From: Topham.Nathan@epamail.epa.gov

Sent: Thursday, October 27, 2011 4:03 PM

To: Cortney_Higgins@omb.eop.gov

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

Stewart.Michael@epamail.epa.gov; tierney.jan@epamail.epa.gov

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

preamble/rule responding to OMB comments

Attachments: EO12866 NESHAP Primary Lead Processing Final AQ-43_DRAFT_10-27-

2011_Response to OMB Comments_Redline.docx; EO12866 NESHAP Primary 

Lead Processing Final AQ-43_DRAFT_10-27-2011_Response to OMB 

Comments_Clean.docx

Hi Cortney, 

I've attached the revised preamble/rule. Take a look and let me know if you think you'd still like to have 

the call we've tentatively scheduled for tomorrow or whether you think we can finish things up via 

email. 

I've attached a version with everything in redline and a totally clean version. 

Give me a call later today or tomorrow morning if you want to chat about any of it. 

Thanks for the continued hard work! 

Nathan Topham 

Environmental Engineer 

US EPA/OAQPS/SPPD/MIG 

Phone - (919)541-0483
Summary of Interagency Working Comments on Draft Language under 

EO12866/13563 Interagency Review. Subject to Further Policy Review

EO12866 NESHAP_Primary Lead Processing Final 2060AQ43_20111005.doc

6560-50-P

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA–HQ–OAR–2004–0305; FRL-XXXX-X]

RIN 2060–AQ43

National Emission Standards for Hazardous Air Pollutant Emissions for 

Primary Lead Processing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This action finalizes the residual risk and technology 

review conducted for the Primary Lead Processing source category

regulated under national emission standards for hazardous air 

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

that include revision of the rule’s title and applicability 

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

modification and addition of testing and monitoring and related 

notification, recordkeeping, and reporting requirements, including 

the addition of a requirement to monitor the lead concentration in 

the air. It also finalizes revisions to the regulatory provisions 

related to emissions during periods of startup, shutdown, and 

malfunction and makes minor non-substantive changes to the rule.

DATES: This final action is effective on [INSERT DATE OF 

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

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

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

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

business information (CBI) or other information whose disclosure is 

restricted by statute. Certain other material, such as copyrighted 

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

available only in hard copy form. Publicly available docket materials 

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

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

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

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

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

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

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

1742.

FOR FURTHER INFORMATION CONTACT: For questions about this final 

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

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

Protection Agency, Research Triangle Park, NC 27711; telephone 

number: (919) 541–0483; fax number: (919) 541-3207; and email 

address: topham.nathan@epa.gov. For additional contact information, 

see the following SUPPLEMENTARY INFORMATION section.
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SUPPLEMENTARY INFORMATION:

For specific information regarding the modeling methodology, 

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

Standards, Health and Environmental Impacts Division, Air Toxics 

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

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

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

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

this NESHAP to a particular entity, contact the appropriate person 

listed in Table 1 to this preamble.

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

Action

NESHAP for: OECA Contact1 OAQPS Contact2

Primary Lead 

Processing 

Maria Malave, (202) 

564-7027, 

malave.maria@epa.gov

Nathan Topham

(919) 541-0483

topham.nathan@epa.gov 1 EPA’s Office of Enforcement and Compliance Assurance. 2 EPA’s Office of Air Quality Planning and Standards.

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

the EPA proposed revisions to the Primary Lead Smelting NESHAP based 

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

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

revisions for the rule. Some of the significant comments and our 

responses are summarized in this preamble; a summary of the other 

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

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

in this action is available in the docket.

Organization of This Document. The following outline is provided to 

aid in locating information in the preamble.

I. General Information

A. Does this action apply to me?

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

C. Judicial Review

II. Background 

III. Summary of the Final Rule

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

Processing source category?

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

and malfunction?

 C. What are the effective and compliance dates of the 

standards?

IV. Summary of Significant Changes Since Proposal

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

of the Clean Air Act

 B. Changes to the Technology Review Performed Under Section 

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

 C. Other Changes Since Proposal

V. Summary of Significant Comments and Responses

A. Timeline for Compliance

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

C. Primary Lead Processing Risk Assessment

VI. Impacts of the Final Rule

VII.Statutory and Executive Order Reviews

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

Executive Order 13563: Improving Regulation and Regulatory 

Review

B. Paperwork Reduction Act 

C. Regulatory Flexibility Act 

D. Unfunded Mandates Reform Act 

E. Executive Order 13132: Federalism 

F. Executive Order 13175: Consultation and Coordination With

Indian Tribal Governments 

G. Executive Order 13045: Protection of Children From

Environmental Health Risks and Safety Risks

H. Executive Order 13211: Actions Concerning Regulations That 

Significantly Affect Energy Supply, Distribution, or Use
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I. National Technology Transfer and Advancement Act 

J. Executive Order 12898: Federal Actions to Address 

Environmental Justice in Minority Populations and Low-Income

Populations

K. Congressional Review Act

I. General Information

A. Does this action apply to me?

Regulated Entities. Categories and entities potentially regulated by 

this action include: 

Table 2 – NESHAP and Industrial Source Categories Affected By 

This Final Action

NESHAP and Source Category NAICS1 Code MACT2

Code

Primary Lead Processing 331419 0204

1 North American Industry Classification System 2 Maximum Achievable Control Technology

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

guide for readers regarding entities likely to be affected by the 

final action for the source category listed. To determine whether 

your facility would be affected, you should examine the applicability 

criteria in the appropriate national emission standards for hazardous 

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

report published by the EPA in 1992, the Primary Lead Smelting source 

category is defined as any facility engaged in producing lead metal 

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

smelting processes: sintering, reduction, preliminary treatment, and 
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refining operations.1 To be consistent with the 1992 listing, the EPA

is revising the applicability of the Primary Lead Smelting NESHAP to 

apply to any facility that produces lead metal from lead ore 

concentrates and is changing the title of the rule to reference 

Primary Lead Processing. For clarification purposes, all reference to 

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

hazardous air pollutant) and all reference to lead production means 

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

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

If you have any questions regarding the applicability of any 

aspect of the Primary Lead Processing NESHAP, please contact the 

appropriate person listed in Table 1 of this preamble in the 

preceding FOR FURTHER INFORMATION CONTACT section.

