning Guidelines

FPUF flexible polyurethane foam

HAP hazardous air pollutants

HEM

- 3 Human Exposure Model, Version 1.1.0

HON Hazardous Organic NESHAP

LDAR leak detection and repair

MACT maximum achievable control technology

NACAA National Association of Clean Air Agencies

NCDENR North Carolina Department of Environment and Natural Re sources

NESHAP National Emissions Standards for Hazardous Air Pollutants

PB

- HAP hazardous air pollutants known to be persistent and bio

- accumulative in the

environment

PFA Polyurethane Foam Association

ppm parts per million

REL reference exposure level

RfC reference concentration

RTR residual risk and technology review

SAB Science Advisory Board

SIP state implementation plan

SSM startup, shutdown and malfunction

tpy tons per year

WWW world wide web1



## 1. Introduction

On November 4, 2013 (78 FR 66108), the U.S. Environmental Protection Agency (EPA) proposed to revise the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Flexible Polyurethane Foam Production under the authority of section 112 of the Clean Air Act (CAA). This document presents summaries of the comments that were submitted in response to this action and our responses to those comments f or all the comments not discussed in th e preamble to the final rule . Within each comment s ummary, the EPA provides one or more Docket ID numbers for commenters who raised particular issues. However, the list of commenter ID numbers is not meant to be exhaustive. The EPA does not individually identify each and every commenter who made a certain point in all instances, particularly in cases where multiple commenters express essentially identical arguments. Although portions of the preamble to the final rule are paraphrased in this document, to the extent any ambiguity is introduced by paraphrasing , the preamble itself remains the definitive statement of the rationale for the final

rule. The comments to which we are responding were submitted in 8 letters from industry representatives, governmental entities, environmental advocacy groups, and citizen s during the public comment period. In addition, the EPA received one comment letter from an industry group following the close of the comment period. Although the EPA is not required to respond to this late comment, to the extent practicable, the EPA ofte n attempts to respond to late comments and our responses to the comments from this group are also presented in this document. A list of the commenters, their affiliations, and the EPA docket number assigned to their correspondence is presented in Table 1

- 1. For simplicity, only the last four digits of the document numbers specific to each commenter are presented in this document ( e.g. , 0051,

instead of EPA

- HQ

- OAR

- 2012

- 0510

- 0051) . The EPA Docket contains all comment letters

submitted and the comments are av ailable for viewing at the EPA Docket Center Reading Room, or electronically through http://www.regulations.gov by searching Docket ID No. EPA

- HQ

OAR

- 2012

- 0510 by docket number.DRAFT

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2 Table 1. List of Commenters on 40 CFR Part 63 Subpart III, Proposed November 4, 2013 (78 FR 66108)

Docket No.

EPA

- HQ

OAR

- 2012

- 0510 Commenter Name Affiliation

0051 Anonymous Not provided

0052 Nancy Jones North Carolina Dept. of Environment and Natural Resources (NCDENR)

0053 Shelia Holman North Carolina Dept. of Environment and Natural Resources (NCDENR)

0054 Robert H. Colby National Association of Clean Air Agencies (NACAA)

0055 Jim Pew, Emma Cheuse Sierra Club

0056 Melvin Ke e ner Coalition for Responsible Waste Incineration (CRWI)

0057 Natalie Varela Private citizen

0058 Robert L ue deka Polyurethane Foam Association (PFA)

0059 (late comment) Robert L ue deka Polyurethane Foam Association (PFA)



## 2. Summary of Public Comments

The following sections of this document summarize the public comments received on the proposal and present the EPA’s responses to those comments. The comment summaries are grouped by topic in Sections 2.1 through 2.4 a s follows:

 Section 2.1

– Risk Assessment

 Section 2.2

– Technology Review

 Section 2.3

– Affirmative Defense and Startup, Shutdown, and Malfunction

 Section 2.4

– Miscellaneous Comments

The comment summaries are numbered sequentially (1, 2, 3, etc.) throughout the document, regardless of section.DRAFT

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3 

### 2.1 . Risk Ass essment

1. Comment: Commenter s 0052 and 005 3

– NCDENR reviewed the data used in the risk modeling and found a North Carolina facility included in the modeling database that should not
have been included

. The commenters stated that the Hickory Springs Manufacturing

– Conover Complex facility is not a major source for HAP subject to 40 CFR part 63 subpart III but is an

area source. Commenter 00 52 provided the current facility operating permit to show that the facility is subject to 40 CFR part 63 subpart OOOOOO (the FPUF production and fabrication area source NESHAP) rather than 40 CFR part 63 subpart III.

