From: Topham.Nathan@epamail.epa.gov

Sent: Friday, October 14, 2011 4:53 PM

To: cortney_higgins@omb.eop.gov; Kymn, Christine J.

Cc: Guinnup.Dave@epamail.epa.gov; Talcott.Fred@epamail.epa.gov; 

tierney.jan@epamail.epa.gov; Stewart.Michael@epamail.epa.gov; Beck, Nancy; 

Frey, Nathan J.; French.Chuck@epamail.epa.gov; Hanzel, Veronica

Subject: E.O. 12866 NESHAP Primary Lead Processing Final AQ-43 - Draft Response to 

Comment Document for OMB Review

Attachments: E.O. 12866 NESHAP Primary Lead Processing Final AQ-43 Response to Comment 

Document-DRAFT-10-14-2011.docx

Hi everyone, 

Attached you'll find the response to comment document for the primary lead processing RTR final rule 

for your review. Please feel free to get in touch with me if you have any questions. 

Nathan Topham 

Environmental Engineer 

US EPA/OAQPS/SPPD/MIG
National Emission Standards for 

Hazardous Air Pollutants: 

Primary Lead Smelting 

Summary of Public Comment and Response

DRAFT – Do Not Cite or Quote

October 14, 2011
i

TABLE OF CONTENTS

TABLE OF CONTENTS................................................................................................................. i

1 Background............................................................................................................................. 1

2 Summary of Public Comments............................................................................................. 11

2.1 Risk Assessment Methodology and Data....................................................................... 12

2.1.1 General Risk Assessment Methodology ................................................................. 12

2.1.2 Primary Lead Risk Assessment Methodology and the Use Of Lead NAAQS and 

Ambient Monitoring ............................................................................................................. 16

2.1.3 The EPA’s modeling relies on inaccurate data ....................................................... 16

2.2 The EPA’s Authority and Approach under the CAA..................................................... 18

2.2.1 Authority to regulate a criteria pollutant (lead) as a HAP ...................................... 18

2.2.2 Support for a Compliance Period of Less than Two Years .................................... 20

2.2.3 Authority for Total Facility Approach and Use of Demographics in Rulemaking. 22

2.3 Removal of the Startup, Shutdown, and Malfunction Exemption ................................. 23

2.4 Affirmative Defense Provisions..................................................................................... 25

2.5 Proposed Standards for Primary Lead Smelting ............................................................ 32

2.5.1 Authority and Approach under CAA Section 112(f)(2) ......................................... 32

2.5.2 CAA 112(d)(6) Technology Review ...................................................................... 35

2.6 Other Primary Lead Smelting Source Category Comments.......................................... 37

2.6.1 Modifying applicability provision to include new “hydrometallurgical” process.. 37

2.7 Miscellaneous Comments .............................................................................................. 38
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1 Background

On February 17, 2011, the U.S. Environmental Protection Agency proposed to revise the 

National Emission Standards for Hazardous Air Pollutants (NESHAP) for Primary Lead 

Smelting under the authority of section 112 of the Clean Air Act (CAA). We summarized and 

responded to major comments in the preamble to our final action. This document presents 

summaries and responses to all comments received, including those also presented in the 

preamble. The comments to which we are responding were submitted in 15 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. 
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TABLE 1-1. List of Commenters on Proposed NESHAP for Primary Lead Smelters, Proposed on February 17, 2011

Docket No. EPA-HQ-OAR-2004-305, All document ID

Document IDa Commenter, Affiliation Abstract

0062 Dennis Lane, Stinson Morrison 

Hecker LLP on behalf of Doe Run 

Resources Corporation d/b/a Doe 

Run Company

0062.1,0063.1

00630068

0068.1

Attachment, Dennis Lane, Stinson 

Morrison Hecker LLP on behalf of 

Doe Run Resources Corporation 

d/b/a Doe Run Company

0064 Gary DeBois, private citizen

0067 J. Castillo, private citizen

0069 B. Robinson, private citizen

0069.1 Attachment, B. Robinson

0071 Melvin E. Keener, Coalition for 

Responsible Waste Incineration 

(CRWI)

0071.1 Attachment, Melvin E. Keener,

Coalition for Responsible Waste 

Incineration (CRWI)

0077 Samuel D. Eisenberg, 

Earthjustice, et al. (part 1 of 4)

Other submitters are Sierra Club, Missouri Coalition for the Environment, California 

Communities Against Toxics, Desert Citizens Against Pollution, and Natural Resources 

Defense Council.

0077 Earthjustice et al. Attachment Comments of Sierra Club, Missouri Coalition For The Environment, California 

Communities Against Toxics, Desert Citizens Against Pollution, Natural Resources 

Defense Council, and Earthjustice

0077.2 Earthjustice et al. (Attachment 1) Report of the Task Group of the Children's Health Protection Advisory Committee on 

America's Children & the Environment, Third Edition

0077.3 Earthjustice et al. (Attachment 2) Gaming the System - How Off-the-Books Industrial Upset Emissions Cheat the Public 

Out of Clean Air report prepared by Environmental Integrity Project (EIP)

0077.4 Earthjustice et al. (Attachment 3) EPA's Action Development Process; Interim Guidance on Considering Environmental 

Justice During the Development of Action
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Document IDa Commenter, Affiliation Abstract

0077.5 Earthjustice et al. (Attachment 4) America's Children and the Environment- Measures of Contaminants, Body Burdens, 

and Illnesses Second Edition; EPA 240-R-03-001

0077.6 Earthjustice et al. (Attachment 5) Concepts, Methods and Data Sources for Cumulative Health Risk Assessment of 

Multiple Chemicals, Exposures and Effects: A Resource Document

0077.7 Earthjustice et al. (Attachment 6) Framework for Cumulative Risk Assessment EPA/630/P-02/001F

0077.8 Earthjustice et al. (Attachment 7) EPA’s Action Development Process Guide to Considering Children's Health When 

Developing EPA Actions: Implementing Executive Order 13045 and EPA's Policy on 

Evaluating Health Risks to Children

0077.9 Earthjustice et al. (Attachment 8) Risk Assessment Guidance for Superfund

Volume I Human Health Evaluation Manual (Part A) Interim Final [EPA/540/1-89/002]

Office of Emergency and Remedial Response U.S. Environmental Protection Agency

00770 Earthjustice et al. (Attachment 9) Proceedings of the U. S. EPA Workshop on Research Needs for Community-Based 

Risk Assessment October 18-19, 2007 Research Triangle Park, NC

00771 Earthjustice et al. (Attachment 10) Synthetic Organic Chemical Manufacturing Industry - Residual Risk Assessment, 

Report Prepared by EC/R Incorporated 

00772 Earthjustice et al. (Attachment 11) The Benefits and Costs of the Clean Air Act: 1990 to 2020 – Summary Report

00773 Earthjustice et al. (Attachment 12) Federal Register Document: National Air Toxics Program: The Integrated Urban 

Strategy (64 FR 38706-01) This document is not available in Regulations.gov since it is 

a copyrighted publication and may not be reproduced without the consent of the 

copyright holder.

00774 Earthjustice et al. (Attachment 13) Improvements in Air Toxics Emissions Data Needed to Conduct Residual Risk 

Assessments Report No. 08-P-0020

00775 Earthjustice et al. (Attachment 14) Letter to The Honorable Lisa P. Jackson

Administrator, USEPA from Dr. Deborah L. Swackhamer, Chair, EPA Science 

Advisory Board and Dr. Jana Milford, Chair, SAB RTR Methods Review Panel 

regarding Review of EPA’s draft entitled, “Risk and Technology Review (RTR) Risk 

Assessment Methodologies: For Review by the EPA’s Science Advisory Board with 

Case Studies – MACT I Petroleum Refining Sources and Portland Cement 

Manufacturing

00776 Earthjustice et al. (Attachment 15) Sources, Transport and Alterations of Metal Compounds: An Overview. I. Arsenic, 

Beryllium, Cadmium, Chromium, and Nickel
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Document IDa Commenter, Affiliation Abstract

00777 Earthjustice et al. (Attachment 16) High-level Strategy and Leadership Needed to Continue Progress toward Protecting 

Children from Environmental Threats

00778 Earthjustice et al. (Attachment 17) Email to Emma Cheuse, Associate Attorney, Earthjustice from Guy A. Gimlen, 

Planning, Rules and Research Division, Bay Area Air Quality Management District 

regarding Staff Report and CEQA Analysis done for our Regulation 8, Rule 32: Wood 

Coatings as part of our rule making process

00779 Earthjustice et al. (Attachment 18) Chromium occurrence in the environment and methods of its speciation This document 

is not available in Regulations.gov since it is a copyrighted publication and may not be 

reproduced without the consent of the copyright holder.

0077.20 Earthjustice et al. (Attachment 19) Evaluating the Health Significance of Hazardous Air Pollutants Using Monitoring Data

This document is not available in Regulations.gov since it is a copyrighted publication 

and may not be reproduced without the consent of the copyright holder.

0078 Earthjustice et al. (part 2 of 4)

0078.1 Earthjustice et al. (Attachment 20) "The Importance of Rigorous Analytical Strategies for Elucidating Cumulative Risk 

Burdens and Disproportionate Effects"

0078.2 Earthjustice et al. (Attachment 21) Separate and Unequal: Residential Segregation and Estimated Cancer Risk Associated 

with Ambient Air Toxics in U.S. Metropolitan Areas

0078.3 Earthjustice et al. (Attachment 22) Letter to EPA Docket Center, from Vinson Hellwig and Robert Colby, National 

Association of Clean Air Agencies (NACAA), dated November 24, 2008

0078.4 Earthjustice et al. (Attachment 23) "Pesticides Diets of Infants and Children" This document is copyrighted and may not be 

reproduced without the consent of the copyright holder

0078.5 Earthjustice et al. (Attachment 24) "Phthalates and Cumulative Risk Assessment" This document is copyrighted and may 

not be reproduced without the consent of the copyright holder

0078.6 Earthjustice et al. (Attachment 25) "Science and Decisions: Advancing Risk Assessment" This document is copyrighted 

and may not be reproduced without the consent of the copyright holder

0078.7 Earthjustice et al. (Attachment 26) "Ensuring Risk Reduction in Communities with Multiple Stressors: Environmental 

Justice and Cumulative Risks/Impacts

0078.8 Earthjustice et al. (Attachment 27) "Comparative Assessment of Air Pollution-Related Health Risks in Houston"
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Document IDa Commenter, Affiliation Abstract

0078.9 Earthjustice et al. (Attachment 28) Letter to Lisa P. Jackson, Administrator, USEPA, from Pamela Shubat, Chair, 

Children's Health Protection Advisory Committee, October 21, 2010

0078.10 Earthjustice et al. (Attachment 29) "Setting Priorities for IRIS: 47 Chemicals that Should Move to the Head of the RiskAssessment Line" This document is copyrighted and may not be reproduced without the 

consent of the copyright holder

0078.11 Earthjustice et al. (Attachment 30) "Current and future risk assessment guidelines, policy, and methods development for 

chemical mixtures" This document is copyrighted and may not be reproduced without 

the consent of the copyright holder

0078.12 Earthjustice et al. (Attachment 31) "Estimating Cancer Risk from Outdoor Concentrations of Hazardous Air Pollutants in 

1990" This document is copyrighted and may not be reproduced without the consent of 

the copyright holder

0078.13 Earthjustice et al. (Attachment 32) Memorandum from Howard J. Hoffman, USEPA, regarding Addendum to Survey of 

Risks: Background Radiation, dated July 27, 1988

0078.14 Earthjustice et al. (Attachment 33) Agency for Toxic Substance & Disease Registry: Public Health Assessments & Health

0078.15 Earthjustice et al. (Attachment 34) Agency for Toxic Substances & Disease Registry: Public Health Assessments & Health; 

Consultations

0078.16 Earthjustice et al. (Attachment 35) "In the Andes, a Toxic Site Also Provides a Livelihood" This document is copyrighted 

and may not be reproduced without the consent of the copyright holder

0078.17 Earthjustice et al. (Attachment 36) Test Show Recontamination of Soils in Herculaneum, Mo., from Doe Run Resources 

Corporation Lead Smelting Operation

0078.18 Earthjustice et al. (Attachment 37) "Doe Run Peru Smelter Future Still Unclear" This document is copyrighted and may not 

be reproduced without the consent of the copyright holder

0078.19 Earthjustice et al. (Attachment 38) Doe Run Resources, Missouri DNR Agree to Address Lead Contamination at St. Joe 

State Park in St. Francois County, Mo.

