From: Topham.Nathan@epamail.epa.gov

Sent: Friday, October 21, 2011 2:37 PM

To: Cortney_Higgins@omb.eop.gov

Cc: French.Chuck@epamail.epa.gov; Hanzel, Veronica; Laney, Michael N.; 

tierney.jan@epamail.epa.gov; Guinnup.Dave@epamail.epa.gov; 

Stewart.Michael@epamail.epa.gov

Subject: E.O. 12866 Review NESHAP Primary Lead Processing Final AQ-43 - Requested 

Documents

Attachments: E.O. 12866 NESHAP Primary Lead Processing Final AQ-43_DRAFT_10-21-

2011_Redline.docx; E.O. 12866 NESHAP Primary Lead Processing Final AQ43_DRAFT_10-21-2011_Clean.docx; E.O. 12866 NESHAP Primary Lead 

Processing Final AQ-43 Response to Comment Document-DRAFT-10-21-

11_Redline.docx; E.O. 12866 NESHAP Primary Lead Processing Final AQ-43 

Response to Comment Document-DRAFT-10-21-11_Clean.docx; E.O. 12866 

NESHAP Primary Lead Processing Final AQ-43_DRAFT_Tech Support Doc_10-21-

11.doc

Hi Cortney, 

Here are the updated preamble/rule and response to comment documents. I've attached redline and 

clean versions. 

I've also attached the technical support document that includes the model-to-monitor comparison on 

page 8. 

Nathan Topham 

Environmental Engineer 

US EPA/OAQPS/SPPD/MIG 

Phone - (919)541-0483
National Emission Standards for 

Hazardous Air Pollutants: 

Primary Lead Smelting 

Summary of Public Comment and Response

DRAFT – Do Not Cite or Quote

October 1421, 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
Draft – Do Not Cite or Quote October 1421, 2011

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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. 
Draft – Do Not Cite or Quote October 1421, 2011

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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
Draft – Do Not Cite or Quote October 1421, 2011

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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
Draft – Do Not Cite or Quote October 1421, 2011

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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"
Draft – Do Not Cite or Quote October 1421, 2011

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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 1421, 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
Draft – Do Not Cite or Quote October 1421, 2011

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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.
Draft – Do Not Cite or Quote October 1421, 2011

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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
Draft – Do Not Cite or Quote October 1421, 2011

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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 
Draft – Do Not Cite or Quote October 1421, 2011

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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).
Draft – Do Not Cite or Quote October 1421, 2011

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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.
Draft – Do Not Cite or Quote October 1421, 2011

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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 
Draft – Do Not Cite or Quote October 1421, 2011

13

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. 
Draft – Do Not Cite or Quote October 1421, 2011

34

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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36

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 
Draft – Do Not Cite or Quote October 1421, 2011

37

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 taking final action in this rulemaking to revise the MACT rule in response to the 

petition filed by NRDC. 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).

We fundamentally disagree with the commenter that EPA does not have authority to revise an existing 

rule that the Agency concludes is deficient regardless of whether the deficiency is first noted by the 

Agency or by an outside party through a petition for rulemaking. An agency generally remains free to 

undo improperly promulgated or otherwise unsupportable rules unless expressly limited by statute. See

Macktal v. Chao, 286 F.3d 822, 825-26 (5th Cir. 2002); see also Last Best Beef, LLC v. Dudas, 506 F.3d 

333, 340 (4th Cir. 2007); Friends of the Boundary Water Wilderness v. Bosworth, 437 F.3d 815, 823 (8th

Cir. 2006). Recent caselaw also supports EPA’s authority to revise regulations addressing hazardous air 

pollutants once an error or flaw is identified. In Medical Waste Institute, the Court agreed with EPA that 

“nothing in the [CAA or Circuit precedent] suggests that [EPA] is prohibited from resetting the MACT 

floors in order to correct [EPA’s] own errors.” 2011 WL 2507842, at *4. Although this case addressed a 

rule issued pursuant to section 129 of the CAA, the provisions of section 112 are similar.We are not 
Draft – Do Not Cite or Quote October 1421, 2011

39

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.

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.
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EO12866 NESHAP_Primary Lead Processing Final 2060AQ43_20111005.doc

6560-50-P

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA–HQ–OAR–2004–0305; FRL-XXXX-X]

RIN 2060–AQ43

National Emission Standards for Hazardous Air Pollutant Emissions for 

Primary Lead Processing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This action finalizes the residual risk and technology 

review conducted for the Primary Lead Processing source category

regulated under national emission standards for hazardous air 

pollutants (NESHAP). This action finalizes amendments to the NESHAP 

that include revision of the rule’s title and applicability 

provision, revisions to the emission limits for lead, and the 

modification and addition of testing and monitoring and related 

notification, recordkeeping, and reporting requirements, including 

the addition of a requirement to monitor the lead concentration in 

the air. It also finalizes revisions to the regulatory provisions 

related to emissions during periods of startup, shutdown, and 

malfunction and makes minor non-substantive changes to the rule.
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DATES: This final action is effective on [INSERT DATE OF 

PUBLICATION].

ADDRESSES: The EPA has established a docket for this action under 

Docket ID No. EPA–HQ–OAR–2004–0305. All documents in the docket are 

listed on the www.regulations.gov website. Although listed in the 

index, some information is not publicly available, e.g., confidential 

business information (CBI) or other information whose disclosure is 

restricted by statute. Certain other material, such as copyrighted 

material, is not placed on the Internet, and will be publicly 

available only in hard copy form. Publicly available docket materials 

are available either electronically through www.regulations.gov, or

in hard copy at the EPA Docket Center, EPA West Building, Room Number 

3334, 1301 Constitution Ave., NW, Washington, DC. The Public Reading 

Room hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Standard 

Time (EST), Monday through Friday. The telephone number for the 

Public Reading Room is (202) 566–1744, and the telephone number for 

the Air and Radiation Docket and Information Center is (202) 566–

1742.

FOR FURTHER INFORMATION CONTACT: For questions about this final 

action, contact Mr. Nathan Topham, Office of Air Quality Planning and 

Standards, Sector Policies and Programs Division, U.S. Environmental 

Protection Agency, Research Triangle Park, NC 27711; telephone 

number: (919) 541–0483; fax number: (919) 541-3207; and email 
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address: topham.nathan@epa.gov. For additional contact information, 

see the following SUPPLEMENTARY INFORMATION section.

SUPPLEMENTARY INFORMATION:

For specific information regarding the modeling methodology, 

contact Dr. Michael Stewart, Office of Air Quality Planning and 

Standards, Health and Environmental Impacts Division, Air Toxics 

Assessment Group (C504–06), U.S. Environmental Protection Agency, 

Research Triangle Park, NC 27711; telephone number: (919) 541–7524;

fax number: (919) 541–0840; and email address: 

stewart.michael@epa.gov. For information about the applicability of 

this NESHAP to a particular entity, contact the appropriate person 

listed in Table 1 to this preamble.

Table 1 – List of EPA Contacts for the NESHAP Addressed in This 

Action

NESHAP for: OECA Contact1 OAQPS Contact2

Primary Lead 

Processing 

Maria Malave, (202) 

564-7027, 

malave.maria@epa.gov

Nathan Topham

(919) 541-0483

topham.nathan@epa.gov

1 EPA’s Office of Enforcement and Compliance Assurance. 

2 EPA’s Office of Air Quality Planning and Standards.

Background Information Document. On February 17, 2011 (76 FR 9410), 

the EPA proposed revisions to the Primary Lead Smelting NESHAP based 

on evaluations performed by the EPA in order to conduct our risk and 

technology review. In this action, we are finalizing decisions and 

revisions for the rule. Some of the significant comments and our 
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responses are summarized in this preamble; a summary of the other 

public comments on the proposal, and the EPA’s responses to those

comments, is available in Docket ID No. EPA-HQ-OAR-2004-0305. A redline version of the regulatory language that incorporates the changes 

in this action is available in the docket.

Organization of This Document. The following outline is provided to 

aid in locating information in the preamble.

I. General Information

A. Does this action apply to me?

B. Where can I get a copy of this document?

C. Judicial Review

II. Background 

III. Summary of the Final Rule

A. What are the final rule amendments for the Primary Lead 

Processing source category?

 B. What are the requirements during periods of startup, shutdown, 

and malfunction?

 C. What are the effective and compliance dates of the 

standards?

IV. Summary of Significant Changes Since Proposal

 A. Changes to the Risk Assessment Performed Under Section 112(f)

of the Clean Air Act

 B. Changes to the Technology Review Performed Under Section 

112(d)(6) of the Clean Air Act

 C. Other Changes Since Proposal

V. Summary of Significant Comments and Responses

A. Timeline for Compliance

B. The EPA’s Authority Under Section 112 of the Clean Air Act

C. Primary Lead Processing Risk Assessment

VI. Impacts of the Final Rule

VII.Statutory and Executive Order Reviews

A. Executive Orders 12866: Regulatory Planning and Review, and

Executive Order 13563: Improving Regulation and Regulatory 

Review

B. Paperwork Reduction Act 

C. Regulatory Flexibility Act 

D. Unfunded Mandates Reform Act 

E. Executive Order 13132: Federalism 
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F. Executive Order 13175: Consultation and Coordination With

Indian Tribal Governments 

G. Executive Order 13045: Protection of Children From

Environmental Health Risks and Safety Risks

H. Executive Order 13211: Actions Concerning Regulations That 

Significantly Affect Energy Supply, Distribution, or Use

I. National Technology Transfer and Advancement Act 

J. Executive Order 12898: Federal Actions to Address 

Environmental Justice in Minority Populations and Low-Income

Populations

K. Congressional Review Act

I. General Information

A. Does this action apply to me?

Regulated Entities. Categories and entities potentially regulated by 

this action include: 

Table 2 – NESHAP and Industrial Source Categories Affected By 

This Final Action

NESHAP and Source Category NAICS1 Code MACT2

Code

Primary Lead Processing 331419 0204

1 North American Industry Classification System

2 Maximum Achievable Control Technology

Table 2 is not intended to be exhaustive, but rather provides a 

guide for readers regarding entities likely to be affected by the 

final action for the source category listed. To determine whether 

your facility would be affected, you should examine the applicability 

criteria in the appropriate national emission standards for hazardous 

air pollutants (NESHAP). As defined in the source category listing 

report published by the EPA in 1992, the Primary Lead Smelting source 
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category is defined as any facility engaged in producing lead metal 

from ore concentrates; including, but not limited to, the following 

smelting processes: sintering, reduction, preliminary treatment, and 

refining operations.1 To be consistent with the 1992 listing, the EPA

is revising the applicability of the Primary Lead Smelting NESHAP to 

apply to any facility that produces lead metal from lead ore 

concentrates and is changing the title of the rule to reference 

Primary Lead Processing. For clarification purposes, all reference to 

lead emissions in this preamble means “lead compounds” (which is a 

hazardous air pollutant) and all reference to lead production means 

elemental lead (which is not a hazardous air pollutant) as provided 

under Clean Air Act (CAA) section 112(b)(7)).

If you have any questions regarding the applicability of any 

aspect of the Primary Lead Processing NESHAP, please contact the 

appropriate person listed in Table 1 of this preamble in the 

preceding FOR FURTHER INFORMATION CONTACT section.

B. Where can I get a copy of this document?

In addition to being available in the docket, an electronic copy 

of this final action will also be available on the World Wide Web 

(www) through the Technology Transfer Network (TTN). Following 

signature, a copy of the final action will be posted on the TTN’s 

 1 USEPA. Documentation for Developing the Initial Source Category List – Final Report, USEPA/OAQPS, EPA-450/3-91-030, 

July, 1992.
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policy and guidance page for newly proposed and promulgated rules at 

the following address: http://www.epa.gov/ttn/caaa/new.html. The TTN 

provides information and technology exchange in various areas of air 

pollution control.

Additional information is available on the residual risk and 

technology review (RTR) web page at 

http://www.epa.gov/ttn/atw/rrisk/rtrpg.html. This information 

includes source category descriptions and detailed emissions and 

other data that were used as inputs to the risk assessments.

C. Judicial Review. 

Under section 307(b)(1) of the CAA, judicial review of this 

final action is available only by filing a petition for review in 

the United States Court of Appeals for the District of Columbia 

Circuit by [INSERT DATE 60 DAYS FROM DATE OF PUBLICATION]. Under 

section 307(b)(2) of the CAA, the requirements established by this

final rule may not be challenged separately in any civil or criminal 

proceedings brought by the EPA to enforce the requirements.

Section 307(d)(7)(B) of the CAA further provides that “[o]nly an 

objection to a rule or procedure which was raised with reasonable 

specificity during the period for public comment (including any 

public hearing) may be raised during judicial review.” This section 

also provides a mechanism for us to convene a proceeding for 

reconsideration, “[i]f the person raising an objection can 
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demonstrate to the EPA that it was impracticable to raise such 

objection within [the period for public comment] or if the grounds 

for such objection arose after the period for public comment (but 

within the time specified for judicial review) and if such objection 

is of central relevance to the outcome of the rule.” Any person 

seeking to make such a demonstration to us should submit a Petition 

for Reconsideration to the Office of the Administrator, U.S. EPA, 

Room 3000, Ariel Rios Building, 1200 Pennsylvania Ave., NW, 

Washington, DC 20460, with a copy to both the person(s) listed in the 

preceding FOR FURTHER INFORMATION CONTACT section, and the Associate 

General Counsel for the Air and Radiation Law Office, Office of 

General Counsel (Mail Code 2344A), U.S. EPA, 1200 Pennsylvania Ave., 

NW, Washington, DC 20460.

II. Background 

Section 112 of the CAA establishes a two-stage regulatory 

process to address emissions of hazardous air pollutants (HAP) from 

stationary sources. In the first stage, after the EPA has identified 

categories of sources emitting one or more of the HAP listed in 

section 112(b) of the CAA, section 112(d) calls for us to promulgate 

NESHAP for those sources. “Major sources” are those that emit, or 

have the potential to emit, any single HAP at a rate of 10 tons per 

year (TPY) or more, or 25 TPY or more of any combination of HAP. For 

major sources, these technology-based standards must reflect the 
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maximum degree of emission reductions of HAP achievable (after

considering cost, energy requirements, and non-air quality health and 

environmental impacts) and are commonly referred to as maximum 

achievable control technology (MACT) standards.

For MACT standards, the statute specifies certain minimum 

stringency requirements, which are referred to as floor requirements

and may not be based on cost considerations. See CAA section 

112(d)(3). For new sources, the MACT floor cannot be less stringent 

than the emission control that is achieved in practice by the best 

controlled similar source. The MACT standards for existing sources 

can be less stringent than floors for new sources, but they cannot be 

less stringent than the average emission limitation achieved by the 

best-performing 12 percent of existing sources in the category or 

subcategory (or the best-performing five sources for categories or 

subcategories with fewer than 30 sources). In developing MACT, we 

must also consider control options that are more stringent than the 

floor, under CAA section 112(d)(2). We may establish standards more 

stringent than the floor, based on the consideration of the cost of 

achieving the emissions reductions, any non-air quality health and 

environmental impacts, and energy requirements. In promulgating MACT 

standards, CAA section 112(d)(2) directs us to consider the 

application of measures, processes, methods, systems, or techniques 

that reduce the volume of or eliminate HAP emissions through process 
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changes, substitution of materials, or other modifications; enclose 

systems or processes to eliminate emissions; collect, capture, or 

treat HAP when released from a process, stack, storage, or fugitive 

emissions point; and/or are design, equipment, work practice, or 

operational standards.

In the second stage of the regulatory process, we undertake two 

different analyses, as required by the CAA: section 112(d)(6) of the 

CAA calls for us to review these technology-based standards and to 

revise them “as necessary (taking into account developments in 

practices, processes, and control technologies)” no less frequently 

than every 8 years; and within 8 years after promulgation of the 

technology standards, CAA section 112(f) calls for us to evaluate the 

risk to public health remaining after application of the technologybased standards and to revise the standards, if necessary, to provide 

an ample margin of safety to protect public health or to prevent, 

taking into consideration costs, energy, safety, and other relevant 

factors, an adverse environmental effect. In doing so, the EPA may 

adopt standards equal to existing MACT standards if the EPA

determines that the existing standards are sufficiently protective.

NRDC v. EPA, 529 F.3d 1077, 1083 (D.C. Cir. 2008).

On February 17, 2011, the EPA published a proposed rule in the 

Federal Register for the Primary Lead Smelting NESHAP, 40 CFR Part 63 

Subpart TTT, that took into consideration the residual risk and 
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technology review (RTR) analyses for that source category. This 

action provides the EPA’s final determinations pursuant to the RTR 

provisions of CAA section 112 for the Primary Lead Processing source 

category. Specifically, as a result of our analyses, we are revising 

the requirements of the NESHAP to ensure public health and the 

environment are protected consistent with section 112(f) and that 

emission reductions are consistent with what is economically and 

technically feasible under section 112(d)(6). In addition, we are 

taking the following actions:

• Revising the requirements in the NESHAP related to emissions 

during periods of startup, shutdown, and malfunction (SSM).

• Revising the title of the rule and amending the applicability 

section consistent with the definition of the source category 

adopted in 1992, to provide that the NESHAP applies to any 

facility processing lead ore concentrate to produce lead metal.

• Replacing the definition of “primary lead smelter” with a 

definition of “primary lead processor” and adding definitions of 

“secondary lead smelters,” “lead refiners,” and “lead 

remelters.”

• Incorporating the use of plain language into the rule.

• Addressing technical and editorial corrections in the rule.

• Responding to the January 2009 petition for rulemaking from the 

Natural Resources Defense Council (NRDC) that the original 
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primary lead NESHAP should have included an emission standard 

for organic HAP and announcing our intention to collect 

additional data needed to develop a standard for organic HAP.

We note that the Doe Run Herculaneum Smelter, the only facility 

in the source category, is subject to a Consent Decree requiring 

submission of a facility-wide cleanup plan by January 1, 2013, 

shutdown of their sintering operations by the end of 2013, and 

shutdown of the blast furnace by April 30, 2014. The Consent Decree 

will achieve drastic reductions in lead emissions and will provide 

substantial environmental and public health benefits. The Herculaneum 

area has also been designated as a nonattainment area for the 2008 

National Ambient Air Quality Standards (NAAQS) for lead. Attainment 

of the 2008 Lead NAAQS (which is demonstrated based on three years of 

data at or below the level of the NAAQS) is required by December 

2015. The State of Missouri is required to submit its attainment 

demonstration State Implementation Plan (SIP) by June 30, 2012.

III. Summary of the Final Rule

A. What are the final rule amendments for the Primary Lead Processing 

source category?

The National Emission Standards for Hazardous Air Pollutant 

Emissions: Primary Lead Smelting was promulgated on June 6, 1999 (64 

FR 30204), and codified at 40 CFR part 63, subpart TTT. The primary 

lead processing industry consists of facilities that produce lead 
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metal from ore concentrates. The source category covered by this MACT 

standard currently includes only one operating facility, The Doe Run 

Company in Herculaneum, Missouri.

For the reasons provided in the proposed rule and in the support 

documents in the docket, we have determined that the risks associated 

with this source category are unacceptable and are therefore 

promulgating requirements to reduce the risk to an acceptable level. 

Once risk is reduced to an acceptable level, we analyze whether there 

are additional controls that will provide an ample margin of safety, 

considering cost, energy, safety, and other relevant factors. We have 

concluded that there are no additional cost-effective controls 

available beyond those that we expect will be applied to reduce risk 

to an acceptable level and thus the same controls to ensure an 

acceptable level of risk will also provide an ample margin of safety. 

To satisfy section 112(f) of the CAA, we are, therefore, revising the 

existing MACT standard to include: 

• An emission cap of 1.2 TPY for the furnace area stack and the 

refining operation stacks, combined.2

• A requirement for the facility to adopt work practice standards to 

address fugitive emissions to ensure emissions do not present an 

 2 EPA notes that it is setting a combined emission limit for these sources because, as noted in the proposal (76 FR 9432),

and the risk assessment documents to support the proposed and final rulemakings, these sources have overlapping points 

of maximum lead impact.
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unacceptable level of risk (i.e., cause the lead concentration in 

air at or near the facility boundary to exceed 0.15 μg/m3 based on 

3-month rolling average) and to conduct air monitoring to ensure 

that such fugitive emissions are adequately addressed.

To satisfy section 112(d)(6) of the CAA, we are, therefore,

revising the existing MACT standard to include a reduction of the 

lead emission limit for the main stack. The MACT standard is being 

lowered from the current 1.0 pound per ton of lead produced to 0.97 

pound of lead per ton of lead produced based on a determination that

developments in practices, processes, or control technologies since 

promulgation of the MACT standards demonstrate that the facility can 

meet a reduced emission limit from the main stack pursuant to CAA 

section 112(d)(6). 

In addition to our reviews under sections 112(f) and 112(d)(6) 

of the CAA, we are promulgating the following:

• The revision of the applicability section of the rule consistent 

with the definition of the source category adopted in 1992, 

subpart TTT which applies to any facility that produces lead metal

from lead concentrate ore. 

• Changes to the Primary Lead Processing MACT standards to eliminate 

the SSM exemption. These changes revise Table 1 in 40 CFR part 63, 

subpart TTT to indicate that several requirements of the 40 CFR 

part 63 General Provisions related to periods of SSM do not apply.
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We are adding provisions to the Primary Lead Processing MACT 

standards requiring sources to operate in a manner that minimizes 

emissions, removing the SSM plan requirement, clarifying the 

required conditions for performance tests, and revising the SSM–

associated recordkeeping and reporting requirements to require 

reporting and recordkeeping for periods of malfunction. We are 

also adding provisions to provide an affirmative defense against 

civil penalties for exceedances of emission standards caused by 

malfunctions, as well as criteria for establishing the affirmative 

defense.

• Replacement of the word “shall” with the word “must” in the 

regulatory text. We are also replacing “thru” with “through.” We 

are replacing the definition of “primary lead smelter” with a 

definition of “primary lead processor” and adding definitions of 

“secondary lead smelters,” “lead refiners,” and “lead remelters.”

These revisions to the Primary Lead Processing MACT standard are 

expected to result in lead emissions reductions and increased 

compliance costs to the industry. No economic impacts on small 

businesses are expected as a result of the revisions to the rule. We 

have determined that the one facility in this source category can 

meet the applicable emissions standards at all times, including 

periods of startup and shutdown, in compliance with the current MACT 

standards.
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B. What are the requirements during periods of startup, shutdown, and 

malfunction?

The United States Court of Appeals for the District of Columbia 

Circuit vacated portions of two provisions in the EPA’s CAA section 

112 regulations governing the emissions of HAP during periods of SSM.

Sierra Club v. EPA, 551 F.3d 1019 (D.C. Cir. 2008), cert. denied, 130 

S. Ct. 1735 (U.S. 2010). Specifically, the Court vacated the SSM 

exemption contained in 40 CFR 63.6(f)(1) and 40 CFR 63.6(h)(1), that 

is part of a regulation, commonly referred to as the “General 

Provisions Rule,” that the EPA promulgated under section 112 of the 

CAA. When incorporated into CAA section 112(d) regulations for 

specific source categories, these two provisions exempt sources from 

the requirement to comply with the otherwise applicable CAA section 

112 emission standards during periods of SSM.

We have eliminated the SSM exemptions in the regulatory text.

Consistent with Sierra Club v. EPA, the EPA has established standards 

in this rule that apply at all times. We have also revised Table 1 

(the General Provisions table) in other respects. For example, we 

have eliminated the incorporation of the General Provisions’ 

requirement that the source develop an SSM plan. We have also 

eliminated or revised certain recordkeeping that related to the SSM 

exemption. The EPA has attempted to ensure that we have not included 
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in the regulatory language any provisions that are inappropriate, 

unnecessary, or redundant in absence of the SSM exemption.

In establishing the standards in this rule, the EPA has taken 

into account startup and shutdown periods and, for the following 

reasons, has not established different standards for those periods.

Information on periods of startup and shutdown in the industry 

indicate that emissions during these periods do not increase. 

Furthermore, all processes are controlled by either control devices 

or work practices, and these controls would not typically be affected 

by startup or shutdown. Also, compliance with the standard already 

requires averaging of emissions over a three month period, which 

accounts for the variability of emissions that may result during 

periods of startup and shutdown. Therefore, separate standards for 

periods of startup and shutdown are not being promulgated.

Periods of startup, normal operations, and shutdown are all 

predictable and routine aspects of a source’s operations. However, by 

contrast, malfunction is defined as a “sudden, infrequent, and not 

reasonably preventable failure of air pollution control equipment, 

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

manner***” (40 CFR 60.2). 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 
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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.

Further, accounting for malfunctions would be difficult, if not 

impossible, given the myriad of different types of malfunctions that 

can occur, 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 
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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.

In the event that a source fails to comply with the applicable 

CAA section 112 standards as a result of a malfunction event, the EPA

would determine an appropriate response based on, among other things, 

the good faith efforts of the source to minimize emissions during 
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malfunction periods, including preventative and corrective actions, 

as well as root cause analyses to ascertain and rectify excess 

emissions. The EPA would also consider whether the source's failure 

to comply with the CAA section 112 standard was, in fact, “sudden, 

infrequent, not reasonably preventable” and was not instead “caused 

in part by poor maintenance or careless operation.” 40 CFR 63.2 

(definition of malfunction).

Finally, the EPA recognizes that even equipment that is properly 

designed and maintained can sometimes fail, and that such failure can 

sometimes cause an exceedance of the relevant emission standard.

(See, e.g., State Implementation Plans: Policy Regarding Excessive 

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

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

Maintenance, and Malfunctions (Feb. 15, 1983)). The EPA is,

therefore, adding to the final rule an affirmative defense to civil 

penalties for exceedances of emission limits that are caused by 

malfunctions. See 40 CFR 63.1542 Primary Lead Processing (defining

“affirmative defense” to mean, in the context of an enforcement 

proceeding, a response or defense put forward by a defendant, 

regarding which the defendant has the burden of proof, and the merits 

of which are independently and objectively evaluated in a judicial or 

administrative proceeding). We also have added other regulatory 

provisions to specify the elements that are necessary to establish 
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this affirmative defense; the source must prove by a preponderance of 

evidence that it has met all of the elements set forth in 63.1551

Primary Lead Processing. (See 40 CFR 22.24). The criteria ensure that 

the affirmative defense is available only where the event that causes 

an exceedance of the emission limit meets the narrow definition of 

malfunction in 40 CFR 63.2 (sudden, infrequent, not reasonably

preventable and not caused by poor maintenance and/or careless 

operation). For example, to successfully assert the affirmative 

defense, the source must prove by a preponderance of the evidence 

that excess emissions “[w]ere caused by a sudden, infrequent, and 

unavoidable failure of air pollution control and monitoring 

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

usual manner...” The criteria also are designed to ensure that steps

are taken to correct the malfunction, to minimize emissions in 

accordance with section 63.1543(i) and 63.1544(e), and to prevent 

future malfunctions. For example, the source must prove by a 

preponderance of the evidence that “[r]epairs were made as 

expeditiously as possible when the applicable emission limitations 

were being exceeded...” and that “[a]ll possible steps were taken to 

minimize the impact of the excess emissions on ambient air quality, 

the environment and human health...” In any judicial or 

administrative proceeding, the Administrator may challenge the 

assertion of the affirmative defense, and, if the respondent has not 
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met its burden of proving all of the requirements in the affirmative 

defense, appropriate penalties may be assessed in accordance with 

section 113 of the CAA (see also 40 CFR part 22.27).

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) Thus, the 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 the 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 
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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.

C. What are the effective and compliance dates of the standards?

The revisions to the MACT standards being promulgated in this action 
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are effective on [INSERT DATE OF PUBLICATION]. For the MACT 

standards being addressed in this action, the compliance date for 

the revised SSM requirements is the effective date of the standards, 

[INSERT DATE OF PUBLICATION]. The compliance date for the revised 

emission standard in § 16.1543(a) is [INSERT DATE 60 DAYS FROM DATE 

OF PUBLICATION]. The compliance date for the new refining and 

furnace area stack emission limits and the requirement to adopt work 

practice standards to address fugitive emissions and to ensure 

compliance using monitoring of the lead concentration in air limit 

is 2 years from the effective date of the standard, [INSERT DATE 2 

YEARS FROM DATE OF PUBLICATION].

IV. Summary of Significant Changes Since Proposal

A. Changes to the Risk Assessment Performed Under CAA Section 112(f)

As noted above, in February of 2011 EPA published the notice of 

proposed rulemaking: National Emission Standards for Hazardous Air 

Pollutants: Primary Lead Smelting. In the proposed rulemaking, EPA 

presented a number of options for additional controls on the primary 

lead smelting source category, which currently includes only one

facility operating in the United States. In the proposed rule, EPA 

solicited comment on these options as well as on all the analyses and 

data the options were based upon, including the risk methods and 

results presented in the draft document: Draft Residual Risk 

Assessment for the Primary Lead Smelting Source Category. 
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During the public comment period for the proposed rule, the one 

facility in the source category, The Doe Run Company, submitted 

substantially updated emissions, meteorological, facility boundary, 

as well as other relevant information bearing on the risk assessment 

(see docket number: EPA-HQ-OAR-2004-0305 for Doe Run’s public 

comments). As a result, to support this final rulemaking EPA revised 

its analyses to reflect the information received during the public 

comment period for the proposed rule. Revised methods, model inputs,

and risk results are presented in the report: “Residual Risk 

Assessment for the Primary Lead Smelting Source Category” which is 

available in the docket for this rulemaking. In addition, a 

discussion of the updated emissions information used in the final 

risk assessment can be found in the Technical Support Document for 

the final rule, which can also be found in the docket for this 

rulemaking.

Table 3 presents the results of the final baseline risk 

assessment, with respect to the risks due to lead emissions, broken 

down by emission point. In the baseline scenario, we estimate that 

approximately 1,550 people may be exposed to lead concentrations 

above the NAAQS. Results indicate that emissions from the refining 

stacks, furnace area stacks, and fugitive emissions can likely result 

in exceedences of the NAAQS for lead beyond the fenceline of the 
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facility.3 These results also indicate that emissions from the main 

stack do not likely result in exceedences of the NAAQS for lead

beyond the fenceline of the facility because emissions are highly 

dispersed due to the height of the main stack. 

Table 3 - Summary of Lead Concentrations Relative to the NAAQS 

Based on Estimated Actual 2009 Emissions

Emission Point

2009 

Emissions 

(tpy)

Maximum Offsite 

Impact

Main stack1 68.3 0.85 times the NAAQS

Refining stacks2 9.1 7.7 times the NAAQS

Furnace area stack: (controlled blast 

and drossing fugitives)

2.5 2 times the NAAQS

Fugitive dust 1.0 1.1 times the NAAQS

1

Results presented for the main stack in this table consider the good engineering 

practice (GEP) stack height of 330 feet (as was done in the SIP and in modeling 

submitted by the Doe Run Company in its public comments on the proposed 

rulemaking). The actual height of the main stack is approximately 550 feet, and 

thus the impact would have likely been lower had actual stack height been modeled. 2

Emission sources controlled by baghouses 8 and 9 at the Doe Run facility.

Consistent with the risk assessment to support the proposed 

rulemaking, the risk assessment to support the final rulemaking also 

indicates that risks are unacceptable, primarily due to lead 

emissions from the furnace area stack and the refining operations 

stacks. However, while the risk assessment supporting the proposed 

rulemaking estimated that a combined emission limit for the furnace 

area and refining operations should be set at 0.91 tons of lead per 

year to ensure that risks are acceptable, the updated risk assessment

 3 For the reasons noted in the proposed rulemaking, 76 FR at 9421, we used the level of the lead NAAQS as the level above 

which we think an unacceptable risk is presented to the public.
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estimates that a combined emission limit of 1.2 tons of lead per year 

will ensure that ambient lead concentrations from those emission 

points do not result in lead levels in the ambient air above the 

level of the NAAQS for lead, thereby resulting in acceptable lead 

risk. In our ample margin of safety analysis, we identified no costeffective controls that are capable of achieving emission levels 

below 1.2 tons per year, as described in the technical support 

document. Thus, EPA is promulgating a combined lead emission limit 

for the furnace area and refining operations stacks at 1.2 tons per 

year.4 The risk assessment also identified potential ambient air 

concentrations above the level of the NAAQS resulting from fugitive 

emissions. Therefore, we are finalizing the requirement for work 

practice standards and monitoring of lead in ambient air to 

demonstrate efficacy of the work practices.

In addition to the updated lead risk assessment results 

presented above, we also note that there were changes to our cancer, 

acute, and PB-HAP multipathway screening analyses for non-lead HAP as 

a result of the new risk analysis performed for the final rule. With 

respect to our updated cancer risk assessment, we estimate that the 

maximum individual risk (MIR) of cancer is 20 in a million (as 

compared to 30 in a million based on the risk assessment to support 

 4 EPA notes that it is setting a combined emission limit for these sources because, as noted in the proposal (76 FR 9432),

and the risk assessment documents to support the proposed and final rulemakings, these sources have overlapping points 

of maximum lead impact.
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the proposed rule), and that the cancer incidence is 0.008 (as 

compared to 0.0008 based on the risk assessment to support the 

proposed rule). In addition, the refined worst-case acute hazard 

quotient (HQ) value is 2.0 (based on the REL for arsenic), driven by 

arsenic emissions from the main stack (as compared to 0.6 based on 

the REL for arsenic and driven by arsenic fugitive dust emissions as 

indicated by the risk assessment to support the proposed rule). 

Finally, while the worst-case multipathway screen to support the 

proposed rule indicated that no non-lead PB-HAP exceeded screening 

levels for potential multipathway effects, in the risk assessment to 

support the final rulemaking, the worst-case multipathway screening 

level was exceeded with respect to cadmium emissions. This is likely 

the result of the revised emissions information provided by the 

company during the comment period, which indicated higher cadmium

emissions from the main stack than were assumed for purposes of the 

risk assessment performed for the proposed rule.

In considering the updated non-lead risk results presented 

above, we note that while cancer incidence increased in our updated 

risk assessment, cancer incidence remains very low with 1 excess 

cancer case being estimated every 125 years. 

With respect to the worst-case acute HQ value of 2 based on the 

REL for arsenic due to emissions from the main stack, we note that 

this is a conservative, worst-case analysis of the potential for
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acute health effects. We also note that in contrast to the risk 

analysis to support the proposed rulemaking, the final risk analysis 

modeled the main stack at the GEP stack height of 330 feet rather 

than the actual stack height of 550 feet. Thus it is very likely that 

the maximum potential worst-case HQ value is significantly lower than 

2.

Finally, with respect to the exceedence of the worst-case 

multipathway screening level for cadmium, we note that this only 

indicates the potential for cadmium exposures above the chronic 

noncancer reference dose (RfD) for cadmium. That is, while in 

general, emission rates below the worst-case multipathway screening 

level indicate no significant potential for multipathway related 

health effects, emission levels above this worst-case screening level 

only indicate the potential for multipathway-related health risks of 

concern based on a worst-case scenario. We were not able to refine 

our multi-pathway analysis beyond the worst-case screening 

assessment. As a result, we can only say that we cannot rule out the 

potential for multipathway risks. However, due to the highly 

conservative nature of this screening assessment and the 

uncertainties related to the results, we have concluded that, after 

implementation of the controls needed to reduce lead levels to the 

NAAQS, risks are acceptable, considering the combination of potential 

multipathway risks, cancer risks, chronic non-cancer risks, and acute 
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non-cancer risks. We also reviewed whether there were cost-effective 

controls that could further reduce risks to provide an ample margin 

of safety. The controls we are requiring to address lead emissions 

also reduce emissions of non-lead HAP. We were unable to identify any 

technically feasible cost effective additional controls that would 

further reduce emissions of lead and non-lead HAP. We are therefore 

determining that the standard we are promulgating today provides an 

ample margin of safety to protect public health.

In summary, the final rule includes an emission standard of 1.2 

tons per year of lead emissions from refining and furnace area 

stacks, combined. The standard also includes a requirement for the 

facility to employ work practice standards to minimize fugitive 

emissions with ambient monitoring to ensure those work practices 

effectively achieve acceptable risk. These standards will ensure 

public health is protected with an ample margin of safety and that 

there is not an adverse environmental effect from HAP emissions from 

the one lead processing facility in this source category.

B. Changes to the Technology Review Performed Under CAA Section 

112(d)(6)

In the proposed rule, the main stack was subject to an emission 

limit of 0.22 pounds of lead per ton of lead produced based on our 

section 112(d)(6) technology review. That proposed limit was based on 

information that in practice the source had significantly lower 
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emissions than the emission limit of 1 pound of lead per ton of lead 

produced required in the MACT standard. In comments on the proposed 

rule, The Doe Run Company indicated that the proposed emission limit 

under Section 112(d)(6) could not be met and that the data on which 

that emission limit was based were not accurate. The facility 

provided a 2009 stack test for the main stack that indicated that 

emissions at the facility are significantly higher than we assumed as 

the basis for the proposed limit. For purposes of our analysis for 

the final rule, the EPA recalculated the emissions performance 

achieved for the main stack as demonstrated by the 2009 and 2008 

stack tests and considered an estimate of emission variability in 

order to determine whether it was appropriate to revise the emission 

limit based on what the source was able to achieve in practice. Based 

on the revised analysis, we are establishing an emission limit for 

main stack of 0.97 pounds of lead per ton of lead produced. 

We have also changed the compliance date for the main stack to 

reflect compliance “as expeditiously as possible” under section 

112(i)(3) of the CAA. The compliance date for the 0.97 lb/ton limit 

is 60 days from the date of publication of the final rule.

C. Other Changes Since Proposal

The EPA has decided not to include the refining and furnace area 

emissions as part of a facility wide emission limit as was proposed. 

We received comments on the proposed rule that inclusion of these 
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sources in the production based emission limit in §63.1543(a) was not 

necessary to achieve acceptable risk and that these sources would 

simultaneously be required to comply with two competing emission 

standards. We agree with the commenters and we are establishing a 

separate emission limit of 1.2 tons per year of lead emissions that 

applies to the combined emissions of the refining and furnace area 

stacks. The emission standard limits the combined emissions from 

these two stacks because the revised risk assessment indicated that 

the location of maximum impact for these two stacks overlapped at the 

same receptor. A production based emission limit will continue to 

apply to sources in §63.1543(a)(1)-(9).

In recent rules promulgated under section 112 and 129, the EPA 

has revised certain terms and conditions of the affirmative defense 

in response to concerns raised by various commenters. The EPA is 

proposing to adopt those same revisions in this rule. Specifically, 

the EPA revising the affirmative defense language to delete “short” 

from 63.1551(a)(1)(i), because other criteria in the affirmative 

defense require that the source assure that the duration of the 

excess emissions “were minimized to the maximum extent practicable.” 

EPA is also deleting the term “severe” in the phrase “severe personal 

injury” in 63.1551(a)(4) because we do not think it is appropriate to 

make the affirmative defense available only when bypass was 

unavoidable to prevent severe personal injury. In addition, the EPA 
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is revising 63.1551(a)(6) to add “consistent with good air pollution 

control practice for minimizing emissions.” EPA is also revising the 

language of 63.1551(a)(9) to clarify that the purpose of the root 

cause analysis is to determine, correct, and eliminate the primary 

cause of the malfunction. The root cause analysis itself does not 

necessarily require that the cause be determined, corrected or 

eliminated. However, in most cases, the EPA believes that a properly 

conducted root cause analysis will have such results. In addition,

the EPA is revising 63.1551(b) to state that a written report must be 

submitted within 45 days of the initial occurrence of the malfunction 

and that the source may seek an extension of up to an additional 30 

days. 