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

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

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

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

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

policy and guidance page for newly proposed and promulgated rules at 

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

provides information and technology exchange in various areas of air 

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

July, 1992.
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pollution control.

Additional information is available on the residual risk and 

technology review (RTR) web page at 

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

includes source category descriptions and detailed emissions and 

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

C. Judicial Review. 

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

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

the United States Court of Appeals for the District of Columbia 

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

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

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

proceedings brought by the EPA to enforce the requirements.

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

objection to a rule or procedure which was raised with reasonable 

specificity during the period for public comment (including any 

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

also provides a mechanism for us to convene a proceeding for 

reconsideration, “[i]f the person raising an objection can 

demonstrate to the EPA that it was impracticable to raise such 

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

for such objection arose after the period for public comment (but 
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within the time specified for judicial review) and if such objection 

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

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

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

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

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

preceding FOR FURTHER INFORMATION CONTACT section, and the Associate 

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

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

NW, Washington, DC 20460.

II. Background 

Section 112 of the CAA establishes a two-stage regulatory 

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

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

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

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

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

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

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

major sources, these technology-based standards must reflect the 

maximum degree of emission reductions of HAP achievable (after

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

environmental impacts) and are commonly referred to as maximum 
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achievable control technology (MACT) standards.

For MACT standards, the statute specifies certain minimum 

stringency requirements, which are referred to as floor requirements

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

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

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

controlled similar source. The MACT standards for existing sources 

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

less stringent than the average emission limitation achieved by the 

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

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

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

must also consider control options that are more stringent than the 

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

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

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

environmental impacts, and energy requirements. In promulgating MACT 

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

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

that reduce the volume of or eliminate HAP emissions through process 

changes, substitution of materials, or other modifications; enclose 

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

treat HAP when released from a process, stack, storage, or fugitive 
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emissions point; and/or are design, equipment, work practice, or 

operational standards.

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

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

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

revise them “as necessary (taking into account developments in 

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

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

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

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

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

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

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

adopt standards equal to existing MACT standards if the EPA

determines that the existing standards are sufficiently protective.

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

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

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

Subpart TTT, that took into consideration the residual risk and 

technology review (RTR) analyses for that source category. This 

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

provisions of CAA section 112 for the Primary Lead Processing source 
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category. Specifically, as a result of our analyses, we are revising 

the requirements of the NESHAP to ensure public health and the 

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

emission reductions are consistent with what is economically and 

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

taking the following actions:

• Revising the requirements in the NESHAP related to emissions 

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

• Revising the title of the rule and amending the applicability 

section consistent with the definition of the source category 

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

facility processing lead ore concentrate to produce lead metal.

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

definition of “primary lead processor” and adding definitions of 

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

remelters.”

• Incorporating the use of plain language into the rule.

• Addressing technical and editorial corrections in the rule.

• Responding to the January 2009 petition for rulemaking from the 

Natural Resources Defense Council (NRDC) that the original 

primary lead NESHAP should have included an emission standard 

for organic HAP and announcing our intention to collect 

additional data needed to develop a standard for organic HAP.
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We note that the Doe Run Herculaneum Smelter, the only facility 

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

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

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

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

will achieve drastic reductions in lead emissions and will provide 

substantial environmental and public health benefits. The Herculaneum 

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

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

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

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

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

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

III. Summary of the Final Rule

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

source category?

The National Emission Standards for Hazardous Air Pollutant 

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

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

lead processing industry consists of facilities that produce lead 

metal from ore concentrates. The source category covered by this MACT 

standard currently includes only one operating facility, The Doe Run 

Company in Herculaneum, Missouri.
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For the reasons provided in the proposed rule and in the support 

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

with this source category are unacceptable and are therefore 

promulgating requirements to reduce the risk to an acceptable level. 

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

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

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

concluded that there are no additional cost-effective controls 

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

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

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

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

existing MACT standard to include: 

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

refining operation stacks, combined.2

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

address fugitive emissions to ensure emissions do not present an 

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

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

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

that such fugitive emissions are adequately addressed.

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

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

of maximum lead impact.
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To satisfy section 112(d)(6) of the CAA, we are, therefore,

revising the existing MACT standard to include a reduction of the 

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

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

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

developments in practices, processes, or control technologies since 

promulgation of the MACT standards demonstrate that the facility can 

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

section 112(d)(6). 

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

of the CAA, we are promulgating the following:

• The revision of the applicability section of the rule consistent 

with the definition of the source category adopted in 1992, 

subpart TTT which applies to any facility that produces lead metal

from lead concentrate ore. 

• Changes to the Primary Lead Processing MACT standards to eliminate 

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

subpart TTT to indicate that several requirements of the 40 CFR 

part 63 General Provisions related to periods of SSM do not apply.

We are adding provisions to the Primary Lead Processing MACT 

standards requiring sources to operate in a manner that minimizes 

emissions, removing the SSM plan requirement, clarifying the 

required conditions for performance tests, and revising the SSM–
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associated recordkeeping and reporting requirements to require 

reporting and recordkeeping for periods of malfunction. We are 

also adding provisions to provide an affirmative defense against 

civil penalties for exceedances of emission standards caused by 

malfunctions, as well as criteria for establishing the affirmative 

defense.

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

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

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

definition of “primary lead processor” and adding definitions of 

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

These revisions to the Primary Lead Processing MACT standard are 

expected to result in lead emissions reductions and increased 

compliance costs to the industry. No economic impacts on small 

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

have determined that the one facility in this source category can 

meet the applicable emissions standards at all times, including 

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

standards.

