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 Pro cessing Final AQ

43_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

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- 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 attache d 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

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## 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 M ethodology 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 prov ision to include new “hydrometallurgical” process

.. 37 2.7 Miscellaneous Comments

................................ ................................ .............................. 38Draft

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1 

## 1 **Background** On February 17 , 2011 , the U.S. Environmental Protection Agency proposed to revise the National Emission Standards for Hazardou s 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 comm ents 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

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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 ID a Commenter, Affiliation Abstract 0062 Dennis Lane, Stinson Morrison Hecker LLP on behalf of Doe Run R esources 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 In cineration (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 C oalition 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 ActionDraft

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3 Document ID a 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 S ources for Cumulative Health Risk Assessment of Multiple Chemicals, Exposures and Effects: A Resource Document 0077.7 Earthjustice et al. (Attachment 6) Framework for Cumulative Ris k 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 0077 0 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 0077 1 Earthjustice et al. (Attachment 10) Synthetic Organic Chemical Manufacturing Industry

- Residual Risk Assessment, Report Prepared by EC/R Incorporated 0077 2 Earthjustice et al. (Attachment 11) The Benefits and Costs of t he Clean Air Act: 1990 to 2020

– Summary Report 0077 3 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 con sent of the copyright holder. 0077 4 Earthjustice et al. (Attachment 13) Improvements in Air Toxics Emissions Data Needed to Conduct Residual Risk Assessments Report No. 08

- P

- 0020 0077 5 Earthjustice et al. (Attachment 14) Letter to The Honorable Lis a 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 Method ologies: For Review by the EPA’s Science Advisory Board with Case Studies

– MACT I Petroleum Refining Sources and Portland Cement Manufacturing 0077 6 Earthjustice et al. (Attachment 15) Sources, Transport and Alte rations of Metal Compounds: An Overview. I. Arsenic, Beryllium, Cadmium, Chromium, and NickelDraft

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4 Document ID a Commenter, Affiliation Abstract 0077 7 Earthjustice et al. (Attachment 16) High

- level Strategy and Lea dership Needed to Continue Progress toward Protecting Children from Environmental Threats 0077 8 Earthjustice et al. (Attachment 17) Email to Emma Cheuse, Assoc iate 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 0077 9 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 Sig nificance 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: Resid ential 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: Adv ancing 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: Enviro n mental Justice and Cumulative Risks/Impacts 0078.8 Earthjustice et al. (Attachment 27) "Comparative Assessment of Air Pollution

- Related Health Risks in Houston"Draft

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5 Document ID a 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 I RIS: 47 Chemicals that Should Move to the Head of the Risk

Assessment 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 f rom 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 Substanc e & 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 Si te 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 Futu re 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, Missour i 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 holderDraft

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6 Document ID a 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, an d 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 f or 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 Toxicolo gy 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 E arthjustice 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 Applic ation. 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 ImpactDraft

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7 Document ID a 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: Herculane um Lead Smelter Roadway Contamination 0079.19 Earthjustice et al. (Attachment 59) Residual Risk Program: Sel ection 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 com ments 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 Herculan eum 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

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8 Document ID a Commenter, Affiliation Abstract 0080.5 Earthjustice et al. (Attachment 66) Herculaneum Lead Contaminati on 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 Test ing Areas 0080.8 Earthjustice et al. (Attachment 69) 0080.9 Earthjustice et al. (Attachment 70) Fourth National Report on Hu man 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 Contaminatio n 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 Contaminatio n 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 Sitin g 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 Sch ool 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 Do cument #: 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 T his 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

- Car ried 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 AnonymousDraft

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9 Document ID a Commenter, Affiliation Abstract 0082 James L. Kavanaugh, Director, Air Pollution Control Program, Mis souri 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 Ba ttery 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 CorporationDraft

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10 Document ID a Commenter, Affiliation Abstract 0088.1 Attachment, Claire McClintic, Attorney, Stinson Morrison

Hecker 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 D ocket No. EPA - HQ - OAR - 2004 - 0 305

. Do cuments 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). Addit ional a ttachments, 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., 0 010 ).Draft

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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

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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 c ommenter state d that for non

- lead emis sions; 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 c ommenter cite s 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 ju stice 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 c ommenter 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 strin gent, 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 acc eptable, 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. On c e we determine that controls are sufficient to ensure risk is acceptable, we aga in 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 determiningDraft

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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 w ay 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 a nd, 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 t he 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. T he 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 risk s due to HAP emissions from this source categor y . We note that this is als o 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 ri s k 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 c ommenter state d 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 c ommenter noted that the facility is located in what would be considered an under

represented area with regard to environmental justice issues. With regard to t he 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 comment er acknowledged that there may not be enough scientific evidence to support a maximum allowable concentration level. The c ommenter 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 arse nic 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 case s per year . E xpressed 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 y ear 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 comment s in section 2.1.2.1Draft

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14 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 re quirement 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 reviewin g census block sizes or configurations to consider how pollutant concentrations might vary within these blocks. The commenter is concerned that the area

weighted centers of census blocks may significantly underestimat e exposure in some cases and re commend s 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. R esponse : 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 n ear 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 assessme nts, 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 ma ximum 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 overesti mate 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 cens us 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 centr oids because: 1) census blocks are the finest resolution available in the national census data, 2) facility fence line s do not typically represent locations where chronic exposures are likely (i.e , people do not typically live at the fence line of faciliti es) 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 th e EPA’s Science Advisory Board.Draft

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15 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 A gency has failed to provide any reasoned explanation for why risk assessments based on actual emi ssions estimates are inadequate. The A gency’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 accoun t 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 assumpti ons 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 conserv ative 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 a ny 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 re sidual 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 m odeling 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 na tional 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 t here 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 Offic e 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 o n 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. R esponse : We acknowledge that population subgroups, including childr en, 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)Draft

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16 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 lifet ime 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 review 1 of th e 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 valu es 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 adjustmen t 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 ag e 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 conside red to be plausible upper

- bound estimate s ; 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 N ational A mbient A ir Q uality S tandards ( NAAQS ) for lead . Notably, the lead NAAQS was set to protect public health, including the health of sensitive populations , wi th an adequate margin of safety from the advers e effects associated wi th 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**  **Ambien t Monitoring**  **2.1.3 The**  **EPA’s modeling relies on inaccurate data**

Comment: Commenter 008 8 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.Draft

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17 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 facilit y 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 008 8 stated the assumption o f 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 t he 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 res ults 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, health

protective 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 Nation al 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 docum ented in the docket. New and corrected data w ere received from the facility and state of Missouri during the public comment period that further refined the risk assessment

. EPA t echnical 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 sin ce the 1996 NEI , which was the basis for the O IG 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.Draft

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18 Documentation for the 2005 NEI point source emissions inventory is available on the EPA's CHIEF we bsite, 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 Assuranc e 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, u pdated 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 Approac h 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 l ead 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 . . . .” Le ad NAAQS, 73 FR 66964, 67052 (Nov. 12, 2008), § 50.16(a). The commenter stated that j ust 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. Failu re to meet the l ead 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 r egulating a criteria pollutant as a HAP, contrary to the intent of CAA § 112(b)(2). T he same unlawful result occurs for environmental risk, with the proposed r ule adopting the secondary l ead NAAQS to identify “the potential for adverse environmental effects.” A single standard using the same measurements improperly controls compliance ques tions under both the secondary l ead 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 nonatta inment.” 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 co mpounds. 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 MACTDraft

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19 Standard for lead compounds is met. Such dual regulat ion 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 sta ted 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 co ncluded 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 consid ered 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 unacce ptable 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 m argin of safety. Comment: Commenter 0087 state d that b ecause 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 prescr iptive 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 t he 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 prot ect 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 faci lity 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 NA AQS. 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 bestDraft

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20 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 state d 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 co mpliance delay simply cannot be reconciled with the EPA’s own recognition that lead emissions from this facility are unacceptable. The c ommenter s tate d 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 fac tors 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 he alth 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 individu al 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 f acility must demonstrate that 2 year s 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 f acility must demonstrate that steps are being taken in the interim period to protect public health

. According to the commenter, th is 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.Draft

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21 • The commenter states that the EPA has already delayed satisfying its legal duties both unde r 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 ne gotiated 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 ag reements 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 it s 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, l ikely 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 f acility must take to comply with the NESHAP, a two year compliance date is appropriate. Furthermore, w e 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 signi ficant 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 contemp late 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 se ction 112(f)(4). Rather section 1 1 2(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 co mmenter notes in detail above, specifies the basis for providing a longer compliance period of up to 2 years. The compliance date f or the mainDraft

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22 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: C ommenters (0077 and 0088 ) challenge the EPA’s proposal to defer the compliance date for new facilities to implement a CEMS. Commenter 0077 states that t he 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 inde finitely. 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 c urrent 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 F ederal 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**  **T otal**  **F acility**  **A pproach**  **and U**  **se of**  **D emographics**  **in R**  **ulemaking**

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 com bined 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 sourc e 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 r elevant for this action.
Comment : Commenter 0087 stated that the EPA should pr ovide 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 regulatio ns. T he 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.Draft

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23 Response: N o 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 state d that EPA’s proposal that facilities meet steady

- state standards dur ing startup, shutdown and malfunction (SSM) is unlawful. Specifically, the commenter note d 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 ev idence 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 condi tions 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 p ossible for the EPA to develop valid floor standards for the periods of startup, shutdown, and malfunction, citing t he EPA’s own National Stack Testing Guidance which discusses the difficulty of getting valid testing results during SSM. The commenter r ecommended 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 existin g 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 a gency to consider malfunctions in determin ing 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. App lying 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, ifDraft

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24 not impossible, given t he 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 proble m. 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, sab otage, 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 con trolled 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

- malfu nctioning 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 a re 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 com menter 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 possib ly 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 info rmation 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 it s analysis of the risk to public health and the environment.

• EPA fail ure 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 worst

performing 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 repo rt, and ensure that its risk analysis and resulting standardDraft

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25 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 emis sions 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 deeme d “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 limit s 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 avo id 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 str ingent 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 w e believe malfunction events do not contr ibute 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 th e contrary. Furthermore, t he 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 stand ard , 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 thanDraft

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26 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 a gency wants to challenge these activities, the bur den of proof would be on them to show that the facility did not undertake reasonable actions to minimize emissions. The commenter state d 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 th e 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. R esponse: The affirmative defense does not ch ange 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 ass ert 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 t he 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 even ts.). T he 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 affirmativ e 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.Draft

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27 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 re gulatory authorities. With regard to the reporting timeframe for asserting affirmative defense, w e 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 d ay 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 impa ct 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 mech anisms 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 th is 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 judg es 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 pr oposal, 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 reme dy, 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’ abili ty 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 cit izen 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 d emonstrates that certain factors [exist], EPA has done just that.Draft

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28 • 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), 4 2 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 on ly 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 b e 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 regardl ess 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 disp lace 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 m onitoring 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.Draft

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29 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 noti fication 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 facili ty 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 no tice 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 the mselves 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 tensi on, 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 estab lish 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” limi tations, 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. 197 3), 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 standar ds 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 EP A’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 affi rmative 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 (9 th 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 emissio n 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.Draft

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30 Further, the EPA’s view is that the affirmative defense is not inconsistent with CAA sectio n 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 as sessed, 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 sect ion 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 sour ce 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 tre ated 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 suc h “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 opport unity 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 h and, 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 30 1(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 11 3(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 defen se 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 anyDraft

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31 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 ov erlap. 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 criter ia 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 ev idence 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 throu gh 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 re but 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 overla p 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 impo se 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 relie f. 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 w hen 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 provisio ns 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 affirm ative 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 state d that the proposed standards with the affirmative defense do not represent emission limitations achieved by the best