V. Summary of Significant Comments and Responses

In the proposed action, we requested public comments on all 

aspects of the proposal, including our residual risk reviews and 

resulting proposed standards, our technology reviews and resulting 

proposed standard, and our proposed amendments to delete the startup 

and shutdown exemptions and the malfunction exemption and to 

establish an affirmative defense for malfunctions. 

We received written comments from 16 commenters. Our responses 

to some of the significant public comments are provided below. A 

response to the comments that are not in the preamble has been placed 

in the docket. See Summary of Public Comments and Responses for 
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Primary Lead Processing NESHAP (October 2011), for summaries of other 

comments and our responses to them.

A. Timeline for Compliance

Comment: Two commenters opposed the compliance timing and supported 

extending the compliance date beyond two years for several reasons. 

One commenter stated that according to the time line in the proposed 

rule, the facility will operate in its current form for only a few 

months after the compliance date of the rule. This creates a dilemma 

for the State and facility in terms of implementation, planning,

resources and compliance. The commenter suggested that the 

implementation and attainment schedules for this MACT rule should

correspond to those of the 2008 NAAQS. 

One commenter identified three provisions they suggest could be 

used to allow more than 2 years for compliance: (1) 112(i)(3)(A) 

establishes 3 years for compliance for section 112 standards, (2) 

112(i)(5) allows exemption for up to 6 years for facilities 

demonstrating 90 percent reduction in HAP prior to first proposal of 

a section 112(d) standard, and (3) 112(h)(3) allows an alternative 

means of compliance in some circumstances. The commenter stated that 

the import of the underlying statutory authority relates to the 

compliance period for existing sources. Under the EPA practice, a 

three-year compliance period applies to § 112(d) MACT standards, 

while a two-year period applies to § 112(f) standards. Although the 
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EPA seems to have reflexively applied the § 112(f) period, this 

approach is not foreordained in the present circumstances. 

Specifically, § 112(i)(3)(A), which allows a three-year compliance 

period for any § 112 standard, merits consideration in light of the 

various proposed MACT standards, including a plant-wide § 112(d)(6) 

standard. With regard to the authority under section 112(i)(5), the 

commenter states that emissions have been reduced from 140 tons in 

the year 2000 to less than 14 tons in 2009, representing a decrease 

of over 90%. With regard to section 112(h)(3), the commenter 

believes that the two year compliance period has serious adverse 

economic effects on the company and the new hydrometallurgical 

process can be considered an alternative means of emission 

limitation. 

The commenter also stated that the circumstances of this case 

present a unique challenge in determining an appropriate compliance 

deadline for a new primary lead smelting MACT standard. The 

commenter stated that there were several differences from the 

typical MACT rulemaking: instead of multiple sources within a 

category, there is only one facility in the category; by virtue of a 

federally enforceable consent decree, the facility must terminate 

its present operations by April 30, 2014; and assuming a final rule 

issues on October 31, 2011, and a two-year compliance deadline, the 

compliance period would be at most six months prior to stoppage of 
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many of the current operations. If forced to achieve compliance that 

would last only for such a short period, the facility would face 

severe economic hardship that could jeopardize its ability to 

finance and to build a new hydrometallurgical lead production 

process that would largely eliminate lead emissions. These 

circumstances raise questions as to the legal necessity as well as 

the feasibility and practicality of implementing a two-year 

compliance deadline.

Further, it was incorrectly assumed that a two-year compliance 

period is consistent with the schedule of required actions contained 

in the Consent Decree, when the opposite is true. Requiring MACT 

standard compliance six months before the required termination of 

Doe Run’s existing lead smelting seriously erodes several Consent 

Decree goals: introducing a new hydrometallurgical lead production 

process that minimizes lead emissions, assuring continued primary 

lead production in the United States, and promoting the development 

of the most technologically advanced lead production process in the 

world. 

Finally, the commenter stated that the primary lead RTR 

proposal effectively accelerates the compliance date for the lead 

NAAQS for the Doe Run facility. According to the commenter a twoyear compliance timeframe relies, in part, on the various steps that 

must be undertaken to implement a plan to monitor lead concentration 
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in air. But this reliance is also misplaced because it requires Doe 

Run to comply with the new Lead NAAQS in 2013, or more than two 

years before the Lead NAAQS itself requires compliance. No statutory 

authority supports such accelerated compliance for the lead NAAQS or 

preemption of the SIP process. In short, the two-year timeframe 

rests on faulty grounds: factually, it is inconsistent with the 

Consent Decree requirements, and legally, it unlawfully attempts to 

speed up the previously-established compliance timeframe for the 

lead NAAQS.

Response: Section 112(i)(3) establishes the compliance timeframe for 

any standard issued under section 112 for existing sources and 

provides that the compliance date shall be as expeditiously as 

practicable but no later than 3 years following the effective date 

of the standard. Section 112(f)(4), however, expressly provides 

more specific requirements for standards issued under section 112(f)

and thus for section 112(f) standards those more prescriptive 

requirements govern in place of the compliance requirements in 

section 112(i)(3). Specifically, section 112(f)(4) provides that a 

source cannot emit an air pollutant in violation of a standard 

issued under subsection (f) except that the standard will not apply 

until 90 days after its effective date. It also provides that the 

Administrator may grant a waiver for a period of up to 2 years from 

the effective date if necessary for the installation of controls and 
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if measures will be taken in the interim to ensure public health is 

protected from imminent endangerment. Thus, for purposes of 

standards applicable to the furnace and refinery area emissions and 

for fugitive emissions, which were issued under section 112(f), the 

compliance period may not exceed two years from the effective date 

of the standard.

The main stack emission limit, proposed under 112(d)(6), is 

subject to the section 112(i)(3) compliance provisions. We are 

establishing an emission standard of 0.97 lb Pb/ton of lead produced 

that would replace the existing standard of 1 lb Pb/ton of lead 

produced. This standard is based on the level of emissions that the 

source is already achieving in practice and thus no additional 

controls would be needed to meet that emission limit for the main 

stack. For that reason, we are requiring compliance with the new 

limit for the main stack within 60 days of the effective date of 

this final rule as this timeframe constitutes compliance “as 

expeditiously as practicable.”

Concerning section 112(i)(5), the provision only applies to 

standards promulgated pursuant to section 112(d) (and not 112(f)) 

and also only where a source achieves a 90% reduction (95% in the 

case of HAPs that are particulate matter) prior to the proposal of 

the section 112(d) standard. Thus, this provision does not apply to 

the standards established under 112(f) in this final rule. With 
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regard to the emission standard proposed for the main stack, stack 

test data indicate that the main stack emissions are substantially 

higher than the 14 tons per year value cited by the commenter. Based 

on performance test data, the facility has not achieved the 

reductions in emissions required to apply the alternative compliance 

dates in section 112(i)(5).

Section 112(h)(3) allows the Administrator through notice and 

comment rulemaking to accept an alternative means of emission limit 

in place of a work practice standard established under 112(h)(1) if 

the owner or operator of a source establishes that such alternative 

means will achieve reductions at least equivalent to those that 

would be achieved by the work practice standard. It is unclear 

precisely what the commenter is suggesting with regard to this 

provision. However, it seems they may be suggesting that the new 

hydrometallurgical process that they plan to install after they 

close the pyrometallurgical processes should be considered an 

alternative means of compliance with the work practice standard. It 

is unclear how this process would address the emissions covered by 

the work practice standard requirement we are establishing which is 

intended to address current fugitive emissions from the facility. 

Those emissions are almost exclusively from lead entrenched in open 

areas and the installation of a new process for lead processing 

would not appear to affect those emissions. Moreover, we understand 
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that the new hydrometallurgical process won’t be operational until 

sometime after the compliance date for the work practice standards 

we are requiring. Thus, even if that process would address in whole 

or in part the fugitive emissions addressed through the work 

practice standards, it would not be an appropriate substitute in the 

absence of being able to achieve the necessary reductions within the 

compliance period. We note that our determination here does not 

preclude Doe Run from submitting additional information that may 

further support a demonstration under section 112(h)(3) and for 

which we could take further action in a separate rulemaking.

As to the concerns the commenter raises about this situation 

being unique, we do not disagree. However, the statute is clear 

that the maximum compliance period for standards issued pursuant to 

section 112(f) is two years. The commenter submits no facts or 

information that supports a legal basis for providing a longer 

period for compliance for the refining and furnace area stacks and 

for fugitive emissions.

Finally, we note that the Lead NAAQS does not apply to a 

specific facility but rather is a level that must be met within the 

designated nonattainment area. However, we recognize that Doe Run is 

the primary contributor to lead nonattainment in the Jefferson 

County lead nonattainment area and the reductions required under the 

rule will help bring the area into attainment with the lead NAAQS. 
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However, this regulation does not preempt the SIP process; the State 

of Missouri is still required to submit a state implementation plan 

demonstrating how the area will attain and maintain the lead NAAQS. 

In doing so, the State may rely on any reductions required under 

this regulation. Finally, we note that this regulation does not 

“speed up” the compliance timeframe for meeting the Lead NAAQS. The 

CAA requires areas to attain the various NAAQS as expeditiously as 

practicable, but no later than specified dates. For the 2008 lead 

NAAQS, areas are required to attain the standard as expeditiously as 

practicable, but no later than December 31, 2015. The Act not only 

contemplates but requires, if practicable, for areas to attain the 

2008 lead NAAQS earlier than December 31, 2015.

Comment: One commenter stated that the proposed emission standards 

and ambient standard had negative implications for determining

compliance under the proposed two-year compliance period and the 

“plantwide reductions” that are “required under section 112(f)(2).” 

76 FR at 9437/1. According to the commenter, the only plant-wide 

reduction proposed in the rule is the plant wide limit of 0.22 

pounds per ton produced while the other two new numerical standards 

are the 0.91 tpy limit for furnace area and refining and casting 

operations and the 0.15 μg/m3 limit for ambient lead concentrations.

The commenter stated that the three proposed numerical 

standards present a confusing regulatory regime as to which standard 
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ultimately controls for determining compliance. If, for example, Doe 

Run achieves an aggregate emission of 0.22 lb/ton on a facility wide 

basis but exceeds 0.91 TPY for its furnace and refining and casting 

operations, would it be in compliance? 

Of the three numerical standards, the commenter stated that 

only the 0.91 tpy limit can arguably be linked to Section 112(f), 

and even that is unclear. The 0.91 tpy standard is derived from the 

Lead NAAQS risk analysis. Despite this starting point, this standard 

is subsumed in the proposed 0.22 lb/ton plant-wide limit which arose 

under the section 112(d)(6) technology review, adjusted for 

“variability in the operations and emissions.” While an effort is 

made to differentiate the components of the 0.22 lb/ton standard as 

to which portion fits under what statutory authority, this single 

plant-wide emission standard rests on the § 112(d)(6) review. 

Although not explicitly stated, this plant-wide standard offers more 

than an ample margin of safety. 

Response: We have decided not to include a facility-wide limit that 

would include the refining and furnace area stacks as well as to the 

main stack. Instead, the 1.2 tpy emissions standard we are 

promulgating under section 112(f) will apply to combined emissions

from the refining and furnace area stacks. The 0.97 lb/ton emission

standard that we are promulgating pursuant to section 112(d)(6) will 

replace the 1.0 lb/ton limit in the original MACT rule and will 
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apply to the same sources subject to the limit in the original MACT 

rule. This change should alleviate the regulatory confusion that 

could arise over the limits in the proposal. Furthermore, we believe 

a plant-wide limit is not necessary to address the residual risk and 

technology review requirements of the Act. As provided in the 

preamble to the proposed and final rules, we evaluated each of the 

emission stacks separately to determine whether additional controls 

are necessary under section 112(f) or 112(d)(6) and a plant-wide 

limit is not needed under either of those statutory requirements. We 

note that the monitoring requirement is primarily for the purpose of 

ensuring that fugitive emissions are appropriately addressed under 

section 112(f). The fenceline ambient monitoring requirement will 

ensure that fugitive emissions are controlled to an extent that they 

do not present an unacceptable risk and also provide an ample margin 

of safety. 

B. The EPA’s Authority Under CAA Section 112

Comment: One commenter stated that the modification to the 

applicability provision does not comport with how smelting is 

defined and used and that the source category listing was intended 

to cover smelting only, not other processes. The commenter lists 

several issues supporting this position:

• The opening phrase of the first sentence “The Primary Lead 

Smelting source category,” describes and limits “any facility” to 
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mean those involving smelting; and the “includes, but is not limited 

to” language does not apply to any lead producing process, but only 

to “the following smelting processes.” 

• The list of processes identified all involve pyrometallurgical 

activities: sintering process, blast furnace, electric smelting 

furnace, reverberatory furnace, slag fuming furnace, drossing 

kettles, and dross reverberatory furnace.

• The plain meaning of that language evidences intent to cover 

any and all types of pyrometallurgical processes for producing lead

but shows no attempt to encompass other, as yet unknown, lead 

production processes. 

• Isolating the phrase “including, not limited to” from the 

company it keeps to justify an expansive reading goes well beyond 

the meaning of the listing as a whole and thus cannot stand.

The commenter also stated that the proposed change in 

applicability is inconsistent with the statutory structure for 

formulating source categories: “To the extent practicable, the 

categories and subcategories listed under this subsection shall be 

consistent with the list of source categories established pursuant 

to section 7411 of this title and part C of this subchapter.” The 

commenter cited several instances in the statute where Primary Lead 

Smelting is referred to as a pyrometallurgical process. In 

summation, the commenter states that the statutory directive of CAA 
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§ 112(c)(1) to assure consistency between a source category 

definition and how the same terms are used in other parts of the Act 

demonstrates that the statutory and regulatory use of “primary lead 

smelting” and “primary lead smelter” was consistently designed to 

cover only pyrometallurgical processes. The EPA’s assertion that the 

originally formulated primary lead smelting source category has a 

“broader definition” is inconsistent with the original source 

category language and the pyro-oriented definitions applied to 

primary lead smelting/smelter found throughout the statute and 

regulations.

The commenter also stated that the EPA’s effort to recast the 

primary lead smelting category is barred by the failure to show a 

major source would be present. The new hydrometallurgical process 

bears no resemblance to the current pyrometallurgical process, other 

than feedstock and end product. The new process will have 

drastically reduced lead emissions and is presented as a minor 

source in the Doe Run Air Construction Permit Application for the 

New Lead Technology submitted to the Missouri Department of Natural 

Resources. 

Response: Section 112(c)(1) describes the process for creating the 

source category list. To the extent that the commenter is concerned 

that the source category listing for primary lead was not issued 

consistent with the requirements of section 112(c)(1), such claim is 
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untimely. We disagree with the commenter that the source category 

description must be read to be limited to pyrometallurgical 

processes. The source category description was intended to include 

all processes used to produce lead metal from ore concentrates, as 

evidenced by the first sentence of the category description. While 

it is true that at the time of the source category listing, the 

hydrometallurgical process described by the commenter did not exist, 

the language left open the possibility that other lead metal 

production processes might be developed in the future and would be 

covered under the source category listing. As noted in the response 

to comments, if a new process such as the hydrometallurgical process 

is developed, EPA would consider what standard should apply to such 

process. We maintain that primary lead processing facilities using 

such a process should still be subject to the NESHAP. 

Comment: A commenter stated that the proposed rule does not suggest 

that the new lead production processes should be listed as area 

sources. If the EPA could make the necessary "adverse effects 

finding" for including a hydrometallurgical lead production process 

as an area source, a separate NESHAP would be required for a new 

area source. The EPA lacks authority to subsume a new area source 

into the Primary Lead Smelting major source category, as it would 

require in the proposed rule. Therefore, the EPA must show that 

either Doe Run’s new lead production process or the entire Doe Run 
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facility after the new process is operational would or could emit 

more than 10 tpy of lead if the facility is to remain a major source 

category and the proposed rule offers no documented evidence that 

Doe Run’s hydrometallurgical lead production process or the 

Herculaneum facility after the new process becomes operational would 

constitute a major source. The commenter contended that neither the 

new process nor the entire Herculaneum facility would be a major 

source. Plant-wide emissions at Doe Run’s facility after the new 

process becomes operational are estimated to approximate 0.65 tpy. 

Absent the presence of a major source at Doe Run’s facility, the new 

lead production process cannot be treated as a major source 

category.

Response: It is our position that once a source is required to 

install controls or take other measures to comply with a MACT 

standard, it should not be able to substitute different controls or

measures that happen to bring the source below major source levels 

to avoid compliance with a standard after the compliance date. 

Otherwise, a facility could backslide from MACT control levels by 

escaping applicability of the MACT standards and increasing

emissions. Therefore, the Doe Run Herculaneum facility will continue 

to be treated as a major source of HAP emissions. We note that the 

emission standards and work practice standards promulgated in this 

action apply to the source in its current form as a 
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pyrometallurgical processing facility. To the extent any of these 

processes remain in place, such as the refining operation, after 

construction of any new hydrometallurgical process, the emission 

limit applicable to that process would continue to apply. As noted 

elsewhere, a new hydrometallurgical process is not subject to an 

emission limit under the existing MACT standard; we would consider 

an appropriate emission limit for the hydrometallurgical process 

once that process is a demonstrated technology.

Comment: Another commenter stated that the EPA appropriately 

proposes to update the applicability of the MACT to cover Doe Run’s 

new type of facility.

Response: We agree with this comment.

Comment: Two commenters stated that the EPA cannot use section 

112(f) authority to establish an ambient air standard because this 

type of standard is not an “emission standard.”

The commenters stated that the NAAQS does not fit within the 

meaning of “emission standard” as used in CAA §§ 112(d)(6) or 

(f)(2), the EPA’s stated authority for the proposed rule. Section 

112(f)(2) is entitled “Emission standards” and the second sentence, 

where the “ample margin of safety” factor is found, has “emission 

standard” as its subject; these specific references clarify the use 

of “standards” elsewhere in the subsection means “emission 

standard.” Likewise, § 112(d)(6) gives the Administrator authority 
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to revise “emission standards.” Both subsections limit the EPA’s 

rule-promulgating authority to setting “emission standards.”

According to commenters, Congress defined “emission standard” 

in CAA § 302(k) to “mean a requirement established by the . . . 

Administrator which limits the quantity, rate or concentration of 

emissions of air pollutants on a continuous basis, including any 

requirement relating to the operation or maintenance of a source . . 

. and any design, equipment, work practice or operational standard 

promulgated under this chapter.” The language can only be reasonably 

read to allow a standard applicable to emissions from specific 

source(s). The lead (or any other) NAAQS, by definition, is not 

targeted to specific source(s), but applies generally to the 

national ambient air. See, e.g., CAA § 109(a)(1)(A) (“regulations 

prescribing a national primary ambient air quality standard . . . 

for each air pollutant”).

The commenters stated that the contrasting language highlights 

that the lead NAAQS does not qualify as an emission standard within 

the meaning of § 112. The NAAQS addresses ambient air rather than 

emissions from a source, and as a result the NAAQS does not put any 

limits on the quantity, rate, or concentration of emissions from a 

particular source or on its operation, maintenance, design, or work 

practices, all of which are central to the § 112(f)(2) mandate or on 

the practices, processes, and control technologies related to 
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sources central to § 112(d)(6). Further, a NAAQS limits ambient air 

lead without regard to source category or types of sources, while 

the MACT standards are particularized to control emissions at 

specific sources. Thus, the primary lead smelting emission standards 

differ from the secondary lead smelting emission standards, but the 

same lead ambient air standards apply throughout the country without 

regard to such distinctions. In short, the lead NAAQS does not fit 

the meaning of “emission standard” as used in § 112 and therefore 

cannot be properly used as the MACT standard here.

One commenter stated further that this error is not cured by 

the wording of proposed § 63.1544(a), which states: “No owner . . . 

shall discharge or cause to be discharged into the atmosphere lead 

compounds that cause the concentration of lead in air to exceed 0.15 

μg/m3 on a 3-month rolling average measured at locations approved by 

the Administrator.” As such, proposed § 63.1544(a) measures ambient 

air levels for compliance (“concentration of lead in air . . . at 

locations”) in what appears to match the source monitoring of 

ambient air required for the Lead NAAQS. See 73 FR at 67052, § 

50.16(a) and at 67059, §58.10; see also 76 FR at 9436/1 (proposing 

that compliance “be demonstrated using a compliance monitoring 

system”). As such, proposed § 63.1544(a) does not limit the 

quantity, rate, or concentration of emissions from a specified 

source or take into account developments in practices, processes, 
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and control technologies. Compare 40 C.F.R. § 63.1544(a)(2010)

(requiring “manual that describes in detail the measures that will 

be put in place to control fugitive dust emissions from the 

sources”). Measuring ambient air at locations presumably near the 

source does not fall within the standards allowed by CAA § 112, and, 

in any event, is redundant to the same monitoring and limitations

already established under the Lead NAAQS. Consequently, the proposed 

rule exceeds the statutory authority granted by § 112, and therefore 

cannot be adopted.

One commenter stated that the proposal requests comments on a 

work practices standard operating procedure (SOP) alternative to 

ambient air monitoring. As opposed to using the Lead NAAQS, which is 

not an emission standard under Section 112, the alternative SOP 

proposal is consistent with the MACT directive that emission 

reductions be tied to specific sources.

One commenter stated that the proposed ambient lead standard is 

procedurally flawed because the EPA fails to explain the legal basis 

for imposing such a standard under § 112(f). The agency’s legal 

authority is of central relevance to this aspect of the proposal and 

the failure to clearly describe the legal basis for the standard 

violates the EPA’s obligation under § 307(d)(3)(C) to set forth the 

“major legal interpretations” that underlie the proposal.

Response: The commenters mistake the purpose of the fenceline 
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monitoring requirement in the proposed rule. The proposed rule 

established emissions standards from the main, furnace area, and 

refinery operations stacks and further provided that fugitive 

emissions would need to be addressed by work practice standards (as 

is allowed under section 112(h)(1)). Finally, it established a 

fenceline monitoring requirement to ensure that the work practice 

standards adequately address fugitive emissions consistent with the 

requirements of section 112(f). Thus the fenceline monitoring is not 

an emission standard, but rather a method to ensure compliance with 

the applicable standards for addressing fugitive emissions, similar 

to how a stack test might be used to ensure compliance with emission 

standards applicable to point source emissions. The facility must 

use work practice standards to reduce fugitive emissions to protect 

public health with an ample margin of safety, and to avoid adverse 

environmental effects. The fenceline monitoring requirement is a 

method for ensuring compliance with the work practice standards to 

provide the protection required under CAA section 112(f)(2). 

We understand that the draft regulatory text from the proposed 

rule may have contributed to the commenters’ confusion on this 

issue. We have modified the regulatory text for the final rule to 

make clear that the applicable standard is the requirement to adopt 

work practice standards and that the fenceline monitoring 

requirement is a tool to help ensure compliance.
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However, even if this were not the case, the EPA could adopt a 

performance standard using the lead NAAQS as the measure of 

performance for a source to achieve. Such a standard would “limi[t] 

the quantity, rate, or concentration of emission of [lead] on a 

continuous basis” (CAA 302 k) since a source’s lead emissions, 

measured at the fenceline, would be limited to the amount 

established by the NAAQS.

We disagree with the suggestion that we do not provide the 

legal basis for our proposed rule. The preamble clearly explains 

that we are addressing residual risk for this source category under 

section 112(f) and clearly explains the rationale for the proposed 

rule and the basis for the proposed requirements. (See 76 FR 9412-

9414 for a discussion of the statutory authority underlying the 

proposed revisions to the standard.) With regard to fugitive 

emissions, we are establishing a requirement for work practice 

standards consistent with section 112(h)(1) in lieu of an emission 

standard because these fugitive emissions, which are predominantly 

from materials handling and roadways cannot be captured and vented 

to a stack for which we could establish an emission limit.

Comment: One commenter stated that the CAA limits the EPA’s ability 

to regulate pollutants subject to NAAQS (“criteria pollutants”) to 

that regime and does not allow supplemental (or supplanting) 

regulation of them under NESHAP. The commenter cited CAA § 112(b)(2) 
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that states in relevant part: “No air pollutant which is listed 

under section 7408(a) of this title may be added to the list under 

this section” with certain exceptions not relevant here. Section 

7408(a) provides the statutory authority for setting NAAQS. Also, 

CAA § 112(b)(7) removes elemental lead from consideration as a HAP. 

According to the commenter, the prohibition is not only clear, but 

also expansive: the statute “unqualifiedly prohibits listing a 

criteria pollutant as a HAP, that is, regardless of the reason.” 

Nat’l Lime Ass’n v. EPA, 233 F.3d 625, 638 (D.C. Cir. 2000).

Response: As we recognized in the preamble to the proposed rule, 

under section 112(b)(7) elemental lead may not be listed as a HAP 

under section 112 and the references to “lead” in the proposed rule 

referred to “lead compounds” which are expressly listed as a HAP in 

CAA section 112(b)(1). 76 FR 9412. Because lead compounds are a 

listed HAP, we are required to regulate them under section 112, as 

we did when we established the original MACT standard for primary 

lead in 1999. 64 FR 30194. The lead emitted from primary lead 

processing is lead compounds with elemental lead present only in 

trace amounts.5 The commenter did not provide any data to refute 

 5 Harrison, R.M. and Williams, C.R. (1981). Environmental Science and Technology, Vol. 15:10, p. 1197-1204.; Ohmsen, 

G.S.(2001). Journal of the Air and Waste Management Association, Vol. 51, p. 1443-1451.; Uzu, G., Sobanska, S., Sarret, G., 

Sauvain, J.J., Pradère, P., and Dumat, C. (2011). Journal of Hazardous Materials, Vol. 186, p. 1018-1027.; Spear, T.M., Svee, 

W., Vincent, J.H., and Stanisich, N. (1998). Environmental Health Perspectives, Vol. 106:9, p. 565-571.; Czaplicka, M., and 

Buzek, Ł. (2011). Water, Air, & Soil Pollution, Vol. 218, p. 157-163.; Sobanska, S., Ricq, N., Laboudigue, A., Guillermo, R., 

Brémard, C., Laureyns, J., Merlin, J.C., Wignacourt, J.P. (1999). Environmental Science and Technology, Vol. 33, p. 1334-
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this. Thus, we disagree with the commenter that we are attempting to 

regulate in contravention of section 112(b)(7) in this action.

The National Lime opinion cited by the commenters addressed a 

different issue than the one being at issue here. In that case, the 

issue was whether EPA could use a NAAQS pollutant (particulate 

matter) as a surrogate for HAP metal emissions. While certain HAP 

listed in 112(b)(1) are considered particulate matter, “particulate 

matter” is not listed on the 112(b)(1) list. In that case, the 

court rejected the argument by the National Lime Association that 

EPA was regulating particulate matter “through the back door.” In 

the present situation, EPA is not regulating lead “through the back 

door” in this rulemaking.

Comment: One commenter stated that the EPA unlawfully refused to set 

a standard for organic HAP. According to the commenter, the EPA 

must set an emission standard for the organic HAP listed on the 

section 112(b)(1) list that this source category emits. 

Specifically, the commenter argues that:

"[w]hen EPA performs a section 112(d)(6) review, 

it must consider the ongoing legality and 

effectiveness of the existing standard. 

Explicitly, in the current rulemaking EPA must 

“review, and revise as necessary” the existing 

MACT standard. 42 U.S.C. § 7412(d)(6). It is 

 

1339.; Harrison, R.M. and Williams, C.R. (1983). The Science of the Total Environment, Vol. 31, p. 129-140.; Batonneau, Y., 

Bremard, C., Gengembre, L., Laureyns, J., Maguer, A.L., Maguer, D.L., Perdrix, E., and Sobanska, S. (2004). Environmental 

Science and Technology, Vol. 38, p. 5281-5289.; Foster, R.L. and Lott, P.F. (1980). Environmental Science and Technology, 

Vol. 14:10, p. 1240-1244.
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clearly “necessary” for EPA to close inherently 

unlawful gaps in the original MACT, by setting a 

standard for an uncontrolled HAP. Indeed, EPA has 

recognized the need and done this during its 

section 112(d)(6) review in its recent rulemaking 

for Marine Tank Vessel Loading Operations and 

Group I Polymers and Resins where it proposed a 

standard for previously uncontrolled 

subcategories of these sources. See Proposed 

Rule, 75 Fed. Reg. 65,068, 65,115, 65,106 (Oct. 

21, 2010). EPA has no legal basis for failing to 

set a MACT standard now for the uncontrolled HAPs 

for the primary lead source category."

Response: We disagree with the commenter that section 112(d)(6) 

mandates that EPA must correct any deficiency in an underlying MACT 

standard when it conducts the “technology review” under that 

section. We believe that section 112 does not expressly address this 

issue, and EPA has discretion in determining how to address a 

purported flaw in a promulgated standard. The "as necessary" 

language cited by the commenter must be read in the context of the 

provision, which focuses on the review of developments that have 

occurred since the time of the original promulgation of the MACT 

standard and thus should not be read as a mandate to correct flaws 

that existed at the time of the original promulgation. In several 

recent rulemakings, we have chosen to fix underlying defects in 

existing MACT standards under sections 112(d)(2) and (3), the 

provisions that directly govern the initial promulgation of MACT 

standards (see National Emission Standards for Hazardous Air 

Pollutants From Petroleum Refineries, October 28, 2009, 74 FR 55670; 
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and National Emission Standards for Hazardous Air Pollutants: Group 

I Polymers and Resins; Marine Tank Vessel Loading Operations; 

Pharmaceuticals Production; and the Printing and Publishing 

Industry, April 21, 2011, 76 FR 22566). (We note that the commenter 

incorrectly states that we revised those standards under 112(d)(6)). 

We believe that this approach is reasonable because using those 

provisions ensures that the process and considerations are those 

associated with initially establishing a MACT standard, and it is 

reasonable to make corrections following the process that would have 

been followed if we had not made an error at the time of the 

original promulgation. 

Nevertheless, based on our review of the commenter's 2009 

petition and their additional comments on this proposed rulemaking, 

we agree that the Primary Lead Smelting NESHAP should have included 

an emission standard for organic HAP. We have evaluated available 

data and believe that we need additional data in order to set an 

emission standard for organic HAP that is representative of current 

operations and emissions. We intend to collect the needed data and 

propose a MACT emission standard under section 112(d)(2) & (3) of 

the CAA. Accordingly, we are not taking final action on the 2009 

petition with respect to the issue of setting a standard or 

standards for organic HAP and will address that petition once we 

have gathered the necessary data.
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C. Primary Lead Processing Risk Assessment

Comment: One commenter stated that the EPA failed to consider or 

account for cumulative risk and that there is no rational or 

scientific basis to dismiss consideration of the cumulative risk of 

exposures to HAPs due to uncertainties. The commenter urged that 

these uncertainties require protective action rather than inaction. 

The commenter stated that the EPA’s Science Advisory Board (SAB) in 

May 2010 urged the EPA to use the RTR rulemaking process to do this 

as well as perform a sensitivity analysis to identify the major 

uncertainties in both the human health and ecological risk 

assessments. According to the commenter, the SAB and numerous other 

scientific experts have developed, and are in the process of 

developing, cutting edge methods to perform these assessments and 

that the EPA, as the lead environmental agency of the United States, 

has a responsibility to show leadership in this process. It should 

rely on the significant information already available and also use 

the current and future RTR rulemakings to further advance this

process.

The commenter stated that it could be done on a site-specific 

basis or for the industry as a whole. Uncertainty in estimates of 

HAP in ambient air has been characterized, so the data available 

from the National-Scale Air Toxics Assessments (NATA) would allow a 

defensible estimate of what might be expected from other sources.
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Response: We disagree with the commenter that our risk assessments 

do not consider cumulative risk. We note that our assessment of 

cancer risks is, in fact, cumulative, summing the risks associated 

with all carcinogens emitted by the facility. Similarly, the use of 

the target organ specific hazard index (TOSHI) for chronic noncancer effects evaluates the cumulative effects of HAP on a given 

target organ. Further, our assessment for Primary Lead Processing is 

cumulative in that it considers all emission points within the 

fenceline (since they are all covered by the MACT). Moreover, the 

level of the lead NAAQS, which we used as the metric for defining 

unacceptable risk, was set based on all air-related exposures in its 

derivation and thus is also a cumulative standard. We note that for 

the present rulemaking, our consideration of cumulative risks for 

the Doe Run facility is the same as that for the industry as a whole 

since Doe Run is the only facility within the source category.

We further disagree with the commenter’s assertion that a 

comprehensive quantitative assessment of risks from all sources 

outside the source category is required under the statute. If such 

were in fact the case, the task of completing such a requirement 

would take an interminable length of time. Instead, to provide the 

quantitative risk information necessary to inform RTR regulatory 

decisions, the EPA conducts a comprehensive assessment of the risks 

associated with exposure to the HAPs emitted by the source category 
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(i.e., those emissions that can actually be affected by the specific 

rulemaking) and supplements that with additional information about 

other possible concurrent and relevant risks that is readily 

available. In some cases, we have additional information about HAP 

emissions that outside the scope of the particular rulemaking but 

within the boundaries of the subject facilities. In other cases, we 

may have ambient HAP monitoring data that can be considered as part 

of the regulatory decision-making. In still other cases, we may have 

very little additional risk information that can be considered. In 

all cases, however, when we consider additional information about 

risks, we also consider its attendant uncertainties, and information 

which carries significant uncertainties generally carries much less 

weight in the overall regulatory decision.

All of the quantitative risk assessment information about HAP 

emissions from the source category under consideration is also 

considered in the manner prescribed by the decision framework set 

forth by the CAA for residual risk decision-making (i.e., the 

Benzene decision framework), and this means that the general 

guidelines of risk acceptability have been developed in a way that 

they already take into account the impossibility of accurately 

quantifying the health risks posed by outside forces on every 

individual in the population. They do this by noting that the 

guidelines apply in “the world in which we live,” a world which is 
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acknowledged to be “not risk-free,” but rather a world which is full 

of risks, many of which can simply not be quantified. This 

acknowledgment allows the EPA to make risk-based decisions by 

focusing on the risks associated with the emissions that are 

themselves the subject of regulation being considered, and not get 

distracted by the daunting task of assessing all the other 

concurrent potential risks that may or may not be relevant and can’t 

be impacted by the regulation in question anyway.

Comment: Two commenters took issue with the modeling methodology 

used for the RTR proposal and disagreed with the risk results based 

on a number of concerns. 

One commenter stated that the RTR modeling characterized the 

maximum air lead concentrations near the facility to be fifty times 

the 2008 NAAQS which is inconsistent with both recent air quality 

monitoring data and Missouri's 2007 attainment demonstration 

modeling and stated that the proposed RTR modeling overestimated the 

maximum air lead concentration by at least a factor of five. The 

commenter stated that the inaccuracies of the EPA’s proposed 

modeling analysis will be in conflict with future baseline and 

attainment demonstration modeling based on more accurate data, 

especially since the RTR proposes to correlate the MACT standard 

with the 2008 NAAQS. The commenter recommended that the EPA remodel 

this facility using higher quality input data that are more 
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representative of current operations at the Herculaneum facility, to 

obtain results that better reflect the actual monitored three-month 

lead concentrations. Alternately, the commenter stated that the EPA 

should either defer to appropriate air quality monitoring 

information or to the modeling run used for the 2007 SIP revision 

attainment demonstration as the basis for this RTR. Some commenters 

also suggested using AERMOD modeling followed by LEADPOST, rather 

than using HEM-3 to ultimately calculate 3-month rolling average 

lead concentrations. 

Two commenters identified specific issues with regard to the 

modeling approach and input data including:

• The ratio of modeled results to monitored data should not 

exceed a factor of two. The commenter provided specific corrections 

and analysis of data.

• The NAAQS attainment demonstration model developed by the State 

of Missouri and the RTR modeling, although conducted for different 

purposes, are both based on compliance with the same standard for 

the same geographic location. Therefore, the output of both 

dispersion models, whether for residual risk assessment or SIP 

development, should reflect the maximum ambient air lead 

concentration. The commenter stated that any data limitations should 

be addressed with input from the commenter. 

• Improvements from the 2007 SIP for the fugitive emissions from 
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the sinter plant and blast furnace building do not appear to be 

reflected in the run script of the model, resulting in 

concentrations up to fifty times the NAAQS. The commenter stated 

that actual monitoring data from 2010 show a maximum three-month 

average ambient air concentration of 1.12 μg/m3 at the Main Street 

site. This actual monitored value is in line with the MDNR modeled 

estimate from the 2007 SIP revision and is recommended to be the 

basis for the risk assessment.

• The EPA did not provide a modeling protocol for their 

dispersion modeling, or all of the modeling inputs, post processing 

and other data in the docket for public review. Therefore, a 

complete, replicable public review of the model and assessment of 

the proposed RTR could not be made. The commenter identified several 

specific modeling parameters and data elements that were not 

correctly applied during the proposal modeling run which could have 

significantly affected the results including model control options,

run script parameters, volume sources modeled as point sources, 

inaccurate fenceline/boundary locations, incorrect elevations for 

sources and receptors, and old census data information for receptor 

centroids.

Response: Because of the availability of newer emissions data, more 

detailed site-specific meteorological data, as well as updated 

facility boundary and other information provided by Doe Run in 
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comments on the proposed rule, we have remodeled the facility with 

these newer data. We remodeled using AERMOD in the default mode to 

estimate monthly lead concentrations, and we used the building and 

particle data submitted by one commenter to model building downwash 

and plume depletion. We used the LEADPOST processor to calculate 3-

month rolling averages. In addition, using the updated facility 

boundary information, the EPA also removed census blocks that would 

now be considered onsite. The methods and results of this modeling 

effort can be found in the document: Residual Risk Assessment for 

the Primary Lead Smelting Source Category, which is available in the 

docket for this rulemaking. The EPA notes that the results of this 

modeling effort are similar to results submitted by the Doe Run 

Company to the State as part of a SIP (this Doe Run modeling effort 

was also submitted to the EPA as part of its public comments). 

Moreover, the EPA notes that a comparison of modeled lead 

concentrations at the sites of six lead monitors are within 50 

percent of measured concentrations at those monitors. These results 

are similar to a model-to-monitor comparison submitted by Doe Run in 

its public comments. 

We note that the docket included all of the input files and 

documentation needed to reproduce the modeling that was performed 

for the proposal risk assessment.

Comment: With respect to using the NAAQS to evaluate potential 
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multipathway risks from lead, one commenter stated that the risk 

assessment used to set the NAAQS was based on quantitative studies 

of young children and that while “the Lead NAAQS obviously applies 

to all ages, that was a qualitative risk management decision made as 

a matter of policy” and that “the task at hand is to provide a 

quantitative risk assessment of the maximum non-adverse facilitylevel emissions rate for all ages, which cannot be done on the basis 

of a risk assessment that studied children only. 

Response: The lead NAAQS was a public health policy judgment 

considering the available health evidence and risk analyses as well 

as the uncertainties associated with the health evidence and risk 

analyses. We disagree with the commenter that the lead NAAQS cannot 

be used in a quantitative manner. The review of the lead NAAQS 

clearly resulted in a quantitative standard: 3-month maximum lead 

concentration not to exceed a level of 0.15 μg/m3. This standard was 

set to protect public health, including the health of sensitive 

populations, with an adequate margin of safety. As the commenter 

notes, the lead NAAQS applies in all areas of the United States and 

is meant to protect the public health with an adequate margin of 

safety regardless of the age of the individuals living in a 

particular area. 