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

malfunction?

The United States Court of Appeals for the District of Columbia 

Circuit vacated portions of two provisions in the EPA’s CAA Section 
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112 regulations governing the emissions of HAP during periods of 

startup, shutdown, and malfunction (SSM). Sierra Club v. EPA, 551 

F.3d 1019 (D.C. Cir. 2008), cert. denied, 130 S. Ct. 1735 (U.S. 

2010). Specifically, the Court vacated the SSM exemption contained in 

40 CFR 63.6(f)(1) and 40 CFR 63.6(h)(1), that are part of a 

regulation, commonly referred to as the “General Provisions Rule,” 

that the EPA promulgated under section 112 of the CAA. When 

incorporated into CAA Section 112(d) regulations for specific source 

categories, these two provisions exempt sources from the requirement 

to comply with the otherwise applicable CAA section 112(d) emission 

standard during periods of SSM.

The United States Court of Appeals for the District of Columbia 

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

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

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

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

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

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

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

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

specific source categories, these two provisions exempt sources from 

the requirement to comply with the otherwise applicable CAA section 

112 emission standards during periods of SSM.
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We have eliminated the SSM exemption in this rule. Consistent 

with Sierra Club v. EPA, the EPA has established standards in this 

rule that apply at all times. We have also revised Table 1 (the 

General Provisions table) in several respects. For example, we have 

eliminated that incorporation of the General Provisions’ requirement 

that the source develop an SSM plan. We have also eliminated or 

revised certain recordkeeping and reporting that related to the SSM 

exemption. The EPA has attempted to ensure that we have not included 

in the regulatory language any provisions that are inappropriate, 

unnecessary, or redundant in the absence of the SSM exemption.We have 

eliminated the SSM exemptions in the regulatory text. Consistent with 

Sierra Club v. EPA, the EPA has established standards in this rule 

that apply at all times. We have also revised Table 1 (the General 

Provisions table) in other respects. For example, we have eliminated 

the incorporation of the General Provisions’ requirement that the 

source develop an SSM plan. We have also eliminated or revised 

certain recordkeeping that related to the SSM exemption. The EPA has 

attempted to ensure that we have not included in the regulatory 

language any provisions that are inappropriate, unnecessary, or 

redundant in absence of the SSM exemption.

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

into account startup and shutdown periods and, for the following 

reasonsreasons explained below, has not established different 
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standards for those periods. Information on periods of startup and 

shutdown in the industry indicate that emissions during these periods 

do not increase. Furthermore, all processes are controlled by either 

control devices or work practices, and these controls would not 

typically be affected by startup or shutdown. Also, compliance with 

the standardstandards already requires averaging of emissions over a

three month periodperiods, which accounts for the variability of 

emissions that may result during periods of startup and shutdown. 

Therefore, separate standards for periods of startup and shutdown are 

not being promulgated.

Periods of startup, normal operations, and shutdown are all 

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

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

reasonably preventable failure of air pollution control and 

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

normal or usual manner * * * ’’(40 CFR 63.2). The EPA has determined 

that CAA section 112 does not require that emissions that occur 

during periods of malfunction be factored into development of CAA 

section 112 standards. Under section 112, emission standards for new 

sources must be no less stringent than the level “achieved” by the 

best controlled similar source and for existing sources generally 

must be no less stringent than the average emission limitation 

“achieved” by the best performing 12 percent of sources in the 
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category. There is nothing in section 112 that directs the Agency to 

consider malfunctions in determining the level “achieved” by the best 

performing or best controlled sources when setting emission 

standards. Moreover, while the EPA accounts for variability in 

setting emissions standards consistent with the section 112 caselaw, 

nothing in that caselaw requires the Agency to consider malfunctions 

as part of that analysis. Section 112 uses the concept of “best 

controlled” and “best performing” unit in defining the level of 

stringency that section 112 performance standards must meet. Applying 

the concept of “best controlled” or “best performing” to a unit that 

is malfunctioning presents significant difficulties, as malfunctions 

are sudden and unexpected events.Periods of startup, normal 

operations, and shutdown are all predictable and routine aspects of a 

source’s operations. However, by contrast, malfunction is defined as 

a “sudden, infrequent, and not reasonably preventable failure of air 

pollution control equipment, process equipment, or a process to 

operate in a normal or usual manner***” (40 CFR 60.2). The EPA has 

determined that CAA section 112 does not require that emissions that 

occur during periods of malfunction be factored into development of 

CAA section 112 standards. Under CAA section 112, emissions standards 

for new sources must be no less stringent than the level “achieved” 

by the best controlled similar source, and, for existing sources,

generally must be no less stringent than the average emission 
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limitation “achieved” by the best performing 12 percent of sources in 

the category. There is nothing in CAA section 112 that directs the 

agency to consider malfunctions in determining the level “achieved” 

by the best performing or best controlled sources when setting 

emission standards. Moreover, while the EPA accounts for variability 

in setting emissions standards consistent with the CAA section 112 

case law, nothing in that case law requires the agency to consider 

malfunctions as part of that analysis. CAA section 112 uses the 

concept of “best controlled” and “best performing” unit in defining 

the level of stringency that CAA section 112 performance standards 

must meet. Applying the concept of “best controlled” or “best 

performing” to a unit that is malfunctioning presents significant 

difficulties, as malfunctions are sudden and unexpected events.