0078.20 Earthjustice et al. (Attachment 39) "An epidemiologic investigation of amyotrophic lateral sclerosis in Jefferson County, 

Missouri, 1998-2002" This document is copyrighted and may not be reproduced without 

the consent of the copyright holder
Draft – Do Not Cite or Quote October 14, 2011

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Document IDa Commenter, Affiliation Abstract

0078.21 Earthjustice et al. (Attachment 40) "Lead Exposure in Children: Prevention, Detection, and Management" This document is 

copyrighted and may not be reproduced without the consent of the copyright holder

0079 Samuel D. Eisenberg, Earthjustice 

et al., (Part 3 of 4)

0079.1 Earthjustice et al. (Attachment 41) Health Consultation

0079.2 Earthjustice et al. (Attachment 42) Cumulative Impacts: Building a Scientific Foundation.

0079.3 Earthjustice et al. (Attachment 43) Development of Health Criteria for School Site Risk Assessment Pursuant to Health and 

Safety Code Section 901(g): Child-Specific Reference Doses (chRDs) for School Site 

Risk Assessment – Cadmium, Chlordane, Heptachlor, Heptachlor Epoxide, 

Methoxychlor, and Nickel

0079.4 Earthjustice et al. (Attachment 44) Appendix J; In Utero and Early Life Susceptibility to Carcinogens: The Derivation of 

Age-at-Exposure Sensitivity Measures

0079.5 Earthjustice et al. (Attachment 45) Technical Support Document for Cancer Potency Factors: Methodologies for derivation, 

listing of available values, and adjustments to allow for early life stage exposures. May 

2009 California Environmental Protection Agency

Office of Environmental Health Hazard Assessment Air Toxicology

0079.6 Earthjustice et al. (Attachment 46) Development of an Integrated Intervention Plan to Reduce Exposure to Lead and Other 

Contaminants in the Mining Center of La Oroya, Perú

0079.7 Earthjustice et al. (Attachment 47) Children's Health Protection Advisory Committee (CHPAC)

0079.8 Earthjustice et al. (Attachment 48) Children's Health Protection Advisory Committee (CHPAC)

0079.9 Earthjustice et al. (Attachment 49) Contamination of The Historic Area Depth of The Lead Issue – A Recent History

0079.10 Earthjustice et al. (Attachment 50) Construction Permit Application. New Lead Technology Herculaneum Plant

0079.11 Earthjustice et al. (Attachment 51) Email to Amy Branning, USEPA and Emma Cheuse from Stacy Stotts, Partner, Stinson 

Morrison Hecker LLP; re: MACT Schedule

0079.12 Earthjustice et al. (Attachment 52) Evaluation of Residential Recontamination Data (Collected Under UAO, July 2009)

0079.13 Earthjustice et al. (Attachment 53) The Flubor Process: A new Hydrometallurgical-Electrochemical Approach to the Lead 

Minerals Cost Effective Low Environment Impact
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Document IDa Commenter, Affiliation Abstract

0079.14 Earthjustice et al. (Attachment 54) The Benefits and Costs of The Clean Air Act from 1990 to 2020

0079.15 Earthjustice et al. (Attachment 55) North America’s Largest Lead Producer to Spend $65 Million to Correct Environmental

Violations at Missouri Facilities

0079.16 Earthjustice et al. (Attachment 56) Environmental Enforcement: EPA Orders Doe Run to Clean Up Former Lead Mine. 

This document is not available in Regulations.gov since it is a copyrighted publication 

and may not be reproduced without consent of the copyright holder.

0079.17 Earthjustice et al. (Attachment 57) Doe Run Resources Corp. of St. Louis, Missouri.

0079.18 Earthjustice et al. (Attachment 58) Letter to Dan Vornberg, Doe Run Resources Corporation, Vice President of 

Environmental Affairs,The Doe Run Company from Dave Cozad, Associate Regional 

Counsel, USEPA; re: Herculaneum Lead Smelter Roadway Contamination

0079.19 Earthjustice et al. (Attachment 59) Residual Risk Program: Selection of Hazard Index Limits

0079.20 Earthjustice et al. (Attachment 60) Review of the National Ambient Air Quality Standards for Lead: Policy Assessment of 

Scientific and Technical Information

0079.21 Earthjustice et al. (Attachment 61) Directions to Herculaneum High School. This Google map is not available in 

Regulations.gov since it is a copyrighted publication and may not be reproduced without 

consent of the copyright holder.

0080 Samuel D. Eisenberg, Earthjustice 

et al. (Part 4 of 4)

These comments are also submitted on behalf of Sierra Club, Missouri Coalition for the 

Environment, California Communities Against Toxics, Desert Citizens Against 

Pollution, and Natural Resources Defense Council.

0080.1 Earthjustice et al. (Attachment 62) Doe Run Herculaneum Smelter Buy Out Zone

0080.2 Earthjustice et al. (Attachment 63 ) Health Consultation, Exposure Investigation

EPA FACILITY ID: MOD006266373

0080.3 Earthjustice et al. (Attachment 64 ) Sunlight Foundation Reporting Group: Current and former officials intervene on 

company’s behalf in battle with Peru

0080.4 Earthjustice et al. (Attachment 65) Foliar Lead Uptake by Lettuce Exposed to Atmospheric Fallouts Please contact the EPA 

Docket Center, Public Reading Room to view this document.
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Document IDa Commenter, Affiliation Abstract

0080.5 Earthjustice et al. (Attachment 66) Herculaneum Lead Contamination http://www.dnr.mo.gov/env/herc/

0080.6 Earthjustice et al. (Attachment 67) Determining baseline Prevalence for Provider-Diagnosed Multiple Sclerosis (MS) and 

Amyotrophic Lateral Sclerosis (ALS) in Herculaneum and Jefferson County, Missouri

0080.7 Earthjustice et al. (Attachment 68) Southeast Missouri Lead Testing Areas

0080.8 Earthjustice et al. (Attachment 69)

0080.9 Earthjustice et al. (Attachment 70) Fourth National Report on Human Exposure to Environmental Chemicals

0080.10 Earthjustice et al. (Attachment 71)

0080.11 Earthjustice et al. (Attachment 72) Lead Poisoning: Prevention, Identification, and Management

0080.12 Earthjustice et al. (Attachment 73) New York City Plan to Eliminate Childhood Lead Poisoning Lead Poisoning Prevention 

Program New York City Department of Health and Mental Hygiene

0080.13 Earthjustice et al. (Attachment 74) Environmental Contamination in the Homes of LA Oroya and Concepcion and its 

Effects in the Health of Community Residents

0080.14 Earthjustice et al. (Attachment 75) Environmental Contamination in the Homes of La Oroya, Peru, and its Effects in the 

Health of Community Residents

0080.15 Earthjustice et al. (Attachment 76) Report of the School Siting Task Group of the Children’s Health Protection Advisory 

Committee

0080.16 Earthjustice et al. (Attachment 77) Living in a sea of lead F changes in blood- and hand-lead of infants living near a smelter

This document is copyright. Please contact the EPA Docket Center, Public Reading 

Room to view this document.

0080.17 Earthjustice et al. (Attachment 78) Saint Louis University School of Public Health Position Statement in Support of More 

Stringent National Air Quality Standards for Lead

0080.18 Earthjustice et al. (Attachment 79) Case: 4:10-cv-01895-JCH Document #: 1 USA and State of Missouri versus The Doe 

Run Resources Corporation and the Buick Resource Recycling Facility, LLC

0080.19 Earthjustice et al. (Attachment 80) Childhood Lead Poisoning This document is copyright. Please contact the EPA Docket 

Center, Public Reading Room to view this document.

0080.20 Earthjustice et al. (Attachment 81) Atmospheric Deposition-Carried Pb, Zn, and Cd from a Zinc Smelter and Their Effect 

on Soil Microorganisms This document is copyright. Please contact the EPA Docket 

Center, Public Reading Room to view this document.

0081 Anonymous
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Document IDa Commenter, Affiliation Abstract

0082 James L. Kavanaugh, Director, Air 

Pollution Control Program, 

Missouri Department of Natural 

Resources

0082 Attachment, James L. Kavanaugh, 

Director, Air Pollution Control 

Program, Missouri Department of 

Natural Resources

0083 Anonymous

0084 D. Knight, private citizen

0085 Robert N. Steinwurtzel, Baker & 

Hostetler LLP, Association of 

Battery Recyclers (ABR)

0085.1 Attachment, Robert N. 

Steinwurtzel, Baker & Hostetler 

LLP, Association of Battery 

Recyclers (ABR)

0086 Carolyn Wilson, LUIS & BJ 

(PEDDLERS)(SPRINKLERS) 

Recycling 

0086.1 Attachment, Carolyn Wilson, 

LUIS & BJ 

(PEDDLERS)(SPRINKLERS) 

Recycling 

0087 Matthew Todd, The Residual Risk 

Coalition (R2C)

0087.1 Attachment, Matthew Todd, The 

Residual Risk Coalition (R2C)

0088 Claire McClintic, Attorney, 

Stinson Morrison-Hecker LLP on 

behalf of The Doe Run Resources 

Corporation 
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Document IDa Commenter, Affiliation Abstract

0088.1 Attachment, Claire McClintic, 

Attorney, Stinson MorrisonHecker LLP on behalf of The Doe 

Run Resources Corporation 

0089 Chris Bryant, Bergeson & 

Campbell, P.C. on behalf of RSR 

Corporation (RSR) 

0089 Attachment, Chris Bryant, 

Bergeson & Campbell, P.C. on 

behalf of RSR Corporation (RSR) a Docket No. EPA-HQ-OAR-2004-0305. 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 using the last four digits (e.g., 0010).
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2 Summary of Public Comments

Comments received on the proposed amendments to the primary lead smelting rule are summarized in 

the following sections along with the EPA’s responses. Some of these comments and responses also 

appear in the preamble to the final rule.

In many instances, commenters provided additional documents as background information or otherwise 

in support of their comments. Those documents are contained in the docket to this rulemaking but are 

not summarized here. The list of commenters and any supporting documentation submitted by the

commenters are summarized in Table 1-1.
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2.1 Risk Assessment Methodology and Data

2.1.1 General Risk Assessment Methodology 

Comment: Commenter 0077 commented generally that the EPA needs to update its framework for 

determining “acceptability” of risks under the residual risk and technology reviews (RTRs) to reflect 

more current science and notes that the science has evolved significantly since the late 1980’s. The 

commenter stated that for non-lead emissions; the EPA presumes that the lifetime cancer risk here is 

“acceptable” because it is lower than 100 in a million. The EPA does not address or explain why any 

risk below that level remains acceptable today. It is arbitrary and capricious for the EPA to continue to 

rely on that presumption as a basis for its decision for several reasons:

1. The CAA requires an up-to-date assessment and relying on an out-dated presumption conflicts 

with the purpose of the residual risk analysis. 

2. There is significant new information on the factors the EPA discussed in its old rulemaking that 

should influence its analysis of what level of risk is currently “acceptable.” 

3. Scientific research has evolved dramatically since the EPA set that presumption. The commenter 

cites risk assessment studies and guidance, studies on children’s exposure to toxics, and CDC 

reports as providing evidence of the EPA and other federal funded research and developments in 

health effects of chemicals. 

4. The EPA’s commitment to environmental justice must inform its consideration of what level of 

risk is “acceptable” as required by the 1994 Environmental Justice Executive Order and 2010 

guidance to direct all federal agencies to take environmental justice into consideration. 