Comment: One commenter stated that rather than finalizing this 

proposal as it stands, the best available science directs the EPA to 
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set a residual risk standard that incorporates protective health 

benchmarks and assures that children living near the facility will

not face an unacceptable neurological effect, such as the loss of IQ 

points. This includes protecting children against a blood lead level 

change of 1.0 μg/dL or more, a benchmark used by California for the 

blood lead level change that is associated with a child’s loss of 

one IQ point. Because there is no safe level of lead exposure and 

because lead persists in the environment, resulting in reservoirs in 

soils and dusts, the EPA has an obligation to control emissions from 

this source category promptly and in a precautionary manner. The 

commenter stated that the EPA should consider requiring zero lead 

emissions. At a minimum, the EPA should set a standard that would 

ensure that the ambient air concentration for lead in the local 

community does not exceed the level of 0.02 μg/m3 as a one-month 

average, in order to protect children. As this is the level the 

Children’s Health Protection Advisory Committee had recommended for 

the lead NAAQS, the EPA must also set additional protections beyond 

this ambient air limit in order to provide an “ample margin of 

safety.” 

Response: In order to assess multipathway risks associated with 

emissions of lead, the EPA compared modeled rolling three month 

average lead concentrations estimated from emissions from the one 

source in this category to the NAAQS for lead. As noted above, we 
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believe that this is a reasonable approach given that the NAAQS is a 

health based standard set to protect the public health, including 

the health of sensitive sub-populations (such as children) with an 

adequate margin of safety. Moreover, the risk assessment supporting 

the NAAQS considered direct inhalation exposures and indirect airrelated multi-pathway exposures from industrial sources like primary 

and secondary lead smelting operations. While we conclude that the 

level of the NAAQS presents an acceptable level of risk from lead in 

ambient air, and are requiring controls to ensure that the level of 

the NAAQS is not exceeded, as part of our “ample margin of safety” 

analysis, we examined whether there were additional cost effective 

controls available to further protect public health including 

monitoring at a level below 0.15 μg/m3. For the reasons explained 

elsewhere in this notice and other supporting documents available in 

the docket, we have determined that there are no additional cost 

effective controls that would provide further risk reductions. 

With respect to the California benchmark for protecting 

children, the EPA has a hierarchy of appropriate health benchmark 

values. In general, this hierarchy places greater weight on EPA 

derived health benchmarks than those from other agencies 

(http://www.epa.gov/ttn/atw/nata1999/99pdfs/healtheffectsinfo.pdf). 

For the reasons provided above, we believe that the lead NAAQS level 

establishes an appropriate benchmark for addressing the acceptable 
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level of risk and we disagree with the commenter that we should 

instead use an ambient concentration of 0.02 μg/m3 based on a one 

month average.6 

Comment: With regard to the source category’s emissions of two 

dozen other hazardous air pollutants, including cadmium and arsenic, 

one commenter stated that the EPA should determine that this health 

risk is also unacceptable. With thousands of people exposed to a 

lifetime risk of cancer above 1 in a million, and with at least 200 

exposed to a lifetime risk of up to 30 in a million, the EPA must 

recognize that this risk is too high for this local community. The 

EPA should set a standard that would reduce cancer risks to an 

acceptable level and ensure an ample margin of safety from non-lead 

emissions.

Response: With respect to cancer risk, section 112 provides for EPA

to follow the benzene decision framework for determining 

acceptability. Under that framework, cancer risk less than 100 in a

million is generally considered acceptable, although this is not a 

bright line and EPA examines a variety of health factors to make its 

determination. Once we concluded that the risk from non-lead HAP was 

acceptable, we then considered whether there were additional costeffective controls that would further reduce risk from the other HAP 

 6 This level is well below the background ambient lead levels measured in the area during the SIP process. See docket ID 

EPA-HQ-OAR-2006-0735-5204.
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emitted in order to provide an ample margin of safety. Because the 

controls for other HAP were the same as the controls for lead, we 

determined (for the same reason we did for lead) that there were no 

additional cost effective controls and that the acceptable level of 

HAP emissions also provided an ample margin of safety. 

Comment: One commenter stated that they oppose the use of the lead 

NAAQS assessment instead of a multi-pathway risk assessment because 

the lead NAAQS provides an inappropriate level of protection, i.e., 

the lead NAAQS requires an adequate margin of safety while a 

residual risk standard requires an ample margin of safety. The 

commenter stated that a residual risk standard should provide a 

level of protection that is higher than the NAAQS. Moreover, the 

commenter noted that the NAAQS is set to protect sensitive 

populations while residual risk rules are set to protect the 

greatest number of individuals possible from unacceptable risk. The 

proposed rule based on the lead NAAQS will not provide as high a 

level of protection as required by CAA § 112(f)(2). 

Response: We disagree with the commenter that the lead NAAQS 

assessment should not be considered as part of our residual risk 

analysis because it provides an inappropriate level of protection. 

The lead NAAQS is set at a level to protect public health, including 

the health of sensitive populations, most critical for lead, the 

health of children. That does not suggest that non-sensitive 
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populations are not protected, but rather that the NAAQS is set at a 

level that will not only protect the general population but also 

those who are more sensitive to lead exposures. In the proposed 

rule, the level of the NAAQS, which protects public health with an 

adequate margin of safety, was used to determine whether or not 

there was unacceptable risk. Once we determined a level of emissions 

that results in risks being acceptable, under the two-step residual 

risk decision process, the EPA then considered whether there were 

additional controls that might further reduce risk to achieve an 

ample margin of safety considering cost and feasibility. There were 

no additional cost-effective controls beyond those that would need 

to be implemented to ensure an acceptable level of risk. Thus, for 

the three emissions points (fugitive dust emissions, the furnace 

area stack, and the refinery stacks) for which we are requiring 

action to ensure an acceptable level of risk, we have concluded that

there are no additional cost-effective controls and that an ample 

margin of safety was provided by the same controls that ensured an 

acceptable level of risk. There are no cost effective controls that 

could reduce the main stack emissions beyond those that are achieved 

in practice. Therefore, an ample margin of safety will be provided 

by the current level of control. A more detailed presentation of the 

economic analysis of additional controls for the refining, furnace 

area, and main stacks can be found in the technical support 
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document, which is available in the docket.

Comment: One commenter stated that the EPA has not appropriately 

accounted for or prevented environmental risks from lead or non-lead 

emissions as required by section 112(f)(2)(A). According to the 

commenter, using the NAAQS to assess ecological risk is problematic 

and EPA’s approach of assuming that “when exposure levels are not 

anticipated to adversely affect human health, they also are not 

anticipated to adversely affect the environment,” 76 Fed. Reg. at 

9425, is illogical and unlawful. Further, based on the information 

the EPA has gathered about the local environment around the Doe Run 

facility, the EPA cannot assume that there would be no effects 

either to wildlife or to natural resources in the environment either 

from inhalation or air deposition of HAP emissions, exacerbated by 

persistence and bioaccumulation. As the EPA’s own Scientific 

Advisory Board has stated: “The assumption that ecological receptors 

will be protected if human health is protected is incorrect.” SAB 

May 2010 at 48. 

Response: The EPA is unaware of any data indicating a direct 

atmospheric impact of non-lead HAP emitted from this source category

on receptors such as plants, birds, and wildlife. Given that there 

is no information supporting that there is an effect, we find it 

appropriate to assume that exposure levels not expected to harm 

humans are also not expected to harm ecological receptors. 
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Although the ecological effects of lead are well documented, 

there was a lack of evidence at the time of the last lead NAAQS 

review linking various ecological effects to specific levels of lead 

in the air. It was determined that the evidence did not provide a 

sufficient basis for establishing a separate secondary standard, but 

that revising the secondary standard to be equal to the revised 

primary standard would provide substantial additional protection to 

ecological receptors from the effects of lead. Thus, we find it 

appropriate to consider the secondary lead NAAQS when evaluating the 

potential for adverse environmental effects. 

Comment: One commenter generally stated that the EPA must not use 

the secondary NAAQS as a benchmark to determine whether there will 

be environmental effects and that the use of the lead NAAQS to 

evaluate ecologic risks is inappropriate. The commenter states that 

the EPA should recognize that the establishment of the Secondary 

lead NAAQS at the same level of the Primary Lead NAAQS was a risk 

management decision, rather than a decision quantitatively founded 

in risk assessment. The commenter cited that in establishing the 

lead NAAQS, the EPA introduced its approach by describing the 

“substantial limitations in the evidence, especially the lack of 

evidence linking various effects to specific levels of ambient Pb” 

(US EPA, 2008. P. 67007), and ultimately concluded that the 

secondary lead NAAQS should be set equal to the primary lead NAAQS. 
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In contrast, in this proposed rule, the EPA concludes that 

“ambient lead concentrations above the lead NAAQS indicates 

potential for adverse environmental effects” (76 FR 9421). 

Response: The secondary lead NAAQS was set to protect against 

adverse welfare effects (including adverse environmental effects) 

and has the same averaging time, form, and level as the primary 

standard. Thus, we find it appropriate to consider the secondary 

lead NAAQS when considering the potential for adverse environmental 

effects. The commenter is correct that we stated in the proposed 

rule that “ambient lead concentrations above the lead NAAQS 

indicates potential for adverse environmental effects.” This 

statement is entirely consistent with the idea that the secondary

lead NAAQS was set at a level above which there may be adverse 

environmental effects but does not support a conclusion that there 

are adverse environmental effects below that level that must be 

addressed as part of this residual risk determination. As we have 

noted previously, there are not sufficient data supporting that a 

lower level is necessary to protect against an environmental risk.

Comment: One commenter stated that in evaluating potential 

multipathway risks from PB-HAP other than lead, the EPA used de 

minimis emission rates to screen for potentially significant multipathway impacts, but for lead, this method was abandoned. The 

commenter disagrees with this approach, stating, “This comparison 
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mirrors NAAQS source monitoring for attainment purposes in its use 

of the national ambient air lead level as the benchmark. As such, it 

is not a proper surrogate for “facility-level de minimis emission 

rates” used as the chronic reference benchmarks for CAA § 112 risk 

assessments.” 

Response: The EPA disagrees that comparing modeled 3-month rolling 

average lead concentrations to the NAAQS for lead mirrors source 

monitoring for NAAQS attainment purposes and that this approach is 

not a proper surrogate for facility-level de minimis emission rates 

used as the chronic reference benchmarks for CAA § 112 risk 

assessments. In general, determining attainment for the lead NAAQS 

is based on aggregate ambient monitoring of all potential sources of 

lead in a given area. In contrast, the Primary Lead Smelting Risk 

Assessment and Preamble clearly state that 3-month rolling average 

lead concentrations are based on modeled lead concentrations from 

lead emissions from the one facility in the source category. 76 FR 

9421. Thus, for example, while for NAAQS attainment purposes ambient 

lead concentrations resulting from lead haul roads outside the 

facility boundary would contribute to the overall 3-month rolling 

average ambient lead concentration measured at a nearby ambient lead 

monitor, for purposes of the risk assessment to support this 

rulemaking, these types of offsite emission sources were not 

included when modeling 3-month rolling lead concentrations (i.e., 
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only emission sources from within the facility boundary were used as 

inputs into the dispersion model to estimate resulting modeled 3-

month average lead concentrations). 

The NAAQS for lead was set to protect, with an adequate margin 

of safety, human health, including the health of children and other 

at-risk populations, against an array of adverse health effects, 

most notably including neurological effects, particularly 

neurobehavioral and neurocognitive effects, in children (73 FR 

67007). In developing the NAAQS for lead, because of the multipathway, multi-media impacts of lead, the risk assessment supporting 

the NAAQS considered direct inhalation exposures and indirect airrelated multi-pathway exposures from industrial sources like primary 

and secondary lead smelting operations. It also considered 

background lead exposures from other sources (like contaminated 

drinking water and exposure to lead-based paints). The EPA believes 

that the lead NAAQS is a reasonable benchmark to evaluate the 

potential for multipathway health effects from lead.

Finally, as noted in the risk assessment document, there is no 

RfD or other comparable chronic health benchmark value for lead 

compounds. That is, in 1988, the EPA’s IRIS program reviewed the 

health effects data regarding lead and its inorganic compounds and 

determined that it would be inappropriate to develop an RfD for 

these compounds, saying, “A great deal of information on the health 
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effects of lead has been obtained through decades of medical 

observation and scientific research. This information has been 

assessed in the development of air and water quality criteria by the 

Agency's Office of Health and Environmental Assessment (OHEA) in 

support of regulatory decision-making by the Office of Air Quality 

Planning and Standards (OAQPS) and by the Office of Drinking Water 

(ODW). By comparison to most other environmental toxicants, the 

degree of uncertainty about the health effects of lead is quite low. 

It appears that some of these effects, particularly changes in the 

levels of certain blood enzymes and in aspects of children's 

neurobehavioral development, may occur at blood lead levels so low 

as to be essentially without a threshold. The agency's RfD Work 

Group discussed inorganic lead (and lead compounds) at two meetings 

(07/08/1985 and 07/22/1985) and considered it inappropriate to 

develop an RfD for inorganic lead.” The EPA’s IRIS assessment for 

Lead and compounds (inorganic) (CASRN 7439-92-1), 

http://www.epa.gov/iris/subst/0277.htm.

Comment: One commenter stated that the EPA must include a plain 

language statement of health risks and benefits of the proposed 

rule. As part of its rulemaking proposal, the EPA should include a 

plain statement of the health impacts and risks at issue. For 

example, the commenter stated that the MIR and chronic and risk 

numbers are not easily understandable by the general public; the IQ 
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point losses at stake or how it is setting a standard to address 

these are not discussed, and the types of cancer or the nature of 

the health disorders or other adverse effects that most of these 

types of HAP emissions present to the public are not discussed. The 

commenter stated that this type of “[e]xpanded discussion is 

important to understanding the ‘real-world’ risk, including dealing 

with health disparities.” SAB May 2010 at 50. 

A full elaboration of the types of health impacts at issue 

here, ranging from significant IQ loss (due to lead emissions), to a 

high lifetime cancer risk (from non-lead emissions), for this 

particular community, is needed to inform the EPA’s and the public’s 

consideration of what level of risk is acceptable or unacceptable, 

and what standard is required to provide an ample margin of safety.

Response: The EPA strives to communicate its health and risk 

information to the public in a manner that is concise, informative, 

and readily understandable. In the risk assessment document, we 

discuss the various metrics used to characterize risk associated 

with the source category (e.g., see section 2.3 of the risk 

assessment document for a discussion of the MIR). Moreover, while 

the commenter is correct that we do not discuss in detail the 

neurological effects associated with exposure to lead (e.g., loss of 

IQ points in children), we do reference the final lead NAAQS 

decision, which does discuss in detail the health effects associated 
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with lead exposure. With regard to how the proposed controls limit 

the health risks associated with lead exposure, we noted in the 

preamble that the proposed controls would ensure that the facility’s 

contribution to ambient concentrations of lead were at or below the 

NAAQS for lead and that this represents an acceptable level of risk 

since the lead NAAQS was set to protect public health, including the 

health of sensitive populations (e.g., children), from the adverse 

health effects associated with lead exposure. In addition, as 

discussed previously, we concluded that the same level of controls 

would also provide an ample margin of safety.

With regard to discussing specific types of cancers potentially 

associated with exposure to a given HAP, we note that the cancer 

unit risk estimates used in the risk assessment are not associated 

with specific types of cancers, but rather with the risk of cancer 

in general. Moreover, since many of the cancer studies the unit risk 

estimates take into account are animal studies, there is appreciable 

uncertainty as to whether the same types of cancers would be seen in 

humans. Thus, we find it appropriate to express the results of our 

cancer assessment in terms of general cancer risk. 

VI. Impacts of the Final Rule

The revisions to the Primary Lead Processing MACT standard will 

ensure that emissions from the one source in this source category do 

not present an unacceptable level of risk and will also provide an 
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ample margin of safety. The estimated reductions include a reduction 

in fugitive dust emissions of lead and as much as 10 tons per year of 

lead from the furnace area and refining operations stacks. These 

controls will also reduce emissions of other HAP emitted from the 

facility. The costs of controls were not directly considered in the 

decision to require work practice standards and fenceline compliance 

monitoring to address fugitive emissions or to add an emission 

standard for furnace area and refining emissions because these

requirements are necessary to bring risk to an acceptable level.

However, as an example the cost for paving all unpaved roads at the 

facility to control fugitive emissions would be around $800,000. The 

EPA evaluated control practices and technology and associated costs 

in determining that the same requirements needed to achieve 

acceptable risks would also provide an ample margin of safety with 

regard to fugitive dust emissions and emissions from the furnace area 

and refining stacks. In addition, we considered other available 

practices, processes and control technologies. For the same reason we 

concluded that no additional controls were necessary to provide an 

ample margin of safety for the fugitive dust and refining and furnace 

area stacks, we concluded that there were no additional cost 

effective developments in practices, processes or control 

technologies for those emission sources. 

VII. Statutory and Executive Order Reviews
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A. Executive Orders 12866: Regulatory Planning and Review, and 

Executive Order 13563: Improving Regulation and Regulatory Review

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 

action is a “significant regulatory action.” This action is a 

significant regulatory action because it raises novel legal and 

policy issues. Accordingly, the EPA submitted this action to the 

Office of Management and Budget (OMB) for review under Executive 

Order 12866 and Executive Order 13563 (76 FR 3821, January 21, 2011), 

and any changes made in response to OMB recommendations have been 

documented in the docket for this action.

B. Paperwork Reduction Act

The Office of Management and Budget (OMB) has approved the 

information collection requirements contained in this rule under the 

provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and 

has assigned OMB control number 2060-0414. 

The information requirements are based on notification, 

recordkeeping, and reporting requirements in the NESHAP General 

Provisions (40 CFR part 63, subpart A), which are mandatory for all 

operators subject to national emission standards. These recordkeeping 

and reporting requirements are specifically authorized by section 114 

of the CAA (42 U.S.C. 7414). All information submitted to the EPA

pursuant to the recordkeeping and reporting requirements for which a 

claim of confidentiality is made is safeguarded according to agency 
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policies set forth in 40 CFR part 2, subpart B.

This final rule includes new paperwork requirements for 

monitoring for lead concentrations in air and increased frequency for 

stack testing as described in 40 CFR 63.1547(k) (compliance 

monitoring) and 40 CFR 63.1546 (stack testing). Although these are 

additional requirements under the final rule, they are consistent 

with existing monitoring and testing currently conducted by the 

facility to meet MACT and SIP requirements and would not constitute 

an undue burden to the facility.

When a malfunction occurs, sources must report them according to 

the applicable reporting requirements of 40 CFR part 63, subpart TTT.

An affirmative defense to civil penalties for exceedances of emission 

limits that are caused by malfunctions is available to a source if it 

can demonstrate that certain criteria and requirements are satisfied.

The criteria ensure that the affirmative defense is available only 

where the event that causes an exceedance of the emission limit meets 

the narrow definition of malfunction in 40 CFR 63.2 (sudden, 

infrequent, not reasonable preventable, and not caused by poor 

maintenance and or careless operation) and where the source took 

necessary actions to minimize emissions. In addition, the source must 

meet certain notification and reporting requirements. For example, 

the source must prepare a written root cause analysis and submit a 

written report to the Administrator documenting that it has met the 
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conditions and requirements for assertion of the affirmative defense.

The EPA is adding affirmative defense to the estimate of burden 

in the ICR. To provide the public with an estimate of the relative 

magnitude of the burden associated with an assertion of the 

affirmative defense position adopted by a source, the EPA has 

provided administrative adjustments to the ICR that show what the 

notification, recordkeeping, and reporting requirements associated 

with the assertion of the affirmative defense might entail. The EPA’s 

estimate for the required notification, reports, and records, 

including the root cause analysis, totals $3,141, and is based on the 

time and effort required of a source to review relevant data, 

interview plant employees, and document the events surrounding a 

malfunction that has caused an exceedance of an emission limit. The 

estimate also includes time to produce and retain the record and 

reports for submission to the EPA. The EPA provides this illustrative 

estimate of this burden, because these costs are only incurred if 

there has been a violation, and a source chooses to take advantage of 

the affirmative defense.

Given the variety of circumstances under which malfunctions 

could occur, as well as differences among sources' operation and 

maintenance practices, we cannot reliably predict the severity and 

frequency of malfunction-related excess emissions events for a

particular source. It is important to note that the EPA has no basis 
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currently for estimating the number of malfunctions that would 

qualify for an affirmative defense. Current historical records would 

be an inappropriate basis, as source owners or operators previously 

operated their facilities in recognition that they were exempt from 

the requirement to comply with emissions standards during 

malfunctions. Of the number of excess emission events reported by 

source operators, only a small number would be expected to result 

from a malfunction (based on the definition above), and only a subset 

of excess emissions caused by malfunctions would result in the source 

choosing to assert the affirmative defense. Thus, we believe the 

number of instances in which source operators might be expected to 

avail themselves of the affirmative defense will be extremely small.

For this reason, we estimate no more than 2 or 3 such occurrences for 

all sources subject to 40 CFR part 63, subpart TTT over the 3-year 

period covered by this ICR. We expect to gather information on such 

events in the future, and will revise this estimate as better 

information becomes available.

For the Primary Lead Processing MACT standard, the ICR document 

prepared by the EPA, which has been revised to include the amendments 

to the standards, has been assigned the EPA ICR number 1856.07.

Burden changes associated with these amendments result from the 

reporting and recordkeeping requirements of the affirmative defense 

provisions and the lead concentration in air limit added to the rule.
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The change in respondents’ annual reporting and recordkeeping burden 

associated with these amendments for this collection (averaged over 

the first 3 years after the effective date of the standards) is 

estimated to be 30 labor hours at a cost of $3,141 per year for the 

affirmative defense reporting and recordkeeping provisions and 1,313

labor hours at a cost of $461,640 per year for the lead concentration 

in air limit reporting and recordkeeping provisions. There will be no 

capital costs associated with the information collection requirements 

of the final rule. There is no estimated change in annual burden to 

the Federal government for these amendments. Burden is defined at 5 

CFR 1320.3(b)

An agency may not conduct or sponsor, and a person is not 

required to respond to, a collection of information unless it 

displays a currently valid OMB control number. The OMB control 

numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. 

In addition, EPA is amending the table in 40 CFR part 9 of currently 

approved OMB control numbers for various regulations to list the 

regulatory citations for the information requirements contained in 

this final rule.

C. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) generally requires an 

agency to prepare a regulatory flexibility analysis of any rule 

subject to notice and comment rulemaking requirements under the 
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Administrative Procedure Act, or any other statute, unless the agency

certifies that the rule will not have a significant economic impact 

on a substantial number of small entities. Small entities include 

small businesses, small organizations, and small governmental 

jurisdictions.

For purposes of assessing the impact of these final rules on 

small entities, small entity is defined as: (1) a small business as 

defined by the Small Business Administration’s regulations at 13 CFR 

121.201; (2) a small governmental jurisdiction that is a government 

of a city, county, town, school district, or special district with a 

population of less than 50,000; and (3) a small organization that is 

any not-for-profit enterprise which is independently owned and 

operated and is not dominant in its field.

After considering the economic impacts of these final rules on 

small entities, I certify that this action will not have a 

significant economic impact on a substantial number of small 

entities. This final action will not impose any requirements on small 

entities. The costs associated with the new requirements in these 

final rules are not expected to present an undue burden to this 

industry as discussed above. 

D. Unfunded Mandates Reform Act 

This action contains no Federal mandates under the provisions of 

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 
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1531-1538 for State, local, or tribal governments or the private 

sector. The action imposes no enforceable duty on any State, local 

or tribal governments or the private sector. Therefore, this action 

is not subject to the requirements of sections 202 or 205 of the 

UMRA.

These rules are also not subject to the regulatory requirements 

that might significantly or uniquely affect small governments. They 

contain no requirements that apply to such governments or impose 

obligations upon them.

E. Executive Order 13132: Federalism

This action does not have federalism implications. It will not 

have substantial direct effects on the States, on the relationship 

between the national government and the States, or on the 

distribution of power and responsibilities among the various levels 

of government, as specified in Executive Order 13132. These final 

rules primarily affect private industry, and do not impose 

significant economic costs on State or local governments. Thus, 

Executive Order 13132 does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian 

Tribal Governments

This action does not have tribal implications, as specified in 

Executive Order 13175 (65 FR 67249, November 9, 2000). It will not 

have substantial direct effect on tribal governments, on the 
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relationship between the Federal government and Indian tribes, or on 

the distribution of power and responsibilities between the Federal 

government and Indian tribes, as specified in Executive Order 13175.

Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental 

Health Risks and Safety Risks

This action is not subject to Executive Order 13045 (62 FR

19885, April 23, 1997), because it is not economically significant as 

defined in Executive Order 12866. However, the agency does believe 

there is a disproportionate risk to children. Modeled ambient air 

lead concentrations from the one facility in this source category are 

in excess of the NAAQS for lead, which was set to “provide increased 

protection for children and other at-risk populations against an 

array of adverse health effects, most notably including neurological 

effects in children, including neurocognitive and neurobehavioral 

effects.” 73 FR 67007. However, the control measures promulgated in 

this notice will result in lead concentration levels that are in 

compliance with the lead NAAQS, thereby mitigating the risk of 

adverse health effects to children.

H. Executive Order 13211: Actions Concerning Regulations That 

Significantly Affect Energy Supply, Distribution, or Use

This action is not a “significant energy action” as defined in

Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not 
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likely to have a significant adverse energy effect on the supply, 

distribution, or use of energy. This action will not create any new 

requirements for sources in the energy supply, distribution, or use 

sectors. Further, we have concluded that these final rules are not 

likely to have any adverse energy effects.

I. National Technology Transfer and Advancement Act

Section 12(d) of the National Technology Transfer and 

Advancement Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 

U.S.C. 272 note) directs the EPA to use voluntary consensus standards 

(VCS) in its regulatory activities, unless to do so would be 

inconsistent with applicable law or otherwise impractical. VCS are 

technical standards (e.g., materials specifications, test methods, 

sampling procedures, and business practices) that are developed or 

adopted by VCS bodies. NTTAA directs the EPA to provide Congress, 

through OMB, explanations when the agency decides not to use 

available and applicable VCS. 

This action does not involve technical standards. Therefore, the 

EPA did not consider the use of any VCS.

J. Executive Order 12898: Federal Actions To Address Environmental 

Justice in Minority Populations and Low-Income Populations

Executive Order 12898 (59 FR 7629, February 16, 1994) 

establishes Federal executive policy on environmental justice. Its 

main provision directs Federal agencies, to the greatest extent 
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practicable and permitted by law, to make environmental justice part 

of their mission by identifying and addressing, as appropriate, 

disproportionately high and adverse human health or environmental 

effects of their programs, policies, and activities on minority 

populations and low-income populations in the United States.

The EPA has determined that this final rule will not have 

disproportionately high and adverse human health or environmental 

effects on minority or low-income populations, because it does not 

decrease the level of protection provided to human health or the 

environment, but in fact decreases emissions of lead. To examine the 

potential for any environmental justice issues that might be 

associated with this rule, we evaluated the distributions of HAPrelated cancer and non-cancer risks across different social, 

demographic, and economic groups within the populations living near 

the one facility that is currently operating in this source category.

Our analyses also show that, although there is potential for an 

adverse environmental and human health effects from emission of lead, 

it does not indicate any significant potential for disparate impacts 

to the specific demographic groups analyzed.

The rule would require additional control measures to address 

the identified environmental and health risks and would therefore, 

decrease risks to any populations exposed to these sources.

K. Congressional Review Act
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The Congressional Review Act, 5 U.S.C. 801, et seq., as added by 

the Small Business Regulatory Enforcement Fairness Act of 1996, 

generally provides that, before a rule may take effect, the agency 

promulgating the rule must submit a rule report, which includes a 

copy of the rule, to each House of the Congress and to the 

Comptroller General of the United States. The EPA will submit a 

report containing this final rule and other required information to 

the United States Senate, the United States House of Representatives, 

and the Comptroller General of the United States prior to publication 

of the final rule in the Federal Register. A major rule cannot take 

effect until 60 days after it is published in the Federal Register.

This action is not a “major rule” as defined by 5 U.S.C. 804(2). The 

final rules will be effective on [INSERT DATE OF PUBLICATION].
National Emission Standards for Hazardous Air Pollutant 

Emissions for Primary Lead Processing--Page 91 of 129

List of Subjects for 40 CFR Part 63

Environmental protection, Administrative practice and 

procedures, Air pollution control, Hazardous substances, 

Intergovernmental relations, Reporting and recordkeeping 

requirements.

______________

Dated: XXXXX XX, 2011.

________________________

Lisa P. Jackson,

Administrator.
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For the reasons stated in the preamble, the Environmental 

Protection Agency proposes to amend title 40, chapter I, of the 

Code of Federal Regulations as follows:

PART 63-–[AMENDED]

1. The authority citation for part 63 continues to read 

as follows:

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

Subpart TTT—[AMENDED]

§63.1541 Applicability.

(a) The provisions of this subpart apply to any facility 

engaged in producing lead metal from ore concentrates. The 

category includes, but is not limited to, the following smelting 

processes: sintering, reduction, preliminary treatment, refining 

and casting operations, process fugitive sources, and fugitive 

dust sources. The sinter process includes an updraft or 

downdraft sintering machine. The reduction process includes the 

blast furnace, electric smelting furnace with a converter or 

reverberatory furnace, and slag fuming furnace process units.

The preliminary treatment process includes the drossing kettles 

and dross reverberatory furnace process units. The refining 

process includes the refinery process unit. The provisions of 

this subpart do not apply to secondary lead smelters, lead 

refiners, or lead remelters.
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(b) Table 1 of this subpart specifies the provisions of 

subpart A of this part that apply and those that do not apply to 

owners and operators of primary lead processors.

3. Section 63.1542 is amended by adding a definition for 

“Affirmative defense,” “Lead refiner,” “Lead remelter,” “Primary 

lead processor,” and “Secondary lead smelter;” deleting the 

definition of “Primary lead smelter;” and revising the 

definitions of ”Fugitive dust source,” “Furnace area,” 

“Malfunction,” “Materials storage and handling area,” “Plant 

roadway,” “Process fugitive source,” “Refining and casting 

area,” “Sinter machine area,” and “Tapping location” to read as 

follows:

§63.1542 Definitions.

* * * * *

 Affirmative defense means, in the context of an enforcement 

proceeding, a response or defense put forward by a defendant, 

regarding which the defendant has the burden of proof, and the 

merits of which are independently and objectively evaluated in a 

judicial or administrative proceeding.

* * * * *

 Fugitive dust source means a stationary source of hazardous 

air pollutant emissions at a primary lead processor resulting 

from the handling, storage, transfer, or other management of 

lead-bearing materials where the source is not part of a 
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specific process, process vent, or stack. Fugitive dust sources 

include roadways, storage piles, materials handling transfer 

points, and materials transport areas.

 Furnace area means any area of a primary lead processor in 

which a blast furnace or dross furnace is located.

 Lead refiner means any facility that refines lead metal that 

is not located at a primary lead processor.

 Lead remelter means any facility that remelts lead metal 

that is not located at a primary lead processor. 

 Malfunction means any sudden, infrequent, and not reasonably 

preventable failure of air pollution control and monitoring 

equipment, process equipment, or a process to operate in a 

normal or usual manner which causes, or has the potential to 

cause, the emission limitations in an applicable standard to be 

exceeded. Failures that are caused in part by poor maintenance 

or careless operation are not malfunctions.

 Materials storage and handling area means any area of a 

primary lead processor in which lead-bearing materials 

(including ore concentrate, sinter, granulated lead, dross, 

slag, and flue dust) are stored or handled between process 

steps, including areas in which materials are stored in piles, 

bins, or tubs, and areas in which material is prepared for 

charging to a sinter machine or smelting furnace or other lead

processing operation.
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* * * * *

 Plant roadway means any area of a primary lead processor 

that is subject to vehicle traffic, including traffic by 

forklifts, front-end loaders, or vehicles carrying ore 

concentrates or cast lead ingots. Excluded from this definition 

are employee and visitor parking areas, provided they are not 

subject to traffic by vehicles carrying lead-bearing materials. 

 Primary lead processor means any facility engaged in the 

production of lead metal from lead sulfide ore concentrates 

through the use of pyrometallurgical or other techniques.

 Process fugitive source means a source of hazardous air 

pollutant emissions at a primary lead processor that is 

associated with lead smelting, processing or refining but is not 

the primary exhaust stream and is not a fugitive dust source. 

Process fugitive sources include sinter machine charging 

locations, sinter machine discharge locations, sinter crushing 

and sizing equipment, furnace charging locations, furnace taps, 

and drossing kettle and refining kettle charging or tapping 

locations.

 Refining and casting area means any area of a primary lead 

processor in which drossing or refining operations occur, or 

casting operations occur.

 Secondary lead smelter means any facility at which leadbearing scrap material, primarily, but not limited to, lead-acid 
Page 96 of 129

batteries, is recycled into elemental lead or lead alloys by 

smelting.

* * * * *

 Sinter machine area means any area of a primary lead 

processor where a sinter machine, or sinter crushing and sizing 

equipment is located.

* * * * *

 Tapping location means the opening through which lead and 

slag are removed from the furnace.

4. Section 63.1543 is revised to read as follows:

§63.1543 Standards for process and process fugitive sources.

(a) No owner or operator of any existing, new, or 

reconstructed primary lead processor shall discharge or cause to 

be discharged into the atmosphere lead compounds in excess of 

0.97 pounds per ton of lead metal produced from the aggregation 

of emissions discharged from air pollution control devices used 

to control emissions from the sources listed in paragraphs 

(a)(1) through (a)(9) of this section.

(1) Sinter machine;

(2) Blast furnace;

(3) Dross furnace;

(4) Dross furnace charging location;

(5) Blast furnace and dross furnace tapping location;
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(6) Sinter machine charging location;

(7) Sinter machine discharge end;

(8) Sinter crushing and sizing equipment; and

(9) Sinter machine area.

(b) No owner or operator of any existing, new, or 

reconstructed primary lead processor shall discharge or cause to 

be discharged into the atmosphere lead compounds in excess of 

1.2 tons per year from the aggregation of the air pollution 

control devices used to control emissions from furnace area and 

refining and casting operations.

(c) The process fugitive sources listed in paragraphs 

(a)(4) through (a)(8) of this section must be equipped with a 

hood and must be ventilated to a baghouse or equivalent control 

device. The hood design and ventilation rate must be consistent 

with American Conference of Governmental Industrial Hygienists 

recommended practices.

(d) The sinter machine area must be enclosed in a building 

that is ventilated to a baghouse or equivalent control device at 

a rate that maintains a positive in-draft through any doorway 

opening.

(e) Except as provided in paragraph (f) of this section, 

following the initial tests to demonstrate compliance with 

paragraphs (a) and (b) of this section, the owner or operator of 

a primary lead processor must conduct compliance tests for lead 
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compounds on an quarterly basis (no later than 100 days 

following any previous compliance test).

(f) If the 12 most recent compliance tests demonstrate 

compliance with the emission limit specified in paragraphs (a) 

and (b) of this section, the owner or operator of a primary lead 

processor shall be allowed up to 12 calendar months from the 

last compliance test to conduct the next compliance test for 

lead compounds.

(g) The owner or operator of a primary lead processor must 

maintain and operate each baghouse used to control emissions 

from the sources listed in paragraphs (a)(1) through (a)(9) and 

(b) of this section such that the alarm on a bag leak detection 

system required under §63.1547(c)(8) does not sound for more 

than five percent of the total operating time in a 6-month 

reporting period.

(h) The owner or operator of a primary lead processor must 

record the date and time of a bag leak detection system alarm 

and initiate procedures to determine the cause of the alarm 

according to the corrective action plan required under 

§63.1547(f) within 1 hour of the alarm. The cause of the alarm 

must be corrected as soon as practicable.

(i) At all times, the owner or operator must operate and 

maintain any affected source, including associated air pollution 
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control equipment and monitoring equipment, in a manner 

consistent with safety and good air pollution control practices 

for minimizing emissions. Determination of whether such 

operation and maintenance procedures are being used will be 

based on information available to the Administrator which may 

include, but is not limited to, monitoring results, review of 

operation and maintenance procedures, review of operation and 

maintenance records, and inspection of the source.

5. Section 63.1544 is revised to read as follows:

§63.1544 Standards for fugitive dust sources.

(a) Each owner or operator of any existing, new or 

reconstructed primary lead processor must adopt and implement 

work practice standards or other measures to reduce fugitive 

dust emissions sufficient to ensure that lead levels in the air 

at the fenceline do not exceed 0.15 μg/m3 on a 3-month rolling 

average.

(b) Consistent with the requirements in section 

63.1547(k), each owner or operator of any existing, new or 

reconstructed primary lead processor must establish a monitoring 

network at locations approved by the Administrator to ensure 

compliance with the requirements of paragraph (a). 

(c) At all times, the owner or operator must operate and 

maintain any affected source, including associated air pollution 
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control equipment and monitoring equipment, in a manner 

consistent with safety and good air pollution control practices 

for minimizing emissions. Determination of whether such 

operation and maintenance procedures are being used will be 

based on information available to the Administrator which may 

include, but is not limited to, monitoring results, review of 

operation and maintenance procedures, review of operation and 

maintenance records, and inspection of the source.

6. Section 63.1545 is revised to read as follows:

§63.1545 Compliance dates.

(a) Each owner or operator of an existing primary lead 

processor must achieve compliance with the requirements in 

§16.1543(a) no later than [INSERT DATE 60 DAYS FROM THE DATE OF 

PUBLICATION OF THESE AMENDMENTS IN THE FEDERAL REGISTER]. Each 

owner or operator of an existing primary lead processor must 

achieve compliance with the requirements in § 63.1543(b), §

63.1543(e), and § 63.1544 of this subpart no later than [INSERT 

DATE TWO YEARS FROM THE DATE OF PUBLICATION OF THESE AMENDMENTS 

IN THE FEDERAL REGISTER].

(b) Each owner or operator of a new primary lead processor

must achieve compliance with the requirements of this subpart no 

later than [INSERT DATE 60 DAYS AFTER PUBLICATION OF THESE 

AMENDMENTS IN THE FERERAL REGISTER] or startup, whichever is 

later.
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(c) Prior to the dates specified in §63.1545(a), each owner 

or operator of an existing primary lead processor must continue 

to comply with the requirements of §63.1543 and §63.1544 as 

promulgated in the June 4, 1999 NESHAP for Primary Lead 

Smelting.

(d) Each owner or operator of an existing primary lead 

processor must comply with the requirements of 63.1547(g)(1), 

63.1547(g)(2), 63.1551, and the revisions to Table 1 of Subpart 

TTT of Part 63 on [INSERT DATE OF PUBLICATION OF THESE 

AMENDMENTS IN THE FEDERAL REGISTER].

7. Section 63.1546 is revised to read as follows:

§63.1546 Performance testing.

(a) The following procedures must be used to determine 

quarterly compliance with the emissions standard for lead 

compounds under §63.1543(a) and (b) for existing sources:

(1) Each owner or operator of existing sources listed in 

§63.1543(a)(1) through (9) and (b) must determine the lead 

compound emissions rate, in units of pounds of lead per hour 

according to the following test methods in appendix A of part 60 

of this chapter:

(i) Method 1 must be used to select the sampling port 

location and the number of traverse points.

(ii) Method 2, 2F, 2G must be used to measure volumetric 

flow rate.
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(iii) Method 3, 3A, 3B must be used for gas analysis.

(iv) Method 4 must be used to determine moisture content of 

the stack gas.

(v) Method 12 or Method 29 must be used to determine lead 

emissions rate of the stack gas.

(2) A performance test shall consist of at least three 

runs. For each test run with Method 12 or Method 29, the minimum 

sample time must be 60 minutes and the minimum volume must be 1 

dry standard cubic meter (35 dry standard cubic feet).