Further, accounting for malfunctions would be difficult, if not 

impossible, given the myriad 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) (EPA typically has wide latitude in determining the 

extent of data-gathering necessary to solve a problem. We generally 

defer to an agency's decision to proceed on the basis of imperfect 
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scientific information, rather than to "invest the resources to 

conduct the perfect study."). See also, Weyerhaeuser v Costle, 590 

F.2d 1011, 1058 (D.C. Cir. 1978) (“ In the nature of things, no 

general limit, individual permit, or even any upset provision can 

anticipate all upset situations. After a certain point, the 

transgression of regulatory limits caused by ‘uncontrollable acts of 

third parties,’ such as strikes, sabotage, operator intoxication or 

insanity, and a variety of other eventualities, must be a matter for 

the administrative exercise of case-by-case enforcement discretion, 

not for specification in advance by regulation.”). In addition, the 

goal of a best controlled or best performing source is to operate in 

such a way as to avoid malfunctions of the source and accounting for 

malfunctions could lead to standards that are significantly less 

stringent than levels that are achieved by a well-performing nonmalfunctioning source. The EPA’s approach to malfunctions is 

consistent with section 112 and is a reasonable interpretation of the 

statute. Further, accounting for malfunctions would be difficult, if 

not impossible, given the myriad of different types of malfunctions 

that can occur, and, given the difficulties associated with 

predicting or accounting for the frequency, degree, and duration of 

various malfunctions that might occur. As such, the performance of 

units that are malfunctioning is not “reasonably” foreseeable. See, 

e.g., Sierra Club v. EPA, 167 F. 3d 658, 662 (D.C. Cir. 1999) (the 
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EPA typically has wide latitude in determining the extent of datagathering necessary to solve a problem. We generally defer to an 

agency's decision to proceed on the basis of imperfect scientific 

information, rather than to "invest the resources to conduct the 

perfect study."). See also, Weyerhaeuser v. Costle, 590 F.2d 1011, 

1058 (D.C. Cir. 1978) (“In the nature of things, no general limit, 

individual permit, or even any upset provision can anticipate all 

upset situations. After a certain point, the transgression of 

regulatory limits caused by ‘uncontrollable acts of third parties,’ 

such as strikes, sabotage, operator intoxication or insanity, and a 

variety of other eventualities, must be a matter for the 

administrative exercise of case-by-case enforcement discretion, not 

for specification in advance by regulation.”). In addition, the goal 

of a best controlled or best performing source is to operate in such 

a way as to avoid malfunctions of the source, and accounting for 

malfunctions could lead to standards that are significantly less 

stringent than levels that are achieved by a well-performing nonmalfunctioning source. The EPA’s approach to malfunctions is 

consistent with CAA section 112, and is a reasonable interpretation 

of the statute.

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

CAA section 112(d) standards as a result of a malfunction event, the

EPA would determine an appropriate response based on, among other 
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things, the good faith efforts of the source to minimize emissions 

during malfunction periods, including preventative and corrective 

actions, as well as root cause analyses to ascertain and rectify 

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

failure to comply with the CAA section 112(d) standard was, in fact, 

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

“caused in part by poor maintenance or careless operation.” 40 C.F.R. 

§ 63.2 (definition of malfunction).event that a source fails to 

comply with the applicable CAA section 112 standards as a result of a 

malfunction event, the EPA would determine an appropriate response 

based on, among other things, the good faith efforts of the source to 

minimize emissions during malfunction periods, including preventative 

and corrective actions, as well as root cause analyses to ascertain 

and rectify excess emissions. The EPA would also consider whether the 

source's failure to comply with the CAA section 112 standard was, in 

fact, “sudden, infrequent, not reasonably preventable” and was not 

instead “caused in part by poor maintenance or careless operation.”

40 CFR 63.2 (definition of malfunction).

Finally, the EPA recognizes that even equipment that is properly 

designed and maintained can sometimes fail and that such failure can 

sometimes cause an exceedance of the relevant emission standard. 

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

Emissions During Malfunctions, Startup, and Shutdown (Sept. 20, 
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1999); Policy on Excess Emissions During Startup, Shutdown, 

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

adding to the final rule an affirmative defense to civil penalties 

for exceedances of emission limits that are caused by malfunctions. 

See 40 CFR Finally, the EPA recognizes that even equipment that is 

properly designed and maintained can sometimes fail, and that such 

failure can sometimes cause an exceedance of the relevant emission 

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

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

20, 1999); Policy on Excess Emissions During Startup, Shutdown, 

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

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

penalties for exceedances of emission limits that are caused by 

malfunctions. See 40 CFR 63.1542 Primary Lead Processing (defining 

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

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

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

of which are independently and objectively evaluated in a judicial or 

administrative proceeding.). We also have added other regulatory 

provisions to specify the elements that are necessary to establish 

this affirmative defense; the source must prove by a preponderance of 

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

in(defining “affirmative defense” to mean, in the context of an 
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enforcement proceeding, a response or defense put forward by a 

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

the merits of which are independently and objectively evaluated in a 

judicial or administrative proceeding). We also have added other 

regulatory provisions to specify the elements that are necessary to 

establish this affirmative defense; the source must prove by a

preponderance of evidence that it has met all of the elements set 

forth in 63.1551 Primary Lead Processing. (See 40 C.F.R. 22.24). The 

criteria ensure that the affirmative defense is available only where 

the event that causes an exceedance of the emission limit meets the 

narrow definition of malfunction in 40 C.F.R. 63.2 (sudden, 

infrequent, not reasonable preventable and not caused by poor 

maintenance and or careless operation). For example, to successfully 

assert the affirmative defense, the source must prove by a 

preponderance of the evidence that excess emissions “[w]ere caused by 

a sudden, infrequent, and unavoidable failure of air pollution 

control and monitoring equipment, process equipment, or a process to 

operate in a normal or usual manner....” The criteria also are designed 

to ensure that steps are taken to correct the malfunction, to 

minimize emissions in accordance with section 63.(See 40 CFR 22.24). 