5. American values and policies have evolved to tolerate less health risk from industrial pollution. 

The commenter stated that the EPA must reassess whether a level below 100 in a million and closer to 

the “aspirational goal” of 1-in-1 million should be adopted as a more stringent, presumptive upper limit 

for what is considered acceptable. This is a question that the EPA cannot evade by assuming everything 

it did in the Benzene Rule will remain per se lawful for all time, all persons and communities, and all 

source categories. 

Response: As an initial matter, we note that in 1990 Congress codified in section 112(f) of the CAA the 

decision approach we use for interpreting our residual risk analyses (i.e., the Benzene NESHAP, 54 FR 

38044). Under that approach, the 100 in a million cancer risk is not a bright line indicating that risk is 

“acceptable,” but rather we consider this health metric in conjunction with a variety of health factors to 

determine whether the risk is acceptable. Where we conclude that the risk is not acceptable, we cannot 

consider costs in requiring controls to bring risks down to an acceptable level. However, the analysis of 

whether risk is acceptable is not the endpoint. Once we determine that controls are sufficient to ensure 

risk is acceptable, we again review the health metrics in conjunction with considering the costs of 

controls to determine whether additional controls should be required to provide an ample margin of 

safety. 

Moreover, the commenter does not support its contention that people are now unwilling to accept a level 

of risk that was acceptable at the time the CAA was amended in 1990. Nor does the commenter support 

how science has evolved in a way that would undermine the codified framework for determining 
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acceptability. We note that for purposes of the proposed rule, relative to environmental justice issues, we 

performed a demographic analysis for the purpose of informing the public, and that analysis is in the 

docket. 

Comment: Commenter 0087 suggested that potential issues could arise due to the EPA’s demographic 

analysis. The EPA’s proposal would unreasonably inject racial, ethnic, and other policy considerations 

into a program designed to provide protection for the public at large. There is no principled way to 

identify and define groups that should receive extra scrutiny from those that do not. The EPA’s approach 

would inappropriately cause arbitrary policy and political considerations to trump objective scientific 

analysis. This is patently unreasonable and, as such, is not a supportable interpretation of § 112(f).

Response: As stated originally in the Benzene NESHAP and confirmed in all previous residual risk 

rulemakings, 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 a million. These considerations are made for all 

people regardless of racial or socioeconomic status. While we analyzed the demographic makeup of the 

at-risk populations surrounding the facility in the source category addressed by this rule making, we 

presented this information for informational purposes and did not rely on it to drive our decision making 

on the acceptable level of risk and ample margin of safety. The results of our demographic analyses only 

served to inform the public about the demographic makeup of the populations currently exposed to the 

bulk of the risks due to HAP emissions from this source category. We note that this is also the 

population which would be expected to receive the majority of the benefits associated with this 

rulemaking.

Comment: Commenter 0069 noted that the calculation of incidence of cancer risk rate is confusing as it 

does not indicate whether it is based on a single point in time or over a period of time, and, if over a 

period of time, what period of time. The commenter stated that a Gaussian Plume model and full risk 

assessment should be used to assess retention rates, intake dose, and bloodstream absorption for the 

affected areas. The commenter noted that the facility is located in what would be considered an underrepresented area with regard to environmental justice issues. With regard to the reference dose, the 

commenter stated that it is inappropriate to set a reference dose for lead and that the EPA needed to 

recognize a concentration at which lead may be harmful, although the commenter acknowledged that 

there may not be enough scientific evidence to support a maximum allowable concentration level. The 

commenter also stated that with regard to fugitive dust, the EPA should consider a tighter limit 

combined with a standard operating plan (SOP) for work practices to assure that lead and arsenic are not 

further distributed in fugitive dust emissions.

Response: The cancer incidence results are presented in excess cases per year. Thus, if the cancer 

incidence rate is 1, then we would expect 1 excess cancer case per year. For an additional example, if the 

cancer incidence rate is 0.05, then we would expect 0.05 excess cancer cases per year. Expressed 

another way, a 0.05 cancer incidence rate would predict one excess case of cancer every 20 years (i.e., 

the universe of 0.05 cancer cases per year is 1 case every 20 years). With respect to the comments on the

lead risk assessment and the health benchmark value used for lead, see response to comments in section 

2.1.2.1
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Finally, with regard to the EPA considering a tighter limit for fugitive dust combined with an SOP for 

work practices, the maximum achievable control technology (MACT) standard includes a requirement 

for the facility to minimize fugitive dust emissions and operate according to an SOP to achieve that goal. 

We are reinforcing that requirement in this final action by coupling it with a requirement to perform 

ambient monitoring in order to ensure that the work practices employed by the facility are reducing

fugitive emissions to a level that will protect the public health with an ample margin of safety and to 

prevent an adverse environmental effect. The facility retains the flexibility to choose which specific 

work practices will best minimize emissions.

Comment: Commenter 0077 expressed concern that the EPA used long-term concentrations affecting 

the most highly-exposed census block for each facility. According to Commenter 0077, this analysis 

dilutes the effect of sources’ emissions by estimating the impact at the centroid of the census block 

instead of at the facility fence or the property line. Further, the center of a census block is almost always 

further away from the facility than the fence line. The commenter stated that census blocks vary greatly 

in size but the EPA provided no evidence of reviewing census block sizes or configurations to consider 

how pollutant concentrations might vary within these blocks. The commenter is concerned that the areaweighted centers of census blocks may significantly underestimate exposure in some cases and

recommends moving receptor points closer to the facility to assess chronic exposure in those instances 

where local residents live nearer to a facility than the geographic centroid of the census block.

Response: As we have noted in the development of previous residual risk regulations, such as the HON, 

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, it is appropriate to use census block 

information on where people actually reside, rather than points on a fence line, to locate the estimation 

of exposures and risks to individuals living near such facilities. Census blocks are the finest resolution 

available as part of the nationwide population data (as developed by the US Census Bureau); each is 

typically comprised of approximately 40 people or about 10 households. In the EPA risk assessments, 

the geographic centroid of each census block containing at least one person is used to represent the 

location where all the people in that census block live. The census block centroid with the highest 

estimated exposure then becomes the location of maximum exposure, and the entire population of that 

census block is assumed to experience the maximum individual risk. In some cases, because actual 

residence locations may be closer to or farther from facility emission points, this may result in an 

overestimate or underestimate of the actual annual concentrations (although there is no systematic bias 

for average levels). Given the relatively small dimensions of census 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. Thus, the EPA concludes that the 

most appropriate locations at which to estimate chronic exposures and risks are the census block 

centroids because: 1) census blocks are the finest resolution available in the national census data, 2) 

facility fence lines do not typically represent locations where chronic exposures are likely (i.e, people do 

not typically live at the fence line of facilities) and 3) as just described above, there is no systematic bias 

with respect to using census block centroids as an exposure surrogate for all individuals residing in that 

block. This approach has broad support across the scientific community, including the EPA’s Science 

Advisory Board.
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Comment: Commenter 0077 stated that the EPA should not use the estimated number described as 

“actual” emissions as the basis for its proposal. The commenter stated that this number is not valid or 

appropriate for use.

Commenter 0087 stated that the EPA cannot lawfully use MACT allowable emissions in the proposed 

risk assessments and residual risk determinations because the Agency has failed to provide any reasoned 

explanation for why risk assessments based on actual emissions estimates are inadequate. The Agency’s 

risk assessment methodology already uses conservative assumptions. For example, health benchmarks, 

such as acute reference doses, typically incorporate two to three orders of magnitude of conservatism to 

account for uncertainties, such as the extrapolation of animal toxicity testing data to humans. Similarly, 

the dispersion models used to predict off-site ambient HAP concentrations attributable to emissions 

from affected sources incorporate conservative assumptions to simplify the analysis of highly complex 

factors, such as meteorology and atmospheric chemistry. In addition, risk assessments assume exposure 

to the most exposed individual on a continuous basis for an entire lifetime. 

In light of the EPA’s conservative approach, the commenter disagrees with the assumption that affected 

sources should be expected to emit more than the actual data indicate. The failure to provide a reasoned 

explanation as to why this approach is justified and the failure to provide any record evidence supporting 

the use of MACT allowable emissions render this proposal insupportable under the law.

Response : 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 a different outcome than the use of the actual emission levels.

Comment: Commenter 0077 stated that there is a particular need for the EPA to address and incorporate 

the new science on vulnerable individuals, including youth, into its risk analysis. For example, the 

Science Advisory Board (SAB) has recommended that the EPA consider other methodologies, such as 

those used by California’s Office of Environmental Health Hazard Assessment, that could affect the 

development of RfC and URE values and make sure that the RTR process adequately covers children’s 

risks. The commenter stated that the EPA’s inhalation analysis should also address the higher chronic 

risk that children face from inhalation and incorporate this higher level of risk into its residual risk 

analysis. As part of their submittal to the docket the commenter included supporting documentation. The 

commenter stated that new data on children’s vulnerability as well as toxic body burden of adults have 

lead to a downward shift in acceptable levels of risks to the public from environmental exposure to toxic 

chemicals.

Response: We acknowledge that population subgroups, including children, may have the potential for 

risk greater than the general population due to greater relative exposure and/or greater susceptibility to 

the toxicant. As explained in previous actions, including the final Hazardous Organic NESHAP (HON) 
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residual risk rule (71 FR 76603, December 21, 2006), the assessments we undertake to estimate risk 

account for this potential vulnerability. With respect to exposure, the risk assessments we perform 

implicitly account for this greater potential for exposure by assuming lifetime exposure, in which 

populations are conservatively presumed to be exposed to airborne concentrations at their residence 

continuously, 24 hours per day for a full lifetime, including childhood. With regard to children’s 

potentially greater susceptibility to non-cancer toxicants, the assessments rely on Agency (or 

comparable) hazard identification and dose-response values which have been developed to be protective 

for all subgroups of the general population, including children. For example, a review1 of the chronic 

reference value process concluded that the Agency’s reference concentration (RfC) derivation processes 

adequately considered potential susceptibility of different subgroups with specific consideration of 

children, such that the resultant RfC values pertain to the full human population ‘‘including sensitive 

subgroups,’’ a phrase which is inclusive of childhood.

On the issue of cancer dose-response values, EPA’s revised cancer guidelines and supplemental 

guidance recommend applying default adjustment factors to account for exposures occurring during 

early-life exposure to those chemicals thought to cause cancer via a mutagenic mode of action.2 For 

these chemicals, the supplemental guidance indicates that, in lieu of chemical-specific data on which age 

or life-stage specific risk estimates or potencies can be determined, default ‘‘age dependent adjustment 

factors’’ can be applied when assessing cancer risk for early-life exposures to chemicals which cause 

cancer through a mutagenic mode. 

We further note that the estimated risks must also be considered in the context of the full set of 

assumptions used for this risk assessment. For example, the cancer unit risk estimates used to estimate 

cancer risks associated with HAP exposures are generally considered to be plausible upper-bound 

estimates; actual cancer potency is likely to be lower and could be as low as zero. 

With respect to risks associated with lead exposure, as previously described, we compared modeled 3-

month rolling average lead concentrations to the National Ambient Air Quality Standards (NAAQS) for 

lead. Notably, the lead NAAQS was set to protect public health, including the health of sensitive 

populations, with an adequate margin of safety from the adverse effects associated with lead exposure. 

In particular, this standard was primarily set to protect children from neurological effects associated with 

exposure to lead (e.g., loss of IQ points). 

2.1.2 Primary Lead Risk Assessment Methodology and the Use Of Lead NAAQS and 

Ambient Monitoring

2.1.3 The EPA’s modeling relies on inaccurate data

Comment: Commenter 0088 commented that the risk estimates provided are inaccurate because the 

population surrounding the facility has changed significantly since the 2000 census.