Response : We have reviewed th e submitted information and agree that this facility is not subject to 40 CFR part 63 subpart III and does not need to be included in the modeling database for the flexible polyurethane foam (FPUF) production source category. W e determined that it is not necessary to perform additional modeling with this revision, as this cha nge w ould decrease emissions from the source category and w ould not affect the cost

- effectiveness of the control measures considered. Thus, this change to the modeling database would not affect our decision that it is not necessary to revise the MACT stand ard for this source category pursuant to our

review under CAA section 112( d )( 6 ) and, to the extent it has any effect on our decision pursuant to CAA section 112(f)(2) that the existing standard provides an ample margin of safety, it would provide further s upport

.

2. Comment: Commenter 0054

– NACAA recommends using potential or allowable

emissions , rather than actual emissions in evaluating residual risk. The commenter expresse s concern with the use of actual emissions in parts of the risk analysis. The commenter argues that, since facility emissions could increase over time for a variety of reasons, the use of potential or allowable emissions is more appropriate. The commenter believe s an analysis based on actual emissions from a single point in tim e could underestimate the resid ual risk from a source category. Further, the commenter note s that the major source HAP thresholds are based on potential

- to

- emit, as opposed to actual emissions, and air agencies issue permits based on potential emissions. A ccording to the commenter, l imiting the scope of a risk evaluation to actual emissions would be inconsistent with the applicability section of Part 63 rules. The commenter i s pleased to see that the EPA used allowable emissions in some areas of the rulemak ing, but is

concerned that the EPA used actual emissions in parts of its risk analysis. Commenter 0054 encourages the EPA to use allowable emissions in the future, including in assessing acute health

risks.

Response : Consistent with previous risk assessm ents, the EPA considers both allowable and actual emissions in assessing chronic risk s under section 112(f)(2). (See, e.g., National Emission Standards for Coke Oven Batteries (70 FR 19998

- 19999, April 15, 2005); proposed

and final National Emission Standa rds for Organic Hazardous Air Pollutants from the Synthetic Organic Chemical Manufacturing Industry (71 FR 34428, June 14, 2006, and 71 FR 76603, December 21, 2006). This approach is both reasonable and consistent with the flexibility

inherent in the Benze ne NESHAP framework for assessing acceptable risk and ample margin of safety. As a general matter, modeling allowable emission levels is inherently reasonable sinceDRAFT

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4 this reflects the maximum level sources could emit and still comply with national emission standards. But it is also reasonable to consider actual emissions, where such data are available, in acceptable risk and ample margin of safety . See National Emission Standards for Coke Oven Batteries, 70 FR 19992, 19998 (April 15, 2005). The commenter cla ims that limiting our review to actual emissions would be inconsistent with the applicability section of Part 63 rules. As explained, however, we did not limit our review to actual emissions

. Finally, the commenter urges the Agency to rely on allowable emissions for pu rpose of

our acute assessment. The use of allowable emissions was not considered due to the conservative assumptions used to gauge worst

- case potential acute health effects. The conservative assumptions built into the screen include: ( 1) us e of peak 1

- hour emissions that are on average

ten times the annual average 1

- hour emission rates; ( 2) that all emission points experienc e peak emissions concurrently; ( 3) worst

- case meteorology (from 1 year of local meteorology); and (4 ) that a person is located downwind at the point of maximum impact during this same 1

­ hour period. Thus, performing an acute screen based on allowable emissions would be overly conservative and at best, of questionable utility to decision makers.