The criteria ensure that the affirmative defense is available only 

where the event that causes an exceedance of the emission limit meets 

the narrow definition of malfunction in 40 CFR 63.2 (sudden, 
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infrequent, not reasonably preventable and not caused by poor 

maintenance and/or careless operation). For example, to successfully 

assert the affirmative defense, the source must prove by a 

preponderance of the evidence that excess emissions “[w]ere caused by 

a sudden, infrequent, and unavoidable failure of air pollution 

control and monitoring equipment, process equipment, or a process to 

operate in a normal or usual manner...” The criteria also are 

designed to ensure that steps are taken to correct the malfunction, 

to minimize emissions in accordance with section 63.1543(i) and 

63.1544(e), and to prevent future malfunctions. For example, the 

source must prove by a preponderance of the evidence that “[r]epairs 

were made as expeditiously as possible when the applicable emission 

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

taken to minimize the impact of the excess emissions on ambient air 

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

administrative proceeding, the Administrator may challenge the 

assertion of the affirmative defense and, if the respondent has not 

met its burden of proving all of the requirements in the affirmative 

defense, appropriate penalties may be assessed in accordance with 

Section 113 of the Clean Air Act (see also 40 C.F.R. Part 22.27). 

and to prevent future malfunctions. For example, the source must 

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

expeditiously as possible when the applicable emission limitations 
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were being exceeded...” and that “[a]ll possible steps were taken to 

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

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

administrative proceeding, the Administrator may challenge the 

assertion of the affirmative defense, and, if the respondent has not 

met its burden of proving all of the requirements in the affirmative 

defense, appropriate penalties may be assessed in accordance with 

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

The EPA included an affirmative defense in the final rule in an 

attempt to balance a tension, inherent in many types of air 

regulation, to ensure adequate compliance while simultaneously 

recognizing that despite the most diligent of efforts, emission 

limits may be exceeded under circumstances beyond the control of the 

source. The EPA must establish emission standards that “limit the 

quantity, rate, or concentration of emissions of air pollutants on a 

continuous basis.” 42 U.S.C. § 7602(k)(defining “emission limitation 

and emission standard”). See generally Sierra Club v. EPA, 551 F.3d 

1019, 1021 (D.C. Cir. 2008) Thus, the EPA is required to ensure that 

section 112 emissions limitations are continuous. The affirmative 

defense for malfunction events meets this requirement by ensuring 

that even where there is a malfunction, the emission limitation is 

still enforceable through injunctive relief. While “continuous” 

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

account for the practical realities of technology. For example, in 

Essex Chemical v. Ruckelshaus, 486 F.2d 427, 433 (D.C. Cir. 1973), 

the D.C. Circuit acknowledged that in setting standards under CAA 

section 111 “variant provisions” such as provisions allowing for 

upsets during startup, shutdown and equipment malfunction “appear 

necessary to preserve the reasonableness of the standards as a whole 

and that the record does not support the ‘never to be exceeded’ 

standard currently in force.” See also, Portland Cement Association 

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

caselaw such as Sierra Club v. EPA and the CAA 1977 amendments 

undermine the relevance of these cases today, they support EPA’s view 

that a system that incorporates some level of flexibility is 

reasonable. The affirmative defense simply provides for a defense to 

civil penalties for excess emissions that are proven to be beyond the 

control of the source. By incorporating an affirmative defense, the 

EPA has formalized its approach to upset events. In a Clean Water Act 

setting, the Ninth Circuit required this type of formalized approach 

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

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

see, Weyerhaeuser Co. v. Costle, 590 F.2d 1011, 1057-58 (D.C. Cir. 

1978) (holding that an informal approach is adequate). The 

affirmative defense provisions give the EPA the flexibility to both 
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ensure that its emission limitations are “continuous” as required by 

42 U.S.C. § 7602(k), and account for unplanned upsets and thus 

support the reasonableness of the standard as a whole.

The EPA included an affirmative defense in the final rule in an 

attempt to balance a tension, inherent in many types of air 

regulation, to ensure adequate compliance while simultaneously 

recognizing that despite the most diligent of efforts, emission 

limits may be exceeded under circumstances beyond the control of the 

source. The EPA must establish emission standards that “limit the 

quantity, rate, or concentration of emissions of air pollutants on a 

continuous basis.” 42 U.S.C. § 7602(k)(defining “emission limitation 

and emission standard”). See generally Sierra Club v. EPA, 551 F.3d 

1019, 1021 (D.C. Cir. 2008) Thus, the EPA is required to ensure that 

section 112 emissions limitations are continuous. The affirmative 

defense for malfunction events meets this requirement by ensuring 

that even where there is a malfunction, the emission limitation is 

still enforceable through injunctive relief. While “continuous” 

limitations, on the one hand, are required, there is also caselaw 

indicating that in many situations it is appropriate for the EPA to 

account for the practical realities of technology. For example, in 

Essex Chemical v. Ruckelshaus, 486 F.2d 427, 433 (D.C. Cir. 1973), 

the D.C. Circuit acknowledged that in setting standards under CAA 

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

necessary to preserve the reasonableness of the standards as a whole 

and that the record does not support the ‘never to be exceeded’ 

standard currently in force.” See also, Portland Cement Association 

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

caselaw such as Sierra Club v. EPA and the CAA 1977 amendments 

undermine the relevance of these cases today, they support the EPA’s 

view that a system that incorporates some level of flexibility is 

reasonable. The affirmative defense simply provides for a defense to 

civil penalties for excess emissions that are proven to be beyond the 

control of the source. By incorporating an affirmative defense, the 

EPA has formalized its approach to upset events. In a Clean Water Act 

setting, the Ninth Circuit required this type of formalized approach 

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

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

see, Weyerhaeuser Co. v. Costle, 590 F.2d 1011, 1057-58 (D.C. Cir. 

1978) (holding that an informal approach is adequate). The 

affirmative defense provisions give the EPA the flexibility to both 

ensure that its emission limitations are “continuous” as required by 

42 U.S.C. § 7602(k), and account for unplanned upsets and thus 

support the reasonableness of the standard as a whole.