 1

A Review of the Reference Dose and Reference Concentration Process. U.S. Environmental Protection Agency. Risk 

Assessment Forum. EPA/630/P–02/002F. December 2002. 2 “Guidelines for Carcinogen Risk Assessment,” (EPA/630/P-03/001F), March 2005; and “Supplemental Guidance for 

Assessing Susceptibility from Early-Life Exposure to Carcinogens,” (EPA/630/R-03/003f), March 2005. 
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Response: The EPA notes that the 2000 census data is the latest census data that is available. However, 

during the public comment period the EPA received an updated facility boundary, which reflects the fact 

that facility purchased additional land around the facility since 2000. As a result, our updated model 

estimates reflect changes in the population surrounding the facility that are the result of previously 

considered offsite census blocks now being located onsite.

Comment: Commenter 0088 stated the assumption of a 70-year exposure duration for cancer is 

inaccurate considering the Doe Run smelter must shut down in 3 years as part of a consent decree.

Response: The purpose of the residual risk assessment is to assess exposure and risk as the facility exists 

currently, not as it may or may not exist in the future. 

Comment: Commenters 0082 and 0088 stated that Table 5 of the preamble includes a typographical 

error for the Main Street monitor; it should read 2.14 rather than 3.14

Response: The commenter is correct and this typographical error has been fixed in the documentation of 

the final rule.

Comment: For the residual risk review, commenter 0077 stated that the EPA should not rely on 

industry-reported, unverified emissions, specifically NEI data. Citing the EPA’s Office of the Inspector 

General (OIG), the commenter stated that review of the NEI data found problems with accuracy and 

significant data gaps, e.g., 57 percent of the data points were blank, and unpopulated records represented 

about 39 percent of total point source emissions. The OIG concluded that “EPA’s reliance on voluntary 

efforts to provide air toxics NEI data has not provided assurance that the data are accurate and reliable,” 

and the commenter recommended that the EPA require reporting of data in order to gain the data needed 

to do an accurate residual risk assessment. Commenter 0077 stated that the use of voluntarily reported 

emission data results in an underestimation of risk. The commenter encouraged the EPA to make every 

effort in this and future rulemakings to use the section 114 information collection process and develop 

the best, most accurate dataset possible. According to the commenter these and other elements of 

uncertainty present in the EPA’s emissions dataset weigh in favor of taking a conservative, healthprotective approach in the residual risk rulemaking process.

Response: With regard to this particular rulemaking, we note that it concerns only a single source and 

we believe any broader concerns with the NEI are not relevant to this specific rulemaking. The data used 

for this MACT rule were not derived solely from the National Emission Inventory (NEI). A request for 

information under Section 114 of the CAA was used to gather information from the one facility in the 

source category. Additional information was obtained from the state of Missouri. The source of the data 

is documented in the docket. New and corrected data were received from the facility and state of 

Missouri during the public comment period that further refined the risk assessment. EPA technical 

experts reviewed the data for accuracy and made changes where appropriate. For example, the main 

stack emission rate was corrected based on stack test data and roadways that were offsite were removed 

from the modeling. 

More generally, we note that we have greatly improved the NEI for HAPs since the 1996 NEI, which 

was the basis for the OIG Report referred to by the commenter. We have worked diligently with state 

and local agencies and tribes to improve emission inventories over the years and we have instituted a 

number of quality assurance (QA) measures to improve data received from state and local agencies since 

1996. The 2005 NEI underwent a number of QA steps that were not used in the 1996 NEI. 
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Documentation for the 2005 NEI point source emissions inventory is available on the 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 corrected based on this expert review.

Further, for this specific source category, updated test data and emission point information were 

received during the public comment period that addressed inaccuracies in the data. 

2.2 The EPA’s Authority and Approach under the CAA

2.2.1 Authority to regulate a criteria pollutant (lead) as a HAP

Comment: Commenter 0088 states that the proposed rule seeks to avoid the conflict with the NAAQS

by claiming that it addresses risks from the emissions of lead compounds. But the lead NAAQS already 

regulates lead compounds: “The national primary and secondary ambient air quality standards for lead 

(Pb) and its compounds are 0.15 micrograms per cubic meter over a 3-month period, measured in the 

ambient air as Pb . . . .” Lead NAAQS, 73 FR 66964, 67052 (Nov. 12, 2008), § 50.16(a). The commenter 

stated that just as lead compounds are encompassed by the lead NAAQS, the proposed rule also seeks to 

regulate lead as a HAP based on the NAAQS benchmark of lead in ambient air.

Failure to meet the lead NAAQS level would thus subject Doe Run to possible claims of nonattainment 

under CAA § 108 and non-compliance under CAA § 112. Thus, the EPA would be regulating a criteria 

pollutant as a HAP, contrary to the intent of CAA § 112(b)(2). The same unlawful result occurs for 

environmental risk, with the proposed rule adopting the secondary lead NAAQS to identify “the 

potential for adverse environmental effects.” A single standard using the same measurements improperly 

controls compliance questions under both the secondary lead NAAQS and the proposed HAP rules.

Response: As an initial matter, we note that the obligation to attain the NAAQS falls to the State, not the 

Doe Run facility. Thus, Doe Run would not be subject to any “claim of nonattainment.” We are required 

under section 112 to regulate lead compounds, which are a listed HAP under 112(b)(1). Section 

112(b)(2) is inapplicable here because it addresses the EPA’s authority to add a pollutant to the section 

112(b)(1) list. Section 112(b)(7) simply provides that the EPA cannot list elemental lead as a HAP, but 

does not address how the EPA should regulate emissions of lead compounds to address the technology 

and risk requirements in section 112. 

Comment: Commenter 0088 stated the proposed rule justifies the approach to evaluate risks from lead

using the lead NAAQS, in part, because there is no RfD or other comparable chronic health benchmark 

value for lead compounds. In lieu of developing an RfD (or other benchmark) for lead compounds, EPA 

substituted a benchmark that uses ambient lead concentrations compared to the NAAQS for lead, 

exactly as was done under CAA § 108 to identify the health risk to be protected by the NAAQS.

The identity between the lead NAAQS regulation and the proposed HAP regulation is codified in 

proposed § 63.1544(a), which incorporates the lead NAAQS level to determine whether the MACT 
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Standard for lead compounds is met. Such dual regulation is prohibited: “This prohibition extends of 

necessity not only to rules that literally list a criteria pollutant as a HAP but also to any rule that in effect 

treats a criteria pollutant as a HAP.” Nat’l Lime Ass’n, 233 F. 3d at 638. 

Response: As stated in the proposed rule and elsewhere in this document, the lead emitted from primary 

lead smelting is in the form of lead compounds. The commenter did not provide data to refute this. In 

the proposed rule, the level of the NAAQS, a health based standard, was used to determine whether or 

not there was unacceptable risk from lead compounds, a listed HAP. Given that modeled ambient lead 

concentrations resulting from emissions from the one facility in the source category were greater than 

the NAAQS, it was concluded that risk was unacceptable, and that it would continue to be unacceptable 

until the NAAQS was met. Once we determined a level of emissions that result in risks being 

acceptable, under the two-step residual risk decision process, the EPA then considered additional 

controls that might further reduce risk to achieve an ample margin of safety considering cost and 

feasibility. Taking cost and feasibility into account, we determined that for the three emission sources 

that drive the unacceptable risks (i.e., fugitive dust emissions, the furnace area stack, and the refinery 

stacks), implementation of all technically and economically feasible controls will be needed in order to 

ensure that the ambient air meets the level of the lead NAAQS, which is the level that we have 

determined will ensure an acceptable level of risk. Because all feasible controls will need to be adopted 

in order to meet that proposed standard, there are no additional controls to consider for the three 

emission sources that lead to unacceptable risk (i.e., fugitive dust emissions, the furnace area stack, and 

the refinery stacks). Thus, we proposed that the controls required to ensure that risk from lead emissions 

are acceptable are also those that will protect public health with an ample margin of safety.

Comment: Commenter 0087 stated that because lead is a criteria pollutant, the regulation of lead 

emissions for purposes of meeting the lead NAAQS is dictated by § 110 of the CAA and the EPA may 

not use the value of the NAAQS for setting an emission standard under § 112(f). Among other things, 

this program dictates deadlines for achieving compliance with the NAAQS, particular programs that 

states must adopt if an area currently is not meeting the NAAQS, and myriad other specific and 

prescriptive planning and emissions control obligations. There is no basis for the EPA to conclude that 

this carefully designed program may be supplanted by the different and sometimes conflicting emissions 

control requirements that flow from § 112.

Response: While the NAAQS and NESHAP/MACT programs are separate programs, Congress 

specifically provided that lead compounds are a HAP and the EPA must regulate emissions of lead 

compounds under section 112 in addition to ensuring that States attain and maintain the lead NAAQS 

within their boundaries. However, this rule does not supplant the NAAQS. Rather, this rule addresses 

the control of lead compounds for the Doe Run facility in order to ensure public health is protected with 

an ample margin of safety and to protect against adverse environmental effects. With regard to the 

NAAQS, Missouri will need to evaluate the Doe Run facility as well as other sources of lead emissions 

to determine how best to bring the area into attainment of the NAAQS. While the Doe Run facility is the 

primary source of the lead nonattainment problem in the area, on site lead emissions are not the sole 

source of ambient lead levels and the State will need to undertake a broader analysis to determine how 

best to attain and maintain the lead NAAQS.

To the extent there is some overlap with the NAAQS program because lead compounds are required to 

be regulated under both programs, there is no statutory bar to the EPA determining, based on the best 
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science it has, that the level of the NAAQS, which is to protect public health with an adequate margin of 

safety will also protect public health from lead compound emissions with an ample margin of safety as 

provided under section 112(f)(2). 

2.2.2 Support for a Compliance Period of Less than Two Years

Comment: Commenter 0077 stated that the EPA unlawfully proposes to delay compliance for both the 

proposed residual risk and MACT standards for existing sources until two years after the effective date 

of the final rules. The EPA’s proposal of a 2-year compliance delay simply cannot be reconciled with 

the EPA’s own recognition that lead emissions from this facility are unacceptable. The commenter 

stated that the two-year compliance time for the rule is unlawful for the following reasons:

 

• CAA states that standards based on section 112(f) have 90 day compliance time. It provides that 

“the Administrator may grant a waiver permitting such source a period of up to 2 years after the 

effective date of a standard to comply with the standard” if two statutory factors are met for a 

particular source. The EPA may grant such a waiver only “if [1] the Administrator finds that 

such period is necessary for the installation of controls and [2] that steps will be taken during the 

period of the waiver to assure that the health of persons will be protected from imminent 

endangerment.”

• Individual facilities can request waiver up to 2 years after promulgation but the EPA has 

unlawfully granted such a waiver in this national rulemaking without meeting the required 

benchmarks. The statute creates a “waiver” process for any such source to apply for an extension 

of the date, if it can meet the statutory factors but does not authorize the EPA to use the national 

rulemaking process to grant a CAA § 112(f)(4) “waiver” to one individual facility. There is no 

indication in this record that any “waiver” application has been submitted to EPA. Using the 

national rule process to delay compliance is arbitrary and capricious and an abuse of discretion.

• A facility must demonstrate that 2 years is necessary to install controls but Doe Run has no plan 

to install new controls during the two-year delay of the rule’s applicability. The EPA bases the 

two-year compliance date on the fact that a two-year compliance period is consistent with the 

schedule of required actions contained in the Consent Decree. That consent decree includes no 

requirement for emission reductions before the shut down. The commenter also stated that 

Section 112(f)(4)(B) does not allow consideration of economic factors or provide for the 

construction of a new facility, and at all times it requires the EPA to protect public health. 

• A facility must demonstrate that steps are being taken in the interim period to protect public 

health. According to the commenter, this second statutory factor also bars the compliance delay 

proposed by the EPA. The record shows that routine operation will continue at the facility during 

these two years without any meaningful emission reductions. The EPA’s proposal requires no 

action to reduce emissions in order to prevent imminent harm to health of people, including 

children, living, working, or going to school near this facility. 
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• The commenter states that the EPA has already delayed satisfying its legal duties both under 

section 112(f)(2) and section 112(d)(6) to promulgate this rule. These provisions actually 

required the EPA to perform this rulemaking and set the required standards no later than 8 years 

after the MACT was first promulgated. The EPA may not rely on a negotiated consent decree 

involving a single source to establish a compliance timeline in a national rulemaking or to delay 

the applicability of national section 112 hazardous air pollutant standards. The EPA must not 

suggest to industry that it can bring agreements in individual facility enforcement cases about 

past legal violations into forward-looking national rulemaking processes. Doe Run’s prior track 

record of violations only provides additional reason not to base this rule on any agreement 

regarding its future compliance or technology changes. 