- performing existingDraft

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32 sources, nor do they meet the criteria for establishing beyond

- the

- floor emission standards and that the affirmative defense is not a permissible substi tute for setting standards for periods of malfunction and is insufficient to meet the EPA’s obligations under CAA §112. Commenter 0087 request ed the EPA set aside the proposed affirmative defense for periods of malfunction and establish a work practice sta ndard 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 u nder 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 signifi cant 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 det ermine acceptability, and also in the ample margin of safety analyses and related decisions. In the pr oposed rule for this source category we concluded that risk s associated with emissions from the Primary Lead Smelting source category were un acceptable , p rimarily 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 a nd, 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 beDraft

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33 “acceptable” becomes unacceptable when, as here, lower income individuals are disproportionately affected. Response: We disagree with the commenter that the EPA found a “disproportio nate 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 facili ty 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 potent ial 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 ex posure, 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

- spe cific 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 chi ld

- specific reference doses. T hat 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 hea lth benchmark values a n d 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 hig h 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 state d 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 ex posure 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 h ealth 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

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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 peo ple 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 con sume the entire non

cancer 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 di scussion 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 t his 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 noncan cer 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 ac ute, 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 accu racy and uncertainty of each piece of information must be considered in a weight

- of

evidence approach for each decision. This relevant body of information is growing fast (and 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 impa cts do not get high enough to cause harm to public health. T hus , w e 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 risk s from lead would also be expected to reduce risks from other metal HAP.Draft

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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 eff ects 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 th e 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 formulat ion 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 onl y 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 an nual 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 su ggested that the furnace area stack emission be removed from the proposed lb/ton limit, and that a more realistic basis for measur ing 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 t he furnace area stack and the main stack

. Th e 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 demon strated by stack tests performed for compliance with the MACT. Comment: Commenter 0082 opposed the proposed plant

- wide emission limit for several reasons. The c ommenter states that the current form of the stack emission limit (i.e. pound per ton of lead p roduced) 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 limi ts (tons per year), although based on quarterly

- averagedDraft

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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 c ommenter su ggested 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 co nsistency 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

- orient ed, 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 conduc ted. 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 th at 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 tim e 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 stand ard 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 st andard 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 risk s from the main stack are more than 20 timesDraft

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37 below the acceptable level and that additional control measures are not warranted as they would n ot 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 s tated 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 b e 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 techni cal 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 cha nges may produce untenable financial burdens or concerns over technical infeasibility that EPA has not recognized in a proposed rule , commenter s should inform the EPA of such issues during the public comment period on th at proposed rule and the EPA will co nsider 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 electrosta tic 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 emissio ns 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 do es 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 thi s 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 d evelopment and proposal of the RTR for secondary lead smelting , which was published in the Federal Register on May 19, 2011 (76 FR 29032).Draft

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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 determin ation 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, proc esses, 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 expres s § 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 (5 th Cir. 2002) ; see also Last Best Beef, LLC v. Dudas , 506 F.3d 333, 340 (4 th Cir. 2007); Friends of the Boundary Water Wilderness v. Bosworth , 437 F.3d 815, 823 (8 th 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 add ressed a rule issued pursuant to section 129 of the CAA, the provisions of section 112 are similar. We are notDraft

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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 dis cussed 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 revie w 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 emis sions 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.***E.O. 12866 Review

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EO12866 NESHAP

_ Primary Lead Processing Final 2060AQ43_2011 1005 .doc **6560 -**  **50 -**  **P**
**ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 63**  **[EPA –**  **HQ –**  **OAR –**  **2004 –**  **0305 ;**  **FRL -**  **XXXX -**  **X ]**  **RIN 2060 –**  **A Q4**  **3 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 categor y regulated under national emission standard s for hazardous air pollutants (NESHAP)
. This action finalizes amendments to the NESHAP that include revision of the ru l e’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

.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **2** of **129**
**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 w eb site. Although listed in the index, some information is not publicly available, e.g., c onfidential b usiness i nformation (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on t he 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 Doc k e t and Information Center is (202) 566

– 1742.
**FOR FURTHER INFORMATION CONTACT:** For questions about this final action, contact M r . N athan 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 e mail***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **3** of **129** 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
. Mic hael Stewart , Office of Air Quality Planning and Standards, Health and Environmental Impacts Division, Air Toxics
Assessment Group ( C 504

– 0 6 ), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711; telephone number : (919) 541

– 7524 ; fax number : (919) 541

– 0840; and e mail 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 Contact 1**  **OAQPS Contact 2**  Primary Lead Processing Maria Malave , (202) 564

- 702 7 , 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 th e rule

. Some of the significant comments and our***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **4** of **129** responses are summarized in this preamble; a summary of the other public comments on the proposal , and the EPA’s responses to th ose
comments , is available in Docket ID No. EPA

- HQ

- OAR

- 2004

- 0305
. A red

line 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 R eview II
. Background III
. Summary of the Final Rule A. What are the final rule amendments for the Primary Lead Processing source categor y ? 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 S ince Proposal A. Changes to the R isk A ssessment P erformed U nder Section 112(f) of the Clean Air Act B. Changes to the T echnology R eview P erformed U nder Section 1 12(d) (6) of the Clean Air Act C
. Other C hanges S ince P roposal V. Summary of Significant Comments and Responses A. Timeline for C ompliance B. The EPA ’s A uthority U nder S ection 112 of the Clean Air Act C
. Primary Lead Processing R isk A ssessment V I . 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **5** of **129** F. Executive Order 13175: Con sultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environme ntal 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 Ad dress Environmental Justice in Minority Populations and Low

- I ncome P opulations 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 NAICS**  **1 Code**  **MACT 2**  **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 categor y listed. To determine whether your facility would be affected, you should exam ine 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

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– Do Not Cite, Quote or Release During Review *** Page **6** of **129** 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 revis ing 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 ( C AA ) 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 W ide 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.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **7** of **129** policy and guidance page for newly proposed and promulgated rules at the following address: http://www.epa.gov/ttn/caaa/new.html

. T he TTN provides information and technology exchange in various areas of air pollution control. Additional information is available on the residual ri sk and technology review (RTR) w eb 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 U nited S tates 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 th is 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 wa s 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

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– Do Not Cite, Quote or Release During Review *** Page **8** of **129** 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 speci fied 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
Gen eral 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **9** of **129** 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 requi rements, which are re ferred 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 control led 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 cate gory 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 esta blish 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **10** of **129** changes, substitution of materials, or other modifications; enclose systems or processes t o 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 under take 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 technology

based 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 adv erse 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 Smelt i ng NESHAP , 40 CFR Part 63 Subpart TTT, that took into consideration the residual risk and***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **11** of **129** technology review ( RTR ) analyses for that source category

. T his 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:

• R evisi ng the requirements in the NESHAP related to emissions during periods of startup, shutdown, and malfunction (SSM).

• Revis ing the title of the rule and amend ing the applicability section consistent with the definition of the source category adopted in 199 2 , to provide that the NESHAP appl ies to any facility processing lead ore concentrate to produce lead metal.

• Replac ing the definition of “primary lead smelter” with a definition of “primary lead processor” and add ing definitions of “secondary lead smelters , ” “lead refiners , ” and “lead remelters

. ”

• Incorporat ing the use o f plain language into the rule

.

• Address ing 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **12** of **129** 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 fa cility 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 Conse nt 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 (NA AQS) 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 Implementa tion 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 categor y ? 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **13** of **129** metal from ore concentrates. The source category covered by this MACT standard currently includes only one operating facility, The D oe 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

- eff ective 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.
T o satisfy section 112(f) of the CAA , w e 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 document s to support the proposed and final rulemakings , these sources have overlapping points of maximum lead impact.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **14** of **129** unacceptable level of risk (i.e., cause the lead concentration in air at or near the facility boundary to exceed 0.15 μg/m 3 based on 3

- month r olling average) and to conduct air monitoring to ensure that such fugitive emissions are adequately addressed.

To satisfy section 112( d ) (6) of the CAA , w e 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 development s in practices, process es, or control technologies since promulgation of the MACT standards demonstrate that the facility can meet a reduced emission limit from the main stack pu rsuant 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 revisi on of the applicability section of the rule consistent with the definition of the source category adopted in 199 2 , subpart TTT which appl ies to any facility that produces lead metal from lead concentrat e ore.

• C hanges 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.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **15** of **129** 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 rev ising 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 standar ds caused by malfunctions, as well as criteria for establishing the affirmative defense.

• Replac e ment 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 add ing 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 reduction s 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 facilit y 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.***E.O. 12866 Review

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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.
S ierra 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 c ategories, 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 r espects. 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 ensu re that we have not included***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **17** of **129** 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 perio ds and, for the following reasons, has not established different standards for those periods

. I nformation 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 routin e 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***E.O. 12866 Review

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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 percen t of sources in the categor y. There is nothing in CAA section 112 that directs the a gency 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 a gency to consider malfunctions as part of that analysis. CAA s ection 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 unexpe cted 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, an d 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **19** of **129** 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 , W eyerhaeuser 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 cause d 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 string ent 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **20** of **129** malfunction periods, including prevent ative 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 p reventable” 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 objectiv ely evaluated in a judicial or administrative proceeding )
. We also have added other regulatory provisions to specify the elements that are necessary to establish***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **21** of **129** 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 malfunc tion in 40 CFR 63.2 (sudden, infrequent, not reasonabl y 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 ex cess 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 expedi tiously 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 ad ministrative proceeding, the Administrator may challenge the assertion of the affirmative defense , and, if the respondent has not***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **22** of **129** met its burden of proving all of the requirements in the affirmative defense, appropriate penalties may be assessed in accorda nce with section 113 of the CAA (see also 40 CFR part 22. 2 7 ). 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 recogni zing 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 emission s 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 enforcea ble 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),
t he D.C. Circuit acknowledged that in setting standards under CAA section 111 “variant provisions” such as provisions allowing for***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **23** of **129** 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 affirm ative 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.2 d 1253, 1272

- 73 (9 th 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 stand ards? The revisions to the MACT standards being promulgated in this action***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **24** of **129** 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 year s from the effective date of the standard, **[ INSERT**  **DATE 2** 
**YEAR S**  **FROM DATE OF PUBLICATION**  **]**
. **IV. Summary of Significant Changes Since Proposal** 

A
. Changes to the Risk Assessment Performed U nder CAA Section 112(f) As noted above, i n 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 s melting 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 method s and results presented in the draft document: Draft Residual Risk Assessment for the Primary Lead Smelting Source Category.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **25** of **129** During the public comment period for the proposed rule, the one fa cility 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 f or 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

. R evised 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 S upport 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 risk s 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 re sult in exceeden ces of the NAAQS for lead beyond the fenceline of the***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **26** of **129** 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 disp ersed 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 200 9 Emissions (tpy) Maximum Offsite Impact Main stack 1 68.3 0.85 times the NAAQS Refining stacks 2 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 5 5 0 feet , and thus the impact would have like ly 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 propos ed rulemaking , t he risk assessment to support the final rulemaking also indicate s that risk s are unacceptable, primarily due to lead emissions from the furnace area stack and the refining operations stacks

. However, while the risk assessment support ing the proposed rulemaking estimated that a combined emission limit for the fu rnace area and refining operations should be set at 0.91 tons of lead per year to ensure that risks are acceptable, the up dated 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.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **27** of **129** 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 th at 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 f or the furnace area and refining operations stacks at 1.2 tons per
year . 4 The ris k 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 a nalyse s 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 sour ces because , as noted in the proposal ( 76 FR 9432 ) , and the risk assessment document s to support the proposed and final rulemakings , these sources have overlapping points of maximum lead impact.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **28** of **129** the pro posed 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 sup port 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 t he proposed rule