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

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

standards being addressed in this action, the compliance date for 

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

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

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

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

furnace area stack emission limits and the requirement to adopt work 

practice standards to address fugitive emissions and to ensure 

compliance using monitoring of the lead concentration in air limit 

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

YEARS FROM DATE OF PUBLICATION].

IV. Summary of Significant Changes Since Proposal

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

of the Clean Air Act

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

proposed rulemaking: National Emission Standards for Hazardous Air 

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

presented a number of options for additional controls on the primary 

lead smelting source category, which currently includes only one

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

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

data the options were based upon, including the risk methods and 
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results presented in the draft document: Draft Residual Risk 

Assessment for the Primary Lead Smelting Source Category. 

During the public comment period for the proposed rule, the one 

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

substantially updated emissions, meteorological, facility boundary, 

as well as other relevant information bearing on the risk assessment 

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

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

its analyses to reflect the information received during the public 

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

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

Assessment for the Primary Lead Smelting Source Category” which is 

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

discussion of the updated emissions information used in the final 

risk assessment can be found in the Technical Support Document for 

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

rulemaking.

Table 3 presents the results of the final baseline risk 

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

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

approximately 1,550 people may be exposed to lead concentrations 

above the NAAQS. Results indicate that emissions from the refining 

stacks, furnace area stacks, and fugitive emissions can likely result 
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in exceedences of the NAAQS for lead beyond the fenceline of the 

facility.3 These results also indicate that emissions from the main 

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

beyond the fenceline of the facility because emissions are highly 

dispersed due to the height of the main stack. 

Table 3 - Summary of Lead Concentrations Relative to the NAAQS Based 

on Estimated Actual 2009 Emissions

Emission Point

2009 

Emissions 

(tpy)

Maximum Modeled 3-

Month Average Lead 

Concentration

(μg/m3)

Offsite Impact3

Main stack1 68.3 0.13 0.85 times the NAAQS

Refining stacks2 9.1 1.16 7.7 times the NAAQS

Furnace area stack:

(controlled blast and 

drossing fugitives)

2.5 0.31 2 times the NAAQS

Fugitive dust 1.0 0.17 1.1 times the NAAQS

1Results presented for the main stack in this table consider the good engineering 

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

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

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

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

Emission sources controlled by baghouses 8 and 9 at the Doe Run facility. 3 For a given emission point, the model receptor location with the highest modeled 

3-month ambient lead concentration was determined. This highest 3-month ambient 

lead concentration was then divided by the NAAQS (0.15 μg/m3) for lead to determine 

the maximum offsite impact for a given emission point.

Consistent with the risk assessment to support the proposed 

rulemaking, , the risk assessment to support the final rulemaking

also indicates that risks are unacceptable. This decision considers 

all the risk estimates presented in the risk assessment document, but 

is , primarily baseddue ontodue to lead emissions from the furnace 

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

which we think an unacceptable risk is presented to the public.

Comment [A1]: Can EPA include a column with 

the modeled concentration wsa for each emissions 

point, along with a footnote including the NAAQS 

value. Furthermore, what is the precision of the 

modeled concentration – is it reliable to two 

significant figures? If not, then wouldn’t the 

exceedence be 1 times the NAAQS for fugitives? 

Comment [M2]: Added this column and footnote 

3 for OMB. We do believe that two significant 

figures is appropriate in this case because the 

NAAQS has been determined to two significant 

figure

Comment [A3]: Also, were any conservative 

assumptions made in the air modeling? Does that 

impact that final concentrations that are 7.7 and 2 

times the NAAQS? 

Could EPA explain in a footnote to the table what 

they mean by “maximum offsite impact,” and how 

the “maximum” was determined?

Comment [M4]: This modeling is consistent with 

that done for all the RTR rules. There were no 

additional factors or layers of conservatism added

Comment [A6]: Why wasn’t the actual stack 

height used?

Comment [M5]: We talked about this yesterdayComment [A7]: Are there other concerns? Please 

clarify and explain.
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area stack and the refining operations stacks. We note that wHowever

However, while the risk assessment supporting the proposed rulemaking

estimated that a combined emission limit for the furnace area and 

refining operations should be set at 0.91 tons of lead per year to 

ensure that risks are acceptable, the updated risk assessment

estimates that a combined emission limit of 1.2 tons of lead per year 

will ensure that ambient lead concentrations from those emission 

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

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

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

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

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

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

year.4 The risk assessment also identified potential ambient air 

concentrations above the level of the NAAQS resulting from fugitive 

emissions. Therefore, we are finalizing the requirement for work 

practice standards and monitoring of lead in ambient air to 

demonstrate efficacy ofofthat the work practices. yield fenceline 

concentrations below 0.15 μg/m3.

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

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

of maximum lead impact.

Comment [A8]: Since the value is 1.1x NAAQS 

(and see earlier question about precision) is this a 

true exceedence that justifies the requirements. 

Comment [M9]: Already discussed above, if 

OMB has some suggestions for qualitative language 

to possibly add, we would be happy to consider it.

Comment [A10]: This is unclear – what does 

“demonstrate efficacy” mean?

Comment [NET11]: Revised the sentence to 

clarify what “demonstrate efficacy” meant.
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In addition to the updated lead risk assessment results 

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

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

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

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

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

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

the proposed rule), and that the cancer incidence is 0.008, or 1 

excess cancer case every 125 years (as compared to 0.0008 based on 

the risk assessment to support the proposed rule). In addition, the 

refined worst-case acute hazard quotient (HQ) value is 2.0 (based on 

the REL for arsenic), driven by arsenic emissions from the main stack

(as compared to 0.6 based on the REL for arsenic and driven by 

arsenic fugitive dust emissions as indicated by the risk assessment 

to support the proposed rule). Finally, while the worst-case 

multipathway screen to support the proposed rule indicated that no 

non-lead PB-HAP exceeded screening levels for potential multipathway 

effects, in the risk assessment to support the final rulemaking, the 

worst-case multipathway screening level was exceeded with respect to 

cadmium emissions. This is likely the resultresult of the revised 

emissions information provided by the company during the comment 

period, which indicated higher cadmium emissions from the main stack 

Comment [A12]: Can you explain what caused 

the 10 fold difference? 