In enacting the provision governing the compliance schedule for section 112(d) overall, commenter 

0077 explained that “Congress stated it wanted ‘expeditious[ ]’ compliance.” NRDC v. EPA, 489 F.3d 

1364, 1374 (D.C. Cir. 2007) (holding that the EPA could not rely on this provision to reset a prior rule’s 

effective date). This principle also applies to section 112(f)(4), in which EPA has set an even stricter 

“prohibition” on non-compliance after a 2-year period. For these reasons, the two-year compliance delay 

for the residual risk rule is arbitrary and capricious, and without the required evidentiary support in the 

record. 

Response: We disagree with the commenter’s assertion that the proposed 2-year compliance period is 

not supported. We examined a variety of factors to determine that the two-year compliance period is 

appropriate. We do believe that the facility will need to install controls in the two year period following 

the effective date of this final rule. Specifically, emissions from the refining and furnace area stacks will 

need to be further controlled, likely with additional baghouses or other control devices. For purposes of

addressing fugitive emissions, the facility will need to develop and implement work practice standards, 

to develop an ambient monitoring plan to ensure compliance, and to obtain approval from the 

Administrator for their ambient monitoring plan. All of these steps and the estimated time required to 

complete the required measures are described more thoroughly in a memo to the docket entitled 

“Estimated Time Needed to Comply with the Revisions to the NESHAP.” Based on the required steps 

the facility must take to comply with the NESHAP, a two year compliance date is appropriate. 

Furthermore, we note that the facility is currently subject to strict production and activity limits as a part 

of their SIP and Consent Decree that will provide significant protection during the two year compliance 

period. The commenter has not indicated any specific concern which presents an “imminent 

endangerment” that will occur during the two-year compliance period, merely making general 

allegations about the risks which formed the basis of the EPA’s decision to promulgate regulations. 

Since Congress recognized that a 2 year compliance period may be granted despite EPA’s determining 

to promulgate regulations to address risk, it is clear that Congress did not contemplate that any risk 

addressed by rules under 112(f)(2) created an imminent and substantial endangerment that would 

preclude a 2 year compliance date.

We note that section 112(i)(3) does not apply where we are setting the compliance date consistent with 

section 112(f)(4). Rather section 112(i)(3) provides a compliance date of “as expeditiously as 

practicable, but no later than 3 years after the effective date of such standard.” Section 112(f)(4) 

independently sets a compliance date of 90 days and, as the commenter notes in detail above, specifies 

the basis for providing a longer compliance period of up to 2 years. The compliance date for the main 
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stack has been revised from two years to 60 days from the effective date of the rule. Since the facility 

will not have to install any additional controls, this compliance timeframe is “as expeditiously as 

practicable”. 

Comment: Commenters (0077 and 0088) challenge the EPA’s proposal to defer the compliance date for 

new facilities to implement a CEMS. Commenter 0077 states that the EPA has no rational justification 

for delay; especially when there is no facility that would need additional time to implement this 

requirement. Failing to require CEMS compliance by rule now defers an important element of 

enforcement indefinitely. The EPA is under a legal duty to complete this rulemaking immediately under 

section 112(f)(2). Further, if it does not require this now, a new facility may take longer to implement 

CEMS precisely because the EPA failed to promulgate this in the current final rule. 

Response: New facilities that are constructed before a performance specification for lead CEMS is 

finalized must comply with the monitoring requirements for existing facilities within 60 days of 

publication of the final rule in the Federal Register or startup, whichever is later. We are requiring

compliance with lead CEMS for new facilities within 180 days after an approved performance 

specification for lead CEMS is promulgated. Currently there is no EPA performance specification for 

lead CEMS and it is therefore inappropriate to require immediate compliance with this monitoring 

technique. 

2.2.3 Authority for Total Facility Approach and Use of Demographics in Rulemaking

Comment: Commenter 0087 stated that the “total facility” approach to conducting risk assessment 

exceeds the EPA’s authority under § 112(f). 

Because the CAA requires residual risk determinations to be conducted on a category by category basis, 

the EPA does not have authority to consider the combined emissions from entire facilities when making 

a § 112(f) risk assessment for a given source category. 

Response: The source category emissions for Primary Lead Smelting risk assessment modeling were 

equal to the facility wide emissions for this source category because there is no other source of HAP 

emissions at the same location for the one facility in this source category. Thus, the issue raised by the 

commenter is not relevant for this action. 

Comment: Commenter 0087 stated that the EPA should provide justification or a rational basis for 

considering demographics in deciding whether an ample margin of safety has been achieved. The 

commenter noted that this is a departure from the risk assessment methods established in prior § 112(f) 

residual risk determinations. Section 112(f)(2)(A) expressly instructs the EPA to impose additional 

emissions controls if needed to provide an ample margin of safety to protect public health. The term 

“public health” is not defined in § 112 or in EPA’s Part 63 regulations. The term “public health” cannot 

reasonably be interpreted to include consideration of environmental justice in the § 112(f) context. In the 

context of the EPA’s national ambient air quality program, the Supreme Court has observed that public 

health means “the health of the public.” The word “public” should be construed expansively as 

describing the people as a whole, and not particular demographic segments. 
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Response: No regulatory decisions were based on the demographics analysis. While the EPA presented 

the demographic information in the preamble to the proposed rule, the EPA did not base any decision on 

that demographic information. We note that the demographics analysis also did not affect any decision 

we are making as part of this final rule.

2.3 Removal of the Startup, Shutdown, and Malfunction Exemption

Comment: Commenter 0071 stated that EPA’s proposal that facilities meet steady-state standards 

during startup, shutdown and malfunction (SSM) is unlawful. Specifically, the commenter noted that the 

EPA does not demonstrate that sources can meet the standards during startup, shutdown, or malfunction, 

citing that:

• MACT floor standards must be based on evidence that top performers have already achieved 

them. The EPA’s statement that sources can meet the standards during startup, shutdown, and 

malfunction is not based on data reflected in the rulemaking docket.

• The proposed standards were developed using data collected during steady-state operations that 

do not reflect variations likely during SSM and no data were collected during periods of SSM.

• The variability included in the proposed emission limit reflects variation in testing during steady 

state conditions only and does not reflect the variability from SSM events. 

• If the EPA requires facilities to meet the same emission standards under both normal operations 

and during SSM events, they must supply supporting data. 

The commenter doubted that it is possible for the EPA to develop valid floor standards for the periods of 

startup, shutdown, and malfunction, citing the EPA’s own National Stack Testing Guidance which 

discusses the difficulty of getting valid testing results during SSM. 

The commenter recommended that if the EPA cannot develop emission-based standards that apply 

during SSM, then they should adopt work practice standards. They stated that is what Congress 

anticipated in CAA § 112(h), which allows the EPA to develop work practice standards where a 

methodology to develop a standard of performance is not feasible due to technological constraints 

including the ability to collect valid test data. 

Response: The EPA has determined that CAA section 112 does not require that emissions that occur 

during periods of malfunction be factored into development of CAA section 112 standards. Under CAA 

section 112, emissions standards for new sources must be no less stringent than the level ‘‘achieved’’ by 

the best controlled similar source, and for existing sources, generally, must be no less stringent than the 

average emission limitation ‘‘achieved’’ by the best performing 12 percent of sources in the category. 

There is nothing in CAA section 112 that directs the agency to consider malfunctions in determining the 

level ‘‘achieved’’ by the best performing or best controlled sources when setting emission standards. 

Moreover, while the EPA accounts for variability in setting emissions standards consistent with the 

CAA section 112 case law, nothing in that case law requires the Agency to consider malfunctions as part 

of that analysis. 

CAA section 112 uses the concept of ‘‘best controlled’’ and ‘‘best performing’’ unit in defining the 

level of stringency that CAA section 112 performance standards must meet. Applying the concept of 

‘‘best controlled’’ or ‘‘best performing’’ to a unit that is malfunctioning presents significant difficulties, 

as malfunctions are sudden and unexpected events. Accounting for malfunctions would be difficult, if 
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not impossible, given the myriad different types of malfunctions that can occur across all sources in the 

category, and given the difficulties associated with predicting or accounting for the frequency, degree, 

and duration of various malfunctions that might occur.

As such, the performance of units that are malfunctioning is not ‘‘reasonably’’ foreseeable. See, e.g., 

Sierra Club v. EPA, 167 F. 3d 658, 662 (D.C. Cir. 1999) (the EPA typically has wide latitude in 

determining the extent of data-gathering necessary to solve a problem. We generally defer to an 

agency’s decision to proceed on the basis of imperfect scientific information, rather than to ‘‘invest the 

resources to conduct the perfect study.’’). See also, Weyerhaeuser v. Costle, 590 F.2d 1011, 1058 (D.C. 

Cir. 1978) (‘‘In the nature of things, no general limit, individual permit, or even any upset provision can 

anticipate all upset situations. After a certain point, the transgression of regulatory limits caused by 

‘uncontrollable acts of third parties,’ such as strikes, sabotage, operator intoxication or insanity, and a 

variety of other eventualities, must be a matter for the administrative exercise of case-by-case 

enforcement discretion, not for specification in advance by regulation.’’). In addition, the goal of a best 

controlled or best performing source is to operate in such a way as to avoid malfunctions of the source, 

and accounting for malfunctions could lead to standards that are significantly less stringent than levels 

that are achieved by a well-performing non-malfunctioning source. The EPA’s approach to malfunctions 

is consistent with CAA section 112, and is a reasonable interpretation of the statute.

The EPA has determined that separate standards for periods of startup and shutdown are not necessary. 

The processes regulated under this rule are controlled by air pollution control devices. We have no data 

to indicate that emissions from primary lead processing are substantially different during periods of 

startup or shutdown and the commenter did not provide any data proving otherwise. 

Comment: Commenter 0077 agreed with the EPA in the removal of the unlawful malfunction 

exemption under the existing rules but noted that the EPA failed to consider increased acute health risks 

and possibly chronic risk from malfunction or other violations of the MACT standard. The commenter 

made the following specific points:

• The EPA must consider data regarding the use of the SSM exemption and enforcement actions in 

the past, at a minimum, and other information it has regarding the history or likelihood of 

malfunctions or other violations of the standard, as part of its analysis. The EPA must recognize 

that a certain level of malfunctions and other violations of the MACT is likely, and factor this 

into its analysis of the risk to public health and the environment.

• EPA failure to look at the true potential for spikes will significantly underestimate the amount of 

emissions considered for this analysis. The Act specifically requires the EPA to base its risk 

analysis on the highest possible level of risk – i.e., the risk “to the individual most exposed to 

emissions from a source in the category or subcategory.” 42 U.S.C. § 7412(f)(2)(A). To do this, 

it is necessary for the EPA to determine the highest level of potential emissions from the worstperforming source, and then use that information to establish the maximum individual risk. That 

requires consideration of malfunction- and other violation-based emissions.

• Research by the Environmental Integrity Project (“EIP”) from 2004 found that significant 

emission exceedances occur routinely, across a range of different industries. Moreover, EIP 

found that releases from upsets actually dwarf a facility’s routine emissions. The EPA must 

look at data, like the EIP report, and ensure that its risk analysis and resulting standard 
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prepare for the likelihood that malfunctions will occur and that the public will need 

protection from the high emissions they cause.

• The EPA must consider emissions during malfunction as part of the risk assessment. The 

commenter stated that by ignoring risks from malfunctions or other violations, the EPA’s 

proposal fails to consider the full risk from this source category. 