. In considering the updated non

- lead risk results presented above, we note that while cancer incidence inc reased in our updated risk assessment , cancer incidence remains very low with 1 excess cancer case be ing estimated every 125 years.
W ith 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***E.O. 12866 Review

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acute health effects. W e also note that in contrast to the r isk analysis to support the proposed rulemaking, the final risk analysis modeled the main stack at the GEP stack height of 330 feet rather tha n the actual stack height of 550 feet

. T hus it i s very likely that th e maximum potential worst

- case HQ value is si gnificantly lower than 2. Finally, with respect to the exceedence of the worst

- case multipathway screen ing 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 m ultipathway

- related health risk s 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 multipathw ay risks. However, d ue 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***E.O. 12866 Review

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non - cancer risks. We also reviewed whether there were cost

- effective controls that c ould further reduce risk s 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 emission s 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 emission s 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 accepta ble 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 T echno logy Review Performed U nder 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **31** of **129** 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 , T he Doe Run Company indicated that the proposed emission limit under Section 112(d)(6) could not be met and that the data on which th at emission limit w as based were not accurate. The facility provided a 2009 stack test for the main stack that indica ted 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 test s 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 e stablishing 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 complia nce date for the 0.97 lb/ton limit is 60 days from the date of publication of the final rule.
C. Other C hanges S ince P roposal
T he 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **32** of **129** 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 compl y 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 sta ndard 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 so urces 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 s ame 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

una voidable to pre vent severe personal injury. In addition, the EPA***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **33** of **129** 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 be lieves 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 se ek 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 1 6 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **34** of **129** Primary Lead Processing NESHAP (October 2011), for summaries of other
comment s and our responses to them

.

A
. Timeline for C ompliance
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) sta ndard, 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **35** of **129** EPA seems to have reflexively applied the § 112(f) period, this approach is not foreordained in the present circumstances. Specifical ly, § 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 ), t he
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), t he commenter believes that the two year compliance period has seriou s 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 categ ory; by virtue of a federally enforceable consent decree, the facility must terminate its present op erations 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **36** of **129** 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 w as 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 Ru n’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 develop ment 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 two

year compliance timeframe relies, in part, on the various steps that must be undertaken to implement a plan to monitor lead concentration***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **37** of **129** 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 : fa ctually, 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 Admin i strator may grant a waiver for a period of up to 2 years from the effective date if necessary for the installation of controls and***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **38** of **129** if measures will be tak e n 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 0.9 7 lb Pb/ton of lead produced that would replace the existing standard of 1 lb Pb/ton of lead produced. T his 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 s tack 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **39** of **129** 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 ton s per year value cited by the commenter. Based on performance test data, the facili ty 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 Administ r ator 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. I t 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, w e understand***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **40** of **129** that the new hydrometal l urgical 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 addres sed 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.
A s 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 standard s 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 r efining and furnace area stacks and for fugitive emissions

. Finally, w e 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 le ad nonattainment area and the reductions required under the rule will help bring the area into attainment with the lead NAAQS.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **41** of **129** However, this regulation does not preempt the SIP process; the State of Missouri is still required to submit a state implementati on 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 Decemb er 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 implicatio ns for determin ing 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 p lant 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/m 3 limit for ambient lead concentrations. The commenter stated that the three proposed numerical standards present a confusing regulatory regime as to which standard***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **42** of **129** 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 operatio ns and emissions. ” While an effort is made to differentiat e the components of the 0.22 lb /ton standard as to which portion fit s under what statutory authority, this single plant

- wide emission standard rests on the § 112(d)(6) review. Although not explicitl y stated, this plant

- wide standard offers more than an ample margin of safety. Response : W e 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. 9 7 lb/ton emission standard that we are promulgating pursuant to section 112(d)(6) will replace the 1.0 lb/ton li mit in the original MACT rule and will***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **43** of **129** 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 li mit 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 n ecessary 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 address ed 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 A uthority U nder 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 c omment er 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **44** of **129** mean those involving smelting; and the “includes, but is not limited to” langua ge 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 furnac e, slag fuming furnace, drossing kettles, and dross reverberatory furnace.

• The plain meaning of that language evidences intent to cover any and all types of pyrometallu r gic al processes for producing lead but shows no attempt to encompass other, as yet un known, lead production processes.

• I solating the phrase “including, not limited to” from the company it keeps to justify an expansive reading goes well beyond the me aning 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 consisten t 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 pyrometallu r gical process. In

summa tion, the commenter states that the statutory directive of CAA***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **45** of **129** § 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 l ead 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 origi nal 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 i s 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **46** of **129** untimely. We disagree with the commenter that the source category descri ption 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 i t 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 n ew process such as the hydrome ta l lurgical process is developed, EPA would consider what standard should apply to such
process. We maintain that primary lead processi ng 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **47** of **129** 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 ev idence 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 tre ated 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 o r 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 appl y to the source in its current form as a***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **48** of **129** pyrometa l lurgical processing facility. To the extent any of these processes remain in place, such as the refining operation, after construction of any new hydrometa l lurgical process, the emission limit applicable to that process would continue to apply. A s 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: A nother 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 “standard s” elsewhere in the subsection means “emission standard.” Likewise, § 112(d)(6) gives the Administrator authority***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **49** of **129** to revise “emission standards.” Both subsections limit the EPA’s rule

- promulgating authority to setting “emission standards.” According to co mmenters, 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 re lating 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

so urce(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 . . . f or 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **50** of **129** 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 co ntrol 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), whi ch 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/m 3 on a 3

- month rolling average measured at locations approved by the Administrator.” As s uch, 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 acco unt developments in practices, processes,***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **51** of **129** 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 amb ient 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 limitation s already established under the Lead NAAQS. Consequently, the proposed rule excee ds 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 Le ad 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 procedu rally 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 stand ard violates the EPA’s obligation under § 307(d)(3)(C) to set forth the “major legal interpretations” that underlie the proposal. Response : The commenter s mistake the purpose of the fenceline***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **52** of **129** 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 ade quately 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 reduc e 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 re quired 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 appli cable standard is the requirement to adopt work practice standards and that the fenceline monitoring requirement is a tool to help ensure compliance.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **53** of **129** 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 limite d to the amount established by the NAAQS. We disagree with the suggest ion 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 cl early explains the rational e 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 roadwa ys 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 (“crite ria pollutants”) to that regime and does not allo w supplemental (or supplanting) regulation of them under NESHAP. The commenter cited CAA § 112(b)(2)***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **54** of **129** 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 certa in 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. T he 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 Sci ence 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 Mater ials, 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

-***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **55** of **129** this. Thus, we disagree with the commenter that we are attempting to regulate in contravention of section 112(b)(7) in t his 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. Wh ile 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 “thr ough 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 eff ectiveness 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 Sci ence and Technology, Vol. 14:10, p. 1240

- 1244.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **56** of **129** clearly “necessary” for EPA to close inherently unlawful gaps in the original MA CT, 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 expr essly 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 devel opments 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 f ix 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, Octo ber 28, 2009, 74 FR 55670;***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **57** of **129** 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
pe tition 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 t o 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.***E.O. 12866 Review

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C
. Primary Lead Processing Risk A ssessment
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
uncerta inties 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.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **59** of **129** 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, summi ng the risks associated with all carcinogens emitted by the facility. Similarly, the use of the target organ specific hazard index (TOSHI) for chronic non

cancer 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

unacce ptable 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 a s 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. I f 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 assessme nt of the risks associated with exposure to the HAPs emitted by the source category***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **60** of **129** (i.e., those emissions that can actually be affected by the specific rulemaking) and supplements that with additional information about other possible concurrent and releva nt 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 monitorin g 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 c onsider 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 cat egory 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 w hich we live,” a world which is***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **61** of **129** 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 w ith 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 q uestion 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **62** of **129** representat ive 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 info rmation 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 ave rage 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 correct ions and analysis of data

.

• T he 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.

• I mprovements from the 2007 SIP for the fugitive emissions from***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **63** of **129** 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 state d that actual monitoring data f rom 2010 show a maximum three

- month average ambient air concentration of 1.12 μ g/m 3 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.

• T he 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 re view of the model and assessment of the proposed RTR could not be made. The c ommenter 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

cen troids. 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **64** of **129** comments on the proposed rule, we have remodeled the f acility 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 docu ment: 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 conce ntrations 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 perfo rmed for the proposal risk assessment.
Comment : With respect to using the NAAQS to evaluate potential***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **65** of **129** 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 “t he task at hand is to provide a quantitative risk assessment of the maximum non

- adverse facility

level 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 he alth 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/m 3 . This standard was set to protect public health, including the health of sensitive populations, with an adequa te 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **66** of **129** 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 i n 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 do es not exceed the level of 0.02 μg/m 3 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 limi t 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **67** of **129** 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 a n adequate margin of safety. Moreover, the risk assessment supporting the NAAQS considered direct inhalation exposures and indirect air

related multi

- pathway exposures from industrial sources like primary and secondary lead smelting operations. While we co nclude 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/m 3

. For the reasons explained elsewhere in this notice and other supporting documents available in the docket , w e 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, thi s 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 approp riate benchmark for addressing the acceptable***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **68** of **129** level of risk and we disagree with the commenter that we should instead use an ambient concentration of 0.02 μg/m 3 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 risk s 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 conside r ed whether there were additional cost

effective 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.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **69** of **129** 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 requir es 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 r esidual 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 t he 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 sensitiv e populations, most critical for lead, the health of children. That does not suggest that non

- sensitive***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **70** of **129** 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 mor e 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 resu lt s 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 wer e no additional cost

- effective controls beyond those that would need to be implemented to ensure an acceptable level of risk. Thus, for th e three emissions points (fugitive dust emissions, the furnace area stack, and the refinery stacks) for which we are r equiring 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 e ffective 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 additio nal controls for the refining, furnace area, and main stacks can be found in the technical support***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **71** of **129** 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 emission s 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 huma n 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 as sume 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 stat ed: “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 categ ory 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 recepto rs.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **72** of **129** 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 no t 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 le ad

. 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 int roduced 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

s econdary lead NAAQS shou ld be set equal to the p rimary lead NAAQS.***E.O. 12866 Review

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I n 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 consist ent 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 no t sufficient data supporting that a lower level is necessary to protect against an environmental risk.
Comment : One commenter stated t hat in evaluating potential multipathway risks from PB

- HAP other than lead, the EPA used de minim i s emission rates to screen for potentially significant multi

pathway impacts, but for lead, this method was abandoned. The
commenter disagrees with this appr oach, stating, “This comparison***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **74** of **129** 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 chr onic 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 s ource 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 m easured 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.,***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **75** of **129** 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 child ren 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 multi

pathway, multi

- media impacts of lead, the risk assessment supporting the NAAQS considered direct inhalation exposures and indirect air

related multi

- pathway exposures from industrial sources like primary and secondary lead smelting operations. It al so considered background lead exposures from other sources (like contaminated drinking water and exposure to lead

- based paints). T he EPA believes that the lead NAAQS is a reasonable benchmark to evaluate the potential for multipathway health effects from l ead. 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 compo unds and determined that it would be inappropriate to develop an RfD for these compounds, saying, “A great deal of information on the health***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **76** of **129** 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 Offi ce 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 lang uage 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

num bers are not easily understandable by the general public; the IQ***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **77** of **129** 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 t hese 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 ful l 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

co nsideration 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, informa tive, 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, w hile 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 a ssociated***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **78** of **129** 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 ex press 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 a n un acceptable level of risk and will also provide an***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **79** of **129** ample margin of safety