Comment [M13]: This is likely due to increased 

emissions from the main stack as well as modeling 

the main stack at GEP stack height. However, the 

incidence is still considered to be low- 1 excess 

cancer case every 125 years and I’ve added that to 

the preamble language 

Comment [A14]: Suggest removing, since you 

should know why the result changed.

Comment [M15]: ok
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than were assumed for purposes of the risk assessment performed for 

the proposed rule.

In considering the updated non-lead risk results presented 

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

risk assessment, cancer incidence remains very low with 1 excess 

cancer case being estimated every 125 years. 

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

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

this is a conservative, worst-case analysis of the potential for

acute health effects. We also note that in contrast to the risk 

analysis to support the proposed rulemaking, the final risk analysis 

modeled the main stack at the good engineering practice (GEP) stack 

height of 330 feet rather than the actual stack height of 550 feet.

Thus it is very likely that the maximum potential worst-case HQ value 

is significantly lower than 2.

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

multipathway screening level for cadmium, we note that this only 

indicates the potential for cadmium exposures above the chronic 

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

general, emission rates below the worst-case multipathway screening 

level indicate no significant potential for multipathway related 

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

only indicate the potential for multipathway-related health risks of 

Comment [A16]: Since this acronym is defined 

in a table footnote, please include it here in the main 

body of the text.

Comment [NET17]: Defined the acronym.

Comment [A18]: Why was this change made? 

Please explain.

Comment [M19]: We talked about the GEP stack 

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

our multi-pathway analysis beyond the worst-case screening 

assessment. As a result, based on worst case screening, we can not 

state whether or not there are going to be multipathway risks at true 

exposure levels, we can only say that there are risks using worst 

case modeling. However, due to the highly conservative nature of this 

screening assessment and the uncertainties related to the results, we 

have concluded that, after implementation of the controls needed to 

reduce lead levels to the NAAQS, risks arewill be acceptable, 

considering the combination of potential multipathway risks, cancer 

risks, chronic non-cancer risks, and acute non-cancer risks. We also 

reviewed whether there were cost-effective controls that could 

further reduce risks to provide ananas part of ample margin of safety

analysis. The controls we are requiring to address lead emissions 

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

technically feasible cost effective additional controls that would 

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

determining that the standard we are promulgating today provides an 

ample margin of safety to protect public health.

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

tons per year of lead emissions from refining and furnace area 

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

facility to employ work practice standards to minimize fugitive 

Comment [NET20]: Accepted OMB’s revised 

language.
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emissions with ambient monitoring to ensure those work practices 

effectively achieve acceptable risk.riskare effective. These

standards will ensure risks are acceptable and public health is 

protected with an ample margin of safety and that there is not an 

adverse environmental effect from HAP emissions from the one lead 

processing facility in this source category.

B. Changes to the Technology Review Performed Under CAA Section

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

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

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

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

information that in practice the source had significantly lower 

emissions than the emission limit of 1 pound of lead per ton of lead 

produced required in the 1999 MACT standard. In comments on the 

proposed rule, The Doe Run Company indicated that the proposed 

emission limit under Section 112(d)(6) could not be met and that the 

data on which that emission limit was based were not accurate. The 

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

that emissions at the facility are significantly higher than we 

assumed as the basis for the proposed limit. For purposes of our 

analysis for the final rule, the EPA recalculated the emissions 

performance achieved for the main stack as demonstrated by the 2009 

and 2008 stack tests and considered an estimate of emission 
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variability in order to determine whether it was appropriate to 

revise the emission limit based on what the source was able to 

achieve in practice. Based on the revised analysis, we are 

establishing an emission limit for the main stack of 0.97 pounds of 

lead per ton of lead produced. 

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

reflect compliance “as expeditiously as possible” under section 

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

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

C. Other Changes Since Proposal

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

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

We received comments from Doe Run on the proposed rule that inclusion 

of these sources in the production based emission limit in 

§63.1543(a) was not necessary to achieve acceptable risk and that 

these sources would simultaneously be required to comply with two 

competing emission standards.standardsthe standard for refining and 

furnace area emissions proposed under section 112(f) and the 

production based limit proposed under section 112(d)(6). We agree 

with the commenters and we are establishing a separate emission limit 

of 1.2 tons per year of lead emissions that applies to the combined 

emissions of the refining and furnace area stacks. The emission 

standard limits the combined emissions from these two stacks because 

Comment [A21]: From whom?

Comment [NET22]: Added text clarifying that 

this comment was from the facility.

Comment [NET24]: Revised to clarify which 

emission standards the commenter was talking about.

Comment [A23]: Can EPA explain further?
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the revised risk assessment indicated that the location of maximum 

impact for these two stacks overlapped at the same receptor. A 

production based emission limit will continue to apply to sources in 

§63.1543(a)(1)-(9).

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

has revised certain terms and conditions of the affirmative defense 

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

proposing to adoptadopting those same revisions in this rule. 

Specifically, the EPA is revising the affirmative defense language to 

delete “short” from 63.1551(a)(1)(i), because other criteria in the 

affirmative defense require that the source assure that the duration 

of the excess emissions “were minimized to the maximum extent 

practicable.” EPA is also deleting the term “severe” in the phrase 

“severe personal injury” in 63.1551(a)(4) because we do not think it 

is appropriate to make the affirmative defense available only when 

bypass was unavoidable to prevent severe personal injury. In 

addition, the EPA is revising 63.1551(a)(6) to add “consistent with 

good air pollution control practice for minimizing emissions.” EPA is 

also revising the language of 63.1551(a)(9) to clarify that the 

purpose of the root cause analysis is to determine, correct, and 

eliminate the primary cause of the malfunction. The root cause 

analysis itself does not necessarily require that the cause be 

determined, corrected or eliminated. However, in most cases, the EPA 

Comment [A25]: Did EPA get any comments on 

these provisions for this rule? 