• The EPA must include in its risk assessment the heightened amount of emissions that occur 

from malfunctions and other violations of the standard. Even the agency’s analysis of risk 

using the “allowable” emissions number is incomplete because facilities may violate that 

standard and emit HAPs at a level above what would be deemed “allowable” under the 

existing MACT. 

Response: We disagree with the commenter that emissions that exceed standards and are violations, 

whether or not caused by malfunction events, should be considered as part of the risk analysis. The 

purpose of the risk review is to evaluate whether the emission limits should be made more stringent to 

reduce the risk posed after compliance with the underlying MACT standard. To the extent that a source 

is violating the underlying MACT standard, no tightening of the emission standard under the residual 

risk rule will avoid or mitigate against such violations. In other words, a source that is violating the 

MACT emissions standard promulgated under section 112(d) would not be any more likely to be able to 

avoid such violations and comply with a different presumably more stringent standard promulgated 

under section 112(f). Such events are violations and subject to enforcement by the EPA, the States or 

citizens and an action for injunctive relief is the most effective means to address violations whether or 

not they are caused by malfunctions if an emissions event poses a significant health or environmental 

risk.

Although we disagree that emissions that result in a violation should be considered as part of the risk 

review, we note that we believe malfunction events do not contribute significantly to cancer or chronic 

noncancer risks for the source category in this rulemaking because malfunction events are inherently 

short-term and infrequent relative to annual operations and emissions. The commenter did not supply 

any data to the contrary.

Furthermore, the conservative estimates built into the acute risk assessment are sufficient to gauge 

worst-case potential acute health effects. The conservative estimates built in to the assessment include 

worst-case meteorology, emissions at ten times the maximum peak emission rate from all point sources 

simultaneously, and the summation of the maximum impact of each emission source, regardless of 

receptor location. Thus, even if we were to consider emissions that are in violation of the standard, we 

do not believe that they would result in any different level of control than we are promulgating here.

2.4 Affirmative Defense Provisions

Comment: Commenter 0071 stated that the EPA should modify the affirmative defense so that it is a 

“rebuttable presumption.” The commenter noted that malfunctions will occur and that even the best run 

facilities will have circumstances where events out of their control e.g., power failures will occur. The 

commenter is concerned that an affirmative defense implies that the facility is guilty until proven 

innocent and that the proposed language improperly puts the burden of proof on the facility rather than 
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on the Agency. The commenter suggested that the EPA establish a rebuttable presumption rather than 

affirmative defense where it is presumed that the facility did everything in their power to minimize 

emissions during these events, unless the Agency proves certain facts that are enumerated in the rules. 

And, if the agency wants to challenge these activities, the burden of proof would be on them to show 

that the facility did not undertake reasonable actions to minimize emissions.

The commenter stated that if the EPA decides to retain the affirmative defense requirement, the 

language should be modified to make it more usable because the requirements proposed in § 63.1551 are 

impossible to meet due to the use of ambiguous terms such as "careful," "proper," or "better." 

Specifically, the commenter suggested the following changes;

• Drop the reference to "Any" or “All” activity in this paragraph that would make it difficult to 

ever satisfy the requirements of an affirmative defense. 

• Limit root cause analyses to significant events or repeat events and only as a last resort when 

other reasonable methods fail to show what caused the malfunction. Commenter stated that for 

many malfunctions, the cause is immediately obvious negating the need for a detailed root cause 

analysis. The EPA should allow for an evaluation of the seriousness of the event to determine if 

root cause analysis necessary. 

• For some malfunctions, a root cause analysis cannot be completed in 30 days. For significant 

malfunctions, a more detailed analysis may be necessary and could require 90 days to complete. 

• Faxing is an obsolete technology. The EPA should allow notification by e-mail or other 

electronic means.

The commenter provided a revised § 63.1551 incorporating specific wording changes recommended in 

their comments. 

Response: The affirmative defense does not change the burden of proof with respect to establishing a 

violation. 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 

the EPA’s use of an affirmative defense to address excess emissions during malfunction events.). The 

EPA 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 the party bringing the 

enforcement action. It is the source, not the EPA (or other party taking enforcement action) that has the 

information relevant to assess whether a particular event qualifies as a malfunction and meets the 

affirmative defense. 

Many of the conditions in the affirmative defense are modeled after the affirmative defense in the 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 the EPA. (40 C.F.R. 50.1312). The 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, therefore, changes in 

language would not be appropriate.

 
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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. The use of telephone or facsimile notification as indicated in the rule, is 

consistent with timely notification methods currently used by regulatory authorities.

With regard to the reporting timeframe for asserting affirmative defense, we have made changes to the 

reporting provision in the final rule allow for 45 days instead of 30 days for the facility to prepare a 

written report supporting the assertion of the affirmative defense. In addition, we have added a provision 

for the facility to request an extension of up to an additional 30 days in cases where circumstances 

prohibit submission of the required documentation within the required 45 day period. 

Comment: Commenter 0077 noted that the affirmative defense is unlawful and unjust, would create a 

new unlawful loophole, would have harmful consequences for communities, undermines citizen’s rights, 

and will greatly reduce the deterrent impact of the standards: 

• An “affirmative defense” for malfunctions will reduce the deterrent value of the MACT standard and 

undermine or cut off the ability of people living near facilities that violate the standard to seek civil 

penalties.

• The statute makes clear how the courts are to assess civil penalties, whether a case is brought by 

EPA or a citizen. 42 U.S.C. § 7413(e). Congress plainly intended citizens to be able to enforce 

emission standards under 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, CAA § 304(b)(1)(B), 42 U.S.C. § 

7604(b)(1)(B). EPA’s rule proposal, by shifting this careful balance and contravening these 

mandates, violates the CAA.

• The affirmative defense that EPA proposes to allow in case of malfunctions goes directly against 

congressional intent in two ways. First, Congress expressed a clear intent as to how judges should 

determine the size of civil penalties whenever they are sought and thus, under Chevron, U.S.A., Inc. 

v. Natural Res. Def. Council, Inc., 467 U.S. 837, 842-43 (1984), flatly barred EPA from limiting 

when civil penalties can be assessed. In this proposal, EPA acts outside of its delegated authority to 

limit civil penalties available in citizen suits or its own enforcement actions. Second, the proposal 

will impermissibly chill citizen participation, and the ability to win an effective, deterrent remedy, in 

CAA enforcement.

• The affirmative defense is fatally flawed because EPA cannot create a bright-line test to decide when 

civil penalties will not be allowed. The CAA itself spells out the only limits that Congress intended 

to impose on citizens’ ability to seek and recover penalties in enforcement suits under § 304. 42 

U.S.C. § 7413(e). By attempting to impose additional agency-created limits, EPA exceeds its 

authority.

• Congressional intent on civil penalties is clear—they are a remedy available to citizen plaintiffs, and 

judges have a list of factors to consider in assessing them. As such, EPA cannot interpret the statute 

to contravene that intent. By attempting to eliminate, via regulations, civil penalties in cases of 

malfunction where the violator demonstrates that certain factors [exist], EPA has done just that.
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• The CAA grants EPA minimal discretion that only applies to administrative penalties, allowing EPA 

to “compromise, modify, or remit, with or without conditions, any administrative penalty which may 

be imposed under [subsection 113(d)].” 42 U.S.C. § 7413(d)(2)(B).

• However, there is no similar grant of authority to EPA to compromise, modify or limit civil penalties 

that a court may impose under section 113(e) or section 304. Section 304(a), 42 U.S.C. § 7604(a), 

grants courts the sole authority “to apply appropriate civil penalties” in citizen suits. The explicit 

reference to EPA’s ability to modify penalties in one subsection and its absence in the other 

subsection of the same provision can only be understood as an intentional decision by Congress that 

EPA cannot contravene by rule.

• EPA’s regulation would mean that if commenters or a local community group sued a primary lead 

processing facility for its violation of the NESHAP, the owner would be exempt from paying civil 

penalties so long as the owner satisfied the requirements set forth in EPA’s regulations. See 

Proposed Rule, 76 Fed. Reg. at 9,415 (to be codified at 40 C.F.R. §§ 63.1551. The owner would not 

be subject to civil penalties regardless how the congressionally mandated factors in the statute cut. 

That is, even if the owner benefited substantially from its violation, the penalty would not harm the 

owner economically, and the violation was extreme, the owner would not have to pay any civil 

penalty.

• It is improper for a court to fail to consider the factors in CAA § 113(e)(1), or to fail to make its own 

determination of what civil penalties are “appropriate” under CAA § 304(a).55 A fortiori it is 

impermissible for EPA to attempt to displace those factors or in any way alter their significance by 

creating an absolute bar to penalties if certain agency-created considerations are met instead.

• There is simply no need for an affirmative defense to penalties to be written into the regulations and 

cause the harm that will result. EPA has discretion to decide what cases to prosecute, to consider 

settlements, and to request civil penalties in a case-by-case manner, as long as it acts consistent with 

the CAA to protect clean air as its top priority, see 42 U.S.C. § 7401. Promulgating this affirmative 

defense is equivalent to giving polluters a “get out of jail free” card for serious emission exceedances 

and MACT violations. Polluters are likely to claim that any violation of the standard is due to a

malfunction in order to evade the requirements. Allowing polluters to evade financial penalties –

which are the real teeth of the standards – through this type of measure is likely to lead to them 

simply ignoring or factoring potential standard violations into their cost of doing business, rather 

than actually trying to prevent malfunctions and violations of the standards as a way to avoid 

financial losses from the application of penalties.

• Assuming arguendo that EPA had authority to promulgate any type of affirmative defense to 

penalties for malfunctions, EPA should also promulgate the following provisions:

1. A specific amount of compensatory damages should apply to each reported 

malfunction. These funds should be dedicated to enforcement, inspections, and 

monitoring in the local community around the specific facility, to create greater 

assurance that malfunctions will not happen again.

2. EPA should modify the regulations so 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. The affirmative defense should become automatically unavailable to a facility 

that has previously had a malfunction within the last 10 years, to ensure that this 

defense does not swallow the value of the standards.
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3. EPA should promulgate specific public reporting and notification requirements for 

malfunctions, or any emission exceedance that occurs of which an operator is aware. 

Specifically, EPA should require that when a facility provides EPA with a 

notification of a malfunction or emission standard exceedance under the regulations, 

this notice will be made publicly available on EPA’s website within 14 days. In 

addition, EPA should promulgate the requirement that when such notification is 

made, the facility must also provide for community notification of the malfunction or 

emission standard exceedance within 2 business days, through an appropriate public 

forum that is designed to reach residents who live near the facility, including but not 

limited to a notice on the facility’s own website (if it has one), a written notice to the 

local municipality and local school district, a press release to the local newspaper, 

radio, and TV news station that contains information community members may need 

to protect themselves and their families from the additional air pollution.

Response: As the EPA explained in the preamble to the proposed rule and in the response to comment 

document, the EPA recognizes that even equipment that is properly designed and maintained can fail 

and that such failure can cause an exceedance of the relevant emission standard. The EPA included an 

affirmative defense in the final rule in an attempt to balance a tension, inherent in many types of air 

regulation, to ensure adequate compliance while simultaneously recognizing that despite the most 

diligent of efforts, emission limits may be exceeded under circumstances beyond the control of the 

source. The EPA must establish emission standards that “limit the quantity, rate, or concentration of 

emissions of air pollutants on a continuous basis.” 42 U.S.C. § 7602(k)(defining “emission limitation 

and emission standard”). See generally Sierra Club v. EPA, 551 F.3d 1019, 1021 (D.C. Cir. 2008) ( 

emissions limitations under CAA section 112 must both continuously apply and meet section 112’s 

minimum stringency requirements, even during periods of startup, shutdown and malfunction). Thus, 

EPA is required to ensure that section 112 emissions limitations are continuous. The affirmative defense 

for malfunction events meets this requirement by ensuring that even where there is a malfunction, the 

emission limitation is still enforceable through injunctive relief. While “continuous” limitations, on the 

one hand, are required, there is also caselaw indicating that in many situations it is appropriate for EPA 

to account for the practical realities of technology. For example, in Essex Chemical v. Ruckelshaus, 486 

F.2d 427, 433 (D.C. Cir. 1973), the D.C. Circuit acknowledged that in setting standards under CAA 

section 111 “variant provisions” such as provisions allowing for upsets during startup, shutdown and 

equipment malfunction “appear necessary to preserve the reasonableness of the standards as a whole and 

that the record does not support the ‘never to be exceeded’ standard currently in force.” See also, 

Portland Cement Association v. Ruckelshaus, 486 F.2d 375 (D.C.Cir. 1973). Though intervening 

caselaw such as Sierra Club v. EPA and the CAA 1977 amendments undermine the relevance of these 

cases today, they support the EPA’s view that a system that incorporates some level of flexibility is 

reasonable. The affirmative defense simply provides for a defense to civil penalties for excess emissions 

that are proven to be beyond the control of the source. By incorporating an affirmative defense, the EPA 

has formalized its approach to upset events. In a Clean Water Act setting, the Ninth Circuit required this 

type of formalized approach when regulating “upsets beyond the control of the permit holder.” 