3. Comment: Commenter 0054

- NA CAA state s that the use of Acute Exposure Guideline Levels ( AEGLs ) or Emergency Response Planning Guidelines ( ERPGs ) in residual risk assessments is not appropriate and does not ensure that public health is adequately protected from the acute impacts of HAP exposure. These limits were developed for accidental release emergency planning and are not appropriate for assess ing daily human exposure scenarios. In the December 2002 EPA document, "A Review of the Reference Dose and Reference Concentration Processes," EPA stated that the primary purpose of the Acute Exposure Guideline Level ( AEGL ) program is to develop guidelines for once

- in

- a

- lifetime, short

- term exposures to airborne concentrations of acutely toxic chemicals. They are not meant to evaluate the acute impacts from routine emissions that occur over the life of a facility. Unlike the reference concentrations (RfCs) for chronic exposures, the AEGLs and ERPGs do not include adequate safety and uncertainty factors and cannot be relied upon to protect the public from the adverse effects of exposure to toxic air pollutants. The commenter supports the EPA’s increased relia nce on the California Reference Exposure Levels ( RELs ) to address acute exposures in the residual risk assessments, and the commenter continued to urge EPA to use RELs for these assessments.

Response: To better characterize the potential health risks as sociated with estimated acute exposures to HAP, and in response to a key recommendation from the SAB’s peer review

of the EPA’s RTR risk assessment methodologies, 1 we generally examine a wider range of available acute health metrics ( e.g., RELs, AEGLs) tha n we do for our chronic risk assessments.
This is in response to the SAB’s acknowledgement that there are generally more data gaps and

inconsistencies in acute reference values than there are in chronic reference values. In some cases, when Reference Value Arrays 2 for HAP have been developed, we consider additional

1 11 The SAB peer r eview of RTR Risk Assessment Methodologies is available at: http://yosemite.epa.gov/sab/sabproduct.nsf/4AB3966E263D943A8525771F00668381/$File/EPASAB

- 10

- 007

- unsigned.pdf

.

2 U.S. EPA. (2009) Chapter 2.9 Chemical Specific Reference Values for Formaldehyde in Graphical Arrays of

Chemical

- Specific Health Effect Reference Values for Inhalation Exposures (Final Report). U.S. Environmental Protection Agency, Washington, DC, EPA/600 /R

– 09/061, and available on

- line at http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=211003.DRAFT

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5 acute values (i.e., occupational and international values) to provide a more complete risk

characterization. As discussed in the preamble to the proposed rule ( 78 FR 66115 ), the exposure gui delines EPA considers depend s on which exposure guidelines are available for the various hazardous air pollutants emitted by the relevant source category. The various guidelines that EPA may consider in assessing the potential for risks from acute exposur es , include the California acute REL, and AEGL and ERPG values,

4. Comment: Commenter 0054

- NACAA note s that, in assessing the cancer risks related to

the source category, EPA use s long

- term concentrations affecting the most highly exposed

census block for each facility. The commenter believes this analysis dilute s the effect of sources’ emissions by estimating the impact at the centroid of the census block instead of at the property line or wherever the maximum exposed individual is. Since census blocks ca n be large geographically, depending on the population density, the maximum point of impact can be far from the centroid, including at or near the property line where people may live or work. Further, the commenter notes, w hile it is possible that population distribution is homogenous over a census block, this assumption is not necessarily accurate in considering the predicted impacts

from the location of a source. The commenter argues that u sing the Human Exposure Model

- 3 ( HEM

- 3), EPA can identify the maximum individual risk at any point in a census block that is

within a 50

- kilometer radius from the center of the modeled facility. Based on HEM

- 3’s power and ability, the commenter suggests that EPA abandon its use of the pre dicted chronic exposures at the census block centroid as surrogates for the exposure concentrations for all people living in that block. Rather, commenter 0054 recommend s that EPA use the truly maximum individual risk, irrespective of its location in the c ensus block, in its section 112(f)(2) risk assessments. With respect to the development of screening estimates of acute exposures and risk for non

cancer health effects, the commenter is pleased that EPA did not focus on the centroid of the

census blocks.

Response: As we have explained in previous RTRs, such as the Hazardous Organic NESHAP ( HON ) RTR (71 FR 76603, December 21, 2006), the EPA believes 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, in determining chronic risks, the EPA believes that it is appropriate to use cen sus block information on where people actually reside, rather than points at the property line, to locate the estimation of exposures and risks to individuals living near such facilities. If a population did indeed live just outside of the property line of a facility, then it would result in a census block near the property line

. To estimate ambient concentrations for evaluating long

- term exposures, the Human Exposure Model (HEM) uses the geographic centroids of census blocks as dispersion model

receptors. The census block centroids are generally good surrogates for where people live within a census block. A census block generally encompasses about 40 people or 10