. The estimated reductions include a reduction in fugitive dust emission s 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. T he cost s of controls w ere 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 the se requirements are necessary to bring risk to a n acceptable level. However, as an example the cost for paving all unpaved roads at the facility to control fugitive emissions woul d 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 a nd emissions from the furnace area and refining stacks. In addition, we considered other available practice s , process es 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** ***E.O. 12866 Review

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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 F R 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 conta ined 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 informa tion submitted to the EPA pursuant to the recordkeeping and reporting requirements for which a claim of confidentiality is made is safeguarded according to a gency***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **81** of **129** policies set forth in 40 CFR part 2, subpart B. Th is 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 und er 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 r eporting 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 cri teria 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 reas onable 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **82** of **129** 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 provide d administrative adjustments to the ICR that show wha t 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 , a nd 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. Gi ven 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
par ticular source

. It is important to note that the EPA has no basis***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **83** of **129** 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 p reviously 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 expecte d to result from a malfunction (based on the definition above), and only a subset of excess emissions caused by malfunctions would result i n the source choosing to assert the affirmative defense. Thus , we believe the number of instances in which source ope rators 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 incl ude 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

.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **84** of **129** 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 3 0 labor h ours at a cost of $3,141 per year for the affirmative defense reporting and recordkeeping provisions and 1,3 1 3 labor hours at a cost of $ 46 1,640 per year for the lead concentration in air limit reporting and recordkeeping provisions. There will be no capit al 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, a nd 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 4 0 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **85** of **129** 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, schoo l 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 t hese 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 r equirements 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.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **86** of **129** 1531

- 1538 for State, local, or tribal governments or the private sector. The action imposes no enforceable duty on any S tate, 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 affe ct 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 indus try , 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **87** of **129** relationship between the Federal government and Indian tribes, or on the distribution of po wer 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 E xecutive O rder 13045 (62 FR 19885, April 23, 1997) , because it is not economically significant as defined in E xecutive O rder 12866
. However, the a gency 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 leve ls 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **88** of **129** likely to have a significant adverse energy effect on the supply, distribution, or use of energy

. This action will not create any new requiremen ts 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 Techn ology Transfe r 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 oth erwise 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 wh en the a gency 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 great est extent***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **89** of **129** 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 activ ities on minority populations and low

- income populations in the United States. The EPA has determined that th is fin al rule will not have disproportionately high and adverse human health or environmental effects on minority or low

- income populations, because it do es 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 HAP

related cancer and non

- cancer risks across different social, demographic, and economic groups wi thin the populations living near th e one facilit y that is currently operating in this source categor y . Our analyses also show that, although there is potential for an adverse environmental and human health effects from emission of lead , it does not indicat e 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 populatio ns exposed to these source s . K. Congressional Review Act***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **90** of **129** 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 th is 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 maj or 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.Page **92** of **129** 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 -**  **– [A**  **MENDED ]** 

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 pr ocess 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.Page **93** of **129** (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 smelt er;” 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 ha s 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 proce ssor resulting from the handling, storage, transfer, or other management of lead

- bearing materials where the source is not part of aPage **94** of **129** specific process, process vent, or stack. Fugitive dust sources include roadways, storage piles, materials handling transfe r 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 pro cessor. 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 operati on 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 proce ss 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.Page **95** of **129**

* * * * * 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 a re 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 fugit ive 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 a nd 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 lead

bearing scrap material, primarily, but not limited to, lead

- acidPage **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 loca tion 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
reconstruct ed 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 fur nace; (3) Dross furnace; (4) Dross furnace charging location; (5) Blast furnace and dross furnace tapping location;Page **97** of **129** (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
cont rol 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 e quivalent 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 bagh ouse 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 leadPage **98** of **129** compounds on an quarterly basis (no later than 100 days following any previous compliance test). (f) If the 12 most recent compliance tests demonstrate compl iance 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 compou nds. (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
sy stem 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 alar m 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 op erator must operate and maintain any affected source, including associated air pollutionPage **99** of **129** control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. Determination of whet her 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

m aintenance 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 no t exceed 0.15 μg/m 3 on a 3

- month rolling
average . (b) Consistent with the requirements in section 63.1547(k), e ach 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 pollutionPage **100** of **129** control equipment and monitoring equipment, in a man ner 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, b ut 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 ow ner 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.Page **101** of **129** (c) Pri or 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 FE DERAL 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 exi sting 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 6 0 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.Page **102** of **129** (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 e mission 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:
E Pb = quarterly lead emissions , pounds per quarter;
ER Pb = 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
pr evious quarter according to the procedures detailed in paragraphs (a)(5)(i) through (iv) of this section:Page **103** of **129** (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 production

based lead compound emission rate, in unit s 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 :
CE Pb = quarterly production

- based lead compound emission rate, in units of pounds of lead emissions per ton of lead produced;
E Pb = quarterly lead emissions, pounds per quarter; and
P Pb = quarterly lead production, tons per quarter. (7) To determine quarter ly compliance with the emissions standard for lead compounds under §63.1543(b), sum the leadPage **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 thi s 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 oper ation 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 deter mine the conditions of performance
tests.Page **105** of **129** 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 p rocedures 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 t he 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.Page **106** of **129** ( 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 rever se 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 i s consistent with the baghouse manufacturer's instructions for routine and long

- term maintenance.Page **107** of **129** (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.Page **108** of **129** (5) The initial adjustment of the system must, at a minimum, consist of esta blishing 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 sensitivi ty 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 per cent 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 t he 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 planPage **109** of **129** must inc lude 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 c ompartment. (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 d etermined according to paragraphs (g)(1) through (g)(3) of this section.Page **110** of **129** (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 c ause 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 seconda ry 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 affect ed 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 measu res, which may include, but not be limited to, the following:Page **1 11**  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 wit h 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 method ology specified in §63.1546(b). (2) Owners and operators must establish and maintain baseline ventilation parameters which result in a positive in

draft according to paragraphs (i)(2)(i) through (i)(2)(iv) of this section. (i) Owners and operators must i nstall, 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 f low rate at thePage **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 monitorin g 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 o wner or operator wishes to re

establish 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 andPage **113** of **129** record damper positions daily to ensure they are in the positions they were in during the most recent in

- draft determi nation. (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 6 0. (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 le ad 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 toPage **114** of **129** measure lead emissions, taking into accoun t 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 Perform ance 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 per iods 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 adjustme nts.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 appli es: (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 previo us 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 an d 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 **116** of **129** (2) The own er 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 justificat ion 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 anal ytical 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 y ears, 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 airPage **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 Adm inistrator 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 Nov ember 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
proces sor, 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 th e primary lead processor is seeking review and approval of the plan. Owners or operators of existingPage **118** of **129** primary lead processors must submit this notification no later than 45 days after promulgation of this subpart. The owner or operator of a new, reconstruct ed, 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
pa ragraph (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 co ntent 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 **119** of **129** (4) Any recordkeeping required as part of the requirements described in the compliance monitoring system plan require d 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 t he 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 con tinuous 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

- draftPage **120** of **129** 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 d aily 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) an d 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 sit e. 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 a ddition 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 a uthority. (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 wit h 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 t aken. (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 whe n the 15

- minute volumetric flow rate(s) dropped below the minimum established during the most recent in

- draftPage **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
op erating 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 anyPage **123** of **129** applicable emission limitation to be e xceeded. 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 b e 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 eviden ce 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 pr evented 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. Off

shift and overtime labor were used, to the extent practicable to make thes e repairs; and (3) The frequency, amount and duration of the excess emissions (including any bypass) were minimized to the maximumPage **125** of **129** extent practicable during periods of such emissions; and (4) If the excess emissions resulted from a bypass of
contro l 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 d ocumented 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 e xcess 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) tra nsmission 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 standard s in this subpart to demonstrate, with all necessary supporting documentation, that it has met the require ments 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 f or 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 fo llows: Table 1 of Subpart TTT

– General Provisions Applicability to Subpart TTTPage **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) YesPage **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 andPage **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

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– Do Not Cite, Quote or Release During Review ***

EO12866 NESHAP

_ Primary Lead Processing Final 2060AQ43_2011 1005 .doc **6560 -**  **50 -**  **P**
**ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 63**  **[EPA –**  **HQ –**  **OAR –**  **2004 –**  **0305 ;**  **FRL -**  **XXXX -**  **X ]**  **RIN 2060 –**  **A Q4**  **3 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 categor y regulated under national emission standard s for hazardous air pollutants (NESHAP)
. This action finalizes amendments to the NESHAP that include revision of the ru l e’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

.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **2** of **130**
**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 w eb site. Although listed in the index, some information is not publicly available, e.g., c onfidential b usiness i nformation (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on t he 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 Doc k e t and Information Center is (202) 566

– 1742.
**FOR FURTHER INFORMATION CONTACT:** For questions about this final action, contact M r . N athan 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 e mail***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **3** of **130** 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
. Mic hael Stewart , Office of Air Quality Planning and Standards, Health and Environmental Impacts Division, Air Toxics
Assessment Group ( C 504

– 0 6 ), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711; telephone number : (919) 541

– 7524 ; fax number : (919) 541

– 0840; and e mail 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 Contact 1**  **OAQPS Contact 2**  Primary Lead Processing Maria Malave , (202) 564

- 702 7 , 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 th e rule

. Some of the significant comments and our***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **4** of **130** responses are summarized in this preamble; a summary of the other public comments on the proposal , and the EPA’s responses to th ose
comments , is available in Docket ID No. EPA

- HQ

- OAR

- 2004

- 0305
. A red

line 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 R eview II
. Background III
. Summary of the Final Rule A. What are the final rule amendments for the Primary Lead Processing source categor y ? 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 S ince Proposal A. Changes to the R isk A ssessment P erformed U nder Section 112(f) of the Clean Air Act B. Changes to the T echnology R eview P erformed U nder Section 1 12(d) (6) of the Clean Air Act C
. Other C hanges S ince P roposal V. Summary of Significant Comments and Responses A. Timeline for C ompliance B. The EPA ’s A uthority U nder S ection 112 of the Clean Air Act C
. Primary Lead Processing R isk A ssessment V I . 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **5** of **130** F. Executive Order 13175: Con sultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environme ntal 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 Ad dress Environmental Justice in Minority Populations and Low

- I ncome P opulations 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 NAICS**  **1 Code**  **MACT 2**  **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 categor y listed. To determine whether your facility would be affected, you should exam ine 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

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– 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 revis ing 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 ( C AA ) 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 W ide 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.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **7** of **130** policy and guidance page for newly proposed and promulgated rules at the following address: http://www.epa.gov/ttn/caaa/new.html

. T he TTN provides information and technology exchange in various areas of air pollution control. Additional information is available on the residual ri sk and technology review (RTR) w eb 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 U nited S tates 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 th is 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 wa s 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

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– Do Not Cite, Quote or Release During Review *** 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 speci fied 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
Gen eral 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **9** of **130** 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 requi rements, which are re ferred 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 control led 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 cate gory 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 esta blish 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **10** of **130** changes, substitution of materials, or other modifications; enclose systems or processes t o 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 under take 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 technology

based 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 adv erse 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 Smelt i ng NESHAP , 40 CFR Part 63 Subpart TTT, that took into consideration the residual risk and***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **11** of **130** technology review ( RTR ) analyses for that source category

. T his 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:

• R evisi ng the requirements in the NESHAP related to emissions during periods of startup, shutdown, and malfunction (SSM).