Marathon Oil Co. v. EPA, 564 F.2d 1253, 1272-73 (9th Cir. 1977). But see, Weyerhaeuser Co. v. Costle, 

590 F.2d 1011, 1057-58 (D.C. Cir. 1978) (holding that an informal approach is adequate). The 

affirmative defense provisions give the EPA the flexibility to both ensure that its emission limitations 

are “continuous” as required by 42 U.S.C. § 7602(k), and account for unplanned upsets and thus support 

the reasonableness of the standard as a whole.
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Further, the EPA’s view is that the affirmative defense is not inconsistent with CAA section 113(e) or 

304. 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. 

In exercising its authority under section 112 to establish emission standards (at a level that meets the 

stringency requirements of section 112), the EPA necessarily defines conduct that constitutes a 

violation. The EPA view is that the affirmative defense is part of the emission standard and defines two 

categories of violation. If there is a violation of the emission standard and the source demonstrates that 

all the elements of the affirmative defense are met, only injunctive relief is available. All other violations 

of the emission standard are subject to injunctive relief and penalties. The CAA does not require that all 

violations be treated equally. Further, a citizen suit claim under section 304 allows citizens to commence 

a civil action against any person alleged to be in violation of “an emission standard or limitation under 

this chapter.” The CAA, however, allows EPA to establish such “enforceable emission limitations.” 

Thus, the citizen suit provision clearly contemplates enforcement of the standards that are defined by 

EPA. As a result, where EPA defines its emissions limitations and enforcement measures to allow a 

source the opportunity to prove its entitlement to a lesser degree of violation (not subject to penalties) in 

narrow, specified circumstances, as the EPA did here, penalties are not “appropriate” under section 304. 

The EPA’s view is that an affirmative defense to civil penalties for exceedances of applicable emission 

standards during periods of malfunction appropriately balances competing concerns. On the one hand, 

citizen enforcers are concerned about additional complications in their enforcement actions. On the other 

hand, industrial sources are concerned about being penalized for violations caused by malfunctions that 

could not have prevented and were otherwise appropriately handled (as reflected in the affirmative 

defense criteria). The EPA has utilized its Section 301(a)(1) authority to issue regulations necessary to 

carry out the Act in a manner that appropriately balances these competing concerns.

The 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. 

The EPA 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 
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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 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, the 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, the EPA does not expect the affirmative 

defense provision to materially affect the practice of CAA enforcement.

Additionally, the affirmative defense is reasonable. The 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 the 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, the EPA’s view is that it would be unfair to impose a 

penalty no matter the size of the business. 

The 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 the EPA has authority to require the 

automatic imposition of compensatory damages and even if such authority exists, the 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, the 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 

the EPA are publicly available pursuant to CAA section 114.

Comment: Commenter 0087 stated that the affirmative defense provisions do not cure the 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. The commenter further stated that the proposed standards with the 

affirmative defense do not represent emission limitations achieved by the best-performing existing 
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sources, nor do they meet the criteria for establishing beyond-the-floor emission standards and that the 

affirmative defense is not a permissible substitute for setting standards for periods of malfunction and is 

insufficient to meet the EPA’s obligations under CAA §112. Commenter 0087 requested the EPA set 

aside the proposed affirmative defense for periods of malfunction and establish a work practice standard 

for these periods.

Response: The affirmative defense applies to malfunction events and not to periods of startup and 

shutdown. The affirmative defense is not intended as a substitute for standards under section 112 – the 

applicable standard applies during malfunctions, but a source may assert an affirmative defense in an 

enforcement action for penalties for emissions in excess of the standard. In a previous response we 

address the commenter’s concern regarding whether the EPA has met its obligation under section 112 in 

addressing emissions during startup and shutdown. 

2.5 Proposed Standards for Primary Lead Smelting

2.5.1 Authority and Approach under CAA Section 112(f)(2)

Comment: Commenter 0077 stated that the EPA’s conclusion that an MIR of 30 in a million based on 

allowable emissions, 4,900 people exposed to a cancer risk greater than 1 in a million, and 200 exposed 

to a risk as high as 30 in a million is acceptable is not justified. The commenter stated that the EPA 

cannot simply assume that any level of risk under 100 in a million remains presumptively acceptable, 

rather they must attempt to achieve the goal of risk no higher than 1 in a million for the maximum 

number of people possible. The commenter stated that in this case, there is a significant level of 

cumulative impacts weighing in favor of a finding of unacceptability for cadmium, arsenic, and other 

non-lead emissions. 

Response: The EPA believes it is appropriate to maintain the benzene decision framework for 

determining acceptability. Under that framework, cancer risk less than 100 in a million is generally 

considered acceptable. However, also under this framework we thoroughly consider all available health 

factors (including the MIR, population risks, non-cancer risks, etc.) as we determine acceptability, and 

also in the ample margin of safety analyses and related decisions. In the proposed rule for this source 

category we concluded that risks associated with emissions from the Primary Lead Smelting source 

category were unacceptable, primarily due to the fact that lead emissions are causing exceedances of the 

lead NAAQS, and we proposed standards to reduce those lead emissions to acceptable levels. After we 

determined the controls and other measures needed to achieve acceptable levels of emissions and risks, 

we then considered, in light of all the various health factors and the availability and costs of additional 

controls, whether any additional reductions were necessary to provide an ample margin of safety for lead 

and non-lead HAPs and, as explained in the preamble, we concluded they were not.

Comment: Commenter 0077 stated that the EPA did not appropriately address issues of socioeconomic 

disparity in health risks from this source category. While supporting the EPA’s effort to gather 

demographic data and to incorporate environmental justice into their consideration of what level of 

public health risk is “acceptable” or not under section 112(f)(2) the commenter stated that the EPA 

should use these data to protect families from unacceptable risk. A level of risk that might otherwise be 
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“acceptable” becomes unacceptable when, as here, lower income individuals are disproportionately 

affected.

Response: We disagree with the commenter that the EPA found a “disproportionate risk” for those 

below the poverty level. The EPA noted that relative to the corresponding national percentage of 

individuals below the poverty level, there was a 2 percent increase with respect to individuals below the 

poverty level around this facility with a cancer risk greater than 1 in a million. However, we also stated 

that given that the total population affected was small (i.e., 4,900 individuals for cancer risk greater than 

1 in a million), we did not think this indicated any significant potential for disparate impacts for this 

demographic group (see 76 Fed. Reg. at 9431). 

Comment: In regard to non-lead emissions, the commenter stated that the EPA must consider and 

incorporate the best available information on particular health impacts and risks to children and infants

as well as from prenatal exposure to hazardous air pollution including California’s Office of 

Environmental Health Hazard Assessment (OEHHA) recently updated methodology that could affect 

the development of RfC and URE values. In particular, in its analysis of the lifetime risk of cancer from 

this source, the EPA should incorporate the particular risk created by early-life exposure. Instead of 

continuing to ignore the different cancer risk created during different windows of exposure, and the 

higher risk from early exposure, the EPA should adopt the California OEHHA guidelines for assessment 

of carcinogenic risks that includes a particular risk from early exposure. 

The commenter stated that California has developed a child-specific reference dose for cadmium, which 

the EPA must incorporate into its risk analysis. 

Response: With respect to HAP emissions other than lead and the California benchmark for protecting 

children, we note that the EPA is currently evaluating whether or not it is appropriate to use the CalEPA 

child-specific reference doses. That is, before using these child-specific reference doses, EPA wants to 

evaluate whether they have been appropriately derived. In addition, the EPA has a hierarchy of 

appropriate health benchmark values and in general, this hierarchy places greater weight on the EPA 

derived health benchmarks than those from other agencies (see 

http://www.epa.gov/ttn/atw/nata1999/99pdfs/healtheffectsinfo.pdf). Notably, this hierarchy favoring 

EPA benchmarks (when they exist) over all others has been endorsed by the SAB.

Comment: Commenter 0077 disagreed with the EPA’s finding that a TOSHI as high as 1.0 is 

acceptable because when combined with cumulative and other HAP impacts, this number is likely to be 

above 1.0 for the maximum exposed individual. 

The commenter stated that in an internal EPA memo the EPA stated that the default HI limit for chronic 

non-cancer risks should be well under 1.0 for individual sources—specifically, it should be 0.2. The 

rationale for a maximum non-cancer HI of 0.2 is that it would allow an individual source to account for 

20 percent of the contribution to total exposure in its vicinity. 

For this source category, the EPA has not evaluated other nearby sources and has not considered or 

addressed the accumulated impacts to this community over time. It also appears not to have factored in 

the transportation-related health risks for the hauling of materials from the mines to and from the 

primary lead smelter, past people’s homes in Herculaneum and other local communities. 
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The arbitrariness of the EPA’s decision to use 1.0 as the HI threshold for harm is highlighted by the fact 

that this source category creates long-term, cumulative risks for people living nearby, and also poses 

other significant health risks, as already discussed. The EPA’s decision also fundamentally undermines 

the intent of the statute to protect people from adverse health effects associated with industrial sources of 

hazardous air pollution. Moreover, this approach, once again, adds to the under-protective bias in the 

EPA’s analysis. It may not permit a single source covered by this rulemaking to consume the entire noncancer risk safety factor. 

Response: The EPA disagrees with the commenter’s notion that any TOSHI value greater than 0.2 

should be considered unacceptable. We note that pollutant-specific reference concentrations (RfCs) are 

not absolute thresholds, but estimates of chronic inhalation exposures at or below which health effects 

would not be expected to occur, including in sensitive subgroups. We further note that these RfCs are 

developed using a health-protective approach (see a discussion of this in the uncertainty section of the 

risk assessment document), that TOSHI values of 1 or less are (like RfC levels) generally considered to 

carry no appreciable risk of adverse health effects and that there is generally no need to compound this 

protection by suggesting that any source category maximum TOSHI value would need to be at or below 

0.2 before we would consider it to be acceptable.

We further note that we generally draw no bright lines of acceptability regarding cancer or noncancer 

risks from source category HAP emissions, and that it is always important to consider the specific 

uncertainties of the emissions and health effects information regarding the source category in question 

when deciding exactly what level of cancer and noncancer risk should be considered acceptable. In 

addition, the source category-specific decision of what constitutes an acceptable level of risk should be a 

holistic one; that is, it should simultaneously consider all potential health impacts -- chronic and acute, 

cancer and noncancer -- along with their uncertainties, when determining the acceptable level of source 

category risk. Experience with source category rulemakings in the past tells us that this means that 

drawing bright lines for such decision-making is impossible. The Benzene NESHAP decision 

framework of 1989 acknowledged this; in today’s world, such flexibility is even more imperative, 

because new information relevant to the question of risk acceptability is being developed all the time, 

and the accuracy and uncertainty of each piece of information must be considered in a weight-ofevidence approach for each decision. This relevant body of information is growing fast (and it will 

continue to grow faster and faster), necessitating a flexible weight-of-evidence approach that 

acknowledges both complexity and uncertainty in the simplest and most transparent way possible. While 

this challenge is daunting, it is nonetheless the goal of the EPA’s RTR decision-making, and it is the 

goal of the risk assessment to provide the information to support the decision-making process. 