- 15 households. We agree with the commenter that in some cases where a census block is large t he centroid may not be representative of the block’s residential locations. Risk estimates based on such centroids can be underestimated if there are residences nearer to a facility than the centroid,

and overestimated if the residences are farther from th e facility than the centroid. Although theDRAFT

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6 risk assessment documentation available in the docket for the proposal rule did not explain this aspect of our analysis , to avoid underestimating the maximum individual risk associated with a facility, we examined aerial images of all large census blocks within one kilometer of any emission source. (Experience from previous risks characterizations show s that in most cases the MIR is located within 1 km of the facility boundary.) If the block centroid did not repres ent the residential locations, we considered a location that better represent ed where people reside in that

census block . If residential locations could not be represented by a single receptor (that is, the residences were spread out over the block), we ad ded additional receptors for residences nearer to the facility than the centroid. For this source category, we added several receptors for census blocks where the centroid location was not representative of the residential locations. We have revised risk assessment documentation to provide additional information on these changes in Appendix 7 of the Residual Risk Assessment for the Flexible Polyurethane Foam Production Source Category. Commenter 54 stated that they were pleased our acute and noncancer risk analyses do not focus on the centroid of the census blocks. This statement is correct for our acute analysis, which assumes a person is located downwind at the point of maximum impact, but no nearer to the source than 100 meters. However, chronic effects other than cancer are expressed in terms of the hazard quotient (HQ) for inhalation, which is calculated for each HAP at each census block centroid. As indicated above, in cases where we determined the centroid did not represent the

residential area for a large census block, we added additional receptors to better represent

residential locations.

5. Comment: Commenter 0054

- NACAA and commenter 0057

– private citizen believe improvements are needed in the EPA’s methods of evaluating environmental justice (EJ)

. Commenter 0057 notes that the analysis emphasize s the demographics of the nearby neighborhoods to these 13 manufacturers, and that the EPA identifies that there is a higher

likel ihood for African Americans to be within 3 miles of these sites. The commenter states that, since the EPA has determined that risks from this site are acceptable for all populations, the EPA claims it is not an environmental justice issue. The commenter argues that in order to better serve the purposes of Executive Order 12898 Feder al Actions to Address Environmental Justice in Minority Populations and Low

‐ Income Populations, the EPA should conduct a more thorough Environmental Justice report than provided by Environmental Justice Review: Flexible Polyurethane Foam Production , and sh ould identify the demographic characteristics of the most highly affected individuals or communities. The commenter also recommends that the EJ report provide the actual locations of the manufacturing sites, to demonstrate trends by regions or any

intersta te trends. Commenter 0054 recommends that EPA conduct the demographic analysis on individuals projected to experience a facility

- wide risk greater than 1

- in

- 1

- million and also on individuals living within five kilometers of the facility, regardless of proj ected risk, consistent with the approach used for the Hard and Decorative Chromium Electroplating and Chromium Anodizing Tanks source category. The commenter notes that EPA determined that the ratio of African Americans living within three miles (4.8 kilom eters) of any source affected by this rule is 48 percent higher than the national average. The commenter argues that EPA failed to address the disproportionate impact on African Americans even though the agency’s Interim Guidance on Considering Environment al Justice During the Development of an Action , states that the agency should consider addressing existing disproportionate impacts on minority, low

- income, orDRAFT

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7 indigenous populations during rulemaking. Commenter 0054 also recommends that EPA rule

writers w ork with the EPA Office of Environmental Justice to develop criteria and specific guidance on how to interpret and apply the outcome of these types of analyses in the rulemaking

process.

Response: Under EO 12898, the EPA is directed to the greatest extent practicable and permitted by law, to make EJ part of its mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies and activities on minority populations an d low

- income populations in the United States.

Consistent with Executive Order (EO) 12898 and the Presidential Memorandum that accompanies it, the EPA’s EJ policies promote EJ by focusing attention and Agency efforts on addressing the types of environmenta l harms and risks that are prevalent among minority, low

income and indigenous populations. EO 12898 and the Agency’s EJ policies do not mandate particular outcomes from an action, but they stipulate that decisions involving the action be informed by a consideration of EJ issues. As noted at proposal (78 FR 66123), we determine whether or not to conduct a demographics analysis considering a combination of factors

, including the MIR, non

- cancer TOSHI, population around the facilities in the source category and other relevant factors. For the FPUF production source category, our analyses show that actual emissions result in no individuals being exposed to cancer risk greater than 1