• Revis ing the title of the rule and amend ing the applicability section consistent with the definition of the source category adopted in 199 2 , to provide that the NESHAP appl ies to any facility processing lead ore concentrate to produce lead metal.

• Replac ing the definition of “primary lead smelter” with a definition of “primary lead processor” and add ing definitions of “secondary lead smelters , ” “lead refiners , ” and “lead remelters

. ”

• Incorporat ing the use o f plain language into the rule

.

• Address ing 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **12** of **130** 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 fa cility 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 Conse nt 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 (NA AQS) 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 Implementa tion 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 categor y ? 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **13** of **130** metal from ore concentrates. The source category covered by this MACT standard currently includes only one operating facility, The D oe 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

- eff ective 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.
T o satisfy section 112(f) of the CAA , w e 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 document s to support the proposed and final rulemakings , these sources have overlapping points of maximum lead impact.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **14** of **130** unacceptable level of risk (i.e., cause the lead concentration in air at or near the facility boundary to exceed 0.15 μg/m 3 based on 3

- month r olling average) and to conduct air monitoring to ensure that such fugitive emissions are adequately addressed.

To satisfy section 112( d ) (6) of the CAA , w e 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 development s in practices, process es, or control technologies since promulgation of the MACT standards demonstrate that the facility can meet a reduced emission limit from the main stack pu rsuant 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 revisi on of the applicability section of the rule consistent with the definition of the source category adopted in 199 2 , subpart TTT which appl ies to any facility that produces lead metal from lead concentrat e ore.

• C hanges 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.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **15** of **130** 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 rev ising 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 standar ds caused by malfunctions, as well as criteria for establishing the affirmative defense.

• Replac e ment 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 add ing 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 reduction s 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 facilit y 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.***E.O. 12866 Review

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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.
S ierra 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 c ategories, 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 r espects. 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 ensu re that we have not included***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **17** of **130** 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 perio ds and, for the following reasons, has not established different standards for those periods

. I nformation 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 routin e 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***E.O. 12866 Review

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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 percen t of sources in the categor y. There is nothing in CAA section 112 that directs the a gency 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 a gency to consider malfunctions as part of that analysis. CAA s ection 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 unexpe cted 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, an d 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **19** of **130** 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 , W eyerhaeuser 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 cause d 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 string ent 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **20** of **130** malfunction periods, including prevent ative 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 p reventable” 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 objectiv ely evaluated in a judicial or administrative proceeding )
. We also have added other regulatory provisions to specify the elements that are necessary to establish***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **21** of **130** 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 malfunc tion in 40 CFR 63.2 (sudden, infrequent, not reasonabl y 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 ex cess 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 expedi tiously 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 ad ministrative proceeding, the Administrator may challenge the assertion of the affirmative defense , and, if the respondent has not***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **22** of **130** met its burden of proving all of the requirements in the affirmative defense, appropriate penalties may be assessed in accorda nce with section 113 of the CAA (see also 40 CFR part 22. 77 2 7 ). 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 ma y 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 lim itation 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 emission s limitations are continuous. The affirmative defense for malfunction events meets this req uirement by ensuring that even where there is a malfunction, the emission limitation is still enforcea ble 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 provi sions” such as provisions allowing for***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **23** of **130** 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.C ir. 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 affirma tive 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

se tting, 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 (9 th Cir. 1977). But see, Weyerhaeuser Co. v. Costle , 590 F.2d 1011, 1057

- 5 8 (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 stand ards? The revisions to the MACT standards being promulgated in this action***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **24** of **130** 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 [ **INSE RT 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 year s from the effective date of the standard, **[ INSERT**  **DATE 2** 
**YEAR S**  **FROM DATE OF PUBLICATION**  **]**
. **IV. Summary of Significant Changes Since Proposal** 

A
. Changes to the Risk Assessment Performed U nder CAA Section 112(f)
As noted above, i n 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 op tions 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.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **25** of **130** During the public comment pe riod for the proposed rule, the one fa cility 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 f or 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

. R evised 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 ri sk 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 risk s 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 emissi ons can likely re sult in exceedences of the NAAQS for lead beyond the fenceline of the***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **26** of **130** 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 200 9 Emissions (tpy) Maximum Offsite Impact Main stack 1 68.3 0.85 times the NAAQS Refining stacks 2 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 5 5 0 fee t , 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 propos ed rulemaking , t he risk assessment to support the final rulemaking also indicate s that lead risk s are unacceptable, primarily due to lead emissions from the furnace area stack and the refining operations stacks are unacceptable

. However, while the risk assessment support ing 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.***E.O. 12866 Review

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up dated risk assessment estimates that a combined emission l imit 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 f or 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 fo r 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 m ultipathway screening a nalyse s 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 sour ces because , as noted in the proposal ( 76 FR 9432 ) , and the risk assessment document s to support the proposed and final rulemakings , these sources have overlapping points of maximum lead impact.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **28** of **130** 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 inc reased in our updated risk assessment , cancer incidence remains very low with 1 excess cancer case be ing estimated every 125 years.
W ith 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

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acute health effects. W e 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 tha n the actual stack height of 550 feet

. T hus it i s very likely that th e maximum poten tial worst

- case HQ value is significantly lower than 2. Finally, with respect to the exceedence of the worst

- case multipathway screen ing level for cadmium , we note that this only indicates the potential for cadmium exposures above the chronic

noncancer re ference 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 risk s 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, d ue to the highly conservative nature of this screening assessment and the uncertainties related to the results, we have concluded that , after implementation o f the controls needed to reduce lead levels to the NAAQS, risks are acceptable, considering the combinatio n of potential multipathway risks, risks are acceptable. The cancer risks, chronic***E.O. 12866 Review

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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 w c ould further reduce risk s 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 cont rols that would also reduce emissions from of non - lead HAP. We were unable to identify any technically feasible cost effective additional controls that would further reduce emissions from 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 for non

lead 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 a chieve 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 T echnology Review Performed U nder CAA Section 112(d)(6)***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **31** of **130** 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 , T he Doe Run Company indicated that the proposed emission limit under Section 112(d)(6) could not be met and that the data on which th at emission limit w as based were not accurate. The facility provided a 2009 stack test for the main stack that indica ted 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 test s 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 e stablishing 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 complia nce date for the 0.97 lb/ton limit is 60 days from the date of publication of the final rule.***E.O. 12866 Review

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C. Other C hanges S ince P roposal
T he 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 compl y 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 sta ndard 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 so urces 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 s ame 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.”***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **33** of **130** 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

una voidable to pre vent 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 be lieves 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 se ek 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

.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **34** of **130** We received written comments from 1 6 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
comment s and our responses to them

.

A
. Timeline for C ompliance
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) sta ndard, and (3) 112(h)(3) allows an alternative means of compliance in some circumstances. The commenter stated that***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **35** of **130** 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. Specifical ly, § 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 ), t he
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), t he commenter believes that the two year compliance period has seriou s 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 rulem aking: instead of multiple sources within a category, there is only one facility in the category; by virtue of a***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **36** of **130** federally enforceable consent decree, the facility must terminate its present op erations 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 f ace 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 th e 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 emission s, 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **37** of **130** proposal effectively acce lerates the compliance date for the lead NAAQS for the Doe Run facility. According to the commenter a two

year 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 o r 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 f or 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **38** of **13 0**  issued under subsection (f) except that the standard will not apply until 90 days after its effective date. It also provides that the Admin i strator 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 tak e n 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 0.9 7 lb Pb/ton of lead produced that would replace the existing standard of 1 lb Pb/ton of lead produced. T his 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 s tack 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))***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **39** of **130** 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 ton s per year value cited by the commenter. Based on performance test data, the facili ty 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 Administ r ator 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. I t is unclear how this process would address the emissions covered by the work practice standard requirement we are establishing which is***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **40** of **130** 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, w e understand that the new hydrometal l urgical 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 addres sed 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.
A s 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 standard s 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 r efining and furnace area stacks and for fugitive emissions

. Finally, w e note that the Lead NAAQS does not apply to a specific facility but rather is a level that must be met within the***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **41** of **130** 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 ea rlier than December 31, 2015.
Comment : One commenter stated that the proposed emission standards and ambient standard had negative implications for determin ing 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **42** of **130** are the 0.91 tpy limit for furnace area and refining and casting operations and the 0.15 μg/m 3 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 st andard 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 differentiat e the components of the 0.22 lb /to n standard as to which portion fit s 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 : W e 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **43** of **130** promulgating under section 112(f) will apply to combined emissions from the refining and furnace area stacks. The 0. 9 7 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 origin al 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 tho se 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 emi ssions 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 A uthority U nder 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **44** of **130** to cover smelting only, not other processes. The c ommenter lists several issues supporting this po sition:

• 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 pr ocess, 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 pyrometallu r gic al processes for producing lead but shows no attempt to encompass other, as yet unknown, lead production processes.

• I solating the phrase “including, not limited to” from the company it keeps to justify an expansive reading goes well beyond the me aning 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **45** of **130** to section 74 11 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 pyrometallu r gical 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

c over 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 hydrometa llurgical 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 Ap plication for the New Lead Technology submitted to the Missouri Department of Natural
Resources.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **46** of **130** 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 catego ry 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 so urce 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 hydromet allurgical 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 n ew process such as the hydrome ta l lurgical 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 NESHA P.
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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **47** of **130** 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 ev idence 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 tre ated 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 o r 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **48** of **130** 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 appl y to the source in its current form as a pyrometa l lurgical processing facility. To the extent any of these processes remain in place, such as the refining operation, after construction of any new hydrometa l lurgical process, the emission limit applicable to that process would continue to apply. A s 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.
Com ment: A nother 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,***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **49** of **130** where the “ample margin of safety” factor is found, has “emission standard” as its subject; these specific references clarify the use of “standard s” 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 co mmenters, 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 re lating 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

so urce(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 . . . f or 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **50** of **130** 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 sour ces. 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/m 3 on a 3

- month rolling average measured at locations approved by the Administrator.” As such, proposed § 63.1544(a) measu res 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **51** of **130** 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, p rocesses, 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 limitation s already established under the Lead NAAQS. Consequently, the proposed rule exceeds the statutory authority grant ed 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 emissi on 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 fai ls 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **52** of **130** the failure to clearly describe the legal basis for the standard violates the EPA’s obligatio n under § 307(d)(3)(C) to set forth the “major legal interpretations” that underlie the proposal. Response : The commenter s 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 ade quately address fugitive emissions consistent with the requirements of section 112(f). Thus the fenceline monit oring 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 e missions

. 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 complian ce 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **53** of **130** 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 sou rce’s lead emissions, measured at the fenceline, would be limited to the amount established by the NAAQS. We disagree with the suggest ion that we do not provide the legal basis for our proposed rule. The preamble clearly explains that we are addressing re sidual risk for this source category under section 112(f) and clearly explains the rational e 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 ma terials handling and roadways cannot be captured and vented to a stack for which we could establish an emission limit.***E.O. 12866 Review

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Comment : One commenter stated that the CAA limits the EPA’s ability to regulate pollutants subject to NAAQS (“crite ria pollutants”) to th at 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 und er 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 onl y 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. T he lead emitted from primary lead processing is lead compounds with elemental lead present only in***E.O. 12866 Review

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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 t his 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. Wh ile 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 “thr ough 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 Sci ence 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 Mater ials, 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 Sci ence and Technology, Vol. 14:10, p. 1240

- 1244.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **56** of **130** Specifically, the commenter argues that: "[w]hen EPA performs a section 112(d)(6) review, it must consider the ongoing legality and eff ectiveness 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 MA CT, 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 expr essly 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 devel opments 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 f ix underlying defects in***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **57** of **130** 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, Octo ber 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **58** of **130** the CAA. Accordingly, we are not taking fin al 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 stand ard 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 sta ndard 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 standa rd under section 112(d)(2) of the CAA , as appropriate

. C
. Primary Lead Processing Risk A ssessment
Comment : One commenter stated that the EPA failed to consider or***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **59** of **130** 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 inac tion. 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 ecologi cal 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 th e 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 cou ld 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **60** of **130** cancer risks is, in fact, cumulative, summing the risks associated with all carcinogen s emitted by the facility. Similarly, the use of the target organ specific hazard index (TOSHI) for chronic non

cancer 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 exposu res 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **61** of **130** other possible concurrent and relevant risks that is readily available. In some cases, w e 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 regulat ory 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **62** of **130** 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 f ifty 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 fact or 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 MA CT 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 m onitored three

- month***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **63** of **130** 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 t his 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 approac h 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

.