(3) Performance tests shall be completed quarterly, once 

every 3 months, to determine compliance.

(4) The lead emission rate in pounds per quarter is 

calculated by multiplying the quarterly lead emission rate in 

pounds per hour by the quarterly plant operating time, in hours 

as shown in Equation 1:

(Eq. 1)

Where: 

EPb = quarterly lead emissions, pounds per quarter;

ERPb = quarterly lead emissions rate, pounds per hour; and

QPOT = quarterly plant operating time, hours per quarter.

(5) The lead production rate, in units of tons per 

quarter, must be determined based on production data for the 

previous quarter according to the procedures detailed in 

paragraphs (a)(5)(i) through (iv) of this section:
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(i) Total lead products production multiplied by the 

fractional lead content must be determined in units of tons.

(ii) Total copper matte production multiplied by the 

fractional lead content must be determined in units of tons.

(iii) Total copper speiss production multiplied by the 

fractional lead content must be determined in units of tons.

(iv) Total quarterly lead production must be determined by

summing the values obtained in paragraphs (a)(5)(i) through 

(a)(5)(iii) of this section.

(6) To determine compliance with the production-based lead 

compound emission rate in §63.1543(a), the quarterly productionbased lead compound emission rate, in units of pounds of lead 

emissions per ton of lead produced, is calculated as shown in 

Equation 2 by dividing lead emissions by lead production.

(Eq. 2)

Where :

CEPb = quarterly production-based lead compound emission 

rate, in units of pounds of lead emissions per ton of lead 

produced;

EPb = quarterly lead emissions, pounds per quarter; and

PPb = quarterly lead production, tons per quarter.

(7) To determine quarterly compliance with the emissions 

standard for lead compounds under §63.1543(b), sum the lead 
Page 104 of 129

compound emission rates for the current and previous three 

quarters for the sources in §63.1543 (b), as determined in 

accordance with paragraphs (a)(1) through (a)(4) of this 

section.

(b) Owner and operators must perform an initial compliance 

test to demonstrate compliance with the sinter building in-draft 

requirements of §63.1543(d) at each doorway opening in 

accordance with paragraphs (b)(1) through (b)(4) of this 

section.

(1) Use a propeller anemometer or equivalent device.

(2) Determine doorway in-draft by placing the anemometer in 

the plane of the doorway opening near its center.

(3) Determine doorway in-draft for each doorway that is 

open during normal operation with all remaining doorways in 

their customary position during normal operation.

(4) Do not determine doorway in-draft when ambient wind 

speed exceeds 2 meters per second.

(c) Performance tests shall be conducted under such 

conditions as the Administrator specifies to the owner or 

operator based on representative performance of the affected 

source for the period being tested. Upon request, the owner or 

operator shall make available to the Administrator such records 

as may be necessary to determine the conditions of performance 

tests.
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8. Section 63.1547 is revised to read as follows:

§63.1547 Monitoring requirements.

(a) Owners and operators of primary lead processors must 

prepare, and at all times operate according to, a standard 

operating procedures manual that describes in detail the 

procedures for inspection, maintenance, and bag leak detection 

and corrective action for all baghouses that are used to control 

process, process fugitive, or fugitive dust emissions from any 

source subject to the lead emission standards in §§63.1543 and 

63.1544, including those used to control emissions from general 

ventilation systems.

(b) The standard operating procedures manual for baghouses 

required by paragraph (a) of this section must be submitted to 

the Administrator or delegated authority for review and 

approval.

(c) The procedures specified in the standard operating 

procedures manual for inspections and routine maintenance must, 

at a minimum, include the requirements of paragraphs (c)(1) 

through (c)(8) of this section.

(1) Weekly confirmation that dust is being removed from 

hoppers through visual inspection or equivalent means of 

ensuring the proper functioning of removal mechanisms.

(2) Daily check of compressed air supply for pulse-jet 

baghouses.
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(3) An appropriate methodology for monitoring cleaning 

cycles to ensure proper operation.

(4) Monthly check of bag cleaning mechanisms for proper 

functioning through visual inspection or equivalent means.

(5) Quarterly visual check of bag tension on reverse air 

and shaker-type baghouses to ensure that bags are not kinked 

(kneed or bent) or laying on their sides. Such checks are not 

required for shaker-type baghouses using self-tensioning (spring 

loaded) devices.

(6) Quarterly confirmation of the physical integrity of the

baghouse through visual inspection of the baghouse interior for 

air leaks.

(7) Quarterly inspection of fans for wear, material 

buildup, and corrosion through visual inspection, vibration 

detectors, or equivalent means.

(8) Except as provided in paragraph (h) of this section, 

continuous operation of a bag leak detection system.

(d) The procedures specified in the standard operating 

procedures manual for maintenance must, at a minimum, include a 

preventative maintenance schedule that is consistent with the 

baghouse manufacturer's instructions for routine and long-term 

maintenance.
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(e) The bag leak detection system required by paragraph 

(c)(8) of this section must meet the specifications and 

requirements of (e)(1) through (e)(8) of this section.

(1) The bag leak detection system must be certified by the 

manufacturer to be capable of detecting particulate matter 

emissions at concentrations of 10 milligram per actual cubic 

meter (0.0044 grains per actual cubic foot) or less.

(2) The bag leak detection system sensor must provide 

output of relative particulate matter loadings, and the owner or 

operator must continuously record the output from the bag leak 

detection system.

(3) The bag leak detection system must be equipped with an 

alarm system that will sound when an increase in relative 

particulate loading is detected over a preset level, and the 

alarm must be located such that it can be heard or otherwise 

determined by the appropriate plant personnel.

(4) Each bag leak detection system that works based on the 

triboelectric effect must be installed, calibrated, and 

maintained in a manner consistent with guidance provided in the 

U.S. Environmental Protection Agency guidance document ”Fabric 

Filter Bag Leak Detection Guidance” (EPA-454/R-98-015). Other 

bag leak detection systems must be installed, calibrated, and 

maintained in a manner consistent with the manufacturer's 

written specifications and recommendations.
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(5) The initial adjustment of the system must, at a 

minimum, consist of establishing the baseline output by 

adjusting the sensitivity (range) and the averaging period of 

the device, and establishing the alarm set points and the alarm 

delay time.

(6) Following initial adjustment, the owner or operator 

must not adjust the sensitivity or range, averaging period, 

alarm set points, or alarm delay time, except as detailed in the 

approved SOP required under paragraph (a) of this section. In no 

event shall the sensitivity be increased by more than 100 

percent or decreased more than 50 percent over a 365-day period 

unless a responsible official certifies that the baghouse has 

been inspected and found to be in good operating condition.

(7) For negative pressure, induced air baghouses, and 

positive pressure baghouses that are discharged to the 

atmosphere through a stack, the bag leak detector must be 

installed downstream of the baghouse and upstream of any wet 

acid gas scrubber.

(8) Where multiple detectors are required, the system's 

instrumentation and alarm may be shared among detectors.

(f) The standard operating procedures manual required by 

paragraph (a) of this section must include a corrective action 

plan that specifies the procedures to be followed in the event 

of a bag leak detection system alarm. The corrective action plan 
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must include at a minimum, procedures to be used to determine 

the cause of an alarm, as well as actions to be taken to 

minimize emissions, which may include, but are not limited to, 

the following.

(1) Inspecting the baghouse for air leaks, torn or broken 

bags or filter media, or any other condition that may cause an 

increase in emissions.

(2) Sealing off defective bags or filter media.

(3) Replacing defective bags or filter media, or otherwise 

repairing the control device.

(4) Sealing off a defective baghouse compartment.

(5) Cleaning the bag leak detection system probe, or 

otherwise repairing or maintaining the bag leak detection 

system.

(6) Shutting down the process producing the particulate 

emissions.

(g) The percentage of total operating time the alarm on the 

bag leak detection system sounds in a 6-month reporting period 

must be calculated in order to determine compliance with the 

five percent operating limit in §63.1543(h). The percentage of 

time the alarm on the bag leak detection system sounds must be 

determined according to paragraphs (g)(1) through (g)(3) of this 

section.
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(1) For each alarm where the owner or operator initiates 

procedures to determine the cause of an alarm within 1 hour of 

the alarm, 1 hour of alarm time must be counted.

(2) For each alarm where the owner or operator does not 

initiate procedures to determine the cause of the alarm within 1 

hour of the alarm, alarm time will be counted as the actual 

amount of time taken by the owner or operator to initiate 

procedures to determine the cause of the alarm.

(3) The percentage of time the alarm on the bag leak 

detection system sounds must be calculated as the ratio of the 

sum of alarm times to the total operating time multiplied by 

100.

(h) Baghouses equipped with HEPA filters as a secondary 

filter used to control process or process fugitive sources 

subject to the lead emission standards in §63.1543 are exempt 

from the requirement in paragraph (c)(8) of this section to be 

equipped with a bag leak detector. The owner or operator of an 

affected source that uses a HEPA filter must monitor and record 

the pressure drop across the HEPA filter system daily. If the 

pressure drop is outside the limit(s) specified by the filter 

manufacturer, the owner or operator must take appropriate 

corrective measures, which may include, but not be limited to, 

the following:
Page 111 of 129

(1) Inspecting the filter and filter housing for air leaks 

and torn or broken filters.

(2) Replacing defective filter media, or otherwise 

repairing the control device.

(3) Sealing off a defective control device by routing air 

to other comparable control devices.

(4) Shutting down the process producing the particulate 

emissions.

(i) Owners and operators must monitor sinter machine 

building in-draft to demonstrate continued compliance with the 

operating standard specified in §63.1543(d) in accordance with 

either paragraph (i)(1), (i)(2), or (i)(3) of this section.

(1) Owners and operators must check and record on a daily 

basis doorway in-draft at each doorway in accordance with the 

methodology specified in §63.1546(b).

(2) Owners and operators must establish and maintain 

baseline ventilation parameters which result in a positive indraft according to paragraphs (i)(2)(i) through (i)(2)(iv) of 

this section.

(i) Owners and operators must install, calibrate, maintain, 

and operate a monitoring device that continuously records the 

volumetric flow rate through each separately ducted hood; or 

install, calibrate, maintain, and operate a monitoring device 

that continuously records the volumetric flow rate at the 
Page 112 of 129

control device inlet of each exhaust system ventilating the 

building. The flow rate monitoring device(s) can be installed in 

any location in the exhaust duct such that reproducible flow 

rate measurements will result. The flow rate monitoring 

device(s) must have an accuracy of plus or minus 10 percent over 

the normal process operating range and must be calibrated 

according to manufacturer's instructions.

(ii) During the initial demonstration of sinter building 

in-draft, and at any time the owner or operator wishes to reestablish the baseline ventilation parameters, the owner or 

operator must continuously record the volumetric flow rate 

through each separately ducted hood, or continuously record the 

volumetric flow rate at the control device inlet of each exhaust 

system ventilating the building and record exhaust system damper 

positions. The owner or operator must determine the average 

volumetric flow rate(s) corresponding to the period of time the 

in-draft compliance determinations are being conducted.

(iii) The owner or operator must maintain the volumetric 

flow rate(s) at or above the value(s) established during the 

most recent in-draft determination at all times the sinter 

machine is in operation. Volumetric flow rate(s) must be 

calculated as a 15-minute average.

(iv) If the volumetric flow rate is monitored at the 

control device inlet, the owner or operator must check and 
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record damper positions daily to ensure they are in the 

positions they were in during the most recent in-draft 

determination.

(3) An owner or operator may request an alternative 

monitoring method by following the procedures and requirements 

in §63.8(f) of the General Provisions.

(j) Each owner or operator of new or modified sources 

listed under §63.1543 (a)(1) through (a)(9) and (b) must 

install, calibrate, maintain, and operate a continuous emission 

monitoring system (CEMS) for measuring lead emissions and a 

continuous emission rate monitoring system (CERMS)subject to 

Performance Specification 6 of Appendix B to part 60.

(1) Each owner or operator of a source subject to the 

emissions limits for lead compounds under §63.1543(a)and (b) 

must install a CEMS for measuring lead emissions within 180 days 

of promulgation of performance specifications for lead CEMS.

(i) Prior to promulgation of performance specifications for 

CEMS used to measure lead concentrations, an owner or operator 

must use the procedure described in §63.1546 (a)(1) through 

(a)(7) of this section to determine compliance. 

(2) If a CEMS used to measure lead emissions is applicable, 

the owner or operator must install a CERMS with a sensor in a 

location that provides representative measurement of the exhaust 

gas flow rate at the sampling location of the CEMS used to 
Page 114 of 129

measure lead emissions, taking into account the manufacturer’s 

recommendations. The flow rate sensor is that portion of the 

system that senses the volumetric flow rate and generates an 

output proportional to that flow rate.

(i) The CERMS must be designed to measure the exhaust gas 

flow rate over a range that extends from a value of at least 20 

percent less than the lowest expected exhaust flow rate to a 

value of at least 20 percent greater than the highest expected 

exhaust gas flow rate. 

(ii) The CERMS must be equipped with a data acquisition and 

recording system that is capable of recording values over the 

entire range specified in paragraph (b)(2)(i) of this section. 

(iii) Each owner or operator must perform an initial 

relative accuracy test of the CERMS in accordance with the 

applicable Performance Specification in Appendix B to part 60 of 

the chapter. 

(iv) Each owner or operator must operate the CERMS and 

record data during all periods of operation of the affected 

facility including periods of startup, shutdown, and 

malfunction, except for periods of monitoring system 

malfunctions, repairs associated with monitoring system 

malfunctions, and required monitoring system quality assurance 

or quality control activities (including, as applicable, 

calibration checks and required zero and span adjustments.
Page 115 of 129

(3) Each owner or operator must calculate the lead 

emissions rate in tons per year by summing all hours of CEMS 

data for a year to determine compliance with 63.1543 (b).

(i) When the CERMS are unable to provide quality assured 

data the following applies:

(A) When data are not available for periods of up to 48 

hours, the highest recorded hourly emission rate from the 

previous 24 hours must be used.

(B) When data are not available for 48 or more hours, the 

maximum daily emission rate based on the previous 30 days must 

be used.

(k) The owner or operator of each source subject to 

§63.1544(a) must operate a continuous monitoring system for the 

measurement of lead compound concentrations in air.

(1) The owner or operator must operate compliance monitors 

sufficient in number, location, and frequency of sample 

collection to detect expected maximum concentrations of lead 

compounds in air due to emissions from the affected source(s) in 

accordance with a written plan as described in (k)(2) of this 

paragraph and approved by the Administrator. The plan must 

include descriptions of the sampling and analytical methods 

used. The plan may take into consideration existing monitoring 

being conducted under a state monitoring plan in accordance with 

Part 58.
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(2) The owner or operator must submit a written plan 

describing and explaining the basis for the design and adequacy 

of the compliance monitoring network, the sampling, analytical, 

and quality assurance procedures, and any other related 

procedures, and the justification for any seasonal, background, 

or other data adjustments within 45 days after the effective 

date of this subpart. 

(3) The Administrator at any time may require changes in, 

or expansion of, the monitoring program, including additional 

sampling and analytical protocols and network design.

(l) If all rolling three-month average concentrations of 

lead in air measured by the compliance monitoring system are 

less than [50 percent] of the lead concentration in air limit in 

§63.1544(a) for three consecutive years, the owner or operator 

may submit a revised plan to reduce the monitoring sampling and 

analysis frequency (e.g., from daily to weekly).

For any subsequent period, if any rolling three-month 

average lead concentration in air measured at any monitor in the 

monitoring system exceeds [50 percent] of the concentration 

limit in §63.1544(a), the owner or operator must resume 

monitoring pursuant to paragraph (k)(1) at all monitors until 

another three consecutive years of lead concentration in air 
Page 117 of 129

measurements less than [50 percent] of the lead concentration in 

air limit is demonstrated.

9. Section 63.1548 is revised to read as follows:

§63.1548 Notification requirements.

(a) The owner or operator of a primary lead processor must 

comply with the notification requirements of §63.9 of subpart A, 

General Provisions as specified in Table 1 of this subpart.

(b) The owner or operator of a primary lead processor must 

submit the standard operating procedures manual for baghouses 

required under §63.1547(a) to the Administrator or delegated 

authority along with a notification that the primary lead 

processor is seeking review and approval of the manual and 

procedures. Owners or operators of existing primary lead 

processors must submit this notification no later than November 

6, 2000. The owner or operator of a primary lead processor that 

commences construction or reconstruction after April 17, 1998, 

must submit this notification no later than 180 days before 

startup of the constructed or reconstructed primary lead 

processor, but no sooner than September 2, 1999.

(c) The owner or operator of a primary lead processor must 

submit the compliance monitoring network plan required under 

§63.1547(k)(2) to the Administrator or delegated authority along 

with a notification that the primary lead processor is seeking 

review and approval of the plan. Owners or operators of existing 
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primary lead processors must submit this notification no later 

than 45 days after promulgation of this subpart. The owner or 

operator of a new, reconstructed, or modified primary lead 

processor must submit this notification no later than 180 days 

before startup of the constructed or reconstructed primary lead 

processor.

10. Section 63.1549 is revised to read as follows:

§63.1549 Recordkeeping and reporting requirements.

(a) The owner or operator of a primary lead processor must 

comply with the recordkeeping requirements of §63.10 of subpart 

A, General Provisions as specified in Table 1 of this subpart.

(b) In addition to the general records required by 

paragraph (a) of this section, each owner or operator of a 

primary lead processor must maintain for a period of 5 years, 

records of the information listed in paragraphs (b)(1) through 

(b)(10) of this section.

(1) Production records of the weight and lead content of 

lead products, copper matte, and copper speiss.

(2) Records of the bag leak detection system output.

(3) An identification of the date and time of all bag leak 

detection system alarms, the time that procedures to determine 

the cause of the alarm were initiated, the cause of the alarm, 

an explanation of the actions taken, and the date and time the 

cause of the alarm was corrected.
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(4) Any recordkeeping required as part of the requirements 

described in the compliance monitoring system plan required 

under §63.1547(k)(2).

(5) Any recordkeeping required as part of the practices 

described in the standard operating procedures manual for 

baghouses required under §63.1547(a).

(6) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(1), the records of the daily doorway in-draft 

checks, an identification of the periods when there was not a 

positive in-draft, and an explanation of the corrective actions 

taken.

(7) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(2), the records of the output from the continuous 

volumetric flow monitor(s), an identification of the periods 

when the 15-minute volumetric flow rate dropped below the 

minimum established during the most recent in-draft 

determination, and an explanation of the corrective actions 

taken.

(8) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 
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requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(2), and volumetric flow rate is monitored at the 

baghouse inlet, records of the daily checks of damper positions, 

an identification of the days that the damper positions were not 

in the positions established during the most recent in-draft 

determination, and an explanation of the corrective actions 

taken.

(9) Records of the occurrence and duration of each 

malfunction of operation (i.e., process equipment) or the air 

pollution control equipment and monitoring equipment. 

(10) Records of actions taken during periods of malfunction 

to minimize emissions in accordance with §§63.1543(i) and 

63.1544(e), including corrective actions to restore 

malfunctioning process and air pollution control and monitoring 

equipment to its normal or usual manner of operation. 

(c) Records for the most recent 2 years of operation must 

be maintained on site. Records for the previous 3 years may be 

maintained off site.

(d) The owner or operator of a primary lead processor must 

comply with the reporting requirements of §63.10 of subpart A, 

General Provisions as specified in Table 1 of this subpart.

(e) In addition to the information required under §63.10 of 

the General Provisions, the owner or operator must provide semi-
Page 121 of 129

annual reports containing the information specified in 

paragraphs (e)(1) through (e)(9) of this section to the 

Administrator or designated authority.

(1) The reports must include records of all alarms from the 

bag leak detection system specified in §63.1547(e).

(2) The reports must include a description of the actions 

taken following each bag leak detection system alarm pursuant to 

§63.1547(f).

(3) The reports must include a calculation of the 

percentage of time the alarm on the bag leak detection system 

sounded during the reporting period pursuant to §63.1547(g).

(4) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(1), the reports must contain an identification of 

the periods when there was not a positive in-draft, and an 

explanation of the corrective actions taken.

(5) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(2), the reports must contain an identification of 

the periods when the 15-minute volumetric flow rate(s) dropped 

below the minimum established during the most recent in-draft 
Page 122 of 129

determination, and an explanation of the corrective actions 

taken.

(6) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(2), and volumetric flow rate is monitored at the 

baghouse inlet, the reports must contain an identification of 

the days that the damper positions were not in the positions 

established during the most recent in-draft determination, and 

an explanation of the corrective actions taken. 

(7) The reports must contain a summary of the records 

maintained as part of the practices described in the standard 

operating procedures manual for baghouses required under 

§63.1547(a), including an explanation of the periods when the 

procedures were not followed and the corrective actions taken.

(8) The reports must contain a summary of the compliance 

monitoring results for the required reporting period, including 

an explanation of any periods when the procedures outlined in 

the compliance monitoring system plan required by §63.1547(k)(2) 

were not followed and the corrective actions taken.

(9) If there was a malfunction during the reporting period, 

the report shall also include the number, duration, and a brief 

description for each type of malfunction which occurred during 

the reporting period and which caused or may have caused any 
Page 123 of 129

applicable emission limitation to be exceeded. The report must 

also include a description of actions taken by an owner or 

operator during a malfunction of an affected source to minimize 

emissions in accordance with §§63.1543(i) and 63.1544(b), 

including actions taken to correct a malfunction.

11. Section 63.1550 is revised to read as follows:

§63.1550 Delegation of authority.

(a) In delegating implementation and enforcement authority 

to a State under section 112(l) of the act, the authorities 

contained in paragraph (b) of this section must be retained by 

the Administrator and not transferred to a State.

(b) Authorities which will not be delegated to States: no

restrictions.

12. Section 63.1551 is added to read as follows:

§63.1551 Affirmative defense for exceedance of emission limit 

during malfunction.

In response to an action to enforce the standards set forth 

in this subpart you may assert an affirmative defense to a claim 

for civil penalties for exceedances of such standards that are 

caused by malfunction, as defined at 40 CFR 63.2. Appropriate 

penalties may be assessed, however, if you fail to meet your 

burden of proving all of the requirements in the affirmative 

defense. The affirmative defense shall not be available for 

claims for injunctive relief.
Page 124 of 129

(a) To establish the affirmative defense in any action to 

enforce such a limit, you must timely meet the notification 

requirements in paragraph (b) of this section, and must prove by 

a preponderance of evidence that:

(1) The excess emissions: 

(i) Were caused by a sudden, infrequent, and unavoidable 

failure of air pollution control and monitoring equipment, 

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

manner, and 

(ii) Could not have been prevented through careful 

planning, proper design or better operation and maintenance 

practices; and

 (iii) Did not stem from any activity or event that could 

have been foreseen and avoided, or planned for; and

(iv) Were not part of a recurring pattern indicative of 

inadequate design, operation, or maintenance; and

(2) Repairs were made as expeditiously as possible when 

the applicable emission limitations were being exceeded. Offshift and overtime labor were used, to the extent practicable to 

make these repairs; and

 (3) The frequency, amount and duration of the excess 

emissions (including any bypass) were minimized to the maximum 
Page 125 of 129

extent practicable during periods of such emissions; and

 (4) If the excess emissions resulted from a bypass of 

control equipment or a process, then the bypass was unavoidable 

to prevent loss of life, personal injury, or severe property 

damage; and

 (5) All possible steps were taken to minimize the impact of 

the excess emissions on ambient air quality, the environment and 

human health; and

 (6) All emissions monitoring and control systems were kept 

in operation if at all possible, consistent with safety and good 

air pollution control practices; and

 (7) All of the actions in response to the excess emissions 

were documented by properly signed, contemporaneous operating 

logs; and

(8) At all times, the facility was operated in a manner 

consistent with good practices for minimizing emissions; and

(9) A written root cause analysis has been prepared, the 

purpose of which is to determine, correct, and eliminate the 

primary causes of the malfunction and the excess emissions 

resulting from the malfunction event at issue. The analysis 

shall also specify, using best monitoring methods and 

engineering judgment, the amount of excess emissions that were 

the result of the malfunction. 
Page 126 of 129

(b) Notification. The owner or operator of the facility 

experiencing an exceedance of its emission limit(s) during a 

malfunction shall notify the Administrator by telephone or 

facsimile (FAX) transmission as soon as possible, but no later 

than two business days after the initial occurrence of the 

malfunction, if it wishes to avail itself of an affirmative 

defense to civil penalties for that malfunction. The owner or 

operator seeking to assert an affirmative defense shall also 

submit a written report to the Administrator within 45 days of 

the initial occurrence of the exceedance of the standards in 

this subpart to demonstrate, with all necessary supporting 

documentation, that it has met the requirements set forth in 

paragraph (a) of this section. The owner or operator may seek 

an extension of this deadline for up to 30 additional days by 

submitting a written request to the Administrator before the 

expiration of the 45 day period. Until a request for an 

extension has been approved by the Administrator, the owner or 

operator is subject to the requirement to submit such report 

within 45 days of the initial occurrence of the exceedance. 

12. Table 1 to Subpart TTT of Part 63 is revised to read as 

follows:

Table 1 of Subpart TTT – General Provisions Applicability to 

Subpart TTT
Page 127 of 129

Reference

Applies 

to 

subpart 

TTT Comment

* * * * * * *

63.6(a), (b), (c) Yes

63.6 (d) No Section reserved.

63.6(e)(1)(i) No See 63.1543(i) 

and 63.1544(b) 

for general duty 

requirement. 

63.6(e)(1)(ii) No

63.6(e)(1)(iii) Yes

63.6(e)(2) No Section reserved.

63.6(e)(3) No

63.6(f)(1) No

63.6(g) Yes

63.6(h) No No opacity limits 

in rule.

63.6(i) Yes

63.6(j) Yes

§63.7(a)-(d) Yes
Page 128 of 129

§63.7(e)(1) No See 63.1546(c). 

§63.7(e)(2)-(e)(4) Yes

63.7(f), (g), (h) Yes

63.8(a)-(b) Yes

63.8(c)(1)(i) No

63.8(c)(1)(ii) Yes

63.8(c)(1)(iii) No

63.8(c)(2)-(d)(2) Yes

63.8(d)(3) Yes, 

except 

for last 

sentence

63.8(e)-(g) Yes

63.9(a),(b),(c),(e),(g),(h)(1)through 

(3), (h)(5) and (6), (i) and (j)

Yes

63.9(f) No

63.9(h)(4) No Reserved

63.10(b)(2)(i) No

63.10(b)(2)(ii) No See 63.1549(b)(9) 

and (10) for 

recordkeeping of 

occurrence and 
Page 129 of 129

duration of 

malfunctions and 

recordkeeping of 

actions taken 

during 

malfunction. 

63.10(b)(2)(iii) Yes

63.10(b)(2)(iv)-(b)(2)(v) No

63.10(b)(2)(vi)-(b)(2)(xiv) Yes

63.(10)(b)(3) Yes

63.10(c)(1)-(9) Yes

63.10(c)(10)-(11) No See 63.1549(b)(9) 

and (10) for 

recordkeeping of 

malfunctions. 

63.10(c)(12)-(c)(14) Yes

63.10(c)(15) No

63.10(d)(1)-(4) Yes

63.10(d)(5) No See 63.1549(e)(9) 

for reporting of 

malfunctions.

63.10(e)-((f) Yes

* * * * * * *
***E.O. 12866 Review – Draft (10/521/2011) – Do Not Cite, Quote or 

Release During Review ***

EO12866 NESHAP_Primary Lead Processing Final 2060AQ43_20111005.doc

6560-50-P

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA–HQ–OAR–2004–0305; FRL-XXXX-X]

RIN 2060–AQ43

National Emission Standards for Hazardous Air Pollutant Emissions for 

Primary Lead Processing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This action finalizes the residual risk and technology 

review conducted for the Primary Lead Processing source category

regulated under national emission standards for hazardous air 

pollutants (NESHAP). This action finalizes amendments to the NESHAP 

that include revision of the rule’s title and applicability 

provision, revisions to the emission limits for lead, and the 

modification and addition of testing and monitoring and related 

notification, recordkeeping, and reporting requirements, including 

the addition of a requirement to monitor the lead concentration in 

the air. It also finalizes revisions to the regulatory provisions 

related to emissions during periods of startup, shutdown, and 

malfunction and makes minor non-substantive changes to the rule.
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DATES: This final action is effective on [INSERT DATE OF 

PUBLICATION].

ADDRESSES: The EPA has established a docket for this action under 

Docket ID No. EPA–HQ–OAR–2004–0305. All documents in the docket are 

listed on the www.regulations.gov website. Although listed in the 

index, some information is not publicly available, e.g., confidential 

business information (CBI) or other information whose disclosure is 

restricted by statute. Certain other material, such as copyrighted 

material, is not placed on the Internet, and will be publicly 

available only in hard copy form. Publicly available docket materials 

are available either electronically through www.regulations.gov, or

in hard copy at the EPA Docket Center, EPA West Building, Room Number 

3334, 1301 Constitution Ave., NW, Washington, DC. The Public Reading 

Room hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Standard 

Time (EST), Monday through Friday. The telephone number for the 

Public Reading Room is (202) 566–1744, and the telephone number for 

the Air and Radiation Docket and Information Center is (202) 566–

1742.

FOR FURTHER INFORMATION CONTACT: For questions about this final 

action, contact Mr. Nathan Topham, Office of Air Quality Planning and 

Standards, Sector Policies and Programs Division, U.S. Environmental 

Protection Agency, Research Triangle Park, NC 27711; telephone 

number: (919) 541–0483; fax number: (919) 541-3207; and email 
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address: topham.nathan@epa.gov. For additional contact information, 

see the following SUPPLEMENTARY INFORMATION section.

SUPPLEMENTARY INFORMATION:

For specific information regarding the modeling methodology, 

contact Dr. Michael Stewart, Office of Air Quality Planning and 

Standards, Health and Environmental Impacts Division, Air Toxics 

Assessment Group (C504–06), U.S. Environmental Protection Agency, 

Research Triangle Park, NC 27711; telephone number: (919) 541–7524;

fax number: (919) 541–0840; and email address: 

stewart.michael@epa.gov. For information about the applicability of 

this NESHAP to a particular entity, contact the appropriate person 

listed in Table 1 to this preamble.

Table 1 – List of EPA Contacts for the NESHAP Addressed in This 

Action

NESHAP for: OECA Contact1 OAQPS Contact2

Primary Lead 

Processing 

Maria Malave, (202) 

564-7027, 

malave.maria@epa.gov

Nathan Topham

(919) 541-0483

topham.nathan@epa.gov

1 EPA’s Office of Enforcement and Compliance Assurance. 

2 EPA’s Office of Air Quality Planning and Standards.

Background Information Document. On February 17, 2011 (76 FR 9410), 

the EPA proposed revisions to the Primary Lead Smelting NESHAP based 

on evaluations performed by the EPA in order to conduct our risk and 

technology review. In this action, we are finalizing decisions and 

revisions for the rule. Some of the significant comments and our 
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responses are summarized in this preamble; a summary of the other 

public comments on the proposal, and the EPA’s responses to those

comments, is available in Docket ID No. EPA-HQ-OAR-2004-0305. A redline version of the regulatory language that incorporates the changes 

in this action is available in the docket.

Organization of This Document. The following outline is provided to 

aid in locating information in the preamble.

I. General Information

A. Does this action apply to me?

B. Where can I get a copy of this document?

C. Judicial Review

II. Background 

III. Summary of the Final Rule

A. What are the final rule amendments for the Primary Lead 

Processing source category?

 B. What are the requirements during periods of startup, shutdown, 

and malfunction?

 C. What are the effective and compliance dates of the 

standards?

IV. Summary of Significant Changes Since Proposal

 A. Changes to the Risk Assessment Performed Under Section 112(f)

of the Clean Air Act

 B. Changes to the Technology Review Performed Under Section 

112(d)(6) of the Clean Air Act

 C. Other Changes Since Proposal

V. Summary of Significant Comments and Responses

A. Timeline for Compliance

B. The EPA’s Authority Under Section 112 of the Clean Air Act

C. Primary Lead Processing Risk Assessment

VI. Impacts of the Final Rule

VII.Statutory and Executive Order Reviews

A. Executive Orders 12866: Regulatory Planning and Review, and

Executive Order 13563: Improving Regulation and Regulatory 

Review

B. Paperwork Reduction Act 

C. Regulatory Flexibility Act 

D. Unfunded Mandates Reform Act 

E. Executive Order 13132: Federalism 
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F. Executive Order 13175: Consultation and Coordination With

Indian Tribal Governments 

G. Executive Order 13045: Protection of Children From

Environmental Health Risks and Safety Risks

H. Executive Order 13211: Actions Concerning Regulations That 

Significantly Affect Energy Supply, Distribution, or Use

I. National Technology Transfer and Advancement Act 

J. Executive Order 12898: Federal Actions to Address 

Environmental Justice in Minority Populations and Low-Income

Populations

K. Congressional Review Act

I. General Information

A. Does this action apply to me?

Regulated Entities. Categories and entities potentially regulated by 

this action include: 

Table 2 – NESHAP and Industrial Source Categories Affected By 

This Final Action

NESHAP and Source Category NAICS1 Code MACT2

Code

Primary Lead Processing 331419 0204

1 North American Industry Classification System

2 Maximum Achievable Control Technology

Table 2 is not intended to be exhaustive, but rather provides a 

guide for readers regarding entities likely to be affected by the 

final action for the source category listed. To determine whether 

your facility would be affected, you should examine the applicability 

criteria in the appropriate national emission standards for hazardous 

air pollutants (NESHAP). As defined in the source category listing 

report published by the EPA in 1992, the Primary Lead Smelting source 
***E.O. 12866 Review – Draft (09/1910/21/2011) – Do Not Cite, Quote 

or Release During Review ***

Page 6 of 130

category is defined as any facility engaged in producing lead metal 

from ore concentrates; including, but not limited to, the following 

smelting processes: sintering, reduction, preliminary treatment, and 

refining operations.1 To be consistent with the 1992 listing, the EPA

is revising the applicability of the Primary Lead Smelting NESHAP to 

apply to any facility that produces lead metal from lead ore 

concentrates and is changing the title of the rule to reference 

Primary Lead Processing. For clarification purposes, all reference to 

lead emissions in this preamble means “lead compounds” (which is a 

hazardous air pollutant) and all reference to lead production means 

elemental lead (which is not a hazardous air pollutant) as provided 

under Clean Air Act (CAA) section 112(b)(7)).

If you have any questions regarding the applicability of any 

aspect of the Primary Lead Processing NESHAP, please contact the 

appropriate person listed in Table 1 of this preamble in the 

preceding FOR FURTHER INFORMATION CONTACT section.

B. Where can I get a copy of this document?

In addition to being available in the docket, an electronic copy 

of this final action will also be available on the World Wide Web 

(www) through the Technology Transfer Network (TTN). Following 

signature, a copy of the final action will be posted on the TTN’s 

 1 USEPA. Documentation for Developing the Initial Source Category List – Final Report, USEPA/OAQPS, EPA-450/3-91-030, 

July, 1992.
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policy and guidance page for newly proposed and promulgated rules at 

the following address: http://www.epa.gov/ttn/caaa/new.html. The TTN 

provides information and technology exchange in various areas of air 

pollution control.

Additional information is available on the residual risk and 

technology review (RTR) web page at 

http://www.epa.gov/ttn/atw/rrisk/rtrpg.html. This information 

includes source category descriptions and detailed emissions and 

other data that were used as inputs to the risk assessments.

C. Judicial Review. 

Under section 307(b)(1) of the CAA, judicial review of this 

final action is available only by filing a petition for review in 

the United States Court of Appeals for the District of Columbia 

Circuit by [INSERT DATE 60 DAYS FROM DATE OF PUBLICATION]. Under 

section 307(b)(2) of the CAA, the requirements established by this

final rule may not be challenged separately in any civil or criminal 

proceedings brought by the EPA to enforce the requirements.

Section 307(d)(7)(B) of the CAA further provides that “[o]nly an 

objection to a rule or procedure which was raised with reasonable 

specificity during the period for public comment (including any 

public hearing) may be raised during judicial review.” This section 

also provides a mechanism for us to convene a proceeding for 

reconsideration, “[i]f the person raising an objection can 
***E.O. 12866 Review – Draft (09/1910/21/2011) – Do Not Cite, Quote 

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Page 8 of 130

demonstrate to the EPA that it was impracticable to raise such 

objection within [the period for public comment] or if the grounds 

for such objection arose after the period for public comment (but 

within the time specified for judicial review) and if such objection 

is of central relevance to the outcome of the rule.” Any person 

seeking to make such a demonstration to us should submit a Petition 

for Reconsideration to the Office of the Administrator, U.S. EPA, 

Room 3000, Ariel Rios Building, 1200 Pennsylvania Ave., NW, 

Washington, DC 20460, with a copy to both the person(s) listed in the 

preceding FOR FURTHER INFORMATION CONTACT section, and the Associate 

General Counsel for the Air and Radiation Law Office, Office of 

General Counsel (Mail Code 2344A), U.S. EPA, 1200 Pennsylvania Ave., 

NW, Washington, DC 20460.

II. Background 

Section 112 of the CAA establishes a two-stage regulatory 

process to address emissions of hazardous air pollutants (HAP) from 

stationary sources. In the first stage, after the EPA has identified 

categories of sources emitting one or more of the HAP listed in 

section 112(b) of the CAA, section 112(d) calls for us to promulgate 

NESHAP for those sources. “Major sources” are those that emit, or 

have the potential to emit, any single HAP at a rate of 10 tons per 

year (TPY) or more, or 25 TPY or more of any combination of HAP. For 

major sources, these technology-based standards must reflect the 
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maximum degree of emission reductions of HAP achievable (after

considering cost, energy requirements, and non-air quality health and 

environmental impacts) and are commonly referred to as maximum 

achievable control technology (MACT) standards.

For MACT standards, the statute specifies certain minimum 

stringency requirements, which are referred to as floor requirements

and may not be based on cost considerations. See CAA section 

112(d)(3). For new sources, the MACT floor cannot be less stringent 

than the emission control that is achieved in practice by the best 

controlled similar source. The MACT standards for existing sources 

can be less stringent than floors for new sources, but they cannot be 

less stringent than the average emission limitation achieved by the 

best-performing 12 percent of existing sources in the category or 

subcategory (or the best-performing five sources for categories or 

subcategories with fewer than 30 sources). In developing MACT, we 

must also consider control options that are more stringent than the 

floor, under CAA section 112(d)(2). We may establish standards more 

stringent than the floor, based on the consideration of the cost of 

achieving the emissions reductions, any non-air quality health and 

environmental impacts, and energy requirements. In promulgating MACT 

standards, CAA section 112(d)(2) directs us to consider the 

application of measures, processes, methods, systems, or techniques 

that reduce the volume of or eliminate HAP emissions through process 
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changes, substitution of materials, or other modifications; enclose 

systems or processes to eliminate emissions; collect, capture, or 

treat HAP when released from a process, stack, storage, or fugitive 

emissions point; and/or are design, equipment, work practice, or 

operational standards.

In the second stage of the regulatory process, we undertake two 

different analyses, as required by the CAA: section 112(d)(6) of the 

CAA calls for us to review these technology-based standards and to 

revise them “as necessary (taking into account developments in 

practices, processes, and control technologies)” no less frequently 

than every 8 years; and within 8 years after promulgation of the 

technology standards, CAA section 112(f) calls for us to evaluate the 

risk to public health remaining after application of the technologybased standards and to revise the standards, if necessary, to provide 

an ample margin of safety to protect public health or to prevent, 

taking into consideration costs, energy, safety, and other relevant 

factors, an adverse environmental effect. In doing so, the EPA may 

adopt standards equal to existing MACT standards if the EPA

determines that the existing standards are sufficiently protective.