- in

- 1 million

, a non

- c ancer TOSHI greater

than 1

, or an acute HQ greater than 1 . Therefore, no individuals experience high and adverse human health effects, regardless of whether those individuals are in minority, low

- income or indigenous populations

. However, we did conduct a proximity analysis to identify the demographic characteristics of the populations near FPUF production facilities, and the results of that analysis were considered in our rulemaking decisions. We also note that we are working

with the Office of Environmen tal Justice in an ongoing effort to develop new tools for considering environmental justice in rulemakings. We thank the commenter for providing feedback that it would be helpful for the EJ report to include the manufacturing site locations. We have added a map of the FPUF locations to the

Final Environmental Justice Review: Flexible Polyurethane Foam Production document, and we will consider including similar information in future EJ documents

.

6. Comment: Commenter 0059

- PFA remarked that emissions from FP UF production facilities are not hazardous to area communities and population groups, and existing air emission data and worker health information collected by the commenter demonstrate that these facilities do not pose any environmental hazards to the sur rounding community or the workforce. The commenter also noted that the facilities are subject to periodic air monitoring and do not have a history of compliance problems. Thus, the commenter believes that even without the proposed changes to the FPUF NESHAP, there are no environmental or health hazards associated with

emissions from the FPUF production source category.

Response: The EPA generally agrees with the commente r. Based on the results of our risk assessment for current actual emissions from the source category, we have determined that the risks from the FPUF production source category are acceptable and provide an ample margin of safety to protect public health a nd prevent an adverse environmental effect. The final amendments to the FPUF production NESHAP prohibit ing the use of HAP or HAP

- basedDRAFT

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8 auxiliary blowing agents (ABAs) , which are not currently used but were once widely used by the FPUF production industry, will ensure that no future emissions or risk increases occur due to

these HAP.



### 2. 2 . Startup, Shutdown and Malfunction

7. Comment: Commenter 0055

- Sierra Club urges the EPA not to adopt the affirmative defense provisions. The commenter states that the affirmative defense provisions are unlawful and harmful. The commenter argues that Congress plainly intended citizens to be able to enforce

emission standards und er the CAA using the full range of civil enforcement mechanisms available to the government, and, in the HAP context, subject only to the limitation that government not be “diligently prosecuting” its own civil enforcement action, according to CAA

section 304(b)(1)(B). The commenter observes that the CAA gives the EPA minimal discretion that only applies to administrative penalties which may be imposed under subsection 113(d), but no authority to compromise, modify or limit civil penalties that a court may impose under section 113(e) or section 304. The commenter further states that the proposal will impermissibly chill citizen participation and the ability to win an effective, deterrent remedy in CAA enforcement

actions. The commenter asserts that the burd en the affirmative defense places on citizens makes it less likely that they will enforce the CAA. The commenter also states that if the EPA had the authority to promulgate any affirmative defense to penalties for malfunction, it should also promulgate st rong reporting, monitoring, and other compliance measures, require a specific monetary penalty for each malfunction, and require that the affirmative defense cannot be used by a specific facility or company more than once within a set period of time, such as 10 years. In contrast, Commenter 0059

– PFA argues that the EPA has the authority to develop an affirmative defense, and the affirmative defense provides tools to ensure that future malfunctions do not occur or are corrected promptly if they do. The co mmenter points out that no systems, including emissions control systems, are perfect and that machinery malfunctions are unfortunate occurrences of everyday life in modern society. In support of the inclusion of an affirmative

defense the commenter contend s that: (1) the affirmative defense the EPA proposes provides the court discretion, as “the merits” of the affirmative defense “are independently and objectively evaluated in a judicial or administrative proceeding

, ” (2) the EPA proposes elements that a

d efendant must prove by a preponderance of the evidence to establish an affirmative defense, such as proving that the violation was caused by a “sudden, infrequent, and unavoidable failure of air pollution control, process equipment, or a process to operate in a normal or usual manner,” (3) a defendant who successfully establishes an affirmative defense is not permitted to continue emitting HAPs above the applicable emission threshold ; and (4) the EPA is not charting new territory by establishing an affirmat ive defense for this rule, and the United States Court of Appeals for the Fifth Circuit recently upheld the EPA’s view that an affirmative defense provision is consistent with CAA section 113(e) ( Luminant Generation Co. LLC v. United States

EPA , 714 F.3d 841 (5 th Cir. Mar. 25, 2013).