• T he 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.

• I mprovements from the 2007 SIP for the fugitive emissions from the sinter plant and blast furn ace building do not appear to be reflected in the run script of the model, resulting in***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **64** of **130** concentrations up to fifty times the NAAQS. The commenter stated that actual monitoring data f rom 2010 show a maximum three

- month average ambient air concentration of 1 .12 μ g/m 3 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.

• T he EPA did not provide a modeling protocol for their dispersi on 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 c ommenter 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 sour ces, 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **65** of **130** estimate monthly lead concentratio ns, 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, th e 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).
More over, 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 it s 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 multipathwa y risks from lead, one commenter stated that the risk assessment used to set the NAAQS was based on quantitative studies***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **66** of **130** 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 f acility

level 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 maximu m lead concentration not to exceed a level of 0.15 μg/m 3 . 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 U nited 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 a vailable science directs the EPA to set a residual risk standard that incorporates protective health benchmarks and assures that children living near the facility will***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **67** of **130** not face an unacceptable neurological effect, such as the loss of IQ points. This includ es 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 becaus e 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 zer o 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 do es not exceed the level of 0.02 μg/m 3 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 multipat hway 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **68** of **130** the health of sensitive sub

- populations (such as children) with an adequate margin of safety. Moreover, the risk assessment supporting the NAAQS considere d direct inhalation exposures and indirect air

related 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 ambi ent 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 includ ing monitoring at a level below 0.15 μg/m 3

. For the reasons explained elsewhere in this notice and other supporting documents available in the docket , w e 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 hierarch y 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 benc hmark 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/m 3 based on a one***E.O. 12866 Review

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. 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 risk s 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 conside r ed whether there were additional cost

effective 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.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **70** of **130** 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 requir es 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 r esidual 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 t he 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 sensitiv e 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **71** of **130** those who are mor e 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 resu lt s 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 wer e no additional cost

- effective controls beyond those that would need to be implemented to ensure an acceptable level of risk. Thus, for th e three emissions points (fugitive dust emissions, the furnace area stack, and the refinery stacks) for which we are r equiring 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 e ffective 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 additio nal 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **72** of **130** accounted for or prevented environmental risks from lead or non

- lead emission s 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 huma n 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 as sume 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 stat ed: “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 categ ory 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 recepto rs. Although the ecological effects of lead are well documented, there was a lack of evidence at the time of the last lead NAAQS***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **73** of **130** review linking various ecological effects to specific levels of lead in the air. It was determined that the evidence did no t 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 le ad

. 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 int roduced 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

s econdary lead NAAQS shou ld be set equal to the p rimary lead NAAQS.
I n contrast, in this proposed rule, the EPA concludes that “ambient lead concentrations above the lead NAAQS indicates***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **74** of **130** 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 consist ent 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 no t sufficient data supporting that a lower level is necessary to protect against an environmental risk.
Comment : One commenter stated t hat in evaluating potential multipathway risks from PB

- HAP other than lead, the EPA used de minim i s emission rates to screen for potentially significant multi

pathway impacts, but for lead, this method was abandoned. The
commenter disagrees with this appr oach, 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **75** of **130** is not a proper surrogate for “facility

- level de minimis emission rates” used as the chr onic 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 s ource 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 m easured 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

-***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **76** of **130** month average lead concentrations). The NAAQS for lead was set to protect, with an adequate margin of safety, human health, including the health of child ren 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 multi

pathway, multi

- media impacts of lead, the risk assessment supporting the NAAQS considered direct inhalation exposures and indirect air

related multi

- pathway exposures from industrial sources like primary and secondary lead smelting operations. It al so considered background lead exposures from other sources (like contaminated drinking water and exposure to lead

- based paints). T he EPA believes that the lead NAAQS is a reasonable benchmark to evaluate the potential for multipathway health effects from l ead. 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 compo unds 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **77** of **130** 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 Offi ce 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 lang uage 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

num bers 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **78** of **130** the health disorders or other adverse effects that most of t hese 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 ful l 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

co nsideration 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, informa tive, 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, w hile 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 a ssociated with lead exposure. With regard to how the proposed controls limit the health risks associated with lead exposure, we noted in the***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **79** of **130** 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 ex press 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 a n un acceptable level of risk and will also provide an ample margin of safety

. The estimated reductions include a reduction in fugitive dust emission s of lead and as much as 10 tons per year of***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **80** of **130** lead from the furnace area and refining operations stacks. These controls will also reduce emissions of other HAP emitted from the facility. T he cost s of controls w ere 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 the se requirements are necessary to bring risk to a n acceptable level. However, as an example the cost for paving all unpaved roads at the facility to control fugitive emissions woul d 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 a nd emissions from the furnace area and refining stacks. In addition, we considered other available practice s , process es 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **81** of **130** Executive Order 13563: Improving Regulation and Regulatory Review Under Executive Order 12866 (58 F R 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 conta ined 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 informa tion submitted to the EPA pursuant to the recordkeeping and reporting requirements for which a claim of confidentiality is made is safeguarded according to a gency policies set forth in 40 CFR part 2, subpart B.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **82** of **130** Th is 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 und er 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 r eporting 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 cri teria 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 reas onable 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.***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **83** of **130** 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 provide d administrative adjustments to the ICR that show wha t 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 , a nd 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. Gi ven 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
par ticular source

. It is important to note that the EPA has no basis currently for estimating the number of malfunctions that would***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **84** of **130** qualify for an affirmative defense. Current historical records would be an inappropriate basis, as source owners or operators p reviously 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 expecte d to result from a malfunction (based on the definition above), and only a subset of excess emissions caused by malfunctions would result i n the source choosing to assert the affirmative defense. Thus , we believe the number of instances in which source ope rators 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 incl ude 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **85** of **130** associated with these amendments for this collection (averaged over the first 3 years after the effective date of the standards) is estimated to be 3 0 labor h ours at a cost of $3,141 per year for the affirmative defense reporting and recordkeeping provisions and 1,3 1 3 labor hours at a cost of $ 46 1,640 per year for the lead concentration in air limit reporting and recordkeeping provisions. There will be no capit al 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, a nd 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 4 0 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **86** of **130** 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, schoo l 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 t hese 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 r equirements 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **87** of **130** sector. The action imposes no enforceable duty on any S tate, 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 affe ct 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 indus try , 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***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **88** of **130** the distribution of po wer 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 E xecutive O rder 13045 (62 FR 19885, April 23, 1997) , because it is not economically significant as defined in E xecutive O rder 12866
. However, the a gency 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 leve ls 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,***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **89** of **130** distribution, or use of energy

. This action will not create any new requiremen ts 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 Techn ology Transfe r 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 oth erwise 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 wh en the a gency 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 great est extent practicable and permitted by law, to make environmental justice part***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **90** of **130** of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activ ities on minority populations and low

- income populations in the United States. The EPA has determined that th is fin al rule will not have disproportionately high and adverse human health or environmental effects on minority or low

- income populations, because it do es 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 HAP

related cancer and non

- cancer risks across different social, demographic, and economic groups wi thin the populations living near th e one facilit y that is currently operating in this source categor y . Our analyses also show that, although there is potential for an adverse environmental and human health effects from emission of lead , it does not indicat e 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 populatio ns exposed to these source s . K. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801, et seq . , as added by***E.O. 12866 Review

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– Do Not Cite, Quote or Release During Review *** Page **91** of **130** 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 th is 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 maj or 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.Page **93** of **130** 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 -**  **– [A**  **MENDED ]** 

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 pr ocess 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.Page **94** of **130** (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 smelt er;” 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 ha s 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 proce ssor resulting from the handling, storage, transfer, or other management of lead

- bearing materials where the source is not part of aPage **95** of **130** specific process, process vent, or stack. Fugitive dust sources include roadways, storage piles, materials handling transfe r 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 pro cessor. 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 operati on 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 proce ss 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.Page **96** of **130**

* * * * * 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 a re 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 fugit ive 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 a nd 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 lead

bearing scrap material, primarily, but not limited to, lead

- acidPage **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 loca tion 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
reconstruct ed 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 fur nace; (3) Dross furnace; (4) Dross furnace charging location; (5) Blast furnace and dross furnace tapping location;Page **98** of **130** (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
cont rol 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 e quivalent 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 bagh ouse 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 leadPage **99** of **130** compounds on an quarterly basis (no later than 100 days following any previous compliance test). (f) If the 12 most recent compliance tests demonstrate compl iance 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 compou nds. (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
sy stem 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 alar m 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 op erator must operate and maintain any affected source, including associated air pollutionPage **100** of **130** control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. Determination of whet her 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

m aintenance 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 no t exceed 0.15 μg/m 3 on a 3

- month rolling
average . (b) Consistent with the requirements in section 63.1547(k), e ach 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 pollutionPage **101** of **130** control equipment and monitoring equipment, in a man ner 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, b ut 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 ow ner 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.Page **102** of **130** (c) Pri or 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 FE DERAL 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 exi sting 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 6 0 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.Page **103** of **130** (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 e mission 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:
E Pb = quarterly lead emissions , pounds per quarter;
ER Pb = 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
pr evious quarter according to the procedures detailed in paragraphs (a)(5)(i) through (iv) of this section:Page **104** of **130** (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 production

based lead compound emission rate, in unit s 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 :
CE Pb = quarterly production

- based lead compound emission rate, in units of pounds of lead emissions per ton of lead produced;
E Pb = quarterly lead emissions, pounds per quarter; and
P Pb = quarterly lead production, tons per quarter. (7) To determine quarter ly compliance with the emissions standard for lead compounds under §63.1543(b), sum the leadPage **105** of **130** 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 thi s 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 oper ation 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 deter mine the conditions of performance
tests.Page **106** of **130** 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 p rocedures 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 t he 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.Page **107** of **130** ( 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 rever se 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 i s consistent with the baghouse manufacturer's instructions for routine and long

- term maintenance.Page **108** of **130** (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.Page **109** of **130** (5) The initial adjustment of the system must, at a minimum, consist of esta blishing 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 sensitivi ty 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 per cent 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 t he 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 planPage **110** of **130** must inc lude 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 c ompartment. (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 d etermined according to paragraphs (g)(1) through (g)(3) of this section.Page **111** of **130** (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 c ause 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 seconda ry 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 affect ed 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 measu res, 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 wit h 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 method ology specified in §63.1546(b). (2) Owners and operators must establish and maintain baseline ventilation parameters which result in a positive in

draft according to paragraphs (i)(2)(i) through (i)(2)(iv) of this section. (i) Owners and operators must i nstall, 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 f low rate at thePage **113** of **130** 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 monitorin g 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 o wner or operator wishes to re

establish 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 andPage **114** of **130** record damper positions daily to ensure they are in the positions they were in during the most recent in