NRDC v. EPA, 529 F.3d 1077, 1083 (D.C. Cir. 2008).

On February 17, 2011, the EPA published a proposed rule in the 

Federal Register for the Primary Lead Smelting NESHAP, 40 CFR Part 63 

Subpart TTT, that took into consideration the residual risk and 
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technology review (RTR) analyses for that source category. This 

action provides the EPA’s final determinations pursuant to the RTR 

provisions of CAA section 112 for the Primary Lead Processing source 

category. Specifically, as a result of our analyses, we are revising 

the requirements of the NESHAP to ensure public health and the 

environment are protected consistent with section 112(f) and that 

emission reductions are consistent with what is economically and 

technically feasible under section 112(d)(6). In addition, we are 

taking the following actions:

• Revising the requirements in the NESHAP related to emissions 

during periods of startup, shutdown, and malfunction (SSM).

• Revising the title of the rule and amending the applicability 

section consistent with the definition of the source category 

adopted in 1992, to provide that the NESHAP applies to any 

facility processing lead ore concentrate to produce lead metal.

• Replacing the definition of “primary lead smelter” with a 

definition of “primary lead processor” and adding definitions of 

“secondary lead smelters,” “lead refiners,” and “lead 

remelters.”

• Incorporating the use of plain language into the rule.

• Addressing technical and editorial corrections in the rule.

• Responding to the January 2009 petition for rulemaking from the 

Natural Resources Defense Council (NRDC) that the original 
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primary lead NESHAP should have included an emission standard 

for organic HAP and announcing our intention to collect 

additional data needed to develop a standard for organic HAP.

We note that the Doe Run Herculaneum Smelter, the only facility 

in the source category, is subject to a Consent Decree requiring 

submission of a facility-wide cleanup plan by January 1, 2013, 

shutdown of their sintering operations by the end of 2013, and 

shutdown of the blast furnace by April 30, 2014. The Consent Decree 

will achieve drastic reductions in lead emissions and will provide 

substantial environmental and public health benefits. The Herculaneum 

area has also been designated as a nonattainment area for the 2008 

National Ambient Air Quality Standards (NAAQS) for lead. Attainment 

of the 2008 Lead NAAQS (which is demonstrated based on three years of 

data at or below the level of the NAAQS) is required by December 

2015. The State of Missouri is required to submit its attainment 

demonstration State Implementation Plan (SIP) by June 30, 2012.

III. Summary of the Final Rule

A. What are the final rule amendments for the Primary Lead Processing 

source category?

The National Emission Standards for Hazardous Air Pollutant 

Emissions: Primary Lead Smelting was promulgated on June 6, 1999 (64 

FR 30204), and codified at 40 CFR part 63, subpart TTT. The primary 

lead processing industry consists of facilities that produce lead 
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metal from ore concentrates. The source category covered by this MACT 

standard currently includes only one operating facility, The Doe Run 

Company in Herculaneum, Missouri.

For the reasons provided in the proposed rule and in the support 

documents in the docket, we have determined that the risks associated 

with this source category are unacceptable and are therefore 

promulgating requirements to reduce the risk to an acceptable level. 

Once risk is reduced to an acceptable level, we analyze whether there 

are additional controls that will provide an ample margin of safety, 

considering cost, energy, safety, and other relevant factors. We have 

concluded that there are no additional cost-effective controls 

available beyond those that we expect will be applied to reduce risk 

to an acceptable level and thus the same controls to ensure an 

acceptable level of risk will also provide an ample margin of safety. 

To satisfy section 112(f) of the CAA, we are, therefore, revising the 

existing MACT standard to include: 

• An emission cap of 1.2 TPY for the furnace area stack and the 

refining operation stacks, combined.2

• A requirement for the facility to adopt work practice standards to 

address fugitive emissions to ensure emissions do not present an 

 2 EPA notes that it is setting a combined emission limit for these sources because, as noted in the proposal (76 FR 9432),

and the risk assessment documents to support the proposed and final rulemakings, these sources have overlapping points 

of maximum lead impact.
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unacceptable level of risk (i.e., cause the lead concentration in 

air at or near the facility boundary to exceed 0.15 μg/m3 based on 

3-month rolling average) and to conduct air monitoring to ensure 

that such fugitive emissions are adequately addressed.

To satisfy section 112(d)(6) of the CAA, we are, therefore,

revising the existing MACT standard to include a reduction of the 

lead emission limit for the main stack. The MACT standard is being 

lowered from the current 1.0 pound per ton of lead produced to 0.97 

pound of lead per ton of lead produced based on a determination that

developments in practices, processes, or control technologies since 

promulgation of the MACT standards demonstrate that the facility can 

meet a reduced emission limit from the main stack pursuant to CAA 

section 112(d)(6). 

In addition to our reviews under sections 112(f) and 112(d)(6) 

of the CAA, we are promulgating the following:

• The revision of the applicability section of the rule consistent 

with the definition of the source category adopted in 1992, 

subpart TTT which applies to any facility that produces lead metal

from lead concentrate ore. 

• Changes to the Primary Lead Processing MACT standards to eliminate 

the SSM exemption. These changes revise Table 1 in 40 CFR part 63, 

subpart TTT to indicate that several requirements of the 40 CFR 

part 63 General Provisions related to periods of SSM do not apply.
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We are adding provisions to the Primary Lead Processing MACT 

standards requiring sources to operate in a manner that minimizes 

emissions, removing the SSM plan requirement, clarifying the 

required conditions for performance tests, and revising the SSM–

associated recordkeeping and reporting requirements to require 

reporting and recordkeeping for periods of malfunction. We are 

also adding provisions to provide an affirmative defense against 

civil penalties for exceedances of emission standards caused by 

malfunctions, as well as criteria for establishing the affirmative 

defense.

• Replacement of the word “shall” with the word “must” in the 

regulatory text. We are also replacing “thru” with “through.” We 

are replacing the definition of “primary lead smelter” with a 

definition of “primary lead processor” and adding definitions of 

“secondary lead smelters,” “lead refiners,” and “lead remelters.”

These revisions to the Primary Lead Processing MACT standard are 

expected to result in lead emissions reductions and increased 

compliance costs to the industry. No economic impacts on small 

businesses are expected as a result of the revisions to the rule. We 

have determined that the one facility in this source category can 

meet the applicable emissions standards at all times, including 

periods of startup and shutdown, in compliance with the current MACT 

standards.
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B. What are the requirements during periods of startup, shutdown, and 

malfunction?

The United States Court of Appeals for the District of Columbia 

Circuit vacated portions of two provisions in the EPA’s CAA section 

112 regulations governing the emissions of HAP during periods of SSM.

Sierra Club v. EPA, 551 F.3d 1019 (D.C. Cir. 2008), cert. denied, 130 

S. Ct. 1735 (U.S. 2010). Specifically, the Court vacated the SSM 

exemption contained in 40 CFR 63.6(f)(1) and 40 CFR 63.6(h)(1), that 

is part of a regulation, commonly referred to as the “General 

Provisions Rule,” that the EPA promulgated under section 112 of the 

CAA. When incorporated into CAA section 112(d) regulations for 

specific source categories, these two provisions exempt sources from 

the requirement to comply with the otherwise applicable CAA section 

112 emission standards during periods of SSM.

We have eliminated the SSM exemptions in the regulatory text.

Consistent with Sierra Club v. EPA, the EPA has established standards 

in this rule that apply at all times. We have also revised Table 1 

(the General Provisions table) in other respects. For example, we 

have eliminated the incorporation of the General Provisions’ 

requirement that the source develop an SSM plan. We have also 

eliminated or revised certain recordkeeping that related to the SSM 

exemption. The EPA has attempted to ensure that we have not included 
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in the regulatory language any provisions that are inappropriate, 

unnecessary, or redundant in absence of the SSM exemption.

In establishing the standards in this rule, the EPA has taken 

into account startup and shutdown periods and, for the following 

reasons, has not established different standards for those periods.

Information on periods of startup and shutdown in the industry 

indicate that emissions during these periods do not increase. 

Furthermore, all processes are controlled by either control devices 

or work practices, and these controls would not typically be affected 

by startup or shutdown. Also, compliance with the standard already 

requires averaging of emissions over a three month period, which 

accounts for the variability of emissions that may result during 

periods of startup and shutdown. Therefore, separate standards for 

periods of startup and shutdown are not being promulgated.

Periods of startup, normal operations, and shutdown are all 

predictable and routine aspects of a source’s operations. However, by 

contrast, malfunction is defined as a “sudden, infrequent, and not 

reasonably preventable failure of air pollution control equipment, 

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

manner***” (40 CFR 60.2). 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 
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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.

Further, accounting for malfunctions would be difficult, if not 

impossible, given the myriad of different types of malfunctions that 

can occur, 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 
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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.

In the event that a source fails to comply with the applicable 

CAA section 112 standards as a result of a malfunction event, the EPA

would determine an appropriate response based on, among other things, 

the good faith efforts of the source to minimize emissions during 
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malfunction periods, including preventative and corrective actions, 

as well as root cause analyses to ascertain and rectify excess 

emissions. The EPA would also consider whether the source's failure 

to comply with the CAA section 112 standard was, in fact, “sudden, 

infrequent, not reasonably preventable” and was not instead “caused 

in part by poor maintenance or careless operation.” 40 CFR 63.2 

(definition of malfunction).

Finally, the EPA recognizes that even equipment that is properly 

designed and maintained can sometimes fail, and that such failure can 

sometimes cause an exceedance of the relevant emission standard.

(See, e.g., State Implementation Plans: Policy Regarding Excessive 

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

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

Maintenance, and Malfunctions (Feb. 15, 1983)). The EPA is,

therefore, adding to the final rule an affirmative defense to civil 

penalties for exceedances of emission limits that are caused by 

malfunctions. See 40 CFR 63.1542 Primary Lead Processing (defining

“affirmative defense” to mean, in the context of an enforcement 

proceeding, a response or defense put forward by a defendant, 

regarding which the defendant has the burden of proof, and the merits 

of which are independently and objectively evaluated in a judicial or 

administrative proceeding). We also have added other regulatory 

provisions to specify the elements that are necessary to establish 
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this affirmative defense; the source must prove by a preponderance of 

evidence that it has met all of the elements set forth in 63.1551

Primary Lead Processing. (See 40 CFR 22.24). The criteria ensure that 

the affirmative defense is available only where the event that causes 

an exceedance of the emission limit meets the narrow definition of 

malfunction in 40 CFR 63.2 (sudden, infrequent, not reasonably

preventable and not caused by poor maintenance and/or careless 

operation). For example, to successfully assert the affirmative 

defense, the source must prove by a preponderance of the evidence 

that excess emissions “[w]ere caused by a sudden, infrequent, and 

unavoidable failure of air pollution control and monitoring 

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

usual manner...” The criteria also are designed to ensure that steps

are taken to correct the malfunction, to minimize emissions in 

accordance with section 63.1543(i) and 63.1544(e), and to prevent 

future malfunctions. For example, the source must prove by a 

preponderance of the evidence that “[r]epairs were made as 

expeditiously as possible when the applicable emission limitations 

were being exceeded...” and that “[a]ll possible steps were taken to 

minimize the impact of the excess emissions on ambient air quality, 

the environment and human health...” In any judicial or 

administrative proceeding, the Administrator may challenge the 

assertion of the affirmative defense, and, if the respondent has not 
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met its burden of proving all of the requirements in the affirmative 

defense, appropriate penalties may be assessed in accordance with 

section 113 of the CAA (see also 40 CFR part 22.7727).

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) Thus, the 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 the 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 
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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.

C. What are the effective and compliance dates of the standards?

The revisions to the MACT standards being promulgated in this action 
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are effective on [INSERT DATE OF PUBLICATION]. For the MACT 

standards being addressed in this action, the compliance date for 

the revised SSM requirements is the effective date of the standards, 

[INSERT DATE OF PUBLICATION]. The compliance date for the revised 

emission standard in § 16.1543(a) is [INSERT DATE 60 DAYS FROM DATE 

OF PUBLICATION]. The compliance date for the new refining and 

furnace area stack emission limits and the requirement to adopt work 

practice standards to address fugitive emissions and to ensure 

compliance using monitoring of the lead concentration in air limit 

is 2 years from the effective date of the standard, [INSERT DATE 2 

YEARS FROM DATE OF PUBLICATION].

IV. Summary of Significant Changes Since Proposal

A. Changes to the Risk Assessment Performed Under CAA Section 112(f)

As noted above, in February of 2011 EPA published the notice of 

proposed rulemaking: National Emission Standards for Hazardous Air 

Pollutants: Primary Lead Smelting. In the proposed rulemaking, EPA 

presented a number of options for additional controls on the primary 

lead smelting source category, which currently includes only one

facility operating in the United States. In the proposed rule, EPA 

solicited comment on these options as well as on all the analyses and 

data the options were based upon, including the risk methods and 

results presented in the draft document: Draft Residual Risk 

Assessment for the Primary Lead Smelting Source Category. 
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During the public comment period for the proposed rule, the one 

facility in the source category, The Doe Run Company, submitted 

substantially updated emissions, meteorological, facility boundary, 

as well as other relevant information bearing on the risk assessment 

(see docket number: EPA-HQ-OAR-2004-0305 for Doe Run’s public 

comments). As a result, to support this final rulemaking EPA revised 

its analyses to reflect the information received during the public 

comment period for the proposed rule. Revised methods, model inputs,

and risk results are presented in the report: “Residual Risk 

Assessment for the Primary Lead Smelting Source Category” which is 

available in the docket for this rulemaking. In addition, a 

discussion of the updated emissions information used in the final 

risk assessment can be found in the Technical Support Document for 

the final rule, which can also be found in the docket for this 

rulemaking.

Table 3 presents the results of the final baseline risk 

assessment, with respect to the risks due to lead emissions, broken 

down by emission point. In the baseline scenario, we estimate that 

approximately 1,550 people may be exposed to lead concentrations 

above the NAAQS. Results indicate that emissions from the refining 

stacks, furnace area stacks, and fugitive emissions can likely result 

in exceedences of the NAAQS for lead beyond the fenceline of the 
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facility.3 These results also indicate that emissions from the main 

stack do not likely result in exceedences of the NAAQS for lead

beyond the fenceline of the facility because emissions are highly 

dispersed due to the height of the main stack. 

Table 3 - Summary of Lead Concentrations Relative to the NAAQS 

Based on Estimated Actual 2009 Emissions

Emission Point

2009 

Emissions 

(tpy)

Maximum Offsite 

Impact

Main stack1 68.3 0.85 times the NAAQS

Refining stacks2 9.1 7.7 times the NAAQS

Furnace area stack: (controlled blast 

and drossing fugitives)

2.5 2 times the NAAQS

Fugitive dust 1.0 1.1 times the NAAQS

1

Results presented for the main stack in this table consider the good engineering 

practice (GEP) stack height of 330 feet (as was done in the SIP and in modeling 

submitted by the Doe Run Company in its public comments on the proposed 

rulemaking). The actual height of the main stack is approximately 550 feet, and 

thus the impact would have likely been lower had actual stack height been modeled. 2

Emission sources controlled by baghouses 8 and 9 at the Doe Run facility.

Consistent with the risk assessment to support the proposed 

rulemaking, the risk assessment to support the final rulemaking also 

indicates that lead risks are unacceptable, primarily due to lead 

emissions from the furnace area stack and the refining operations 

stacks are unacceptable. However, while the risk assessment

supporting the proposed rulemaking estimated that a combined emission 

limit for the furnace area and refining operations should be set at 

0.91 tons of lead per year to ensure that risks are acceptable, the 

 3 For the reasons noted in the proposed rulemaking, 76 FR at 9421, we used the level of the lead NAAQS as the level above 

which we think an unacceptable risk is presented to the public.
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updated risk assessment estimates that a combined emission limit of 

1.2 tons of lead per year will ensure that ambient lead 

concentrations from those emission points do not result in lead 

levels in the ambient air above the level of the NAAQS for lead, 

thereby resulting in acceptable lead risk. In our ample margin of 

safety analysis, we identified no cost-effective controls that are 

capable of achieving emission levels below 1.2 tons per year, as 

described in the technical support document. Thus, EPA is 

promulgating a combined lead emission limit for the furnace area and 

refining operations stacks at 1.2 tons per year.4 The risk assessment 

also identified potential ambient air concentrations above the level 

of the NAAQS resulting from fugitive emissions. Therefore, we are 

finalizing the requirement for work practice standards and monitoring 

of lead in ambient air to demonstrate efficacy of the work practices.

In addition to the updated lead risk assessment results 

presented above, we also note that there were changes to our cancer, 

acute, and PB-HAP multipathway screening analyses for non-lead HAP as 

a result of the new risk analysis performed for the final rule. With 

respect to our updated cancer risk assessment, we estimate that the 

maximum individual risk (MIR) of cancer is 20 in a million (as 

compared to 30 in a million based on the risk assessment to support 

 4 EPA notes that it is setting a combined emission limit for these sources because, as noted in the proposal (76 FR 9432),

and the risk assessment documents to support the proposed and final rulemakings, these sources have overlapping points 

of maximum lead impact.
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the proposed rule), and that the cancer incidence is 0.008 (as 

compared to 0.0008 based on the risk assessment to support the 

proposed rule). In addition, the refined worst-case acute hazard 

quotient (HQ) value is 2.0 (based on the REL for arsenic), driven by 

arsenic emissions from the main stack (as compared to 0.6 based on 

the REL for arsenic and driven by arsenic fugitive dust emissions as 

indicated by the risk assessment to support the proposed rule). 

Finally, while the worst-case multipathway screen to support the 

proposed rule indicated that no non-lead PB-HAP exceeded screening 

levels for potential multipathway effects, in the risk assessment to 

support the final rulemaking, the worst-case multipathway screening 

level was exceeded with respect to cadmium emissions. This is likely 

the result of the revised emissions information provided by the 

company during the comment period, which indicated higher cadmium

emissions from the main stack than were assumed for purposes of the 

risk assessment performed for the proposed rule.

In considering the updated non-lead risk results presented 

above, we note that while cancer incidence increased in our updated 

risk assessment, cancer incidence remains very low with 1 excess 

cancer case being estimated every 125 years. 

With respect to the worst-case acute HQ value of 2 based on the 

REL for arsenic due to emissions from the main stack, we note that 

this is a conservative, worst-case analysis of the potential for
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acute health effects. We also note that in contrast to the risk 

analysis to support the proposed rulemaking, the final risk analysis 

modeled the main stack at the GEP stack height of 330 feet rather 

than the actual stack height of 550 feet. Thus it is very likely that 

the maximum potential worst-case HQ value is significantly lower than 

2.

Finally, with respect to the exceedence of the worst-case 

multipathway screening level for cadmium, we note that this only 

indicates the potential for cadmium exposures above the chronic 

noncancer reference dose (RfD) for cadmium. That is, while in 

general, emission rates below the worst-case multipathway screening 

level indicate no significant potential for multipathway related 

health effects, emission levels above this worst-case screening level 

only indicate the potential for multipathway-related health risks of 

concern based on a worst-case scenario. We were not able to refine 

our multi-pathway analysis beyond the worst-case screening 

assessment. As a result, we can only say that we cannot rule out the 

potential for multipathway risks. However, due to the highly 

conservative nature of this screening assessment and the 

uncertainties related to the results, we have concluded that, after 

implementation of the controls needed to reduce lead levels to the 

NAAQS, risks are acceptable, considering the combination of potential 

multipathway risks, risks are acceptable. The cancer risks, chronic 
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non-cancer risks, and acute non-cancer risks are also acceptable. We 

also reviewed whether there were cost- effective controls that wcould 

further reduce risks from the non-lead HAP and that should be 

required to provide an ample margin of safety. The controls we are 

requiring to address lead emissions are the same controls that 

wouldalso reduce emissions fromof non-lead HAP. We were unable to 

identify any technically feasible cost effective additional controls 

that would further reduce emissions fromof lead and non-lead HAP. We 

are therefore determining that the standard we are promulgating today 

provides an ample margin of safety to protect public health for nonlead HAP emissions.

In summary, the final rule includes an emission standard of 1.2 

tons per year of lead emissions from refining and furnace area 

stacks, combined. The standard also includes a requirement for the 

facility to employ work practice standards to minimize fugitive 

emissions with ambient monitoring to ensure those work practices 

effectively achieve acceptable risk. These standards will ensure 

public health is protected with an ample margin of safety and that 

there is not an adverse environmental effect from HAP emissions from 

the one lead processing facility in this source category.

B. Changes to the Technology Review Performed Under CAA Section 

112(d)(6)
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In the proposed rule, the main stack was subject to an emission 

limit of 0.22 pounds of lead per ton of lead produced based on our 

section 112(d)(6) technology review. That proposed limit was based on 

information that in practice the source had significantly lower 

emissions than the emission limit of 1 pound of lead per ton of lead 

produced required in the MACT standard. In comments on the proposed 

rule, The Doe Run Company indicated that the proposed emission limit 

under Section 112(d)(6) could not be met and that the data on which 

that emission limit was based were not accurate. The facility 

provided a 2009 stack test for the main stack that indicated that 

emissions at the facility are significantly higher than we assumed as 

the basis for the proposed limit. For purposes of our analysis for 

the final rule, the EPA recalculated the emissions performance 

achieved for the main stack as demonstrated by the 2009 and 2008 

stack tests and considered an estimate of emission variability in 

order to determine whether it was appropriate to revise the emission 

limit based on what the source was able to achieve in practice. Based 

on the revised analysis, we are establishing an emission limit for 

main stack of 0.97 pounds of lead per ton of lead produced. 

We have also changed the compliance date for the main stack to 

reflect compliance “as expeditiously as possible” under section 

112(i)(3) of the CAA. The compliance date for the 0.97 lb/ton limit 

is 60 days from the date of publication of the final rule.
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C. Other Changes Since Proposal

The EPA has decided not to include the refining and furnace area 

emissions as part of a facility wide emission limit as was proposed. 

We received comments on the proposed rule that inclusion of these 

sources in the production based emission limit in §63.1543(a) was not 

necessary to achieve acceptable risk and that these sources would 

simultaneously be required to comply with two competing emission 

standards. We agree with the commenters and we are establishing a 

separate emission limit of 1.2 tons per year of lead emissions that 

applies to the combined emissions of the refining and furnace area 

stacks. The emission standard limits the combined emissions from 

these two stacks because the revised risk assessment indicated that 

the location of maximum impact for these two stacks overlapped at the 

same receptor. A production based emission limit will continue to 

apply to sources in §63.1543(a)(1)-(9).

In recent rules promulgated under section 112 and 129, the EPA 

has revised certain terms and conditions of the affirmative defense 

in response to concerns raised by various commenters. The EPA is 

proposing to adopt those same revisions in this rule. Specifically, 

the EPA revising the affirmative defense language to delete “short” 

from 63.1551(a)(1)(i), because other criteria in the affirmative 

defense require that the source assure that the duration of the 

excess emissions “were minimized to the maximum extent practicable.” 
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EPA is also deleting the term “severe” in the phrase “severe personal 

injury” in 63.1551(a)(4) because we do not think it is appropriate to 

make the affirmative defense available only when bypass was 

unavoidable to prevent severe personal injury. In addition, the EPA 

is revising 63.1551(a)(6) to add “consistent with good air pollution 

control practice for minimizing emissions.” EPA is also revising the 

language of 63.1551(a)(9) to clarify that the purpose of the root 

cause analysis is to determine, correct, and eliminate the primary 

cause of the malfunction. The root cause analysis itself does not 

necessarily require that the cause be determined, corrected or 

eliminated. However, in most cases, the EPA believes that a properly 

conducted root cause analysis will have such results. In addition,

the EPA is revising 63.1551(b) to state that a written report must be 

submitted within 45 days of the initial occurrence of the malfunction 

and that the source may seek an extension of up to an additional 30 

days. 

V. Summary of Significant Comments and Responses

In the proposed action, we requested public comments on all 

aspects of the proposal, including our residual risk reviews and 

resulting proposed standards, our technology reviews and resulting 

proposed standard, and our proposed amendments to delete the startup 

and shutdown exemptions and the malfunction exemption and to 

establish an affirmative defense for malfunctions. 
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We received written comments from 16 commenters. Our responses 

to some of the significant public comments are provided below. A 

response to the comments that are not in the preamble has been placed 

in the docket. See Summary of Public Comments and Responses for 

Primary Lead Processing NESHAP (October 2011), for summaries of other 

comments and our responses to them.

A. Timeline for Compliance

Comment: Two commenters opposed the compliance timing and supported 

extending the compliance date beyond two years for several reasons. 

One commenter stated that according to the time line in the proposed 

rule, the facility will operate in its current form for only a few 

months after the compliance date of the rule. This creates a dilemma 

for the State and facility in terms of implementation, planning,

resources and compliance. The commenter suggested that the 

implementation and attainment schedules for this MACT rule should

correspond to those of the 2008 NAAQS. 

One commenter identified three provisions they suggest could be 

used to allow more than 2 years for compliance: (1) 112(i)(3)(A) 

establishes 3 years for compliance for section 112 standards, (2) 

112(i)(5) allows exemption for up to 6 years for facilities 

demonstrating 90 percent reduction in HAP prior to first proposal of 

a section 112(d) standard, and (3) 112(h)(3) allows an alternative 

means of compliance in some circumstances. The commenter stated that 
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the import of the underlying statutory authority relates to the 

compliance period for existing sources. Under the EPA practice, a 

three-year compliance period applies to § 112(d) MACT standards, 

while a two-year period applies to § 112(f) standards. Although the 

EPA seems to have reflexively applied the § 112(f) period, this 

approach is not foreordained in the present circumstances. 

Specifically, § 112(i)(3)(A), which allows a three-year compliance 

period for any § 112 standard, merits consideration in light of the 

various proposed MACT standards, including a plant-wide § 112(d)(6) 

standard. With regard to the authority under section 112(i)(5), the 

commenter states that emissions have been reduced from 140 tons in 

the year 2000 to less than 14 tons in 2009, representing a decrease 

of over 90%. With regard to section 112(h)(3), the commenter 

believes that the two year compliance period has serious adverse 

economic effects on the company and the new hydrometallurgical 

process can be considered an alternative means of emission 

limitation. 

The commenter also stated that the circumstances of this case 

present a unique challenge in determining an appropriate compliance 

deadline for a new primary lead smelting MACT standard. The 

commenter stated that there were several differences from the 

typical MACT rulemaking: instead of multiple sources within a 

category, there is only one facility in the category; by virtue of a 
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federally enforceable consent decree, the facility must terminate 

its present operations by April 30, 2014; and assuming a final rule 

issues on October 31, 2011, and a two-year compliance deadline, the 

compliance period would be at most six months prior to stoppage of 

many of the current operations. If forced to achieve compliance that 

would last only for such a short period, the facility would face 

severe economic hardship that could jeopardize its ability to 

finance and to build a new hydrometallurgical lead production 

process that would largely eliminate lead emissions. These 

circumstances raise questions as to the legal necessity as well as 

the feasibility and practicality of implementing a two-year 

compliance deadline.

Further, it was incorrectly assumed that a two-year compliance 

period is consistent with the schedule of required actions contained 

in the Consent Decree, when the opposite is true. Requiring MACT 

standard compliance six months before the required termination of 

Doe Run’s existing lead smelting seriously erodes several Consent 

Decree goals: introducing a new hydrometallurgical lead production 

process that minimizes lead emissions, assuring continued primary 

lead production in the United States, and promoting the development 

of the most technologically advanced lead production process in the 

world. 

Finally, the commenter stated that the primary lead RTR 
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proposal effectively accelerates the compliance date for the lead 

NAAQS for the Doe Run facility. According to the commenter a twoyear compliance timeframe relies, in part, on the various steps that 

must be undertaken to implement a plan to monitor lead concentration 

in air. But this reliance is also misplaced because it requires Doe 

Run to comply with the new Lead NAAQS in 2013, or more than two 

years before the Lead NAAQS itself requires compliance. No statutory 

authority supports such accelerated compliance for the lead NAAQS or 

preemption of the SIP process. In short, the two-year timeframe 

rests on faulty grounds: factually, it is inconsistent with the 

Consent Decree requirements, and legally, it unlawfully attempts to 

speed up the previously-established compliance timeframe for the 

lead NAAQS.

Response: Section 112(i)(3) establishes the compliance timeframe for 

any standard issued under section 112 for existing sources and 

provides that the compliance date shall be as expeditiously as 

practicable but no later than 3 years following the effective date 

of the standard. Section 112(f)(4), however, expressly provides 

more specific requirements for standards issued under section 112(f)

and thus for section 112(f) standards those more prescriptive 

requirements govern in place of the compliance requirements in 

section 112(i)(3). Specifically, section 112(f)(4) provides that a 

source cannot emit an air pollutant in violation of a standard 
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issued under subsection (f) except that the standard will not apply 

until 90 days after its effective date. It also provides that the 

Administrator may grant a waiver for a period of up to 2 years from 

the effective date if necessary for the installation of controls and 

if measures will be taken in the interim to ensure public health is 

protected from imminent endangerment. Thus, for purposes of 

standards applicable to the furnace and refinery area emissions and 

for fugitive emissions, which were issued under section 112(f), the 

compliance period may not exceed two years from the effective date 

of the standard.

The main stack emission limit, proposed under 112(d)(6), is 

subject to the section 112(i)(3) compliance provisions. We are 

establishing an emission standard of 0.97 lb Pb/ton of lead produced 

that would replace the existing standard of 1 lb Pb/ton of lead 

produced. This standard is based on the level of emissions that the 

source is already achieving in practice and thus no additional 

controls would be needed to meet that emission limit for the main 

stack. For that reason, we are requiring compliance with the new 

limit for the main stack within 60 days of the effective date of 

this final rule as this timeframe constitutes compliance “as 

expeditiously as practicable.”

Concerning section 112(i)(5), the provision only applies to 

standards promulgated pursuant to section 112(d) (and not 112(f)) 
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and also only where a source achieves a 90% reduction (95% in the 

case of HAPs that are particulate matter) prior to the proposal of 

the section 112(d) standard. Thus, this provision does not apply to 

the standards established under 112(f) in this final rule. With 

regard to the emission standard proposed for the main stack, stack 

test data indicate that the main stack emissions are substantially 

higher than the 14 tons per year value cited by the commenter. Based 

on performance test data, the facility has not achieved the 

reductions in emissions required to apply the alternative compliance 

dates in section 112(i)(5).

Section 112(h)(3) allows the Administrator through notice and 

comment rulemaking to accept an alternative means of emission limit 

in place of a work practice standard established under 112(h)(1) if 

the owner or operator of a source establishes that such alternative 

means will achieve reductions at least equivalent to those that 

would be achieved by the work practice standard. It is unclear 

precisely what the commenter is suggesting with regard to this 

provision. However, it seems they may be suggesting that the new 

hydrometallurgical process that they plan to install after they 

close the pyrometallurgical processes should be considered an 

alternative means of compliance with the work practice standard. It 

is unclear how this process would address the emissions covered by 

the work practice standard requirement we are establishing which is 
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intended to address current fugitive emissions from the facility. 

Those emissions are almost exclusively from lead entrenched in open 

areas and the installation of a new process for lead processing 

would not appear to affect those emissions. Moreover, we understand 

that the new hydrometallurgical process won’t be operational until 

sometime after the compliance date for the work practice standards 

we are requiring. Thus, even if that process would address in whole 

or in part the fugitive emissions addressed through the work 

practice standards, it would not be an appropriate substitute in the 

absence of being able to achieve the necessary reductions within the 

compliance period. We note that our determination here does not 

preclude Doe Run from submitting additional information that may 

further support a demonstration under section 112(h)(3) and for 

which we could take further action in a separate rulemaking.

As to the concerns the commenter raises about this situation 

being unique, we do not disagree. However, the statute is clear 

that the maximum compliance period for standards issued pursuant to 

section 112(f) is two years. The commenter submits no facts or 

information that supports a legal basis for providing a longer 

period for compliance for the refining and furnace area stacks and 

for fugitive emissions.

Finally, we note that the Lead NAAQS does not apply to a 

specific facility but rather is a level that must be met within the 
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designated nonattainment area. However, we recognize that Doe Run is 

the primary contributor to lead nonattainment in the Jefferson 

County lead nonattainment area and the reductions required under the 

rule will help bring the area into attainment with the lead NAAQS. 

However, this regulation does not preempt the SIP process; the State 

of Missouri is still required to submit a state implementation plan 

demonstrating how the area will attain and maintain the lead NAAQS. 

In doing so, the State may rely on any reductions required under 

this regulation. Finally, we note that this regulation does not 

“speed up” the compliance timeframe for meeting the Lead NAAQS. The 

CAA requires areas to attain the various NAAQS as expeditiously as 

practicable, but no later than specified dates. For the 2008 lead 

NAAQS, areas are required to attain the standard as expeditiously as 

practicable, but no later than December 31, 2015. The Act not only 

contemplates but requires, if practicable, for areas to attain the 

2008 lead NAAQS earlier than December 31, 2015.

Comment: One commenter stated that the proposed emission standards 

and ambient standard had negative implications for determining

compliance under the proposed two-year compliance period and the 

“plantwide reductions” that are “required under section 112(f)(2).” 

76 FR at 9437/1. According to the commenter, the only plant-wide 

reduction proposed in the rule is the plant wide limit of 0.22 

pounds per ton produced while the other two new numerical standards 
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are the 0.91 tpy limit for furnace area and refining and casting 

operations and the 0.15 μg/m3 limit for ambient lead concentrations.

The commenter stated that the three proposed numerical 

standards present a confusing regulatory regime as to which standard 

ultimately controls for determining compliance. If, for example, Doe 

Run achieves an aggregate emission of 0.22 lb/ton on a facility wide 

basis but exceeds 0.91 TPY for its furnace and refining and casting 

operations, would it be in compliance? 

Of the three numerical standards, the commenter stated that 

only the 0.91 tpy limit can arguably be linked to Section 112(f), 

and even that is unclear. The 0.91 tpy standard is derived from the 

Lead NAAQS risk analysis. Despite this starting point, this standard 

is subsumed in the proposed 0.22 lb/ton plant-wide limit which arose 

under the section 112(d)(6) technology review, adjusted for 

“variability in the operations and emissions.” While an effort is 

made to differentiate the components of the 0.22 lb/ton standard as 

to which portion fits under what statutory authority, this single 

plant-wide emission standard rests on the § 112(d)(6) review. 

Although not explicitly stated, this plant-wide standard offers more 

than an ample margin of safety. 

Response: We have decided not to include a facility-wide limit that 

would include the refining and furnace area stacks as well as to the 

main stack. Instead, the 1.2 tpy emissions standard we are 
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promulgating under section 112(f) will apply to combined emissions

from the refining and furnace area stacks. The 0.97 lb/ton emission

standard that we are promulgating pursuant to section 112(d)(6) will 

replace the 1.0 lb/ton limit in the original MACT rule and will 

apply to the same sources subject to the limit in the original MACT 

rule. This change should alleviate the regulatory confusion that 

could arise over the limits in the proposal. Furthermore, we believe 

a plant-wide limit is not necessary to address the residual risk and 

technology review requirements of the Act. As provided in the 

preamble to the proposed and final rules, we evaluated each of the 

emission stacks separately to determine whether additional controls 

are necessary under section 112(f) or 112(d)(6) and a plant-wide 

limit is not needed under either of those statutory requirements. We 

note that the monitoring requirement is primarily for the purpose of 

ensuring that fugitive emissions are appropriately addressed under 

section 112(f). The fenceline ambient monitoring requirement will 

ensure that fugitive emissions are controlled to an extent that they 

do not present an unacceptable risk and also provide an ample margin 

of safety. 

B. The EPA’s Authority Under CAA Section 112

Comment: One commenter stated that the modification to the 

applicability provision does not comport with how smelting is 

defined and used and that the source category listing was intended 
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to cover smelting only, not other processes. The commenter lists 

several issues supporting this position:

• The opening phrase of the first sentence “The Primary Lead 

Smelting source category,” describes and limits “any facility” to 

mean those involving smelting; and the “includes, but is not limited 

to” language does not apply to any lead producing process, but only 

to “the following smelting processes.” 

• The list of processes identified all involve pyrometallurgical 

activities: sintering process, blast furnace, electric smelting 

furnace, reverberatory furnace, slag fuming furnace, drossing 

kettles, and dross reverberatory furnace.

• The plain meaning of that language evidences intent to cover 

any and all types of pyrometallurgical processes for producing lead

but shows no attempt to encompass other, as yet unknown, lead 

production processes. 

• Isolating the phrase “including, not limited to” from the 

company it keeps to justify an expansive reading goes well beyond 

the meaning of the listing as a whole and thus cannot stand.

The commenter also stated that the proposed change in 

applicability is inconsistent with the statutory structure for 

formulating source categories: “To the extent practicable, the 

categories and subcategories listed under this subsection shall be 

consistent with the list of source categories established pursuant 
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to section 7411 of this title and part C of this subchapter.” The 

commenter cited several instances in the statute where Primary Lead 

Smelting is referred to as a pyrometallurgical process. In 

summation, the commenter states that the statutory directive of CAA 

§ 112(c)(1) to assure consistency between a source category 

definition and how the same terms are used in other parts of the Act 

demonstrates that the statutory and regulatory use of “primary lead 

smelting” and “primary lead smelter” was consistently designed to 

cover only pyrometallurgical processes. The EPA’s assertion that the 

originally formulated primary lead smelting source category has a 

“broader definition” is inconsistent with the original source 

category language and the pyro-oriented definitions applied to 

primary lead smelting/smelter found throughout the statute and 

regulations.

The commenter also stated that the EPA’s effort to recast the 

primary lead smelting category is barred by the failure to show a 

major source would be present. The new hydrometallurgical process 

bears no resemblance to the current pyrometallurgical process, other 

than feedstock and end product. The new process will have 

drastically reduced lead emissions and is presented as a minor 

source in the Doe Run Air Construction Permit Application for the 

New Lead Technology submitted to the Missouri Department of Natural 

Resources. 
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Response: Section 112(c)(1) describes the process for creating the 

source category list. To the extent that the commenter is concerned 

that the source category listing for primary lead was not issued 

consistent with the requirements of section 112(c)(1), such claim is 

untimely. We disagree with the commenter that the source category 

description must be read to be limited to pyrometallurgical 

processes. The source category description was intended to include 

all processes used to produce lead metal from ore concentrates, as 

evidenced by the first sentence of the category description. While 

it is true that at the time of the source category listing, the 

hydrometallurgical process described by the commenter did not exist, 

the language left open the possibility that other lead metal 

production processes might be developed in the future and would be 

covered under the source category listing. As noted in the response

to comments, if a new process such as the hydrometallurgical process 

is developed, EPA would consider what standard should apply to such 

process. We maintain that primary lead processing facilities using 

such a process should still be subject to the NESHAP. 

Comment: A commenter stated that the proposed rule does not suggest 

that the new lead production processes should be listed as area 

sources. If the EPA could make the necessary "adverse effects 

finding" for including a hydrometallurgical lead production process 

as an area source, a separate NESHAP would be required for a new 
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area source. The EPA lacks authority to subsume a new area source 

into the Primary Lead Smelting major source category, as it would 

require in the proposed rule. Therefore, the EPA must show that 

either Doe Run’s new lead production process or the entire Doe Run 

facility after the new process is operational would or could emit 

more than 10 tpy of lead if the facility is to remain a major source 

category and the proposed rule offers no documented evidence that 

Doe Run’s hydrometallurgical lead production process or the 

Herculaneum facility after the new process becomes operational would 

constitute a major source. The commenter contended that neither the 

new process nor the entire Herculaneum facility would be a major 

source. Plant-wide emissions at Doe Run’s facility after the new 

process becomes operational are estimated to approximate 0.65 tpy. 