A third c ommenter 0056

- CRWI suggests several modifications to the affirmative defense provisions concerning the phrase “preponderance of evidence,” as is used in paragraph 63.1290(e)(1) ; the use of the words “any” and “all” ; the requirement for “properly signed, contemporaneous operating logs” ; t he definition of malfunction ; and the formal root cause analyses

.DRAFT

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9 Response: The EPA received several comments on the affirmative defense to civil penalties for violations caused by m alfunctions that the EPA proposed to include in the rule.

One commenter supported the affirmative defense

. Two o ther commenters opposed the affirmative defense or various components of the affirmative defense. Recently, the United States Court of Appe als for the District of Columbia Circuit vacated an affirmative defense in one of the EPA’s Section 112 regulations. NRDC v. EPA , No. 10

- 1371 (D.C. Cir. April 18, 2014) 2014 U.S. App. LEXIS 7281 (vacating affirmative defense provisions

in Section 112 rule establishing emission standards for Portland cement kilns). The court found that the EPA lacked authority to establish an affirmative defense for private civil suits and held that under the CAA, the authority to determine civil penalty amounts in such case s lies exclusively with the courts, not the EPA. Specifically, the Court found: “As the language of the
statute makes clear, the courts determine, on a case

- by

- case basis, whether civil penalties are ‘appropriate.’” See NRDC , 2014 U.S. App. LEXIS 7281 at * 21 (“[U]nder this statute, deciding whether penalties are ‘appropriate’ in a given private civil suit is a job for the courts, not EPA.”). The EPA is not including a regulatory affirmative defense provision in the final rule. In the event

that a source fa ils to comply with an applicable CAA section 112 standards as a result of a malfunction event, the EPA’s ability to exercise its case

- by

- case

- enforcement discretion to determine an appropriate response provides sufficient flexibility in such circumstances as is explained in more detail in the preamble to the final rule. Further, as the D.C. Circuit recognized, in an EPA or citizen enforcement action, the court has the discretion to consider any defense raised and determine whether penalties are appropriate. Cf. NRDC, 2014 U.S. App. LEXIS 7281 at *24 (arguments that violation were caused by unavoidable technology failure can be made to the courts in future civil cases when the issue arises). The same is true for the presiding officer in

EPA administrative enf

orcement actions. In light of the EPA’s decision not to include the affirmative defense in the final rule, we are not responding to the comments opposing the

affirmative defense or to comments recommending revisions to a regulatory affirmative defense

prov ision . With respect to comments that supported the affirmative defense the preamble to the final rule explains in detail the EPA’s reasons for not including an affirmative defense provision

in the final rule.



### 2. 3 . Miscellaneous Comments

8. Comment: Commenter 0058 PFA

- The PFA agrees with the review and recommendations of the EPA concerning the effectiveness of the initial MACT standard and that further controls to reduce residual risks are unnecessary. The commenter also concurs with the EPA's prop osal to add an affirmative defense to civil penalties for violations of emission standards that are caused by equipment malfunctions and commends the EPA for recognizing that, in spite of diligent efforts to properly maintain equipment, emission standards may be violated under circumstances beyond the control of the source. Commenter 0057

– Private

Citizen supports the pr o posed prohibition of the use of HAP or HAP based ABAs and the requirements for period s of startup, shutdown and malfunction.

Response: We acknowledge the commenter s ’ support for the EPA’s proposed rule requirements. We discuss the affirmative defense in our responses in section 2. 2 of this

document.DRAFT

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10 9. Comment: Commenter 0051

- Anonymous states that the NSPS and MACT regulations

should have explicit requirements for the types of activities that would trigger a recertification of

continuous emissions monitor s (CEMs ). The commenter suggests requirements similar to the 40 CFR Part 75 CEM requirements, such as CEM replacement, sampling line replacement, major CEM components, etc. should be used. The commenter adds that the regulation should state how data collected from a CEM should be handled from the time period the "upgraded" CEM was

rest arted until it was re

- certified (e.g., d ata reported as downtime or good data, how exceedances should be handled)

.

Response: T he FPUF MACT standards do not include CEM requirements; therefore, the commenter’s remarks are beyond the scope of this rule.