- draft determi nation. (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 6 0. (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 le ad 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 toPage **115** of **130** measure lead emissions, taking into accoun t 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 Perform ance 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 per iods 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 adjustme nts.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 appli es: (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 previo us 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 an d 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 own er 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 justificat ion 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 anal ytical 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 y ears, 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 airPage **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 Adm inistrator 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 Nov ember 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
proces sor, 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 th e primary lead processor is seeking review and approval of the plan. Owners or operators of existingPage **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, reconstruct ed, 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
pa ragraph (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 co ntent 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 require d 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 t he 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 con tinuous 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

- draftPage **121** of **130** 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 d aily 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) an d 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 sit e. 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 a ddition to the information required under §63.10 of the General Provisions, the owner or operator must provide semi

-Page **122** of **130** annual reports containing the information specified in paragraphs (e)(1) through (e)(9) of this section to the Administrator or designated a uthority. (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 wit h 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 t aken. (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 whe n the 15

- minute volumetric flow rate(s) dropped below the minimum established during the most recent in

- draftPage **123** of **130** 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
op erating 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 anyPage **124** of **130** applicable emission limitation to be e xceeded. 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 b e 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 **125** of **130** (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 eviden ce 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 pr evented 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. Off

shift and overtime labor were used, to the extent practicable to make thes e repairs; and (3) The frequency, amount and duration of the excess emissions (including any bypass) were minimized to the maximumPage **126** of **130** extent practicable during periods of such emissions; and (4) If the excess emissions resulted from a bypass of
contro l 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 d ocumented 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 e xcess 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) tra nsmission 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 standard s in this subpart to demonstrate, with all necessary supporting documentation, that it has met the require ments 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 f or 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 fo llows: Table 1 of Subpart TTT

– General Provisions Applicability to Subpart TTTPage **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) YesPage **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 andPage **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

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## 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 modeli ng 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

................................ ................................ .............................. 38Draft

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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

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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 ID a 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 Morriso n 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 In cineration (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 C oalition 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 ActionDraft

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3 Document ID a 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 S ources for Cumulative Health Risk Assessment of Multiple Chemicals, Exposures and Effects: A Resource Document 0077.7 Earthjustice et al. (Attachment 6) Framework for Cumulative Ris k 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 0077 0 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 0077 1 Earthjustice et al. (Attachment 10) Synthetic Organic Chemical Manufacturing Industry

- Residual Risk Assessment, Report Prepared by EC/R Incorporated 0077 2 Earthjustice et al. (Attachment 11) The Benefits and Costs of t he Clean Air Act: 1990 to 2020

– Summary Report 0077 3 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 con sent of the copyright holder. 0077 4 Earthjustice et al. (Attachment 13) Improvements in Air Toxics Emissions Data Needed to Conduct Residual Risk Assessments Report No. 08

- P

- 0020 0077 5 Earthjustice et al. (Attachment 14) Letter to The Honorable Lis a 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 Method ologies: For Review by the EPA’s Science Advisory Board with Case Studies

– MACT I Petroleum Refining Sources and Portland Cement Manufacturing 0077 6 Earthjustice et al. (Attachment 15) Sources, Transport and Alte rations of Metal Compounds: An Overview. I. Arsenic, Beryllium, Cadmium, Chromium, and NickelDraft

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4 Document ID a Commenter, Affiliation Abstract 0077 7 Earthjustice et al. (Attachment 16) High

- level Strategy and Lea dership Needed to Continue Progress toward Protecting Children from Environmental Threats 0077 8 Earthjustice et al. (Attachment 17) Email to Emma Cheuse, Assoc iate 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 0077 9 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: Resid ential 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: Enviro n mental Justice and Cumulative Risks/Impacts 0078.8 Earthjustice et al. (Attachment 27) "Comparative Assessment of Air Pollution

- Related Health Risks in Houston"Draft

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5 Document ID a 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 I RIS: 47 Chemicals that Should Move to the Head of the Risk

Assessment 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 f rom 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 Substanc e & 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 Si te 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 Futu re 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, Missour i 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 investig ation 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 holderDraft

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6 Document ID a 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, an d 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 f or 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 Toxicolo gy 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 Applic ation. 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 ImpactDraft

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7 Document ID a 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: Herculane um Lead Smelter Roadway Contamination 0079.19 Earthjustice et al. (Attachment 59) Residual Risk Program: Sel ection 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 com ments 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 Herculan eum 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

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8 Document ID a Commenter, Affiliation Abstract 0080.5 Earthjustice et al. (Attachment 66) Herculaneum Lead Contaminati on 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 Test ing Areas 0080.8 Earthjustice et al. (Attachment 69) 0080.9 Earthjustice et al. (Attachment 70) Fourth National Report on Hu man 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 Elim inate Childhood Lead Poisoning Lead Poisoning Prevention Program New York City Department of Health and Mental Hygiene 0080.13 Earthjustice et al. (Attachment 74) Environmental Contaminatio n 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 Contaminatio n 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 Sitin g 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 Sch ool 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 Do cument #: 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 T his 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

- Car ried 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 AnonymousDraft

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9 Document ID a Commenter, Affiliation Abstract 0082 James L. Kavanaugh, Director, Air Pollution Control Program, Mis souri 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 Ba ttery 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 CorporationDraft

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10 Document ID a Commenter, Affiliation Abstract 0088.1 Attachment, Claire McClintic, Attorney, Stinson Morrison

Hecker 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 D ocket No. EPA - HQ - OAR - 2004 - 0 305

. Do cuments 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 a ttachments, if any, would follow the same pattern (e.g., 0 019.2, 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., 0 010 ).Draft

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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 documentatio n submitted by the commenters are summarized in Table 1 - 1

.Draft

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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 c ommenter state d that for non

- lead emissions; the EPA presumes th at 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 c ommenter cite s 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 ju stice 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 c ommenter 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 strin gent, 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 acc eptable, 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. On c e we determine that controls are sufficient to ensure risk is acceptable, we aga in 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 determiningDraft

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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 w ay 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 a nd, 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 t he 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. T he 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 risk s due to HAP emissions from this source categor y . We note that this is als o 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 ri s k 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 c ommenter state d 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 c ommenter noted that the facility is located in what would be considered an under

represented area with regard to environmental justice issues. With regard to t he 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 comment er acknowledged that there may not be enough scientific evidence to support a maximum allowable concentration level. The c ommenter 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 arse nic 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 case s per year . E xpressed 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 y ear 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 comment s in section 2.1.2.1Draft

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14 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 re quirement 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 reviewin g census block sizes or configurations to consider how pollutant concentrations might vary within these blocks. The commenter is concerned that the area

weighted centers of census blocks may significantly underestimat e exposure in some cases and re commend s 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. R esponse : 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 n ear 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 assessme nts, 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 ma ximum 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 overesti mate 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 cens us 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 centr oids because: 1) census blocks are the finest resolution available in the national census data, 2) facility fence line s do not typically represent locations where chronic exposures are likely (i.e , people do not typically live at the fence line of faciliti es) 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 th e EPA’s Science Advisory Board.Draft

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15 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 A gency has failed to provide any reasoned explanation for why risk assessments based on actual emi ssions estimates are inadequate. The A gency’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 accoun t 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 assumpti ons 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 conserv ative 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 a ny 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 re sidual 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 m odeling 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 na tional 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 t here 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 Offic e 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 o n 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. R esponse : We acknowledge that population subgroups, including childr en, 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)Draft

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16 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 lifet ime 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 review 1 of th e 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 valu es 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 adjustmen t 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 ag e 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 conside red to be plausible upper

- bound estimate s ; 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 N ational A mbient A ir Q uality S tandards ( NAAQS ) for lead . Notably, the lead NAAQS was set to protect public health, including the health of sensitive populations , wi th an adequate margin of safety from the advers e effects associated wi th 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**  **Ambien t Monitoring**  **2.1.3 The**  **EPA’s modeling relies on inaccurate data**

Comment: Commenter 008 8 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.Draft

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17 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 facilit y 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 008 8 stated the assumption o f 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 t he 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 res ults 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, health

protective 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 Nation al 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 docum ented in the docket. New and corrected data w ere received from the facility and state of Missouri during the public comment period that further refined the risk assessment

. EPA t echnical 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 sin ce the 1996 NEI , which was the basis for the O IG 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.Draft

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18 Documentation for the 2005 NEI point source emissions inventory is available on the EPA's CHIEF we bsite, 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 Assuranc e 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, u pdated 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 Approac h 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 l ead 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 . . . .” Le ad NAAQS, 73 FR 66964, 67052 (Nov. 12, 2008), § 50.16(a). The commenter stated that j ust 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. Failu re to meet the l ead 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 r egulating a criteria pollutant as a HAP, contrary to the intent of CAA § 112(b)(2). T he same unlawful result occurs for environmental risk, with the proposed r ule adopting the secondary l ead NAAQS to identify “the potential for adverse environmental effects.” A single standard using the same measurements improperly controls compliance ques tions under both the secondary l ead 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 nonatta inment.” 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 co mpounds. 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 MACTDraft

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19 Standard for lead compounds is met. Such dual regulat ion 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 sta ted 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 co ncluded 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 consid ered 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 unacce ptable 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 m argin of safety. Comment: Commenter 0087 state d that b ecause 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 prescr iptive 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 t he 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 prot ect 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 faci lity 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 NA AQS. 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 bestDraft

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20 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 state d 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 co mpliance delay simply cannot be reconciled with the EPA’s own recognition that lead emissions from this facility are unacceptable. The c ommenter s tate d 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 fac tors 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 he alth 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 individu al 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 f acility must demonstrate that 2 year s 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 f acility must demonstrate that steps are being taken in the interim period to protect public health

. According to the commenter, th is 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.Draft

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21 • The commenter states that the EPA has already delayed satisfying its legal duties both unde r 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 ne gotiated 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 ag reements 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 it s 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 “proh ibition” 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 c ontrols 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, l ikely 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 the se 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, w e 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 ris k 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 1 1 2(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 f or the mainDraft

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22 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: C ommenters (0077 and 0088 ) challenge the EPA’s proposal to defer the compliance date for new facilities to implement a CEMS. Commenter 0077 states that t he 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 EP A 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 rul e. 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**  **T otal**  **F acility**  **A pproach**  **and U**  **se of**  **D emographics**  **in R**  **ulemaking**

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 com bined 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 sourc e 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 r elevant for this action.
Comment : Commenter 0087 stated that the EPA should pr ovide 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 regulatio ns. T he 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.Draft

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23 Response: N o 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 state d that EPA’s proposal that facilities meet steady

- state standards dur ing startup, shutdown and malfunction (SSM) is unlawful. Specifically, the commenter note d 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 ev idence 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 condi tions 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 p ossible for the EPA to develop valid floor standards for the periods of startup, shutdown, and malfunction, citing t he EPA’s own National Stack Testing Guidance which discusses the difficulty of getting valid testing results during SSM. The commenter r ecommended 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 existin g 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 a gency to consider malfunctions in determin ing 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. App lying 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, ifDraft

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24 not impossible, given t he 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 proble m. 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, sab otage, 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 con trolled 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

- malfu nctioning 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 a re 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 com menter 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 possib ly 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 info rmation 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 it s analysis of the risk to public health and the environment.