Absent the presence of a major source at Doe Run’s facility, the new 

lead production process cannot be treated as a major source 

category.

Response: It is our position that once a source is required to 

install controls or take other measures to comply with a MACT 

standard, it should not be able to substitute different controls or

measures that happen to bring the source below major source levels 

to avoid compliance with a standard after the compliance date. 

Otherwise, a facility could backslide from MACT control levels by 

escaping applicability of the MACT standards and increasing
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emissions. Therefore, the Doe Run Herculaneum facility will continue 

to be treated as a major source of HAP emissions. We note that the 

emission standards and work practice standards promulgated in this 

action apply to the source in its current form as a 

pyrometallurgical processing facility. To the extent any of these 

processes remain in place, such as the refining operation, after 

construction of any new hydrometallurgical process, the emission 

limit applicable to that process would continue to apply. As noted 

elsewhere, a new hydrometallurgical process is not subject to an 

emission limit under the existing MACT standard; we would consider 

an appropriate emission limit for the hydrometallurgical process 

once that process is a demonstrated technology.

Comment: Another commenter stated that the EPA appropriately 

proposes to update the applicability of the MACT to cover Doe Run’s 

new type of facility.

Response: We agree with this comment.

Comment: Two commenters stated that the EPA cannot use section 

112(f) authority to establish an ambient air standard because this 

type of standard is not an “emission standard.”

The commenters stated that the NAAQS does not fit within the 

meaning of “emission standard” as used in CAA §§ 112(d)(6) or 

(f)(2), the EPA’s stated authority for the proposed rule. Section 

112(f)(2) is entitled “Emission standards” and the second sentence, 
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where the “ample margin of safety” factor is found, has “emission 

standard” as its subject; these specific references clarify the use 

of “standards” elsewhere in the subsection means “emission 

standard.” Likewise, § 112(d)(6) gives the Administrator authority 

to revise “emission standards.” Both subsections limit the EPA’s 

rule-promulgating authority to setting “emission standards.”

According to commenters, Congress defined “emission standard” 

in CAA § 302(k) to “mean a requirement established by the . . . 

Administrator which limits the quantity, rate or concentration of 

emissions of air pollutants on a continuous basis, including any 

requirement relating to the operation or maintenance of a source . . 

. and any design, equipment, work practice or operational standard 

promulgated under this chapter.” The language can only be reasonably 

read to allow a standard applicable to emissions from specific 

source(s). The lead (or any other) NAAQS, by definition, is not 

targeted to specific source(s), but applies generally to the 

national ambient air. See, e.g., CAA § 109(a)(1)(A) (“regulations 

prescribing a national primary ambient air quality standard . . . 

for each air pollutant”).

The commenters stated that the contrasting language highlights 

that the lead NAAQS does not qualify as an emission standard within 

the meaning of § 112. The NAAQS addresses ambient air rather than 

emissions from a source, and as a result the NAAQS does not put any 
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limits on the quantity, rate, or concentration of emissions from a 

particular source or on its operation, maintenance, design, or work 

practices, all of which are central to the § 112(f)(2) mandate or on 

the practices, processes, and control technologies related to 

sources central to § 112(d)(6). Further, a NAAQS limits ambient air 

lead without regard to source category or types of sources, while 

the MACT standards are particularized to control emissions at 

specific sources. Thus, the primary lead smelting emission standards 

differ from the secondary lead smelting emission standards, but the 

same lead ambient air standards apply throughout the country without 

regard to such distinctions. In short, the lead NAAQS does not fit 

the meaning of “emission standard” as used in § 112 and therefore 

cannot be properly used as the MACT standard here.

One commenter stated further that this error is not cured by 

the wording of proposed § 63.1544(a), which states: “No owner . . . 

shall discharge or cause to be discharged into the atmosphere lead 

compounds that cause the concentration of lead in air to exceed 0.15 

μg/m3 on a 3-month rolling average measured at locations approved by 

the Administrator.” As such, proposed § 63.1544(a) measures ambient 

air levels for compliance (“concentration of lead in air . . . at 

locations”) in what appears to match the source monitoring of 

ambient air required for the Lead NAAQS. See 73 FR at 67052, § 

50.16(a) and at 67059, §58.10; see also 76 FR at 9436/1 (proposing 
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that compliance “be demonstrated using a compliance monitoring 

system”). As such, proposed § 63.1544(a) does not limit the 

quantity, rate, or concentration of emissions from a specified 

source or take into account developments in practices, processes, 

and control technologies. Compare 40 C.F.R. § 63.1544(a)(2010)

(requiring “manual that describes in detail the measures that will 

be put in place to control fugitive dust emissions from the 

sources”). Measuring ambient air at locations presumably near the 

source does not fall within the standards allowed by CAA § 112, and, 

in any event, is redundant to the same monitoring and limitations

already established under the Lead NAAQS. Consequently, the proposed 

rule exceeds the statutory authority granted by § 112, and therefore 

cannot be adopted.

One commenter stated that the proposal requests comments on a 

work practices standard operating procedure (SOP) alternative to 

ambient air monitoring. As opposed to using the Lead NAAQS, which is 

not an emission standard under Section 112, the alternative SOP 

proposal is consistent with the MACT directive that emission 

reductions be tied to specific sources.

One commenter stated that the proposed ambient lead standard is 

procedurally flawed because the EPA fails to explain the legal basis 

for imposing such a standard under § 112(f). The agency’s legal 

authority is of central relevance to this aspect of the proposal and 
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the failure to clearly describe the legal basis for the standard 

violates the EPA’s obligation under § 307(d)(3)(C) to set forth the 

“major legal interpretations” that underlie the proposal.

Response: The commenters mistake the purpose of the fenceline

monitoring requirement in the proposed rule. The proposed rule 

established emissions standards from the main, furnace area, and 

refinery operations stacks and further provided that fugitive 

emissions would need to be addressed by work practice standards (as 

is allowed under section 112(h)(1)). Finally, it established a 

fenceline monitoring requirement to ensure that the work practice 

standards adequately address fugitive emissions consistent with the 

requirements of section 112(f). Thus the fenceline monitoring is not 

an emission standard, but rather a method to ensure compliance with 

the applicable standards for addressing fugitive emissions, similar 

to how a stack test might be used to ensure compliance with emission 

standards applicable to point source emissions. The facility must 

use work practice standards to reduce fugitive emissions to protect 

public health with an ample margin of safety, and to avoid adverse 

environmental effects. The fenceline monitoring requirement is a 

method for ensuring compliance with the work practice standards to 

provide the protection required under CAA section 112(f)(2). 

We understand that the draft regulatory text from the proposed 

rule may have contributed to the commenters’ confusion on this 
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issue. We have modified the regulatory text for the final rule to 

make clear that the applicable standard is the requirement to adopt 

work practice standards and that the fenceline monitoring 

requirement is a tool to help ensure compliance.

However, even if this were not the case, the EPA could adopt a 

performance standard using the lead NAAQS as the measure of 

performance for a source to achieve. Such a standard would “limi[t] 

the quantity, rate, or concentration of emission of [lead] on a 

continuous basis” (CAA 302 k) since a source’s lead emissions, 

measured at the fenceline, would be limited to the amount 

established by the NAAQS.

We disagree with the suggestion that we do not provide the 

legal basis for our proposed rule. The preamble clearly explains 

that we are addressing residual risk for this source category under 

section 112(f) and clearly explains the rationale for the proposed 

rule and the basis for the proposed requirements. (See 76 FR 9412-

9414 for a discussion of the statutory authority underlying the 

proposed revisions to the standard.) With regard to fugitive 

emissions, we are establishing a requirement for work practice 

standards consistent with section 112(h)(1) in lieu of an emission 

standard because these fugitive emissions, which are predominantly 

from materials handling and roadways cannot be captured and vented 

to a stack for which we could establish an emission limit.
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Comment: One commenter stated that the CAA limits the EPA’s ability 

to regulate pollutants subject to NAAQS (“criteria pollutants”) to 

that regime and does not allow supplemental (or supplanting) 

regulation of them under NESHAP. The commenter cited CAA § 112(b)(2) 

that states in relevant part: “No air pollutant which is listed 

under section 7408(a) of this title may be added to the list under 

this section” with certain exceptions not relevant here. Section 

7408(a) provides the statutory authority for setting NAAQS. Also, 

CAA § 112(b)(7) removes elemental lead from consideration as a HAP. 

According to the commenter, the prohibition is not only clear, but 

also expansive: the statute “unqualifiedly prohibits listing a 

criteria pollutant as a HAP, that is, regardless of the reason.” 

Nat’l Lime Ass’n v. EPA, 233 F.3d 625, 638 (D.C. Cir. 2000).

Response: As we recognized in the preamble to the proposed rule, 

under section 112(b)(7) elemental lead may not be listed as a HAP 

under section 112 and the references to “lead” in the proposed rule 

referred to “lead compounds” which are expressly listed as a HAP in 

CAA section 112(b)(1). 76 FR 9412. Because lead compounds are a 

listed HAP, we are required to regulate them under section 112, as 

we did when we established the original MACT standard for primary 

lead in 1999. 64 FR 30194. The lead emitted from primary lead 

processing is lead compounds with elemental lead present only in 
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trace amounts.5 The commenter did not provide any data to refute 

this. Thus, we disagree with the commenter that we are attempting to 

regulate in contravention of section 112(b)(7) in this action.

The National Lime opinion cited by the commenters addressed a 

different issue than the one being at issue here. In that case, the 

issue was whether EPA could use a NAAQS pollutant (particulate 

matter) as a surrogate for HAP metal emissions. While certain HAP 

listed in 112(b)(1) are considered particulate matter, “particulate 

matter” is not listed on the 112(b)(1) list. In that case, the 

court rejected the argument by the National Lime Association that 

EPA was regulating particulate matter “through the back door.” In 

the present situation, EPA is not regulating lead “through the back 

door” in this rulemaking.

Comment: One commenter stated that the EPA unlawfully refused to set 

a standard for organic HAP. According to the commenter, the EPA 

must set an emission standard for the organic HAP listed on the 

section 112(b)(1) list that this source category emits. 

 5 Harrison, R.M. and Williams, C.R. (1981). Environmental Science and Technology, Vol. 15:10, p. 1197-1204.; Ohmsen, 

G.S.(2001). Journal of the Air and Waste Management Association, Vol. 51, p. 1443-1451.; Uzu, G., Sobanska, S., Sarret, G., 

Sauvain, J.J., Pradère, P., and Dumat, C. (2011). Journal of Hazardous Materials, Vol. 186, p. 1018-1027.; Spear, T.M., Svee, 

W., Vincent, J.H., and Stanisich, N. (1998). Environmental Health Perspectives, Vol. 106:9, p. 565-571.; Czaplicka, M., and 

Buzek, Ł. (2011). Water, Air, & Soil Pollution, Vol. 218, p. 157-163.; Sobanska, S., Ricq, N., Laboudigue, A., Guillermo, R., 

Brémard, C., Laureyns, J., Merlin, J.C., Wignacourt, J.P. (1999). Environmental Science and Technology, Vol. 33, p. 1334-

1339.; Harrison, R.M. and Williams, C.R. (1983). The Science of the Total Environment, Vol. 31, p. 129-140.; Batonneau, Y., 

Bremard, C., Gengembre, L., Laureyns, J., Maguer, A.L., Maguer, D.L., Perdrix, E., and Sobanska, S. (2004). Environmental 

Science and Technology, Vol. 38, p. 5281-5289.; Foster, R.L. and Lott, P.F. (1980). Environmental Science and Technology, 

Vol. 14:10, p. 1240-1244.
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Specifically, the commenter argues that:

"[w]hen EPA performs a section 112(d)(6) review, 

it must consider the ongoing legality and 

effectiveness of the existing standard. 

Explicitly, in the current rulemaking EPA must 

“review, and revise as necessary” the existing 

MACT standard. 42 U.S.C. § 7412(d)(6). It is 

clearly “necessary” for EPA to close inherently 

unlawful gaps in the original MACT, by setting a 

standard for an uncontrolled HAP. Indeed, EPA has 

recognized the need and done this during its 

section 112(d)(6) review in its recent rulemaking 

for Marine Tank Vessel Loading Operations and 

Group I Polymers and Resins where it proposed a 

standard for previously uncontrolled 

subcategories of these sources. See Proposed 

Rule, 75 Fed. Reg. 65,068, 65,115, 65,106 (Oct. 

21, 2010). EPA has no legal basis for failing to 

set a MACT standard now for the uncontrolled HAPs 

for the primary lead source category."

Response: We disagree with the commenter that section 112(d)(6) 

mandates that EPA must correct any deficiency in an underlying MACT 

standard when it conducts the “technology review” under that 

section. We believe that section 112 does not expressly address this 

issue, and EPA has discretion in determining how to address a 

purported flaw in a promulgated standard. The "as necessary" 

language cited by the commenter must be read in the context of the 

provision, which focuses on the review of developments that have 

occurred since the time of the original promulgation of the MACT 

standard and thus should not be read as a mandate to correct flaws 

that existed at the time of the original promulgation. In several 

recent rulemakings, we have chosen to fix underlying defects in 
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existing MACT standards under sections 112(d)(2) and (3), the 

provisions that directly govern the initial promulgation of MACT 

standards (see National Emission Standards for Hazardous Air 

Pollutants From Petroleum Refineries, October 28, 2009, 74 FR 55670; 

and National Emission Standards for Hazardous Air Pollutants: Group 

I Polymers and Resins; Marine Tank Vessel Loading Operations; 

Pharmaceuticals Production; and the Printing and Publishing 

Industry, April 21, 2011, 76 FR 22566). (We note that the commenter 

incorrectly states that we revised those standards under 112(d)(6)). 

We believe that this approach is reasonable because using those 

provisions ensures that the process and considerations are those 

associated with initially establishing a MACT standard, and it is 

reasonable to make corrections following the process that would have 

been followed if we had not made an error at the time of the 

original promulgation. 

Nevertheless, based on our review of the commenter's 2009 

petition and their additional comments on this proposed rulemaking, 

we agree that the Primary Lead Smelting NESHAP should have included 

an emission standard for organic HAP. We have evaluated available 

data and believe that we need additional data in order to set an 

emission standard for organic HAP that is representative of current 

operations and emissions. We intend to collect the needed data and 

propose a MACT emission standard under section 112(d)(2) & (3) of 
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the CAA. Accordingly, we are not taking final action on the 2009 

petition with respect to the issue of setting a standard or 

standards for organic HAP and will address that petition once we 

have gathered the necessary data.Comment: One commenter stated that

the EPA unlawfully refuses to set a standard for organic HAP. The 

commenter stated that the EPA must not deny the petition of January 

2009 filed by NRDC and Sierra Club to correct problems in the MACT 

including setting limits for volatile organic compounds and acid 

gases that the current MACT for this source category does not 

control. According to the commenter, the EPA must set an emission 

standard for each organic HAP listed on the section 112(b)(1) list 

that this source category emits and the EPA has no legal basis for 

failing to set a MACT standard now for the uncontrolled HAPs for the 

primary lead source category.

Response: We agree that the Primary Lead Smelting NESHAP should have 

included an emission standard for organic HAP. We have determined 

that it will be necessary to collect additional data in order to set 

an emission standard for organic HAP that is representative of 

current operations and emissions. We intend to collect the needed 

data and propose a MACT emission standard under section 112(d)(2) of 

the CAA, as appropriate.

C. Primary Lead Processing Risk Assessment

Comment: One commenter stated that the EPA failed to consider or 
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account for cumulative risk and that there is no rational or 

scientific basis to dismiss consideration of the cumulative risk of 

exposures to HAPs due to uncertainties. The commenter urged that 

these uncertainties require protective action rather than inaction. 

The commenter stated that the EPA’s Science Advisory Board (SAB) in 

May 2010 urged the EPA to use the RTR rulemaking process to do this 

as well as perform a sensitivity analysis to identify the major 

uncertainties in both the human health and ecological risk 

assessments. According to the commenter, the SAB and numerous other 

scientific experts have developed, and are in the process of 

developing, cutting edge methods to perform these assessments and 

that the EPA, as the lead environmental agency of the United States, 

has a responsibility to show leadership in this process. It should 

rely on the significant information already available and also use 

the current and future RTR rulemakings to further advance this 

process.

The commenter stated that it could be done on a site-specific 

basis or for the industry as a whole. Uncertainty in estimates of 

HAP in ambient air has been characterized, so the data available 

from the National-Scale Air Toxics Assessments (NATA) would allow a 

defensible estimate of what might be expected from other sources.

Response: We disagree with the commenter that our risk assessments 

do not consider cumulative risk. We note that our assessment of 
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cancer risks is, in fact, cumulative, summing the risks associated 

with all carcinogens emitted by the facility. Similarly, the use of 

the target organ specific hazard index (TOSHI) for chronic noncancer effects evaluates the cumulative effects of HAP on a given 

target organ. Further, our assessment for Primary Lead Processing is 

cumulative in that it considers all emission points within the 

fenceline (since they are all covered by the MACT). Moreover, the 

level of the lead NAAQS, which we used as the metric for defining 

unacceptable risk, was set based on all air-related exposures in its 

derivation and thus is also a cumulative standard. We note that for 

the present rulemaking, our consideration of cumulative risks for 

the Doe Run facility is the same as that for the industry as a whole 

since Doe Run is the only facility within the source category.

We further disagree with the commenter’s assertion that a 

comprehensive quantitative assessment of risks from all sources 

outside the source category is required under the statute. If such 

were in fact the case, the task of completing such a requirement 

would take an interminable length of time. Instead, to provide the 

quantitative risk information necessary to inform RTR regulatory 

decisions, the EPA conducts a comprehensive assessment of the risks 

associated with exposure to the HAPs emitted by the source category 

(i.e., those emissions that can actually be affected by the specific 

rulemaking) and supplements that with additional information about 
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other possible concurrent and relevant risks that is readily 

available. In some cases, we have additional information about HAP 

emissions that outside the scope of the particular rulemaking but 

within the boundaries of the subject facilities. In other cases, we 

may have ambient HAP monitoring data that can be considered as part 

of the regulatory decision-making. In still other cases, we may have 

very little additional risk information that can be considered. In 

all cases, however, when we consider additional information about 

risks, we also consider its attendant uncertainties, and information

which carries significant uncertainties generally carries much less 

weight in the overall regulatory decision.

All of the quantitative risk assessment information about HAP 

emissions from the source category under consideration is also 

considered in the manner prescribed by the decision framework set 

forth by the CAA for residual risk decision-making (i.e., the 

Benzene decision framework), and this means that the general 

guidelines of risk acceptability have been developed in a way that 

they already take into account the impossibility of accurately 

quantifying the health risks posed by outside forces on every 

individual in the population. They do this by noting that the 

guidelines apply in “the world in which we live,” a world which is 

acknowledged to be “not risk-free,” but rather a world which is full 

of risks, many of which can simply not be quantified. This 
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acknowledgment allows the EPA to make risk-based decisions by 

focusing on the risks associated with the emissions that are 

themselves the subject of regulation being considered, and not get 

distracted by the daunting task of assessing all the other 

concurrent potential risks that may or may not be relevant and can’t 

be impacted by the regulation in question anyway.

Comment: Two commenters took issue with the modeling methodology 

used for the RTR proposal and disagreed with the risk results based 

on a number of concerns. 

One commenter stated that the RTR modeling characterized the 

maximum air lead concentrations near the facility to be fifty times 

the 2008 NAAQS which is inconsistent with both recent air quality 

monitoring data and Missouri's 2007 attainment demonstration 

modeling and stated that the proposed RTR modeling overestimated the 

maximum air lead concentration by at least a factor of five. The 

commenter stated that the inaccuracies of the EPA’s proposed 

modeling analysis will be in conflict with future baseline and 

attainment demonstration modeling based on more accurate data, 

especially since the RTR proposes to correlate the MACT standard 

with the 2008 NAAQS. The commenter recommended that the EPA remodel 

this facility using higher quality input data that are more 

representative of current operations at the Herculaneum facility, to 

obtain results that better reflect the actual monitored three-month 
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lead concentrations. Alternately, the commenter stated that the EPA 

should either defer to appropriate air quality monitoring 

information or to the modeling run used for the 2007 SIP revision 

attainment demonstration as the basis for this RTR. Some commenters 

also suggested using AERMOD modeling followed by LEADPOST, rather 

than using HEM-3 to ultimately calculate 3-month rolling average 

lead concentrations. 

Two commenters identified specific issues with regard to the 

modeling approach and input data including:

• The ratio of modeled results to monitored data should not 

exceed a factor of two. The commenter provided specific corrections 

and analysis of data.

• The NAAQS attainment demonstration model developed by the State 

of Missouri and the RTR modeling, although conducted for different 

purposes, are both based on compliance with the same standard for 

the same geographic location. Therefore, the output of both 

dispersion models, whether for residual risk assessment or SIP 

development, should reflect the maximum ambient air lead 

concentration. The commenter stated that any data limitations should 

be addressed with input from the commenter. 

• Improvements from the 2007 SIP for the fugitive emissions from 

the sinter plant and blast furnace building do not appear to be 

reflected in the run script of the model, resulting in 
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concentrations up to fifty times the NAAQS. The commenter stated 

that actual monitoring data from 2010 show a maximum three-month 

average ambient air concentration of 1.12 μg/m3 at the Main Street 

site. This actual monitored value is in line with the MDNR modeled 

estimate from the 2007 SIP revision and is recommended to be the 

basis for the risk assessment.

• The EPA did not provide a modeling protocol for their 

dispersion modeling, or all of the modeling inputs, post processing 

and other data in the docket for public review. Therefore, a 

complete, replicable public review of the model and assessment of 

the proposed RTR could not be made. The commenter identified several 

specific modeling parameters and data elements that were not 

correctly applied during the proposal modeling run which could have 

significantly affected the results including model control options,

run script parameters, volume sources modeled as point sources, 

inaccurate fenceline/boundary locations, incorrect elevations for 

sources and receptors, and old census data information for receptor 

centroids.

Response: Because of the availability of newer emissions data, more 

detailed site-specific meteorological data, as well as updated 

facility boundary and other information provided by Doe Run in 

comments on the proposed rule, we have remodeled the facility with 

these newer data. We remodeled using AERMOD in the default mode to 
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estimate monthly lead concentrations, and we used the building and 

particle data submitted by one commenter to model building downwash 

and plume depletion. We used the LEADPOST processor to calculate 3-

month rolling averages. In addition, using the updated facility 

boundary information, the EPA also removed census blocks that would 

now be considered onsite. The methods and results of this modeling 

effort can be found in the document: Residual Risk Assessment for 

the Primary Lead Smelting Source Category, which is available in the 

docket for this rulemaking. The EPA notes that the results of this 

modeling effort are similar to results submitted by the Doe Run 

Company to the State as part of a SIP (this Doe Run modeling effort 

was also submitted to the EPA as part of its public comments). 

Moreover, the EPA notes that a comparison of modeled lead 

concentrations at the sites of six lead monitors are within 50 

percent of measured concentrations at those monitors. These results 

are similar to a model-to-monitor comparison submitted by Doe Run in 

its public comments. 

We note that the docket included all of the input files and 

documentation needed to reproduce the modeling that was performed 

for the proposal risk assessment.

Comment: With respect to using the NAAQS to evaluate potential 

multipathway risks from lead, one commenter stated that the risk 

assessment used to set the NAAQS was based on quantitative studies 
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of young children and that while “the Lead NAAQS obviously applies 

to all ages, that was a qualitative risk management decision made as 

a matter of policy” and that “the task at hand is to provide a 

quantitative risk assessment of the maximum non-adverse facilitylevel emissions rate for all ages, which cannot be done on the basis 

of a risk assessment that studied children only. 

Response: The lead NAAQS was a public health policy judgment 

considering the available health evidence and risk analyses as well 

as the uncertainties associated with the health evidence and risk 

analyses. We disagree with the commenter that the lead NAAQS cannot 

be used in a quantitative manner. The review of the lead NAAQS 

clearly resulted in a quantitative standard: 3-month maximum lead 

concentration not to exceed a level of 0.15 μg/m3. This standard was 

set to protect public health, including the health of sensitive 

populations, with an adequate margin of safety. As the commenter 

notes, the lead NAAQS applies in all areas of the United States and 

is meant to protect the public health with an adequate margin of 

safety regardless of the age of the individuals living in a 

particular area. 

Comment: One commenter stated that rather than finalizing this 

proposal as it stands, the best available science directs the EPA to 

set a residual risk standard that incorporates protective health 

benchmarks and assures that children living near the facility will 
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not face an unacceptable neurological effect, such as the loss of IQ 

points. This includes protecting children against a blood lead level 

change of 1.0 μg/dL or more, a benchmark used by California for the 

blood lead level change that is associated with a child’s loss of 

one IQ point. Because there is no safe level of lead exposure and 

because lead persists in the environment, resulting in reservoirs in 

soils and dusts, the EPA has an obligation to control emissions from 

this source category promptly and in a precautionary manner. The 

commenter stated that the EPA should consider requiring zero lead 

emissions. At a minimum, the EPA should set a standard that would 

ensure that the ambient air concentration for lead in the local 

community does not exceed the level of 0.02 μg/m3 as a one-month 

average, in order to protect children. As this is the level the 

Children’s Health Protection Advisory Committee had recommended for 

the lead NAAQS, the EPA must also set additional protections beyond 

this ambient air limit in order to provide an “ample margin of 

safety.” 

Response: In order to assess multipathway risks associated with 

emissions of lead, the EPA compared modeled rolling three month 

average lead concentrations estimated from emissions from the one 

source in this category to the NAAQS for lead. As noted above, we 

believe that this is a reasonable approach given that the NAAQS is a 

health based standard set to protect the public health, including 
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the health of sensitive sub-populations (such as children) with an 

adequate margin of safety. Moreover, the risk assessment supporting 

the NAAQS considered direct inhalation exposures and indirect airrelated multi-pathway exposures from industrial sources like primary 

and secondary lead smelting operations. While we conclude that the 

level of the NAAQS presents an acceptable level of risk from lead in 

ambient air, and are requiring controls to ensure that the level of 

the NAAQS is not exceeded, as part of our “ample margin of safety” 

analysis, we examined whether there were additional cost effective 

controls available to further protect public health including 

monitoring at a level below 0.15 μg/m3. For the reasons explained 

elsewhere in this notice and other supporting documents available in 

the docket, we have determined that there are no additional cost 

effective controls that would provide further risk reductions. 

With respect to the California benchmark for protecting 

children, the EPA has a hierarchy of appropriate health benchmark 

values. In general, this hierarchy places greater weight on EPA 

derived health benchmarks than those from other agencies 

(http://www.epa.gov/ttn/atw/nata1999/99pdfs/healtheffectsinfo.pdf). 

For the reasons provided above, we believe that the lead NAAQS level 

establishes an appropriate benchmark for addressing the acceptable 

level of risk and we disagree with the commenter that we should 

instead use an ambient concentration of 0.02 μg/m3 based on a one 
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month average.6

 

Comment: With regard to the source category’s emissions of two 

dozen other hazardous air pollutants, including cadmium and arsenic, 

one commenter stated that the EPA should determine that this health 

risk is also unacceptable. With thousands of people exposed to a 

lifetime risk of cancer above 1 in a million, and with at least 200 

exposed to a lifetime risk of up to 30 in a million, the EPA must 

recognize that this risk is too high for this local community. The 

EPA should set a standard that would reduce cancer risks to an 

acceptable level and ensure an ample margin of safety from non-lead 

emissions.

Response: With respect to cancer risk, section 112 provides for EPA

to follow the benzene decision framework for determining 

acceptability. Under that framework, cancer risk less than 100 in a

million is generally considered acceptable, although this is not a 

bright line and EPA examines a variety of health factors to make its 

determination. Once we concluded that the risk from non-lead HAP was 

acceptable, we then considered whether there were additional costeffective controls that would further reduce risk from the other HAP 

emitted in order to provide an ample margin of safety. Because the 

controls for other HAP were the same as the controls for lead, we 

 6 This level is well below the background ambient lead levels measured in the area during the SIP process. See docket ID 

EPA-HQ-OAR-2006-0735-5204.
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determined (for the same reason we did for lead) that there were no 

additional cost effective controls and that the acceptable level of 

HAP emissions also provided an ample margin of safety. 

Comment: One commenter stated that they oppose the use of the lead 

NAAQS assessment instead of a multi-pathway risk assessment because 

the lead NAAQS provides an inappropriate level of protection, i.e., 

the lead NAAQS requires an adequate margin of safety while a 

residual risk standard requires an ample margin of safety. The 

commenter stated that a residual risk standard should provide a 

level of protection that is higher than the NAAQS. Moreover, the 

commenter noted that the NAAQS is set to protect sensitive 

populations while residual risk rules are set to protect the 

greatest number of individuals possible from unacceptable risk. The 

proposed rule based on the lead NAAQS will not provide as high a 

level of protection as required by CAA § 112(f)(2). 

Response: We disagree with the commenter that the lead NAAQS 

assessment should not be considered as part of our residual risk 

analysis because it provides an inappropriate level of protection. 

The lead NAAQS is set at a level to protect public health, including 

the health of sensitive populations, most critical for lead, the 

health of children. That does not suggest that non-sensitive 

populations are not protected, but rather that the NAAQS is set at a 

level that will not only protect the general population but also 
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those who are more sensitive to lead exposures. In the proposed 

rule, the level of the NAAQS, which protects public health with an 

adequate margin of safety, was used to determine whether or not 

there was unacceptable risk. Once we determined a level of emissions 

that results in risks being acceptable, under the two-step residual 

risk decision process, the EPA then considered whether there were 

additional controls that might further reduce risk to achieve an 

ample margin of safety considering cost and feasibility. There were 

no additional cost-effective controls beyond those that would need 

to be implemented to ensure an acceptable level of risk. Thus, for 

the three emissions points (fugitive dust emissions, the furnace 

area stack, and the refinery stacks) for which we are requiring 

action to ensure an acceptable level of risk, we have concluded that

there are no additional cost-effective controls and that an ample 

margin of safety was provided by the same controls that ensured an 

acceptable level of risk. There are no cost effective controls that 

could reduce the main stack emissions beyond those that are achieved 

in practice. Therefore, an ample margin of safety will be provided 

by the current level of control. A more detailed presentation of the 

economic analysis of additional controls for the refining, furnace 

area, and main stacks can be found in the technical support 

document, which is available in the docket.

Comment: One commenter stated that the EPA has not appropriately 
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accounted for or prevented environmental risks from lead or non-lead 

emissions as required by section 112(f)(2)(A). According to the 

commenter, using the NAAQS to assess ecological risk is problematic 

and EPA’s approach of assuming that “when exposure levels are not 

anticipated to adversely affect human health, they also are not 

anticipated to adversely affect the environment,” 76 Fed. Reg. at 

9425, is illogical and unlawful. Further, based on the information 

the EPA has gathered about the local environment around the Doe Run 

facility, the EPA cannot assume that there would be no effects 

either to wildlife or to natural resources in the environment either 

from inhalation or air deposition of HAP emissions, exacerbated by 

persistence and bioaccumulation. As the EPA’s own Scientific 

Advisory Board has stated: “The assumption that ecological receptors 

will be protected if human health is protected is incorrect.” SAB 

May 2010 at 48. 

Response: The EPA is unaware of any data indicating a direct 

atmospheric impact of non-lead HAP emitted from this source category

on receptors such as plants, birds, and wildlife. Given that there 

is no information supporting that there is an effect, we find it 

appropriate to assume that exposure levels not expected to harm 

humans are also not expected to harm ecological receptors. 

Although the ecological effects of lead are well documented, 

there was a lack of evidence at the time of the last lead NAAQS 
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review linking various ecological effects to specific levels of lead 

in the air. It was determined that the evidence did not provide a 

sufficient basis for establishing a separate secondary standard, but 

that revising the secondary standard to be equal to the revised 

primary standard would provide substantial additional protection to 

ecological receptors from the effects of lead. Thus, we find it 

appropriate to consider the secondary lead NAAQS when evaluating the 

potential for adverse environmental effects. 

Comment: One commenter generally stated that the EPA must not use 

the secondary NAAQS as a benchmark to determine whether there will 

be environmental effects and that the use of the lead NAAQS to 

evaluate ecologic risks is inappropriate. The commenter states that 

the EPA should recognize that the establishment of the Secondary 

lead NAAQS at the same level of the Primary Lead NAAQS was a risk 

management decision, rather than a decision quantitatively founded 

in risk assessment. The commenter cited that in establishing the 

lead NAAQS, the EPA introduced its approach by describing the 

“substantial limitations in the evidence, especially the lack of 

evidence linking various effects to specific levels of ambient Pb” 

(US EPA, 2008. P. 67007), and ultimately concluded that the 

secondary lead NAAQS should be set equal to the primary lead NAAQS. 

In contrast, in this proposed rule, the EPA concludes that 

“ambient lead concentrations above the lead NAAQS indicates 
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potential for adverse environmental effects” (76 FR 9421). 

Response: The secondary lead NAAQS was set to protect against 

adverse welfare effects (including adverse environmental effects) 

and has the same averaging time, form, and level as the primary 

standard. Thus, we find it appropriate to consider the secondary 

lead NAAQS when considering the potential for adverse environmental 

effects. The commenter is correct that we stated in the proposed 

rule that “ambient lead concentrations above the lead NAAQS 

indicates potential for adverse environmental effects.” This 

statement is entirely consistent with the idea that the secondary

lead NAAQS was set at a level above which there may be adverse 

environmental effects but does not support a conclusion that there 

are adverse environmental effects below that level that must be 

addressed as part of this residual risk determination. As we have 

noted previously, there are not sufficient data supporting that a 

lower level is necessary to protect against an environmental risk.

Comment: One commenter stated that in evaluating potential 

multipathway risks from PB-HAP other than lead, the EPA used de 

minimis emission rates to screen for potentially significant multipathway impacts, but for lead, this method was abandoned. The 

commenter disagrees with this approach, stating, “This comparison 

mirrors NAAQS source monitoring for attainment purposes in its use 

of the national ambient air lead level as the benchmark. As such, it 
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is not a proper surrogate for “facility-level de minimis emission 

rates” used as the chronic reference benchmarks for CAA § 112 risk 

assessments.” 

Response: The EPA disagrees that comparing modeled 3-month rolling 

average lead concentrations to the NAAQS for lead mirrors source 

monitoring for NAAQS attainment purposes and that this approach is 

not a proper surrogate for facility-level de minimis emission rates 

used as the chronic reference benchmarks for CAA § 112 risk 

assessments. In general, determining attainment for the lead NAAQS 

is based on aggregate ambient monitoring of all potential sources of 

lead in a given area. In contrast, the Primary Lead Smelting Risk 

Assessment and Preamble clearly state that 3-month rolling average 

lead concentrations are based on modeled lead concentrations from 

lead emissions from the one facility in the source category. 76 FR 

9421. Thus, for example, while for NAAQS attainment purposes ambient 

lead concentrations resulting from lead haul roads outside the 

facility boundary would contribute to the overall 3-month rolling 

average ambient lead concentration measured at a nearby ambient lead 

monitor, for purposes of the risk assessment to support this 

rulemaking, these types of offsite emission sources were not 

included when modeling 3-month rolling lead concentrations (i.e., 

only emission sources from within the facility boundary were used as 

inputs into the dispersion model to estimate resulting modeled 3-
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month average lead concentrations). 

The NAAQS for lead was set to protect, with an adequate margin 

of safety, human health, including the health of children and other 

at-risk populations, against an array of adverse health effects, 

most notably including neurological effects, particularly 

neurobehavioral and neurocognitive effects, in children (73 FR 

67007). In developing the NAAQS for lead, because of the multipathway, multi-media impacts of lead, the risk assessment supporting 

the NAAQS considered direct inhalation exposures and indirect airrelated multi-pathway exposures from industrial sources like primary 

and secondary lead smelting operations. It also considered 

background lead exposures from other sources (like contaminated 

drinking water and exposure to lead-based paints). The EPA believes 

that the lead NAAQS is a reasonable benchmark to evaluate the 

potential for multipathway health effects from lead.

Finally, as noted in the risk assessment document, there is no 

RfD or other comparable chronic health benchmark value for lead 

compounds. That is, in 1988, the EPA’s IRIS program reviewed the 

health effects data regarding lead and its inorganic compounds and 

determined that it would be inappropriate to develop an RfD for 

these compounds, saying, “A great deal of information on the health 

effects of lead has been obtained through decades of medical 

observation and scientific research. This information has been 
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assessed in the development of air and water quality criteria by the 

Agency's Office of Health and Environmental Assessment (OHEA) in 

support of regulatory decision-making by the Office of Air Quality 

Planning and Standards (OAQPS) and by the Office of Drinking Water 

(ODW). By comparison to most other environmental toxicants, the 

degree of uncertainty about the health effects of lead is quite low. 

It appears that some of these effects, particularly changes in the 

levels of certain blood enzymes and in aspects of children's 

neurobehavioral development, may occur at blood lead levels so low 

as to be essentially without a threshold. The agency's RfD Work 

Group discussed inorganic lead (and lead compounds) at two meetings 

(07/08/1985 and 07/22/1985) and considered it inappropriate to 

develop an RfD for inorganic lead.” The EPA’s IRIS assessment for 

Lead and compounds (inorganic) (CASRN 7439-92-1), 

http://www.epa.gov/iris/subst/0277.htm.

Comment: One commenter stated that the EPA must include a plain 

language statement of health risks and benefits of the proposed 

rule. As part of its rulemaking proposal, the EPA should include a 

plain statement of the health impacts and risks at issue. For 

example, the commenter stated that the MIR and chronic and risk 

numbers are not easily understandable by the general public; the IQ 

point losses at stake or how it is setting a standard to address 

these are not discussed, and the types of cancer or the nature of 
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the health disorders or other adverse effects that most of these 

types of HAP emissions present to the public are not discussed. The 

commenter stated that this type of “[e]xpanded discussion is 

important to understanding the ‘real-world’ risk, including dealing 

with health disparities.” SAB May 2010 at 50. 

A full elaboration of the types of health impacts at issue 

here, ranging from significant IQ loss (due to lead emissions), to a 

high lifetime cancer risk (from non-lead emissions), for this 

particular community, is needed to inform the EPA’s and the public’s 

consideration of what level of risk is acceptable or unacceptable, 

and what standard is required to provide an ample margin of safety.

Response: The EPA strives to communicate its health and risk 

information to the public in a manner that is concise, informative, 

and readily understandable. In the risk assessment document, we 

discuss the various metrics used to characterize risk associated 

with the source category (e.g., see section 2.3 of the risk 

assessment document for a discussion of the MIR). Moreover, while 

the commenter is correct that we do not discuss in detail the 

neurological effects associated with exposure to lead (e.g., loss of 

IQ points in children), we do reference the final lead NAAQS 

decision, which does discuss in detail the health effects associated 

with lead exposure. With regard to how the proposed controls limit 

the health risks associated with lead exposure, we noted in the 
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preamble that the proposed controls would ensure that the facility’s 

contribution to ambient concentrations of lead were at or below the 

NAAQS for lead and that this represents an acceptable level of risk 

since the lead NAAQS was set to protect public health, including the 

health of sensitive populations (e.g., children), from the adverse 

health effects associated with lead exposure. In addition, as 

discussed previously, we concluded that the same level of controls 

would also provide an ample margin of safety.

