From: Topham.Nathan@epamail.epa.gov

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

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

Cc: Guinnup.Dave@epamail.epa.gov; Talcott.Fred@epamail.epa.gov;
tierney.jan@epamail.epa.gov; Stewart.Michael@epamail.epa.gov; Beck, Nancy; Frey, Nathan J.; French.Chuck@epamail.epa.gov; Hanzel, Veronica Subject: E.O. 12866 NESHAP Primary Lead Processing Final AQ

- 43

- Draft Response to

Comment Document for OMB Review

Attachments: E.O. 12866 NESHAP Primary Lead Processing Final A Q

- 43 Response to Comment

Document

- DRAFT

- 10

- 14

- 2011.docx

Hi everyone,

Attached you'll find the response to comment document for the primary lead processing RTR final rule for your review. Please feel free to get in touch with me if you have any quest ions.

Nathan Topham
Environmental Engineer US EPA/OAQPS/SPPD/MIG

# National Emission Standards for

Hazardous Air Pollutants: Primary Lead Smelting

Summary of Public Comment and Response

DRAFT

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October 14 , 2011i 

## 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 granting the NRDC petition in this rulemaking; thus these comments are not

relevant. We note that in the context of recent rulemakings we have discussed our position on our continuing authority to set standards under section 112(d)(2) and (3) and our authority under 112(d)(6). See, e.g., 76 FR 22577. In ad dition, we discuss this issue in responding to a comment from NRDC regarding our obligation to review “defective” MACT standards under section 112(d)(6).

Comment: Commenter 0064 opposed the EPA regulating industry due to impacts on jobs and economic

recovery.

Response: We are required by the CAA to conduct the residual risk and technology review that make up this rulemaking. The EPA strives to ensure that our rules minimize negative impact s 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.Draft

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39 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.