• EPA fail ure 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 worst

performing 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 repo rt, and ensure that its risk analysis and resulting standardDraft

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25 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 emis sions 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 deeme d “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 ot her 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 w e believe malfunction events do not contribute significantly to cancer or chronic nonc ancer 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, t he conservative es timates 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 malfu nctions 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 inno cent and that the proposed language improperly puts the burden of proof on the facility rather thanDraft

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26 on the Agency. The commenter suggested that the EPA establish a rebuttable presumption rather than affirmative defense where it is presumed that the facilit y 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 a gency wants to challenge these activities, the burden of proof would be on them to show that th e facility did not undertake reasonable actions to minimize emissions. The commenter state d 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 th e 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. R esponse: The affirmative defense does not ch ange 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 ass ert 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 t he 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 even ts.). T he 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 affirmativ e 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.Draft

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27 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 re gulatory authorities. With regard to the reporting timeframe for asserting affirmative defense, w e 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 d ay 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 impa ct 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 mech anisms 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 th is 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 judg es 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 pr oposal, 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 reme dy, 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’ abili ty 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 cit izen 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 d emonstrates that certain factors [exist], EPA has done just that.Draft

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28 • 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), 4 2 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 on ly 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 b e 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 regardl ess 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 disp lace 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 m onitoring 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.Draft

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29 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 noti fication 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 facili ty 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 no tice 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 the mselves 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 tensi on, 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 estab lish 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” limi tations, 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. 197 3), 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 standar ds 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 EP A’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 affi rmative 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 (9 th 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 emissio n 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.Draft

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30 Further, the EPA’s view is that the affirmative defense is not inconsistent with CAA sectio n 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 as sessed, 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 sect ion 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 sour ce 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 tre ated 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 suc h “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 opport unity 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 h and, 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 30 1(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 th at 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 an y 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 th e 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 anyDraft

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31 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 requireme nt 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 criter ia 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 desig n 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 overla p 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 impo se 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 relie f. 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 w hen 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 provisio ns 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 affirm ative 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 state d that the proposed standards with the affirmative defense do not represent emission limitations achieved by the best

- performing existingDraft

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32 sources, nor do they meet the criteria for establishing beyond

- the

- floor emission standards and that the affirmative defense is not a permissible substi tute for setting standards for periods of malfunction and is insufficient to meet the EPA’s obligations under CAA §112. Commenter 0087 request ed the EPA set aside the proposed affirmative defense for periods of malfunction and establish a work practice sta ndard 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 u nder 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 framewo rk 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 pr oposed rule for this source category we concluded that risk s associated with emissions from the Primary Lead Smelting sou rce category were un acceptable , 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 nee ded 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 sa fety 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 sup porting 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 beDraft

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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 signif icant 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 w indows 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 evaluatin g whether or not it is appropriate to use the CalEPA chi ld

- specific reference doses. T hat 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 app ropriate health benchmark values a n d 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 hig h 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 state d 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 ex posure 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 h ealth 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

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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 peo ple 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 con sume the entire non

cancer 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 di scussion 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 t his 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 noncan cer 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 ac ute, 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 accu racy and uncertainty of each piece of information must be considered in a weight

- of

evidence approach for each decision. This relevant body of information is growing fast (and 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 impa cts do not get high enough to cause harm to public health. T hus , w e 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 risk s from lead would also be expected to reduce risks from other metal HAP.Draft

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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 eff ects 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 th e 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 formulat ion 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 onl y 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 an nual 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 su ggested that the furnace area stack emission be removed from the proposed lb/ton limit, and that a more realistic basis for measur ing 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 t he furnace area stack and the main stack

. Th e 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 demon strated by stack tests performed for compliance with the MACT. Comment: Commenter 0082 opposed the proposed plant

- wide emission limit for several reasons. The c ommenter states that the current form of the stack emission limit (i.e. pound per ton of lead p roduced) 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 limi ts (tons per year), although based on quarterly

- averagedDraft

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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 c ommenter su ggested 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 co nsistency 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

- orient ed, 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 conduc ted. 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 th at 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 tim e 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 stand ard 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 st andard 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 risk s from the main stack are more than 20 timesDraft

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37 below the acceptable level and that additional control measures are not warranted as they would n ot 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 s tated 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 b e 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 fin ancial burdens or concerns over technical infeasibility that EPA has not recognized in a proposed rule , commenter s should inform the EPA of such issues during the public comment period on th at proposed rule and the EPA will consider those comments when dec iding 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 p olishing 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 ind ustry do es 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 spec ial 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 th e RTR for secondary lead smelting , which was published in the Federal Register on May 19, 2011 (76 FR 29032).Draft

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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 determin ation 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, proc esses, 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 expres s § 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 (5 th Cir. 2002) ; see also Last Best Beef, LLC v. Dudas , 506 F.3d 333, 340 (4 th Cir. 2007); Friends of the Boundary Water Wilderness v. Bosworth , 437 F.3d 815, 823 (8 th 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 add ressed a rule issued pursuant to section 129 of the CAA, the provisions of section 112 are similar.Draft

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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 th is rule or record. Response: We do not have any response to these unrelated comments.Primary Lea d 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 Lea d Processing NESHAP Technical Support Document : Final Rule

i Table of Co ntents

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 o n Modeled Concentrations

..... 4 3.0 Model to Monitor Comparison

................................ ................................ ........................... 7 4.0 Estimated Costs of Revisions to the Primary Lead Smelting NESHA P

............................. 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 CostsPrimary Lea d Processing NESHAP Technical Support Document : Final Rule

1 

### 1.0 Residual Risk Analysis

– Revisions to the Emissio ns 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 Cle an Air Act (CAA). In order to conduct the risk analysis of sources in the Primary Lead Smelting source category, a n 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 t he 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 threshold s for each HAP to estimate residual risk s . 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 comment s on the emissions and other data used to conduct the residual risk assessment and received significant comment s on the data used along with submittal of revised and/or corrected emissions data , source characteristic information , and meteorological data. Commen t s 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 comment s , 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], Em ission rate [g/s ·m 2 ], X side length [m], y side length [m], angle from North [deg.], initial vertical dimension [m]. In addition, Doe Run provided p article size range s and distribution s pro vided hours of operation for several sources which indicated the d istribution of the emission rate from the source file over a 24

- hour period.Primary Lea d 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. B elow 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 propo sal data set

. 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 ( S ource ID 50008 ) emissions wer e 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 w as not included in the risk assessment as the facility reported that it no longer exist ed 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 2000 4, 20004B, 20004C (fume handling) and 60004 (low alpha baghouse) were shown with emissions totaling 0.2125 ton year and the new submission reported ze ro emissions from these sources because they are no longer operating the low alpha baghouse and the fume h andling is now performed in such a way that fugitive emissions are not generated at those locations

.

• P lantwide resuspension was characterized with emissions of 0. 31 tpy in the proposal dataset. This was reported as zero emissions in the new submittal ; howe ver, 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 us ed 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 provide d 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 55 0 feet which is the actual stack height. However, the Doe Run submittal limited the height fo r the main stack consistent with

“ Good Engineering Practice ” which is required when modeling for NAAQS compliance demonstration.Primary Lea d 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 m odeling was not used for the revised risk assessment. Lead f ugitive 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 dat aset and a n 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 change s in lead emissions levels reflected in the comparison of the proposal da taset (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) Na me 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 % 5 000 8 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 emissio ns 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 a nalysis 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 wasPrimary Lea d 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 th at 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 op erating

. 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 a nalysis model ed 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 compare d to the Primary National Ambient Air Quality Standard (NAAQS) for lead ( 0.15 μg/m 3 ). If the modeled emission s exceeded the lead NAAQS, the risk at that location w as considered to be unacceptable. The results indicated multiple locations exceeded the level of the NAAQ S to various degrees. M odeling results indicated that t he 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 st ack were the largest contribut o rs ) and fugitive dust emissions. As in the proposal modeling, t he 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 emiss ions being treated as one emission point) was analyzed to d etermine what emission level s 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 highes t 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 risk s for that emission point at any location would be reduced to an acceptable level. Further, the E PA 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 b e linear, a percentage reduction applied to an annual emissions rate for a given emission point would produce the same reduction in modeled concentration s . A calculation was made for each emission point to determine what percent reduction in concentration was required for each of the highest concentration location s 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 andPrimary Lea d 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 concen tration 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. T he 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 9 0 percent. Monitoring to ensure work practices for fugitive emissions achieve acceptable risk remains at 0.15 ug/m 3 lead concentration in air. For the combined furnace area and refining operations stacks the total emissions reported w ere 11.5 6 tons per year. Based on the required reduction percentage to meet a lead concent ration in air of 0.15 μ g/m 3 , 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 stack s . While we ar e 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/m 3

.Primary Lea d Processing NESHAP Technical Support Document : Final Rule

6 Table 2 - Calculations of Risk - Based Emission Limits Based on Modeled Concen tration s

Modeled Source 2009 Emissions Maximum Modeled L ead C oncentration* Rollback to M eet 0.15μg/m 3 * Estimated Emissions A fter R ollback (tpy) (μg/m 3 ) % (tpy) Stacks

- Baghouse 8 & 9(refinery) 9.1 1.1 6 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 0.1 7 1 3 0. 9

FINAL EMISSION LIMIT Furnace Area and Refinery Stacks 1.2 TPY FINAL MONITORING REQUIREMENT** Lead Concentration in Air 0.15 μg/m 3 Calcu lations: 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 a pproved by the AdministratorPrimary Lea d 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 monitor s located close to the Doe Run facility in Herculane um , 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 Ci rcle Street monitors, AERMOD underestimate d 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 reasona bly 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 estimate s are a reasonable representation of the measured 3

- month maximum lead concent rations in the ambient air near this facility. For the final rule, the facility emissions were re modeled based on revised and new information submitted through the public comment process. A model

- to

- monitor comparison was conducted for six monitor locatio ns close to the facility for the year 2009

. The resulting model

- to

- monitor ratio indicates that for any monitor analyzed, the maximum model ed concentration is within 50% of the maximum monitored concentration at the same location which demonstrates a reas onable 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 Lea d Processing NESHAP Technical Support Document : Final Rule

8 Table 3 Remodeling for Final Rule

– Model - to - Monitor Comparison

Monitor Name Latitude Longitude AE R MOD Modeled Lead C oncentration 2 (μg/m 3 ) Maximum Monitored Lead Concentration 2 (μg/m 3 ) Max Modeled/ Max Monitored Percent Difference 3 City Hall/Main St. 4238290 729319 0.776 1 .2 6 4

. 67 %

- 3 5

. 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% Ursuline 1 4235800 72 9617 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 underestimationPrimary Lea d Processing NESHAP Technical Support Document : Final Rule

9 

### 4.0 Estimated Costs of Revisions to the Primary Lead Smelting NES HAP 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 m ain stack to achieve acceptable risk. Under our ample margin of safety technology review analys e s, 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 redu ced 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 analy sis 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 em ission limit requirement s . In the proposed rule f or 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 eva luate 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 prec ipitator s (WESP) may technologically feasible for achieving additional emission reductions from the main stac k, 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 th at 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 det ermine 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

. N o 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 Lea d 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 th at 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 fo r 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 woul d 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 dock et 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 stack s 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 pr ohibitively 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, reduc tions in the emission standards based on WESP technology w ere 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 Lea d 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 ($US) Emissions Reduction (tons) Contro l Efficiency ($/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 baghousesPrimary Lea d 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 a nd baghouse 8 stacks. The add itional 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 Testing 1 Met hod 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 testsPrimary Lea d Processing NESHAP Technical Support Document : Final Rule

Appendix A Page 1 APPENDIX A

Cost Estimates for West Electrostatic Prec ipitator Control Technology For Doe Run Company Primary Lead Processing Facility Based on EPA Cost ManualPrimary Lea d 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 Cos t 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 9 0% 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 $2,389,8 53 $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

W ESP Auxiliary $ 500,000

1998 389.5 Multiplier 2010 540 1.386393 2008 575.4