With regard to discussing specific types of cancers potentially 

associated with exposure to a given HAP, we note that the cancer 

unit risk estimates used in the risk assessment are not associated 

with specific types of cancers, but rather with the risk of cancer 

in general. Moreover, since many of the cancer studies the unit risk 

estimates take into account are animal studies, there is appreciable 

uncertainty as to whether the same types of cancers would be seen in 

humans. Thus, we find it appropriate to express the results of our 

cancer assessment in terms of general cancer risk. 

VI. Impacts of the Final Rule

The revisions to the Primary Lead Processing MACT standard will 

ensure that emissions from the one source in this source category do 

not present an unacceptable level of risk and will also provide an 

ample margin of safety. The estimated reductions include a reduction 

in fugitive dust emissions of lead and as much as 10 tons per year of 
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lead from the furnace area and refining operations stacks. These 

controls will also reduce emissions of other HAP emitted from the 

facility. The costs of controls were not directly considered in the 

decision to require work practice standards and fenceline compliance 

monitoring to address fugitive emissions or to add an emission 

standard for furnace area and refining emissions because these

requirements are necessary to bring risk to an acceptable level.

However, as an example the cost for paving all unpaved roads at the 

facility to control fugitive emissions would be around $800,000. The 

EPA evaluated control practices and technology and associated costs 

in determining that the same requirements needed to achieve 

acceptable risks would also provide an ample margin of safety with 

regard to fugitive dust emissions and emissions from the furnace area 

and refining stacks. In addition, we considered other available 

practices, processes and control technologies. For the same reason we 

concluded that no additional controls were necessary to provide an 

ample margin of safety for the fugitive dust and refining and furnace 

area stacks, we concluded that there were no additional cost 

effective developments in practices, processes or control 

technologies for those emission sources. 

VII. Statutory and Executive Order Reviews

A. Executive Orders 12866: Regulatory Planning and Review, and 
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Executive Order 13563: Improving Regulation and Regulatory Review

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 

action is a “significant regulatory action.” This action is a 

significant regulatory action because it raises novel legal and 

policy issues. Accordingly, the EPA submitted this action to the 

Office of Management and Budget (OMB) for review under Executive 

Order 12866 and Executive Order 13563 (76 FR 3821, January 21, 2011), 

and any changes made in response to OMB recommendations have been 

documented in the docket for this action.

B. Paperwork Reduction Act

The Office of Management and Budget (OMB) has approved the 

information collection requirements contained in this rule under the 

provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and 

has assigned OMB control number 2060-0414. 

The information requirements are based on notification, 

recordkeeping, and reporting requirements in the NESHAP General 

Provisions (40 CFR part 63, subpart A), which are mandatory for all 

operators subject to national emission standards. These recordkeeping 

and reporting requirements are specifically authorized by section 114 

of the CAA (42 U.S.C. 7414). All information submitted to the EPA

pursuant to the recordkeeping and reporting requirements for which a 

claim of confidentiality is made is safeguarded according to agency 

policies set forth in 40 CFR part 2, subpart B.
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This final rule includes new paperwork requirements for 

monitoring for lead concentrations in air and increased frequency for 

stack testing as described in 40 CFR 63.1547(k) (compliance 

monitoring) and 40 CFR 63.1546 (stack testing). Although these are 

additional requirements under the final rule, they are consistent 

with existing monitoring and testing currently conducted by the 

facility to meet MACT and SIP requirements and would not constitute 

an undue burden to the facility.

When a malfunction occurs, sources must report them according to 

the applicable reporting requirements of 40 CFR part 63, subpart TTT.

An affirmative defense to civil penalties for exceedances of emission 

limits that are caused by malfunctions is available to a source if it 

can demonstrate that certain criteria and requirements are satisfied.

The criteria ensure that the affirmative defense is available only 

where the event that causes an exceedance of the emission limit meets 

the narrow definition of malfunction in 40 CFR 63.2 (sudden, 

infrequent, not reasonable preventable, and not caused by poor 

maintenance and or careless operation) and where the source took 

necessary actions to minimize emissions. In addition, the source must 

meet certain notification and reporting requirements. For example, 

the source must prepare a written root cause analysis and submit a 

written report to the Administrator documenting that it has met the 

conditions and requirements for assertion of the affirmative defense.
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The EPA is adding affirmative defense to the estimate of burden 

in the ICR. To provide the public with an estimate of the relative 

magnitude of the burden associated with an assertion of the 

affirmative defense position adopted by a source, the EPA has 

provided administrative adjustments to the ICR that show what the 

notification, recordkeeping, and reporting requirements associated 

with the assertion of the affirmative defense might entail. The EPA’s 

estimate for the required notification, reports, and records, 

including the root cause analysis, totals $3,141, and is based on the 

time and effort required of a source to review relevant data, 

interview plant employees, and document the events surrounding a 

malfunction that has caused an exceedance of an emission limit. The 

estimate also includes time to produce and retain the record and 

reports for submission to the EPA. The EPA provides this illustrative 

estimate of this burden, because these costs are only incurred if 

there has been a violation, and a source chooses to take advantage of 

the affirmative defense.

Given the variety of circumstances under which malfunctions 

could occur, as well as differences among sources' operation and 

maintenance practices, we cannot reliably predict the severity and 

frequency of malfunction-related excess emissions events for a

particular source. It is important to note that the EPA has no basis 

currently for estimating the number of malfunctions that would 
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qualify for an affirmative defense. Current historical records would 

be an inappropriate basis, as source owners or operators previously 

operated their facilities in recognition that they were exempt from 

the requirement to comply with emissions standards during 

malfunctions. Of the number of excess emission events reported by 

source operators, only a small number would be expected to result 

from a malfunction (based on the definition above), and only a subset 

of excess emissions caused by malfunctions would result in the source 

choosing to assert the affirmative defense. Thus, we believe the 

number of instances in which source operators might be expected to 

avail themselves of the affirmative defense will be extremely small.

For this reason, we estimate no more than 2 or 3 such occurrences for 

all sources subject to 40 CFR part 63, subpart TTT over the 3-year 

period covered by this ICR. We expect to gather information on such 

events in the future, and will revise this estimate as better 

information becomes available.

For the Primary Lead Processing MACT standard, the ICR document 

prepared by the EPA, which has been revised to include the amendments 

to the standards, has been assigned the EPA ICR number 1856.07.

Burden changes associated with these amendments result from the 

reporting and recordkeeping requirements of the affirmative defense 

provisions and the lead concentration in air limit added to the rule.

The change in respondents’ annual reporting and recordkeeping burden 
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associated with these amendments for this collection (averaged over 

the first 3 years after the effective date of the standards) is 

estimated to be 30 labor hours at a cost of $3,141 per year for the 

affirmative defense reporting and recordkeeping provisions and 1,313

labor hours at a cost of $461,640 per year for the lead concentration 

in air limit reporting and recordkeeping provisions. There will be no 

capital costs associated with the information collection requirements 

of the final rule. There is no estimated change in annual burden to 

the Federal government for these amendments. Burden is defined at 5 

CFR 1320.3(b)

An agency may not conduct or sponsor, and a person is not 

required to respond to, a collection of information unless it 

displays a currently valid OMB control number. The OMB control 

numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. 

In addition, EPA is amending the table in 40 CFR part 9 of currently 

approved OMB control numbers for various regulations to list the 

regulatory citations for the information requirements contained in 

this final rule.

C. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) generally requires an 

agency to prepare a regulatory flexibility analysis of any rule 

subject to notice and comment rulemaking requirements under the 

Administrative Procedure Act, or any other statute, unless the agency
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certifies that the rule will not have a significant economic impact 

on a substantial number of small entities. Small entities include 

small businesses, small organizations, and small governmental 

jurisdictions.

For purposes of assessing the impact of these final rules on 

small entities, small entity is defined as: (1) a small business as 

defined by the Small Business Administration’s regulations at 13 CFR 

121.201; (2) a small governmental jurisdiction that is a government 

of a city, county, town, school district, or special district with a 

population of less than 50,000; and (3) a small organization that is 

any not-for-profit enterprise which is independently owned and 

operated and is not dominant in its field.

After considering the economic impacts of these final rules on 

small entities, I certify that this action will not have a 

significant economic impact on a substantial number of small 

entities. This final action will not impose any requirements on small 

entities. The costs associated with the new requirements in these 

final rules are not expected to present an undue burden to this 

industry as discussed above. 

D. Unfunded Mandates Reform Act 

This action contains no Federal mandates under the provisions of 

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 

1531-1538 for State, local, or tribal governments or the private 
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sector. The action imposes no enforceable duty on any State, local 

or tribal governments or the private sector. Therefore, this action 

is not subject to the requirements of sections 202 or 205 of the 

UMRA.

These rules are also not subject to the regulatory requirements 

that might significantly or uniquely affect small governments. They 

contain no requirements that apply to such governments or impose 

obligations upon them.

E. Executive Order 13132: Federalism

This action does not have federalism implications. It will not 

have substantial direct effects on the States, on the relationship 

between the national government and the States, or on the 

distribution of power and responsibilities among the various levels 

of government, as specified in Executive Order 13132. These final 

rules primarily affect private industry, and do not impose 

significant economic costs on State or local governments. Thus, 

Executive Order 13132 does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian 

Tribal Governments

This action does not have tribal implications, as specified in 

Executive Order 13175 (65 FR 67249, November 9, 2000). It will not 

have substantial direct effect on tribal governments, on the 

relationship between the Federal government and Indian tribes, or on 
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the distribution of power and responsibilities between the Federal 

government and Indian tribes, as specified in Executive Order 13175.

Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental 

Health Risks and Safety Risks

This action is not subject to Executive Order 13045 (62 FR

19885, April 23, 1997), because it is not economically significant as 

defined in Executive Order 12866. However, the agency does believe 

there is a disproportionate risk to children. Modeled ambient air 

lead concentrations from the one facility in this source category are 

in excess of the NAAQS for lead, which was set to “provide increased 

protection for children and other at-risk populations against an 

array of adverse health effects, most notably including neurological 

effects in children, including neurocognitive and neurobehavioral 

effects.” 73 FR 67007. However, the control measures promulgated in 

this notice will result in lead concentration levels that are in 

compliance with the lead NAAQS, thereby mitigating the risk of 

adverse health effects to children.

H. Executive Order 13211: Actions Concerning Regulations That 

Significantly Affect Energy Supply, Distribution, or Use

This action is not a “significant energy action” as defined in

Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not 

likely to have a significant adverse energy effect on the supply, 
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distribution, or use of energy. This action will not create any new 

requirements for sources in the energy supply, distribution, or use 

sectors. Further, we have concluded that these final rules are not 

likely to have any adverse energy effects.

I. National Technology Transfer and Advancement Act

Section 12(d) of the National Technology Transfer and 

Advancement Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 

U.S.C. 272 note) directs the EPA to use voluntary consensus standards 

(VCS) in its regulatory activities, unless to do so would be 

inconsistent with applicable law or otherwise impractical. VCS are 

technical standards (e.g., materials specifications, test methods, 

sampling procedures, and business practices) that are developed or 

adopted by VCS bodies. NTTAA directs the EPA to provide Congress, 

through OMB, explanations when the agency decides not to use 

available and applicable VCS. 

This action does not involve technical standards. Therefore, the 

EPA did not consider the use of any VCS.

J. Executive Order 12898: Federal Actions To Address Environmental 

Justice in Minority Populations and Low-Income Populations

Executive Order 12898 (59 FR 7629, February 16, 1994) 

establishes Federal executive policy on environmental justice. Its 

main provision directs Federal agencies, to the greatest extent 

practicable and permitted by law, to make environmental justice part 
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of their mission by identifying and addressing, as appropriate, 

disproportionately high and adverse human health or environmental 

effects of their programs, policies, and activities on minority 

populations and low-income populations in the United States.

The EPA has determined that this final rule will not have 

disproportionately high and adverse human health or environmental 

effects on minority or low-income populations, because it does not 

decrease the level of protection provided to human health or the 

environment, but in fact decreases emissions of lead. To examine the 

potential for any environmental justice issues that might be 

associated with this rule, we evaluated the distributions of HAPrelated cancer and non-cancer risks across different social, 

demographic, and economic groups within the populations living near 

the one facility that is currently operating in this source category.

Our analyses also show that, although there is potential for an 

adverse environmental and human health effects from emission of lead, 

it does not indicate any significant potential for disparate impacts 

to the specific demographic groups analyzed.

The rule would require additional control measures to address 

the identified environmental and health risks and would therefore, 

decrease risks to any populations exposed to these sources.

K. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801, et seq., as added by 
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the Small Business Regulatory Enforcement Fairness Act of 1996, 

generally provides that, before a rule may take effect, the agency 

promulgating the rule must submit a rule report, which includes a 

copy of the rule, to each House of the Congress and to the 

Comptroller General of the United States. The EPA will submit a 

report containing this final rule and other required information to 

the United States Senate, the United States House of Representatives, 

and the Comptroller General of the United States prior to publication 

of the final rule in the Federal Register. A major rule cannot take 

effect until 60 days after it is published in the Federal Register.

This action is not a “major rule” as defined by 5 U.S.C. 804(2). The 

final rules will be effective on [INSERT DATE OF PUBLICATION].
National Emission Standards for Hazardous Air Pollutant 

Emissions for Primary Lead Processing--Page 92 of 130

List of Subjects for 40 CFR Part 63

Environmental protection, Administrative practice and 

procedures, Air pollution control, Hazardous substances, 

Intergovernmental relations, Reporting and recordkeeping 

requirements.

______________

Dated: XXXXX XX, 2011.

________________________

Lisa P. Jackson,

Administrator.
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For the reasons stated in the preamble, the Environmental 

Protection Agency proposes to amend title 40, chapter I, of the 

Code of Federal Regulations as follows:

PART 63-–[AMENDED]

1. The authority citation for part 63 continues to read 

as follows:

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

Subpart TTT—[AMENDED]

§63.1541 Applicability.

(a) The provisions of this subpart apply to any facility 

engaged in producing lead metal from ore concentrates. The 

category includes, but is not limited to, the following smelting 

processes: sintering, reduction, preliminary treatment, refining 

and casting operations, process fugitive sources, and fugitive 

dust sources. The sinter process includes an updraft or 

downdraft sintering machine. The reduction process includes the 

blast furnace, electric smelting furnace with a converter or 

reverberatory furnace, and slag fuming furnace process units.

The preliminary treatment process includes the drossing kettles 

and dross reverberatory furnace process units. The refining 

process includes the refinery process unit. The provisions of 

this subpart do not apply to secondary lead smelters, lead 

refiners, or lead remelters.
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(b) Table 1 of this subpart specifies the provisions of 

subpart A of this part that apply and those that do not apply to 

owners and operators of primary lead processors.

3. Section 63.1542 is amended by adding a definition for 

“Affirmative defense,” “Lead refiner,” “Lead remelter,” “Primary 

lead processor,” and “Secondary lead smelter;” deleting the 

definition of “Primary lead smelter;” and revising the 

definitions of ”Fugitive dust source,” “Furnace area,” 

“Malfunction,” “Materials storage and handling area,” “Plant 

roadway,” “Process fugitive source,” “Refining and casting 

area,” “Sinter machine area,” and “Tapping location” to read as 

follows:

§63.1542 Definitions.

* * * * *

 Affirmative defense means, in the context of an enforcement 

proceeding, a response or defense put forward by a defendant, 

regarding which the defendant has the burden of proof, and the 

merits of which are independently and objectively evaluated in a 

judicial or administrative proceeding.

* * * * *

 Fugitive dust source means a stationary source of hazardous 

air pollutant emissions at a primary lead processor resulting 

from the handling, storage, transfer, or other management of 

lead-bearing materials where the source is not part of a 
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specific process, process vent, or stack. Fugitive dust sources 

include roadways, storage piles, materials handling transfer 

points, and materials transport areas.

 Furnace area means any area of a primary lead processor in 

which a blast furnace or dross furnace is located.

 Lead refiner means any facility that refines lead metal that 

is not located at a primary lead processor.

 Lead remelter means any facility that remelts lead metal 

that is not located at a primary lead processor. 

 Malfunction means any sudden, infrequent, and not reasonably 

preventable failure of air pollution control and monitoring 

equipment, process equipment, or a process to operate in a 

normal or usual manner which causes, or has the potential to 

cause, the emission limitations in an applicable standard to be 

exceeded. Failures that are caused in part by poor maintenance 

or careless operation are not malfunctions.

 Materials storage and handling area means any area of a 

primary lead processor in which lead-bearing materials 

(including ore concentrate, sinter, granulated lead, dross, 

slag, and flue dust) are stored or handled between process 

steps, including areas in which materials are stored in piles, 

bins, or tubs, and areas in which material is prepared for 

charging to a sinter machine or smelting furnace or other lead

processing operation.
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* * * * *

 Plant roadway means any area of a primary lead processor 

that is subject to vehicle traffic, including traffic by 

forklifts, front-end loaders, or vehicles carrying ore 

concentrates or cast lead ingots. Excluded from this definition 

are employee and visitor parking areas, provided they are not 

subject to traffic by vehicles carrying lead-bearing materials. 

 Primary lead processor means any facility engaged in the 

production of lead metal from lead sulfide ore concentrates 

through the use of pyrometallurgical or other techniques.

 Process fugitive source means a source of hazardous air 

pollutant emissions at a primary lead processor that is 

associated with lead smelting, processing or refining but is not 

the primary exhaust stream and is not a fugitive dust source. 

Process fugitive sources include sinter machine charging 

locations, sinter machine discharge locations, sinter crushing 

and sizing equipment, furnace charging locations, furnace taps, 

and drossing kettle and refining kettle charging or tapping 

locations.

 Refining and casting area means any area of a primary lead 

processor in which drossing or refining operations occur, or 

casting operations occur.

 Secondary lead smelter means any facility at which leadbearing scrap material, primarily, but not limited to, lead-acid 
Page 97 of 130

batteries, is recycled into elemental lead or lead alloys by 

smelting.

* * * * *

 Sinter machine area means any area of a primary lead 

processor where a sinter machine, or sinter crushing and sizing 

equipment is located.

* * * * *

 Tapping location means the opening through which lead and 

slag are removed from the furnace.

4. Section 63.1543 is revised to read as follows:

§63.1543 Standards for process and process fugitive sources.

(a) No owner or operator of any existing, new, or 

reconstructed primary lead processor shall discharge or cause to 

be discharged into the atmosphere lead compounds in excess of 

0.97 pounds per ton of lead metal produced from the aggregation 

of emissions discharged from air pollution control devices used 

to control emissions from the sources listed in paragraphs 

(a)(1) through (a)(9) of this section.

(1) Sinter machine;

(2) Blast furnace;

(3) Dross furnace;

(4) Dross furnace charging location;

(5) Blast furnace and dross furnace tapping location;
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(6) Sinter machine charging location;

(7) Sinter machine discharge end;

(8) Sinter crushing and sizing equipment; and

(9) Sinter machine area.

(b) No owner or operator of any existing, new, or 

reconstructed primary lead processor shall discharge or cause to 

be discharged into the atmosphere lead compounds in excess of 

1.2 tons per year from the aggregation of the air pollution 

control devices used to control emissions from furnace area and 

refining and casting operations.

(c) The process fugitive sources listed in paragraphs 

(a)(4) through (a)(8) of this section must be equipped with a 

hood and must be ventilated to a baghouse or equivalent control 

device. The hood design and ventilation rate must be consistent 

with American Conference of Governmental Industrial Hygienists 

recommended practices.

(d) The sinter machine area must be enclosed in a building 

that is ventilated to a baghouse or equivalent control device at 

a rate that maintains a positive in-draft through any doorway 

opening.

(e) Except as provided in paragraph (f) of this section, 

following the initial tests to demonstrate compliance with 

paragraphs (a) and (b) of this section, the owner or operator of 

a primary lead processor must conduct compliance tests for lead 
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compounds on an quarterly basis (no later than 100 days 

following any previous compliance test).

(f) If the 12 most recent compliance tests demonstrate 

compliance with the emission limit specified in paragraphs (a) 

and (b) of this section, the owner or operator of a primary lead 

processor shall be allowed up to 12 calendar months from the 

last compliance test to conduct the next compliance test for 

lead compounds.

(g) The owner or operator of a primary lead processor must 

maintain and operate each baghouse used to control emissions 

from the sources listed in paragraphs (a)(1) through (a)(9) and 

(b) of this section such that the alarm on a bag leak detection 

system required under §63.1547(c)(8) does not sound for more 

than five percent of the total operating time in a 6-month 

reporting period.

(h) The owner or operator of a primary lead processor must 

record the date and time of a bag leak detection system alarm 

and initiate procedures to determine the cause of the alarm 

according to the corrective action plan required under 

§63.1547(f) within 1 hour of the alarm. The cause of the alarm 

must be corrected as soon as practicable.

(i) At all times, the owner or operator must operate and 

maintain any affected source, including associated air pollution 
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control equipment and monitoring equipment, in a manner 

consistent with safety and good air pollution control practices 

for minimizing emissions. Determination of whether such 

operation and maintenance procedures are being used will be 

based on information available to the Administrator which may 

include, but is not limited to, monitoring results, review of 

operation and maintenance procedures, review of operation and 

maintenance records, and inspection of the source.

5. Section 63.1544 is revised to read as follows:

§63.1544 Standards for fugitive dust sources.

(a) Each owner or operator of any existing, new or 

reconstructed primary lead processor must adopt and implement 

work practice standards or other measures to reduce fugitive 

dust emissions sufficient to ensure that lead levels in the air 

at the fenceline do not exceed 0.15 μg/m3 on a 3-month rolling 

average.

(b) Consistent with the requirements in section 

63.1547(k), each owner or operator of any existing, new or 

reconstructed primary lead processor must establish a monitoring 

network at locations approved by the Administrator to ensure 

compliance with the requirements of paragraph (a). 

(c) At all times, the owner or operator must operate and 

maintain any affected source, including associated air pollution 
Page 101 of 130

control equipment and monitoring equipment, in a manner 

consistent with safety and good air pollution control practices 

for minimizing emissions. Determination of whether such 

operation and maintenance procedures are being used will be 

based on information available to the Administrator which may 

include, but is not limited to, monitoring results, review of 

operation and maintenance procedures, review of operation and 

maintenance records, and inspection of the source.

6. Section 63.1545 is revised to read as follows:

§63.1545 Compliance dates.

(a) Each owner or operator of an existing primary lead 

processor must achieve compliance with the requirements in 

§16.1543(a) no later than [INSERT DATE 60 DAYS FROM THE DATE OF 

PUBLICATION OF THESE AMENDMENTS IN THE FEDERAL REGISTER]. Each 

owner or operator of an existing primary lead processor must 

achieve compliance with the requirements in § 63.1543(b), §

63.1543(e), and § 63.1544 of this subpart no later than [INSERT 

DATE TWO YEARS FROM THE DATE OF PUBLICATION OF THESE AMENDMENTS 

IN THE FEDERAL REGISTER].

(b) Each owner or operator of a new primary lead processor

must achieve compliance with the requirements of this subpart no 

later than [INSERT DATE 60 DAYS AFTER PUBLICATION OF THESE 

AMENDMENTS IN THE FERERAL REGISTER] or startup, whichever is 

later.
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(c) Prior to the dates specified in §63.1545(a), each owner 

or operator of an existing primary lead processor must continue 

to comply with the requirements of §63.1543 and §63.1544 as 

promulgated in the June 4, 1999 NESHAP for Primary Lead 

Smelting.

(d) Each owner or operator of an existing primary lead 

processor must comply with the requirements of 63.1547(g)(1), 

63.1547(g)(2), 63.1551, and the revisions to Table 1 of Subpart 

TTT of Part 63 on [INSERT DATE OF PUBLICATION OF THESE 

AMENDMENTS IN THE FEDERAL REGISTER].

7. Section 63.1546 is revised to read as follows:

§63.1546 Performance testing.

(a) The following procedures must be used to determine 

quarterly compliance with the emissions standard for lead 

compounds under §63.1543(a) and (b) for existing sources:

(1) Each owner or operator of existing sources listed in 

§63.1543(a)(1) through (9) and (b) must determine the lead 

compound emissions rate, in units of pounds of lead per hour 

according to the following test methods in appendix A of part 60 

of this chapter:

(i) Method 1 must be used to select the sampling port 

location and the number of traverse points.

(ii) Method 2, 2F, 2G must be used to measure volumetric 

flow rate.
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(iii) Method 3, 3A, 3B must be used for gas analysis.

(iv) Method 4 must be used to determine moisture content of 

the stack gas.

(v) Method 12 or Method 29 must be used to determine lead 

emissions rate of the stack gas.

(2) A performance test shall consist of at least three 

runs. For each test run with Method 12 or Method 29, the minimum 

sample time must be 60 minutes and the minimum volume must be 1 

dry standard cubic meter (35 dry standard cubic feet).

(3) Performance tests shall be completed quarterly, once 

every 3 months, to determine compliance.

(4) The lead emission rate in pounds per quarter is 

calculated by multiplying the quarterly lead emission rate in 

pounds per hour by the quarterly plant operating time, in hours 

as shown in Equation 1:

(Eq. 1)

Where: 

EPb = quarterly lead emissions, pounds per quarter;

ERPb = quarterly lead emissions rate, pounds per hour; and

QPOT = quarterly plant operating time, hours per quarter.

(5) The lead production rate, in units of tons per 

quarter, must be determined based on production data for the 

previous quarter according to the procedures detailed in 

paragraphs (a)(5)(i) through (iv) of this section:
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(i) Total lead products production multiplied by the 

fractional lead content must be determined in units of tons.

(ii) Total copper matte production multiplied by the 

fractional lead content must be determined in units of tons.

(iii) Total copper speiss production multiplied by the 

fractional lead content must be determined in units of tons.

(iv) Total quarterly lead production must be determined by

summing the values obtained in paragraphs (a)(5)(i) through 

(a)(5)(iii) of this section.

(6) To determine compliance with the production-based lead 

compound emission rate in §63.1543(a), the quarterly productionbased lead compound emission rate, in units of pounds of lead 

emissions per ton of lead produced, is calculated as shown in 

Equation 2 by dividing lead emissions by lead production.

(Eq. 2)

Where :

CEPb = quarterly production-based lead compound emission 

rate, in units of pounds of lead emissions per ton of lead 

produced;

EPb = quarterly lead emissions, pounds per quarter; and

PPb = quarterly lead production, tons per quarter.

(7) To determine quarterly compliance with the emissions 

standard for lead compounds under §63.1543(b), sum the lead 
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compound emission rates for the current and previous three 

quarters for the sources in §63.1543 (b), as determined in 

accordance with paragraphs (a)(1) through (a)(4) of this 

section.

(b) Owner and operators must perform an initial compliance 

test to demonstrate compliance with the sinter building in-draft 

requirements of §63.1543(d) at each doorway opening in 

accordance with paragraphs (b)(1) through (b)(4) of this 

section.

(1) Use a propeller anemometer or equivalent device.

(2) Determine doorway in-draft by placing the anemometer in 

the plane of the doorway opening near its center.

(3) Determine doorway in-draft for each doorway that is 

open during normal operation with all remaining doorways in 

their customary position during normal operation.

(4) Do not determine doorway in-draft when ambient wind 

speed exceeds 2 meters per second.

(c) Performance tests shall be conducted under such 

conditions as the Administrator specifies to the owner or 

operator based on representative performance of the affected 

source for the period being tested. Upon request, the owner or 

operator shall make available to the Administrator such records 

as may be necessary to determine the conditions of performance 

tests.
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8. Section 63.1547 is revised to read as follows:

§63.1547 Monitoring requirements.

(a) Owners and operators of primary lead processors must 

prepare, and at all times operate according to, a standard 

operating procedures manual that describes in detail the 

procedures for inspection, maintenance, and bag leak detection 

and corrective action for all baghouses that are used to control 

process, process fugitive, or fugitive dust emissions from any 

source subject to the lead emission standards in §§63.1543 and 

63.1544, including those used to control emissions from general 

ventilation systems.

(b) The standard operating procedures manual for baghouses 

required by paragraph (a) of this section must be submitted to 

the Administrator or delegated authority for review and 

approval.

(c) The procedures specified in the standard operating 

procedures manual for inspections and routine maintenance must, 

at a minimum, include the requirements of paragraphs (c)(1) 

through (c)(8) of this section.

(1) Weekly confirmation that dust is being removed from 

hoppers through visual inspection or equivalent means of 

ensuring the proper functioning of removal mechanisms.

(2) Daily check of compressed air supply for pulse-jet 

baghouses.
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(3) An appropriate methodology for monitoring cleaning 

cycles to ensure proper operation.

(4) Monthly check of bag cleaning mechanisms for proper 

functioning through visual inspection or equivalent means.

(5) Quarterly visual check of bag tension on reverse air 

and shaker-type baghouses to ensure that bags are not kinked 

(kneed or bent) or laying on their sides. Such checks are not 

required for shaker-type baghouses using self-tensioning (spring 

loaded) devices.

(6) Quarterly confirmation of the physical integrity of the

baghouse through visual inspection of the baghouse interior for 

air leaks.

(7) Quarterly inspection of fans for wear, material 

buildup, and corrosion through visual inspection, vibration 

detectors, or equivalent means.

(8) Except as provided in paragraph (h) of this section, 

continuous operation of a bag leak detection system.

(d) The procedures specified in the standard operating 

procedures manual for maintenance must, at a minimum, include a 

preventative maintenance schedule that is consistent with the 

baghouse manufacturer's instructions for routine and long-term 

maintenance.
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(e) The bag leak detection system required by paragraph 

(c)(8) of this section must meet the specifications and 

requirements of (e)(1) through (e)(8) of this section.

(1) The bag leak detection system must be certified by the 

manufacturer to be capable of detecting particulate matter 

emissions at concentrations of 10 milligram per actual cubic 

meter (0.0044 grains per actual cubic foot) or less.

(2) The bag leak detection system sensor must provide 

output of relative particulate matter loadings, and the owner or 

operator must continuously record the output from the bag leak 

detection system.

(3) The bag leak detection system must be equipped with an 

alarm system that will sound when an increase in relative 

particulate loading is detected over a preset level, and the 

alarm must be located such that it can be heard or otherwise 

determined by the appropriate plant personnel.

(4) Each bag leak detection system that works based on the 

triboelectric effect must be installed, calibrated, and 

maintained in a manner consistent with guidance provided in the 

U.S. Environmental Protection Agency guidance document ”Fabric 

Filter Bag Leak Detection Guidance” (EPA-454/R-98-015). Other 

bag leak detection systems must be installed, calibrated, and 

maintained in a manner consistent with the manufacturer's 

written specifications and recommendations.
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(5) The initial adjustment of the system must, at a 

minimum, consist of establishing the baseline output by 

adjusting the sensitivity (range) and the averaging period of 

the device, and establishing the alarm set points and the alarm 

delay time.

(6) Following initial adjustment, the owner or operator 

must not adjust the sensitivity or range, averaging period, 

alarm set points, or alarm delay time, except as detailed in the 

approved SOP required under paragraph (a) of this section. In no 

event shall the sensitivity be increased by more than 100 

percent or decreased more than 50 percent over a 365-day period 

unless a responsible official certifies that the baghouse has 

been inspected and found to be in good operating condition.

(7) For negative pressure, induced air baghouses, and 

positive pressure baghouses that are discharged to the 

atmosphere through a stack, the bag leak detector must be 

installed downstream of the baghouse and upstream of any wet 

acid gas scrubber.

(8) Where multiple detectors are required, the system's 

instrumentation and alarm may be shared among detectors.

(f) The standard operating procedures manual required by 

paragraph (a) of this section must include a corrective action 

plan that specifies the procedures to be followed in the event 

of a bag leak detection system alarm. The corrective action plan 
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must include at a minimum, procedures to be used to determine 

the cause of an alarm, as well as actions to be taken to 

minimize emissions, which may include, but are not limited to, 

the following.

(1) Inspecting the baghouse for air leaks, torn or broken 

bags or filter media, or any other condition that may cause an 

increase in emissions.

(2) Sealing off defective bags or filter media.

(3) Replacing defective bags or filter media, or otherwise 

repairing the control device.

(4) Sealing off a defective baghouse compartment.

(5) Cleaning the bag leak detection system probe, or 

otherwise repairing or maintaining the bag leak detection 

system.

(6) Shutting down the process producing the particulate 

emissions.

(g) The percentage of total operating time the alarm on the 

bag leak detection system sounds in a 6-month reporting period 

must be calculated in order to determine compliance with the 

five percent operating limit in §63.1543(h). The percentage of 

time the alarm on the bag leak detection system sounds must be 

determined according to paragraphs (g)(1) through (g)(3) of this 

section.
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(1) For each alarm where the owner or operator initiates 

procedures to determine the cause of an alarm within 1 hour of 

the alarm, 1 hour of alarm time must be counted.

(2) For each alarm where the owner or operator does not 

initiate procedures to determine the cause of the alarm within 1 

hour of the alarm, alarm time will be counted as the actual 

amount of time taken by the owner or operator to initiate 

procedures to determine the cause of the alarm.

(3) The percentage of time the alarm on the bag leak 

detection system sounds must be calculated as the ratio of the 

sum of alarm times to the total operating time multiplied by 

100.

(h) Baghouses equipped with HEPA filters as a secondary 

filter used to control process or process fugitive sources 

subject to the lead emission standards in §63.1543 are exempt 

from the requirement in paragraph (c)(8) of this section to be 

equipped with a bag leak detector. The owner or operator of an 

affected source that uses a HEPA filter must monitor and record 

the pressure drop across the HEPA filter system daily. If the 

pressure drop is outside the limit(s) specified by the filter 

manufacturer, the owner or operator must take appropriate 

corrective measures, which may include, but not be limited to, 

the following:
Page 112 of 130

(1) Inspecting the filter and filter housing for air leaks 

and torn or broken filters.

(2) Replacing defective filter media, or otherwise 

repairing the control device.

(3) Sealing off a defective control device by routing air 

to other comparable control devices.

(4) Shutting down the process producing the particulate 

emissions.

(i) Owners and operators must monitor sinter machine 

building in-draft to demonstrate continued compliance with the 

operating standard specified in §63.1543(d) in accordance with 

either paragraph (i)(1), (i)(2), or (i)(3) of this section.

(1) Owners and operators must check and record on a daily 

basis doorway in-draft at each doorway in accordance with the 

methodology specified in §63.1546(b).

(2) Owners and operators must establish and maintain 

baseline ventilation parameters which result in a positive indraft according to paragraphs (i)(2)(i) through (i)(2)(iv) of 

this section.

(i) Owners and operators must install, calibrate, maintain, 

and operate a monitoring device that continuously records the 

volumetric flow rate through each separately ducted hood; or 

install, calibrate, maintain, and operate a monitoring device 

that continuously records the volumetric flow rate at the 
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control device inlet of each exhaust system ventilating the 

building. The flow rate monitoring device(s) can be installed in 

any location in the exhaust duct such that reproducible flow 

rate measurements will result. The flow rate monitoring 

device(s) must have an accuracy of plus or minus 10 percent over 

the normal process operating range and must be calibrated 

according to manufacturer's instructions.

(ii) During the initial demonstration of sinter building 

in-draft, and at any time the owner or operator wishes to reestablish the baseline ventilation parameters, the owner or 

operator must continuously record the volumetric flow rate 

through each separately ducted hood, or continuously record the 

volumetric flow rate at the control device inlet of each exhaust 

system ventilating the building and record exhaust system damper 

positions. The owner or operator must determine the average 

volumetric flow rate(s) corresponding to the period of time the 

in-draft compliance determinations are being conducted.

(iii) The owner or operator must maintain the volumetric 

flow rate(s) at or above the value(s) established during the 

most recent in-draft determination at all times the sinter 

machine is in operation. Volumetric flow rate(s) must be 

calculated as a 15-minute average.

(iv) If the volumetric flow rate is monitored at the 

control device inlet, the owner or operator must check and 
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record damper positions daily to ensure they are in the 

positions they were in during the most recent in-draft 

determination.

(3) An owner or operator may request an alternative 

monitoring method by following the procedures and requirements 

in §63.8(f) of the General Provisions.

(j) Each owner or operator of new or modified sources 

listed under §63.1543 (a)(1) through (a)(9) and (b) must 

install, calibrate, maintain, and operate a continuous emission 

monitoring system (CEMS) for measuring lead emissions and a 

continuous emission rate monitoring system (CERMS)subject to 

Performance Specification 6 of Appendix B to part 60.

(1) Each owner or operator of a source subject to the 

emissions limits for lead compounds under §63.1543(a)and (b) 

must install a CEMS for measuring lead emissions within 180 days 

of promulgation of performance specifications for lead CEMS.

(i) Prior to promulgation of performance specifications for 

CEMS used to measure lead concentrations, an owner or operator 

must use the procedure described in §63.1546 (a)(1) through 

(a)(7) of this section to determine compliance. 

(2) If a CEMS used to measure lead emissions is applicable, 

the owner or operator must install a CERMS with a sensor in a 

location that provides representative measurement of the exhaust 

gas flow rate at the sampling location of the CEMS used to 
Page 115 of 130

measure lead emissions, taking into account the manufacturer’s 

recommendations. The flow rate sensor is that portion of the 

system that senses the volumetric flow rate and generates an 

output proportional to that flow rate.

(i) The CERMS must be designed to measure the exhaust gas 

flow rate over a range that extends from a value of at least 20 

percent less than the lowest expected exhaust flow rate to a 

value of at least 20 percent greater than the highest expected 

exhaust gas flow rate. 

(ii) The CERMS must be equipped with a data acquisition and 

recording system that is capable of recording values over the 

entire range specified in paragraph (b)(2)(i) of this section. 

(iii) Each owner or operator must perform an initial 

relative accuracy test of the CERMS in accordance with the 

applicable Performance Specification in Appendix B to part 60 of 

the chapter. 

(iv) Each owner or operator must operate the CERMS and 

record data during all periods of operation of the affected 

facility including periods of startup, shutdown, and 

malfunction, except for periods of monitoring system 

malfunctions, repairs associated with monitoring system 

malfunctions, and required monitoring system quality assurance 

or quality control activities (including, as applicable, 

calibration checks and required zero and span adjustments.
Page 116 of 130

(3) Each owner or operator must calculate the lead 

emissions rate in tons per year by summing all hours of CEMS 

data for a year to determine compliance with 63.1543 (b).

(i) When the CERMS are unable to provide quality assured 

data the following applies:

(A) When data are not available for periods of up to 48 

hours, the highest recorded hourly emission rate from the 

previous 24 hours must be used.

(B) When data are not available for 48 or more hours, the 

maximum daily emission rate based on the previous 30 days must 

be used.

(k) The owner or operator of each source subject to 

§63.1544(a) must operate a continuous monitoring system for the 

measurement of lead compound concentrations in air.

(1) The owner or operator must operate compliance monitors 

sufficient in number, location, and frequency of sample 

collection to detect expected maximum concentrations of lead 

compounds in air due to emissions from the affected source(s) in 

accordance with a written plan as described in (k)(2) of this 

paragraph and approved by the Administrator. The plan must 

include descriptions of the sampling and analytical methods 

used. The plan may take into consideration existing monitoring 

being conducted under a state monitoring plan in accordance with 

Part 58.
Page 117 of 130

(2) The owner or operator must submit a written plan 

describing and explaining the basis for the design and adequacy 

of the compliance monitoring network, the sampling, analytical, 

and quality assurance procedures, and any other related 

procedures, and the justification for any seasonal, background, 

or other data adjustments within 45 days after the effective 

date of this subpart. 