In this case, the pollutant driving the unacceptable risk is lead, and in addition to this rulemaking, we 

have the lead NAAQS (and its implementation) as a backup to ensure that lead impacts do not get high 

enough to cause harm to public health. Thus, we have crafted the final rule to work together with the 

lead NAAQS to ensure the protection of public health. With regard to other HAP, while we did find the 

risks this source category to be acceptable, we did look for additional controls and process 

improvements that might further reduce risks in a cost-effective manner. In this case, we didn't find any

additional cost-effective controls. However, we note that the steps needed to reduce risks from lead 

would also be expected to reduce risks from other metal HAP.
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Comment: Commenter 0088 stated that the site where the EPA predicted the maximum lead 

concentrations (at 50 times the NAAQS value) is likely either part of the facility’s property, or is located 

in the river. They stated that basing a risk assessment on estimates from such an unpopulated area does 

not offer a sound basis for protecting the public health. Rather, a risk assessment offers more valuable 

information when it estimates effects where people actually live, which means measurements from 

locations to the west of the facility where a town exists.

Response: Considering updated facility boundary information, we have determined that the model 

receptor predicting the maximum lead concentration at the time of the proposed rule is actually located 

on Doe Run Company’s property. Based on all of the new information submitted during the comment 

period, including new information regarding the property boundaries, we performed a revised risk 

assessment, which is located in the docket: Residual Risk Assessment for the Primary Lead Smelting 

Source Category. 

2.5.2 CAA 112(d)(6) Technology Review

Comment: Commenter 0088 stated that the formulation of the plant-wide emission limit is incorrect, in 

that, only the main stack is subject to the current pound per ton limit; the furnace area stack (Baghouse 

#7) captures fugitive dust emissions from the blast furnace and dross kettles and is subject only to 

emissions controls based on work practices. The commenter stated that there are two critical issues that 

undercut the validity of setting a MACT standard for this stack:

 

1. The emissions and production numbers used to determine the emission cap are annual figures, 

whereas, the stack test is a snapshot in time measurement. Depending on the conditions during 

the stack test, the pound/ton emission rate at that time could be higher or lower than the rate set 

using annual numbers.

2. Stack testing conducted in 2009 indicates that the emission rate average was 0.7757 pound/ton, 

which is significantly higher than the proposed 0.22 lb/ton limit. Based on this data, it does not 

appear that the facility would be able to meet the proposed standard.

Commenter 0088 suggested that the furnace area stack emission be removed from the proposed lb/ton 

limit, and that a more realistic basis for measuring compliance than a stack test be employed if the 

proposed MACT limit is to be based on annual TPY and production numbers. 

Response: We agree that it is not necessary to set a “plantwide” limit that combines emissions from the 

furnace area stack and the main stack. The furnace areas and refinery stacks are subject to a separate 

combined emission limit of 1.2 TPY pursuant to section 112(f). With respect to the 0.22 lb/ton limit that 

was proposed, we have recalculated the limit with the new data submitted during the public comment 

period and the limit is now 0.97 lb/ton. This limit is achieved in practice, as demonstrated by stack tests 

performed for compliance with the MACT.

Comment: Commenter 0082 opposed the proposed plant-wide emission limit for several reasons. The 

commenter states that the current form of the stack emission limit (i.e. pound per ton of lead produced) 

is based on annualized production averages and that an average based on this period of production is too 

long term to have meaningful correspondence with a one-hour stack test. The commenter stated that the 

proposed form of the stack emission limits (tons per year), although based on quarterly-averaged 
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production and quarterly stack testing is an improvement, there is still a concern about the reliability of 

using short term stack tests combined with long term productions averages. The commenter suggested 

that the EPA consider a concentration-based stack limit in units of mass emitted per unit volume of stack 

air (mg/DSCM) similar to the form of the current Secondary Lead Smelter MACT. In addition, the 

commenter recommended this form of limit for consistency since there is a great deal of similarity 

between primary and secondary smelting both in terms of the processes and control technologies. 

Commenter 0082 stated that if a production-based emission limit is still contemplated, it should contain 

a requirement that on the day of testing, production on that day, and for the previous day or two, be 

within 10 percent of annual average production. This short-term retrospective process rate requirement 

is necessary because some processes are batch-oriented, such as drossing and refining, requiring a long 

time to complete and may therefore not be adequately captured in a single plant process rate calculated 

over the duration of compliance testing, or even over the entire day during which the test is conducted. 

Such a limit, with a requirement for typical production, would address the problem noted above where 

either emissions or production rate during the test do not represent actual operation during the preceding 

year (or quarter).

Response: We believe that the required quarterly stack testing will alleviate the potential problems of 

using annual production averages to calculate compliance for the main stack cited by the commenter. 

The emission cap from refining and furnace area stacks is in a mass per time format, which should 

eliminate potential problems related to the averaging time for production. The mass per time format for 

the refining and furnace area emission cap is appropriate because it is based on the emissions needed to 

achieve acceptable risk.

Comment: Commenter 0077 stated that the EPA must perform a technology review of the new 

hydrometallurgical technology in order to satisfy section 112(d)(6) and propose a MACT standard. The 

commenter stated that instead of proposing a MACT standard based on existing technology, the EPA 

must set an updated MACT standard to reflect Doe Run’s new technology, and prohibit any air 

emissions from this source category beyond the amounts Doe Run has found to be “achievable,” which 

would include the limit of 14.21 pounds of lead per year (as indicated in the Doe Run Permit to 

Construct Application submitted to the State of Missouri). Additionally, the commenter stated that 

failure to set a MACT for the new technology is inconsistent with the proposal to update the 

applicability of the standard to include the new technology and that the EPA cannot justify not updating 

the MACT for the new technology as being “as-yet undemonstrated” noting that Section 112(d)(6) 

required consideration of all “developments” and what is “achievable.” As the Doe Run Company has 

stated that “minimal” lead emissions are achievable, EPA should collect data from Doe Run and update 

the MACT to include the new hydrometallurgical technology.

Response: It is inappropriate to set a emission standard for a technology that has yet to be demonstrated 

based on an estimate of emissions developed for a permit application. Once the new hydrometallurgical 

lead processing technology is constructed, we will evaluate whether it is appropriate to develop a 

standard to address that technology based on actual emissions data.

Comment: Commenter 0087 stated that EPA should not use the authority of § 112(d)(6) to adjust the 

MACT standard to reflect emission levels “achieved in practice” under the current standard. The 

commenter noted that the EPA’s risk analysis indicates risks from the main stack are more than 20 times 
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below the acceptable level and that additional control measures are not warranted as they would not 

appreciably reduce existing risk. The commenter stated that EPA should determine what level of 

emission reduction is necessary to achieve an ample margin of safety, and then prescribe emission limits 

that achieve that level of reduction. The commenter stated that the EPA’s approach of lowering the 

MACT limit based on emission achieved in practice could have significant adverse consequences in 

other source categories where the EPA might conclude that a more stringent category-wide emissions 

limit should be imposed under § 112(d)(6) based on a subset of low-emitting sources, even though such 

additional reductions might not be needed to achieve an ample margin of safety. 

Response: The purpose of section 112(d)(6) is to evaluate whether there have been “developments in 

practices, processes, and control technologies” to determine that would justify tightening current 

standards. This analysis allows the EPA to consider costs and technical feasibility of revising a standard 

based on such developments. In this case, the revision to the production based emission limit is not 

expected to place any significant financial burden on the facility. If there are other rulemakings in which 

such changes may produce untenable financial burdens or concerns over technical infeasibility that EPA 

has not recognized in a proposed rule, commenters should inform the EPA of such issues during the 

public comment period on that proposed rule and the EPA will consider those comments when deciding 

whether or not to revise standards. 

Comment: Commenter 0089 stated that the EPA should consider setting emission standards based on 

emission reductions achieved at a secondary lead smelter that employs a wet electrostatic precipitator 

(WESP) as a polishing control device placed in series after their fabric filters. 

Response: We have evaluated the technology suggested by the commenter. While it may be 

technologically feasible to apply WESP technology to control emissions from primary lead smelting, the 

cost of such technology is not economically feasible. See the technical support document for the final 

rule available in the docket for the estimated cost required to install WESPs at the one existing facility.

2.6 Other Primary Lead Smelting Source Category Comments

2.6.1 Modifying applicability provision to include new “hydrometallurgical” process

Comment: Commenter 0085 supported the EPA’s proposal to include regulatory language clarifying 

that the proposed NESHAP for the primary lead smelting industry does not apply to secondary lead 

smelters, lead refiners, or lead remelters. The commenter requested that the EPA state in the preamble to 

the final primary lead NESHAP that the EPA’s findings and emission standards have no precedential 

value or special applicability to any NESHAP for the secondary lead smelting industry. 

Response: The EPA has provided regulatory language that indicates that secondary lead smelter, lead 

refiners, and lead remelters are not subject to this rule and we do not believe further clarification of 

those differences or applicability of the rule to those industries is necessary. With regard to the 

remaining substance of the comment, the issues presented by the commenter are more applicable to the 

development and proposal of the RTR for secondary lead smelting, which was published in the Federal 

Register on May 19, 2011 (76 FR 29032). 
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2.7 Miscellaneous Comments

Comment: Commenter 0087 stated that the EPA must not (and may not) revise the MACT based on the 

January 14, 2009 Natural Resource Defense Council and Sierra Club petition. Commenter 0087 

provided the following reasons as to why no action is necessary. 

First, once the EPA makes a MACT determination for a particular category, § 112(d)(6) provides the 

only authority for the Agency to later review and possibly revise the determination. NRDC asserts in its 

petition that the EPA should re-issue existing MACT standards as necessary to correct alleged flaws in 

the original MACT determinations. In essence, the NRDC Petition asks the EPA to invoke §§ 112(d)(2) 

and (4) to reissue MACT determinations as if the existing determinations had not been issued. Yet, the 

EPA does not have such authority. 

Second, the NRDC Petition could also be seen as an invitation for the EPA to revise prior MACT 

determinations under the authority of § 112(d)(6). But, such prior determinations may be revised only 

“as necessary (taking into account developments in practices, processes, and control technologies).” 

Alleged legal flaws in the original MACT determinations are not “practices, processes, and control 

technologies” that are properly within the scope of a § 112(d)(6) review.

Lastly, and fundamentally, the NRDC Petition is effectively an unlawful effort to challenge issues that 

can only have been raised during the 60-day period provided under § 307(b)(1) of the CAA for seeking 

judicial review after publication of the final Primary Lead Smelter MACT. The unstated premise of the 

NRDC Petition is that the petition creates a new and time-unlimited opportunity to raise (and eventually 

litigate) issues that could have been raised at the conclusion of the original rulemaking. This premise is 

wrong because it would render the express § 307(b)(1) 60-day time limit a nullity. 

For these reasons, the EPA has even greater authority and justification for denying the NRDC Petition 

than was asserted in the Proposal.

Response: We are not granting the NRDC petition in this rulemaking; thus these comments are not 

relevant. We note that in the context of recent rulemakings we have discussed our position on our 

continuing authority to set standards under section 112(d)(2) and (3) and our authority under 112(d)(6).

See, e.g., 76 FR 22577. In addition, we discuss this issue in responding to a comment from NRDC 

regarding our obligation to review “defective” MACT standards under section 112(d)(6).

Comment: Commenter 0064 opposed the EPA regulating industry due to impacts on jobs and economic 

recovery. 

Response: We are required by the CAA to conduct the residual risk and technology review that make up 

this rulemaking. The EPA strives to ensure that our rules minimize negative impacts on jobs and the 

economy while also ensuring that we meet our statutory obligations.

Comment: Commenter 0067 supported the EPA’s proposal to reduce lead emissions and address 

potential health effects.

Response: We acknowledge the commenter’s support.
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Comment: Commenters 0081, 0084, and 0086 submitted comments that do not appear to relevant to 

this rule or record.

Response: We do not have any response to these unrelated comments.