(3) The Administrator at any time may require changes in, 

or expansion of, the monitoring program, including additional 

sampling and analytical protocols and network design.

(l) If all rolling three-month average concentrations of 

lead in air measured by the compliance monitoring system are 

less than [50 percent] of the lead concentration in air limit in 

§63.1544(a) for three consecutive years, the owner or operator 

may submit a revised plan to reduce the monitoring sampling and 

analysis frequency (e.g., from daily to weekly).

For any subsequent period, if any rolling three-month 

average lead concentration in air measured at any monitor in the 

monitoring system exceeds [50 percent] of the concentration 

limit in §63.1544(a), the owner or operator must resume 

monitoring pursuant to paragraph (k)(1) at all monitors until 

another three consecutive years of lead concentration in air 
Page 118 of 130

measurements less than [50 percent] of the lead concentration in 

air limit is demonstrated.

9. Section 63.1548 is revised to read as follows:

§63.1548 Notification requirements.

(a) The owner or operator of a primary lead processor must 

comply with the notification requirements of §63.9 of subpart A, 

General Provisions as specified in Table 1 of this subpart.

(b) The owner or operator of a primary lead processor must 

submit the standard operating procedures manual for baghouses 

required under §63.1547(a) to the Administrator or delegated 

authority along with a notification that the primary lead 

processor is seeking review and approval of the manual and 

procedures. Owners or operators of existing primary lead 

processors must submit this notification no later than November 

6, 2000. The owner or operator of a primary lead processor that 

commences construction or reconstruction after April 17, 1998, 

must submit this notification no later than 180 days before 

startup of the constructed or reconstructed primary lead 

processor, but no sooner than September 2, 1999.

(c) The owner or operator of a primary lead processor must 

submit the compliance monitoring network plan required under 

§63.1547(k)(2) to the Administrator or delegated authority along 

with a notification that the primary lead processor is seeking 

review and approval of the plan. Owners or operators of existing 
Page 119 of 130

primary lead processors must submit this notification no later 

than 45 days after promulgation of this subpart. The owner or 

operator of a new, reconstructed, or modified primary lead 

processor must submit this notification no later than 180 days 

before startup of the constructed or reconstructed primary lead 

processor.

10. Section 63.1549 is revised to read as follows:

§63.1549 Recordkeeping and reporting requirements.

(a) The owner or operator of a primary lead processor must 

comply with the recordkeeping requirements of §63.10 of subpart 

A, General Provisions as specified in Table 1 of this subpart.

(b) In addition to the general records required by 

paragraph (a) of this section, each owner or operator of a 

primary lead processor must maintain for a period of 5 years, 

records of the information listed in paragraphs (b)(1) through 

(b)(10) of this section.

(1) Production records of the weight and lead content of 

lead products, copper matte, and copper speiss.

(2) Records of the bag leak detection system output.

(3) An identification of the date and time of all bag leak 

detection system alarms, the time that procedures to determine 

the cause of the alarm were initiated, the cause of the alarm, 

an explanation of the actions taken, and the date and time the 

cause of the alarm was corrected.
Page 120 of 130

(4) Any recordkeeping required as part of the requirements 

described in the compliance monitoring system plan required 

under §63.1547(k)(2).

(5) Any recordkeeping required as part of the practices 

described in the standard operating procedures manual for 

baghouses required under §63.1547(a).

(6) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(1), the records of the daily doorway in-draft 

checks, an identification of the periods when there was not a 

positive in-draft, and an explanation of the corrective actions 

taken.

(7) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(2), the records of the output from the continuous 

volumetric flow monitor(s), an identification of the periods 

when the 15-minute volumetric flow rate dropped below the 

minimum established during the most recent in-draft 

determination, and an explanation of the corrective actions 

taken.

(8) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 
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requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(2), and volumetric flow rate is monitored at the 

baghouse inlet, records of the daily checks of damper positions, 

an identification of the days that the damper positions were not 

in the positions established during the most recent in-draft 

determination, and an explanation of the corrective actions 

taken.

(9) Records of the occurrence and duration of each 

malfunction of operation (i.e., process equipment) or the air 

pollution control equipment and monitoring equipment. 

(10) Records of actions taken during periods of malfunction 

to minimize emissions in accordance with §§63.1543(i) and 

63.1544(e), including corrective actions to restore 

malfunctioning process and air pollution control and monitoring 

equipment to its normal or usual manner of operation. 

(c) Records for the most recent 2 years of operation must 

be maintained on site. Records for the previous 3 years may be 

maintained off site.

(d) The owner or operator of a primary lead processor must 

comply with the reporting requirements of §63.10 of subpart A, 

General Provisions as specified in Table 1 of this subpart.

(e) In addition to the information required under §63.10 of 

the General Provisions, the owner or operator must provide semi-
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annual reports containing the information specified in 

paragraphs (e)(1) through (e)(9) of this section to the 

Administrator or designated authority.

(1) The reports must include records of all alarms from the 

bag leak detection system specified in §63.1547(e).

(2) The reports must include a description of the actions 

taken following each bag leak detection system alarm pursuant to 

§63.1547(f).

(3) The reports must include a calculation of the 

percentage of time the alarm on the bag leak detection system 

sounded during the reporting period pursuant to §63.1547(g).

(4) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(1), the reports must contain an identification of 

the periods when there was not a positive in-draft, and an 

explanation of the corrective actions taken.

(5) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(2), the reports must contain an identification of 

the periods when the 15-minute volumetric flow rate(s) dropped 

below the minimum established during the most recent in-draft 
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determination, and an explanation of the corrective actions 

taken.

(6) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(2), and volumetric flow rate is monitored at the 

baghouse inlet, the reports must contain an identification of 

the days that the damper positions were not in the positions 

established during the most recent in-draft determination, and 

an explanation of the corrective actions taken. 

(7) The reports must contain a summary of the records 

maintained as part of the practices described in the standard 

operating procedures manual for baghouses required under 

§63.1547(a), including an explanation of the periods when the 

procedures were not followed and the corrective actions taken.

(8) The reports must contain a summary of the compliance 

monitoring results for the required reporting period, including 

an explanation of any periods when the procedures outlined in 

the compliance monitoring system plan required by §63.1547(k)(2) 

were not followed and the corrective actions taken.

(9) If there was a malfunction during the reporting period, 

the report shall also include the number, duration, and a brief 

description for each type of malfunction which occurred during 

the reporting period and which caused or may have caused any 
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applicable emission limitation to be exceeded. The report must 

also include a description of actions taken by an owner or 

operator during a malfunction of an affected source to minimize 

emissions in accordance with §§63.1543(i) and 63.1544(b), 

including actions taken to correct a malfunction.

11. Section 63.1550 is revised to read as follows:

§63.1550 Delegation of authority.

(a) In delegating implementation and enforcement authority 

to a State under section 112(l) of the act, the authorities 

contained in paragraph (b) of this section must be retained by 

the Administrator and not transferred to a State.

(b) Authorities which will not be delegated to States: no

restrictions.

12. Section 63.1551 is added to read as follows:

§63.1551 Affirmative defense for exceedance of emission limit 

during malfunction.

In response to an action to enforce the standards set forth 

in this subpart you may assert an affirmative defense to a claim 

for civil penalties for exceedances of such standards that are 

caused by malfunction, as defined at 40 CFR 63.2. Appropriate 

penalties may be assessed, however, if you fail to meet your 

burden of proving all of the requirements in the affirmative 

defense. The affirmative defense shall not be available for 

claims for injunctive relief.
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(a) To establish the affirmative defense in any action to 

enforce such a limit, you must timely meet the notification 

requirements in paragraph (b) of this section, and must prove by 

a preponderance of evidence that:

(1) The excess emissions: 

(i) Were caused by a sudden, infrequent, and unavoidable 

failure of air pollution control and monitoring equipment, 

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

manner, and 

(ii) Could not have been prevented through careful 

planning, proper design or better operation and maintenance 

practices; and

 (iii) Did not stem from any activity or event that could 

have been foreseen and avoided, or planned for; and

(iv) Were not part of a recurring pattern indicative of 

inadequate design, operation, or maintenance; and

(2) Repairs were made as expeditiously as possible when 

the applicable emission limitations were being exceeded. Offshift and overtime labor were used, to the extent practicable to 

make these repairs; and

 (3) The frequency, amount and duration of the excess 

emissions (including any bypass) were minimized to the maximum 
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extent practicable during periods of such emissions; and

 (4) If the excess emissions resulted from a bypass of 

control equipment or a process, then the bypass was unavoidable 

to prevent loss of life, personal injury, or severe property 

damage; and

 (5) All possible steps were taken to minimize the impact of 

the excess emissions on ambient air quality, the environment and 

human health; and

 (6) All emissions monitoring and control systems were kept 

in operation if at all possible, consistent with safety and good 

air pollution control practices; and

 (7) All of the actions in response to the excess emissions 

were documented by properly signed, contemporaneous operating 

logs; and

(8) At all times, the facility was operated in a manner 

consistent with good practices for minimizing emissions; and

(9) A written root cause analysis has been prepared, the 

purpose of which is to determine, correct, and eliminate the 

primary causes of the malfunction and the excess emissions 

resulting from the malfunction event at issue. The analysis 

shall also specify, using best monitoring methods and 

engineering judgment, the amount of excess emissions that were 

the result of the malfunction. 
Page 127 of 130

(b) Notification. The owner or operator of the facility 

experiencing an exceedance of its emission limit(s) during a 

malfunction shall notify the Administrator by telephone or 

facsimile (FAX) transmission as soon as possible, but no later 

than two business days after the initial occurrence of the 

malfunction, if it wishes to avail itself of an affirmative 

defense to civil penalties for that malfunction. The owner or 

operator seeking to assert an affirmative defense shall also 

submit a written report to the Administrator within 45 days of 

the initial occurrence of the exceedance of the standards in 

this subpart to demonstrate, with all necessary supporting 

documentation, that it has met the requirements set forth in 

paragraph (a) of this section. The owner or operator may seek 

an extension of this deadline for up to 30 additional days by 

submitting a written request to the Administrator before the 

expiration of the 45 day period. Until a request for an 

extension has been approved by the Administrator, the owner or 

operator is subject to the requirement to submit such report 

within 45 days of the initial occurrence of the exceedance. 

12. Table 1 to Subpart TTT of Part 63 is revised to read as 

follows:

Table 1 of Subpart TTT – General Provisions Applicability to 

Subpart TTT
Page 128 of 130

Reference

Applies 

to 

subpart 

TTT Comment

* * * * * * *

63.6(a), (b), (c) Yes

63.6 (d) No Section reserved.

63.6(e)(1)(i) No See 63.1543(i) 

and 63.1544(b) 

for general duty 

requirement. 

63.6(e)(1)(ii) No

63.6(e)(1)(iii) Yes

63.6(e)(2) No Section reserved.

63.6(e)(3) No

63.6(f)(1) No

63.6(g) Yes

63.6(h) No No opacity limits 

in rule.

63.6(i) Yes

63.6(j) Yes

§63.7(a)-(d) Yes
Page 129 of 130

§63.7(e)(1) No See 63.1546(c). 

§63.7(e)(2)-(e)(4) Yes

63.7(f), (g), (h) Yes

63.8(a)-(b) Yes

63.8(c)(1)(i) No

63.8(c)(1)(ii) Yes

63.8(c)(1)(iii) No

63.8(c)(2)-(d)(2) Yes

63.8(d)(3) Yes, 

except 

for last 

sentence

63.8(e)-(g) Yes

63.9(a),(b),(c),(e),(g),(h)(1)through 

(3), (h)(5) and (6), (i) and (j)

Yes

63.9(f) No

63.9(h)(4) No Reserved

63.10(b)(2)(i) No

63.10(b)(2)(ii) No See 63.1549(b)(9) 

and (10) for 

recordkeeping of 

occurrence and 
Page 130 of 130

duration of 

malfunctions and 

recordkeeping of 

actions taken 

during 

malfunction. 

63.10(b)(2)(iii) Yes

63.10(b)(2)(iv)-(b)(2)(v) No

63.10(b)(2)(vi)-(b)(2)(xiv) Yes

63.(10)(b)(3) Yes

63.10(c)(1)-(9) Yes

63.10(c)(10)-(11) No See 63.1549(b)(9) 

and (10) for 

recordkeeping of 

malfunctions. 

63.10(c)(12)-(c)(14) Yes

63.10(c)(15) No

63.10(d)(1)-(4) Yes

63.10(d)(5) No See 63.1549(e)(9) 

for reporting of 

malfunctions.

63.10(e)-((f) Yes

* * * * * * *
National Emission Standards for 

Hazardous Air Pollutants: 

Primary Lead Smelting 

Summary of Public Comment and Response

DRAFT – Do Not Cite or Quote

October 21, 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
Draft – Do Not Cite or Quote October 21, 2011

1

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. 
Draft – Do Not Cite or Quote October 21, 2011

2

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
Draft – Do Not Cite or Quote October 21, 2011

3

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
Draft – Do Not Cite or Quote October 21, 2011

4

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"
Draft – Do Not Cite or Quote October 21, 2011

5

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 21, 2011

6

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
Draft – Do Not Cite or Quote October 21, 2011

7

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.
Draft – Do Not Cite or Quote October 21, 2011

8

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
Draft – Do Not Cite or Quote October 21, 2011

9

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 
Draft – Do Not Cite or Quote October 21, 2011

10

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).
Draft – Do Not Cite or Quote October 21, 2011

11

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.
Draft – Do Not Cite or Quote October 21, 2011

12

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 
Draft – Do Not Cite or Quote October 21, 2011

13

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 
Draft – Do Not Cite or Quote October 21, 2011

33

“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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34

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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35

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 
Draft – Do Not Cite or Quote October 21, 2011

36

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 
Draft – Do Not Cite or Quote October 21, 2011

37

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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38

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 taking final action in this rulemaking to revise the MACT rule in response to the 

petition filed by NRDC. 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).

We fundamentally disagree with the commenter that EPA does not have authority to revise an existing 

rule that the Agency concludes is deficient regardless of whether the deficiency is first noted by the 

Agency or by an outside party through a petition for rulemaking. An agency generally remains free to 

undo improperly promulgated or otherwise unsupportable rules unless expressly limited by statute. See

Macktal v. Chao, 286 F.3d 822, 825-26 (5th Cir. 2002); see also Last Best Beef, LLC v. Dudas, 506 F.3d 

333, 340 (4th Cir. 2007); Friends of the Boundary Water Wilderness v. Bosworth, 437 F.3d 815, 823 (8th

Cir. 2006). Recent caselaw also supports EPA’s authority to revise regulations addressing hazardous air 

pollutants once an error or flaw is identified. In Medical Waste Institute, the Court agreed with EPA that 

“nothing in the [CAA or Circuit precedent] suggests that [EPA] is prohibited from resetting the MACT 

floors in order to correct [EPA’s] own errors.” 2011 WL 2507842, at *4. Although this case addressed a 

rule issued pursuant to section 129 of the CAA, the provisions of section 112 are similar.
Draft – Do Not Cite or Quote October 21, 2011

39

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.

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.
Primary Lead Processing NESHAP Technical Support Document: Final Rule

Risk and Technology Review 

National Emission Standards for Hazardous Air Pollutants (NESHAP) 

for the Primary Lead Processing Source Category

Technical Support Document: Final Rule

Docket No. EPA-HQ-OAR-2004-0305

October 31, 2011
Primary Lead Processing NESHAP Technical Support Document: Final Rule

i

Table of Contents

1.0 Residual Risk Analysis – Revisions to the Emissions Dataset Since Proposal for the Primary 

Lead Smelting Source Category ......................................................................................... 1

1.1 Comparison of Emission Sources..................................................................................2

1.2 Comparison of Emissions..............................................................................................2

2.0 Calculation of Final Risk-Based Emission Limits Based on Modeled Concentrations ..... 4

3.0 Model to Monitor Comparison ........................................................................................... 7

4.0 Estimated Costs of Revisions to the Primary Lead Smelting NESHAP............................. 9

3.1 Emission Control Costs for Ample Margin of Safety Reductions.................................9

3.2 Additional Testing and Monitoring Costs....................................................................12

Tables

Table 1 Comparison of Lead Emissions (TPY) from Proposal and 2009 Doe Run Submitted 

Modeling Data 

Table 2 Calculations of Risk-Based Emission Limits Based on Modeled Concentrations

Table 3 Remodeling for Final Rule – Model-to-Monitor Comparison

Table 4 Estimated Costs for Wet Electrostatic Precipitator Control Technology for Doe Run 

Company Primary Lead Processing Facility

Table 5 Additional Testing and Monitoring Costs
Primary Lead Processing NESHAP Technical Support Document: Final Rule

1

1.0 Residual Risk Analysis – Revisions to the Emissions Dataset from Proposal for 

the Primary Lead Processing Source Category

On February 17, 2011, the EPA proposed changes to the Primary Lead Smelting NESHAP based on the

results of a residual risk analysis conducted to fulfill Section 112 (f)(2) of the Clean Air Act (CAA). In 

order to conduct the risk analysis of sources in the Primary Lead Smelting source category, an emissions

dataset was developed that included estimates of individual hazardous air pollutants (HAP) emissions 

from each HAP emitting source as well as source characteristics. Using the emissions dataset emissions

were modeled to determine concentrations of lead and other HAP at the modeled receptor locations. 

Those concentrations were compared to established risk-based thresholds for each HAP to estimate

residual risks. The methods, thresholds, and results of risk analysis and modeling are described in the 

“Residual Risk Assessment for the Primary Lead Smelting Source Category” memorandum included in 

the docket. 

The EPA solicited comments on the emissions and other data used to conduct the residual risk 

assessment and received significant comments on the data used along with submittal of revised and/or 

corrected emissions data, source characteristic information, and meteorological data. Comments on the 

modeling methodology and parameters were also received along with additional model parameter 

information. Based on the comment response, a revised emissions dataset was developed and emissions 

were remodeled. 

As part of their comments, the Doe Run Company (Doe Run) provided a modeling file developed by 

Shell Engineering which they indicated included the appropriate emissions and source characteristic 

information for the facility. The following information was extracted from the Doe Run modeling files:

• For Point sources: Source ID, X Coord. [m], Y Coord. [m], Base elevation [m], Release height 

[m], Emission rate [g/s], gas exit temperature [K], gas velocity [m/s], inside diameter [m]

• For Volume sources; Source ID, X Coord. [m], Y Coord. [m], Base elevation [m], Release height 

[m], Emission rate [g/s], side length [m], building height [m], initial lateral dimension [m], initial 

vertical dimension [m]

• For Area sources; Source ID, X Coord. [m], Y Coord. [m], Base elevation [m], Release height 

[m], Emission rate [g/s·m2

], X side length [m], y side length [m], angle from North [deg.], initial 

vertical dimension [m].

In addition, Doe Run provided particle size ranges and distributions provided hours of operation for 

several sources which indicated the distribution of the emission rate from the source file over a 24-hour 

period.
Primary Lead Processing NESHAP Technical Support Document: Final Rule

2

Because the original emissions file and modeling data did not include particle distribution data or an 

operations profile, these files were not compared to the original dataset. Below is a comparison of the 

dataset used in the proposal and the dataset used for remodeling exercise. 

1.1 Comparison of Emission Sources

We compared information on emission sources from the Doe Run submittal against the source 

information in the proposal dataset. The majority of the sources submitted by Doe Run matched those in

the proposal dataset. The following list itemizes the differences found in the datasets with regard to 

sources and level of emissions;

• Baghouse 7 (Source ID 50008) emissions were accounted for under Baghouse 9, which shares a 

common stack with Baghouse 7. Emissions were combined in the modeling performed by Doe 

Run; however, emission rate estimates for each baghouse were provided in their comments.

• For proposal, Source ID 50006 was not included in the risk assessment as the facility reported 

that it no longer existed and that those emissions were now captured and vented through a

baghouse. However, the new submission reported this source with 0.0018 tpy emissions.

• Source IDs 20004, 20004B, 20004C (fume handling) and 60004 (low alpha baghouse) were 

shown with emissions totaling 0.2125 ton year and the new submission reported zero emissions 

from these sources because they are no longer operating the low alpha baghouse and the fume 

handling is now performed in such a way that fugitive emissions are not generated at those 

locations.

• Plantwide resuspension was characterized with emissions of 0.31 tpy in the proposal dataset. 

This was reported as zero emissions in the new submittal; however, Doe Run reported individual

haul road segments with a total of 0.51 tons per year of fugitive dust emissions.

1.2 Comparison of Emissions 

We used data provided in the Doe Run submittal to develop an emissions profile for modeling. 

Specifically, we used the temporal restrictions on operations of some sources to determine operating 

hours for each source. Where a specific operating scenario was not listed, we assumed even distribution 

over 24 hours for 365 days per year. We used the emission rate provided in grams per second and 

operating hours to calculate the estimated tons per year emissions for each source. We also reviewed the

new stack height data, which showed an increase in height for the Baghouse 8 and 7/9 stacks to 150 feet 

from the 100 feet in the proposal dataset. The Doe Run submittal listed the stack height for the main 

stack as 330 feet. The proposal dataset listed the stack height for the main as 550 feet which is the actual 

stack height. However, the Doe Run submittal limited the height for the main stack consistent with 

“Good Engineering Practice” which is required when modeling for NAAQS compliance demonstration.
Primary Lead Processing NESHAP Technical Support Document: Final Rule

3

The difference in total lead emissions in the modeling submitted as a part of Doe Run’s comments was

an increase of 11.27 tons per year from the proposal dataset. The stacks, which include the main stack, 

Baghouse 8, Baghouse 9 account for an additional 13.49 tons of lead per year. However, as described 

more fully below, the emission rate for the main stack included in Doe Run’s modeling was not used for 

the revised risk assessment.

Lead fugitive dust emissions decreased by a total of approximately 1.54 tons per year. This included a 

65 percent increase in emissions reported for the plantwide resuspension source in the proposal dataset

and an 81 percent decrease from the reported emissions for other fugitive dust emission sources (i.e., 

concentrate, sinter and fume handling). Table 1 below summarizes the changes in lead emissions levels 

reflected in the comparison of the proposal dataset (based on 2008 emissions) and the Doe Run 

submission (based on 2009 emissions).

Table 1 Comparison of Lead Emissions (TPY) from Proposal and 2009 Doe Run Submitted 

Modeling Data

New Submittal* Proposal Dataset**

Source ID Name

Emissions 

(tpy) Name

Emissions 

(tpy) Comment:

7000#s Haul roads 0.51 plantwide 

resuspension 0.31 increase of 65%

30001 main stack*** 68.32 main stack 13.31 increase of 410%

50008 BH 7 2.46 BH7 1.81 increase of 36%

50007 BH 8 1.17 BH 8 0.45 increase of 160%

50008 BH 9 7.96 BH 9 2.03 increase of 290% 

NA Other stacks 0.40 Other stacks 0.26 increase of 55%

NA Other fugitive 0.49 Other fugitive 2.54 decrease of 81%

Total 81.31 20.71

*Based on 2009 emissions data.

**Based on 2008 emissions data.

***The main stack emission rate (19.53 tpy) included in the new submittal was not included for reasons described below.

The final dataset included emissions of lead compounds and other metal HAP (i.e. antimony, arsenic, 

cadmium, chromium, cobalt, and nickel). 

The emissions dataset for this facility represents the entire source category. Likewise, all emission 

points located at this facility and that emit HAP are included in the risk analysis dataset; therefore, the 

facility-wide emission dataset is the same as the risk analysis dataset for this source category. 

The emission rate for the main stack was revised using the results of a 2009 stack test submitted by Doe 

Run rather than the rate provided in the Doe Run modeling run submittal. The lead emission rate for the 

main stack included in Doe Run’s modeling was based on an emission factor used since 2004 that was 
Primary Lead Processing NESHAP Technical Support Document: Final Rule

4

not reflective of the emission rate measured during the stack test performed for their 2009 compliance 

demonstration. The emission rate of 68.32 tons per year that was modeled for the revised risk 

assessment is likely a conservative estimate of annual emissions. This emission rate does not reflect the 

fact that some downtime occurs throughout the year during which sources emitting through the main 

stack are not operating. 

The emissions and source parameters used in the residual risk modeling conducted for the final rule can 

be reviewed in the docket of this rule.

2.0 Calculation of Final Risk-Based Emission Limits Based on Modeled 

Concentrations 

The final risk analysis modeled actual lead emissions to determine lead concentration at individual 

receptor locations. For this source category, the emissions for the lead emissions sources were 

individually modeled for each receptor location and the results were compared to the Primary National 

Ambient Air Quality Standard (NAAQS) for lead (0.15 μg/m3

). If the modeled emissions exceeded the 

lead NAAQS, the risk at that location was considered to be unacceptable. The results indicated multiple 

locations exceeded the level of the NAAQS to various degrees. 

Modeling results indicated that the highest concentration location was a point on the property boundary. 

Emissions contributing to this concentration were cumulative stack emissions (Baghouse 7/9 stack and

Baghouse 8 stack were the largest contributors) and fugitive dust emissions. As in the proposal 

modeling, the emissions from the main stack did not exceed NAAQS within the 50 km radius modeled

area.

Each emission point (with roadways and all other fugitive dust emissions being treated as one emission 

point) was analyzed to determine what emission levels would be necessary to reduce risk to an 

acceptable level i.e., such that modeled emissions met or were below the level of the NAAQS. The EPA 

assumes that if the highest or worst-case concentration at a receptor location resulting from the 

emissions from each emission point were reduced to below the NAAQS level, then the risks for that 

emission point at any location would be reduced to an acceptable level. Further, the EPA assumes that a 

reduction in emissions from an emission point will result in a proportionate reduction in the modeled 

concentration at a given receptor location. Since the relationship between level of emissions and 

modeled concentrations is assumed to be linear, a percentage reduction applied to an annual emissions

rate for a given emission point would produce the same reduction in modeled concentrations. A

calculation was made for each emission point to determine what percent reduction in concentration was 

required for each of the highest concentration locations to meet the NAAQS. 

The reduction necessary in fugitive dust emissions (including roadways and other fugitives) was 

determined to be approximately 10 percent. The furnace area is vented through Baghouse 7 and exhausts 

through a stack shared with Baghouse 9. The refining operations consist of the refining kettles and 
Primary Lead Processing NESHAP Technical Support Document: Final Rule

5

refining building which exhaust through Baghouse 8 and Baghouse 9, respectively. Our analysis 

indicated that the maximum lead concentration location for the furnace area (Baghouse 7) and refinery 

operations (Baghouse 8 and 9) overlapped at the same census block. Therefore, their combined 

concentrations at that location would be the driver for the reduction from these emission points. The

reduction necessary for the combined furnace area stack and refinery stack emissions from the emission 

levels provided by Doe Run in their comments was determined to be approximately 90 percent. 

Monitoring to ensure work practices for fugitive emissions achieve acceptable risk remains at 0.15 

ug/m3 lead concentration in air.

For the combined furnace area and refining operations stacks the total emissions reported were 11.56

tons per year. Based on the required reduction percentage to meet a lead concentration in air of 0.15 

μg/m3

, the new lead emission limit for the combined furnace area and refining operations stacks would 

be 1.2 tons per year. 

Table 2 summarizes the calculations and recommended limits for the furnace area/refinery stacks. While 

we are not recommending a specific emission limit for fugitive emissions, we have estimated the level 

of fugitive emissions that will meet the monitoring requirement of 0.15 μg/m3. 
Primary Lead Processing NESHAP Technical Support Document: Final Rule

6

Table 2 - Calculations of Risk-Based Emission Limits Based on Modeled Concentrations

Modeled Source

2009 

Emissions 

Maximum 

Modeled Lead 

Concentration*

Rollback to 

Meet 

0.15μg/m3*

Estimated 

Emissions 

After Rollback

(tpy) (μg/m3) % (tpy)

Stacks 

 - Baghouse 8 & 9(refinery) 9.1 1.16 87 1.2

 - Baghouse 7 (furnace area) 2.5 0.31 52 1.2

 Combined Stacks 11.6 1.47 90 1.2

Fugitives

 All Fugitives 1.0 0.17 13 0.9

FINAL EMISSION LIMIT

 Furnace Area and Refinery Stacks 1.2 TPY

FINAL MONITORING REQUIREMENT**

 Lead Concentration in Air 0.15 μg/m3

Calculations:

 Roll back % = (Actual concentration - 0.15)/actual concentration

 Emissions after rollback = 2009 emissions * (1-(rollback%/100))

* At the site of modeled location of maximum impact

** Measured at locations approved by the Administrator
Primary Lead Processing NESHAP Technical Support Document: Final Rule

7

3.0 Model to Monitor Comparison

In the proposed rule the EPA compared the maximum modeled estimates of ambient air lead 

concentrations with those measured at four monitors located close to the Doe Run facility in 

Herculaneum, Missouri for calendar year 2008. More specifically, the maximum 3-month rolling 

average lead concentrations (for calendar year 2008) calculated from data reported at the Main Street, 

Circle Street, South Cross, and Church Street monitors were compared to the maximum 3-month rolling 

average lead concentrations at model receptor locations in close proximity to these monitoring sites. 

Results of this analysis were presented in the proposal preamble and indicated that with respect to the 

Main Street and Circle Street monitors, AERMOD underestimated 3-month maximum lead 

concentrations by approximately 2.8- and 4.2-fold, respectively. The EPA received comment that the 

modeled-to-monitored ratio was too high indicating that the modeled results were not reasonably in 

agreement with modeled concentrations. According to commenters, the model-to-monitor ratio should 

have been less than two in order to demonstrate that the AERMOD estimates are a reasonable 

representation of the measured 3-month maximum lead concentrations in the ambient air near this 

facility.

For the final rule, the facility emissions were remodeled based on revised and new information 

submitted through the public comment process. A model-to-monitor comparison was conducted for six 

monitor locations close to the facility for the year 2009. The resulting model-to-monitor ratio indicates 

that for any monitor analyzed, the maximum modeled concentration is within 50% of the maximum 

monitored concentration at the same location which demonstrates a reasonable agreement of the 

modeled concentrations with the monitored concentrations at the six monitor locations. Table 3

provides a summary of the model-to-monitor comparison for the remodeling of emissions data for the 

final rule.
Primary Lead Processing NESHAP Technical Support Document: Final Rule

8

Table 3 Remodeling for Final Rule – Model-to-Monitor Comparison

Monitor Name Latitude Longitude

AERMOD 

Modeled Lead 

Concentration2 

(μg/m3)

Maximum 

Monitored Lead 

Concentration2 

(μg/m3)

Max Modeled/

Max Monitored

Percent 

Difference 3

City Hall/Main St. 4238290 729319 0.776 1.2 64.67% -35.33%

Sherman 4239206 729503 0.19 0.16 118.75% 18.75%

North Cross 4238151 729121 0.34 0.59 57.63% -42.37%

High School/Dunklin 4238702 729334 0.343 0.39 87.95% -12.05%

Church St. 4237753 729168 0.601 0.45 133.56% 33.56%

Ursuline1 4235800 729617 0.073 0.08 91.25% -8.75% 1

There is no 2009 data for this monitor. The value for "Max Monitored" is from 2010.

2 Maximum 3-month average

3 Negative value = model underestimation
Primary Lead Processing NESHAP Technical Support Document: Final Rule

9

4.0 Estimated Costs of Revisions to the Primary Lead Smelting NESHAP

With regard to lead emissions, we are finalizing emission limits that are consistent with the results of our 

risk and technology reviews of the current NESHAP for primary lead processing. We found that no 

emission reductions were required from the main stack to achieve acceptable risk. Under our ample 

margin of safety technology review analyses, we evaluated addition controls beyond the existing level of 

control for the main stack as well as the refining and furnace area stacks to determine if a reduced 

standard was warranted in order to provide an ample margin of safety, or whether there were 

developments in practices, processes, or control technologies that warranted a reduced standard

considering cost and technical feasibility. 

Although our analysis indicated that additional controls were not warranted for the main stack to achieve 

acceptable risk, we are reducing the main stack emission limit under section 112(d)(6) to reflect 

performance achievable from technological improvements. In addition we are increasing the frequency 

of monitoring stack emission from the current annual emissions testing to quarterly testing. This section, 

therefore, also includes estimates of the impacts for the additional monitoring costs necessary to comply 

with final emission limit requirements. 

In the proposed rule for the main stack emission point, we considered and rejected the option of 

upgrading existing controls by adding in-series baghouses. During the public comment period, 

commenters suggested that the EPA evaluate wet electrostatic precipitators as polishing control devices 

in the analysis performed under section 112(d)(6) of the CAA and the ample margin of safety analysis 

performed under section 112(f) of the CAA. The EPA has determined wet electrostatic precipitators

(WESP) may technologically feasible for achieving additional emission reductions from the main stack, 

refinery stacks, and furnace area stack, but the technology is not economically feasible in this case.

Therefore, we are not requiring a reduced emission standard that reflects the performance of WESP 

technology for these three stacks. This section summarizes the impacts analysis that was conducted on

adding this additional emission control option to the existing control configuration.

We note that the controls that reduce lead emissions are the same controls that would reduce emissions 

and risks from other metal HAP; therefore we are not proposing additional controls for other metal 

HAP. We further note that the analysis for the ample margin of safety determination and the technology 

review both evaluated the same technology. This technology has been determined to be cost prohibitive 

in both analyses.

4.1 Emission Control Costs for Ample Margin of Safety and Technology Review Analyses

Once we determine that risk will be reduced to a level that is acceptable, we then determine whether 

further reductions are appropriate to ensure an ample margin of safety. We investigated available 

control options that could be implemented by the facility to attain the additional emissions reductions 

that would provide an ample margin of safety. 

No additional controls other than the WESP technology described in public comments were identified to 

further control emissions from the furnace area stack or the refinery stacks that are already controlled 

with baghouses using membrane bags. 
Primary Lead Processing NESHAP Technical Support Document: Final Rule

10

For the main stack, our risk analysis indicates that emissions do not result in ambient lead levels 

exceeding the NAAQS based on the actual emission levels. However, we determined that it is 

technologically feasible to reduce emissions from the main stack to a level below the allowable level of 

the MACT, since those levels are currently being achieved. We evaluated additional controls beyond 

what is already achieved such as a WESP for achieving further reductions and reducing associated risk. 

The investment required to install as a polishing control device after the baghouses ducted to the main 

stack would approach $100 million dollars. We determined that the additional controls would not be 

economically feasible based on the associated cost. However, we have determined that emissions 

allowable under MACT should be reduced under the section 112(d)(6) technology review as described 

in the technology review memorandum found in the docket for this action. There is no cost associated 

with the revised main stack emission standard promulgated under section 112(d)(6) as this level of 

emissions is already achieved. As with the main stack, we evaluated the cost of installing WESPs on the 

stacks for which emission standards are being promulgated under 112(f) during our ample margin of 

safety and 112(d)(6) technology review analyses. The cost of installing WESPs on Baghouses 7/9 and 

Baghouse 8 is approximately $50 million dollars. This cost is prohibitively high and makes the 

reductions based on installation of WESPs on these sources economically infeasible. Based on the 

economic infeasibility of installing additional control devices, reductions in the emission standards 

based on WESP technology were rejected under the 112(f) ample margin of safety analysis and the 

112(d)(6) technology review.

Table 4 summarizes the costs and cost-effectiveness of adding a WESP to the main stack, the Baghouse 

7 & 9 stack, and Baghouse 8 stack.
Primary Lead Processing NESHAP Technical Support Document: Final Rule

11

Table 4 Estimated Costs for Wet Electrostatic Precipitator Control Technology for Doe Run Company Primary Lead 

Processing Facility

Cost Efficiency at 95% RE

Source

Volumetric Flow 

(cfm)

Total Capital 

Investment

Total Annual Costs

($US)

Emissions Reduction

(tons)

Control Efficiency 

($/ton of lead)

Main stack 1,023,723 $ 86,104,296 $ 15,355,845 65 $237,707

BH 7 & 9 * 519,614 $ 44,354,995 $ 7,794,210 9 $901,586

BH 8 76,274 $ 7,638,460 $ 1,144,110 2 $487,582

* Baghouses 7 and 9 are discharged to the same stack. Therefore, costing was based on air flow for both baghouses
Primary Lead Processing NESHAP Technical Support Document: Final Rule

12

4.2 Additional Testing and Monitoring Costs

To demonstrate compliance with the new 0.97 lb/ton emission limit, EPA is requiring quarterly stack 

testing. Although the method for testing is the same as it was under the current MACT, the quarterly 

frequency requirement imposes additional impact with regard to the cost of additional testing. Quarterly 

stack testing will also be required for the baghouse 7/9 and baghouse 8 stacks.

The additional testing and monitoring requirements will result in additional cost as summarized in Table

5.

Table 5 - Additional Testing and Monitoring Costs

Type of Testing/Monitoring Notes Cost Annual Cost

Main Stack Testing1 Method 12 $13,000 per test $39,000

Baghouse 7/9 Stack Testing Method 12 $13,000 per test $52,000

Baghouse 8 Stack Testing Method 12 $13,000 per test $52,000 1 Includes 3 additional stack tests
Primary Lead Processing NESHAP Technical Support Document: Final Rule

Appendix A 

Page 1

APPENDIX A

Cost Estimates for West Electrostatic Precipitator Control Technology

For Doe Run Company Primary Lead Processing Facility

Based on

EPA Cost Manual
Primary Lead Processing NESHAP Technical Support Document: Final Rule

Appendix A 

Page 1

WESP Cost Estimates - EPA Cost Manual

DEC

volumetric flow rate A B .67B .57B 5$/CFM

Main Stack 1,023,723 cfm

WESP 

initial Cost Cost

Purchased 

equipment 

cost

Direct 

Installation 

Costs

Total Direct 

Costs

Indirect 

Installation 

Costs

TCI TAC O&M

for 95% efficiency 22.6 $/cfm $32,075,778 $32,575,778 $38,439,418 $25,754,410 $64,193,828 $21,910,468 $86,104,296 $15,355,845 $5,118,615

for 90% efficiency 18 $/cfm $25,547,080 $26,047,080 $30,735,554 $20,592,821 $51,328,375 $17,519,266 $68,847,641 $14,332,122 $5,118,615

for 85% efficiency 14.7 $/cfm $20,863,448 $21,363,448 $25,208,869 $16,889,942 $42,098,812 $14,369,055 $56,467,867 $13,308,399 $5,118,615

Baghouse 7 & 9 519,614 cfm

for 95% efficiency 22.6 $/cfm $16,280,794 $16,780,794 $19,801,337 $13,266,896 $33,068,233 $11,286,762 $44,354,995 $7,794,210 $2,598,070

for 90% efficiency 18 $/cfm $12,967,004 $13,467,004 $15,891,065 $10,647,013 $26,538,078 $9,057,907 $35,595,985 $7,274,596 $2,598,070

for 85% efficiency 14.7 $/cfm $10,589,720 $11,089,720 $13,085,870 $8,767,533 $21,853,402 $7,458,946 $29,312,348 $6,754,982 $2,598,070

Baghouse 8 76,274 cfm

for 95% efficiency 22.6 $/cfm $2,389,853 $2,889,853 $3,410,027 $2,284,718 $5,694,745 $1,943,715 $7,638,460 $1,144,110 $381,370

for 90% efficiency 18 $/cfm $1,903,423 $2,403,423 $2,836,039 $1,900,146 $4,736,185 $1,616,542 $6,352,728 $1,067,836 $381,370

for 85% efficiency 14.7 $/cfm $1,554,462 $2,054,462 $2,424,265 $1,624,258 $4,048,523 $1,381,831 $5,430,354 $991,562 $381,370

WESP Auxiliary $ 500,000

1998 389.5 Multiplier

2010 540 1.386393

2008 575.4