Comment [NET26]: Yes, we got the same 

comments that we’ve gotten on all of our recent 

rules. We clarified this language in packages that 

were proposed more recently but this rule was 

proposed before the changes were made. The revised 

language is consistent with our other recent

packages.
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believes that a properly conducted root cause analysis will have such 

results. In addition, the EPA is revising 63.1551(b) to state that a 

written report must be submitted within 45 days of the initial 

occurrence of the malfunction and that the source may seek an 

extension of up to an additional 30 days. 

V. Summary of Significant Comments and Responses

In the proposed action, we requested public comments on all 

aspects of the proposal, including our residual risk reviews and 

resulting proposed standards, our technology reviews and resulting 

proposed standard, and our proposed amendments to delete the startup 

and shutdown exemptions and the malfunction exemption and to 

establish an affirmative defense for malfunctions. 

We received written comments from 16 commenters. Our responses 

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

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

in the docket. See Summary of Public Comments and Responses for 

Primary Lead Processing NESHAP (October 2011), for summaries of other 

comments and our responses to them.

A. Timeline for Compliance

Comment: Two commenters opposed the compliance timing and supported 

extending the compliance date beyond two years for several reasons. 

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

rule, the facility will operate in its current form for only a few 
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months after the compliance date of the rule. This creates a dilemma 

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

resources and compliance. The commenter suggested that the 

implementation and attainment schedules for this MACT rule should

correspond to those of the 2008 NAAQS. 

One commenter identified three provisions they suggest could be 

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

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

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

demonstrating 90 percent reduction in HAP prior to first proposal of 

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

means of compliance in some circumstances. The commenter stated that 

the import of the underlying statutory authority relates to the 

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

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

standards, while a two-year period applies to §section 112(f) 

standards. Although the EPA seems to have reflexively applied the 

§section 112(f) period, this approach is not foreordained in the 

present circumstances. Specifically, §section 112(i)(3)(A), which 

allows a three-year compliance period for any §section 112 standard, 

merits consideration in light of the various proposed MACT 

standards, including a plant-wide §section 112(d)(6) standard. With 

regard to the authority under section 112(i)(5), the commenter 
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states that emissions have been reduced from 140 tons in the year 

2000 to less than 14 tons in 2009, representing a decrease of over 

90%. With regard to section 112(h)(3), the commenter believes that

the two year compliance period has serious adverse economic effects 

on the company and the new hydrometallurgical process can be 

considered an alternative means of emission limitation. 

The commenter also stated that the circumstances of this case 

present a unique challenge in determining an appropriate compliance 

deadline for a new primary lead smelting MACT standard. The 

commenter stated that there were several differences from the 

typical MACT rulemaking: instead of multiple sources within a 

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

federally enforceable consent decree, the facility must terminate 

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

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

compliance period would be at most six months prior to stoppage of 

many of the current operations. If forced to achieve compliance that 

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

severe economic hardship that could jeopardize its ability to 

finance and to build a new hydrometallurgical lead production 

process that would largely eliminate lead emissions. These 

circumstances raise questions as to the legal necessity as well as 

the feasibility and practicality of implementing a two-year 
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compliance deadline.

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

period is consistent with the schedule of required actions contained 

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

standard compliance six months before the required termination of 

Doe Run’s existing lead smelting seriously erodes several Consent 

Decree goals: introducing a new hydrometallurgical lead production 

process that minimizes lead emissions, assuring continued primary 

lead production in the United States, and promoting the development 

of the most technologically advanced lead production process in the 

world. 

Finally, the commenter stated that the primary lead RTR 

proposal effectively accelerates the compliance date for the lead 

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

must be undertaken to implement a plan to monitor lead concentration 

in air. But this reliance is also misplaced because it requires Doe 

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

years before the Lead NAAQS itself requires compliance. No statutory 

authority supports such accelerated compliance for the lead NAAQS or 

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

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

Consent Decree requirements, and legally, it unlawfully attempts to 
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speed up the previously-established compliance timeframe for the 

lead NAAQS.

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

any standard issued under section 112 for existing sources and 

provides that the compliance date shall be as expeditiously as 

practicable but no later than 3 years following the effective date 

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

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

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

requirements govern in place of the compliance requirements in 

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

source cannot emit an air pollutant in violation of a standard 

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

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

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

the effective date if necessary for the installation of controls and 

if measures will be taken in the interim to ensure public health is 

protected from imminent endangerment. Thus, for purposes of 

standards applicable to the furnace and refinery area emissions and 

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

compliance period may not exceed two years from the effective date 

of the standard.

The main stack emission limit, proposed under 112(d)(6), is 
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subject to the section 112(i)(3) compliance provisions. We are 

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

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

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

source is already achieving in practice and thus no additional 

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

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

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

this final rule as this timeframe constitutes compliance “as 

expeditiously as practicable.”

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

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

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

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

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

the standards established under 112(f) in this final rule. With 

regard to the emission standard proposed for the main stack, stack 

test data indicate that the main stack emissions are substantially 

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

on performance test data, the facility has not achieved the 

reductions in emissions required to apply the alternative compliance 

dates in section 112(i)(5).

Section 112(h)(3) allows the Administrator through notice and 
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comment rulemaking to accept an alternative means of emission limit 

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

the owner or operator of a source establishes that such alternative 

means will achieve reductions at least equivalent to those that 

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

precisely what the commenter is suggesting with regard to this 

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

hydrometallurgical process that they plan to install after they 

close the pyrometallurgical processes should be considered an 

alternative means of compliance with the work practice standard. It 

is unclear how this process would address the emissions covered by 

the work practice standard requirement we are establishing which is 

intended to address current fugitive emissions from the facility. 

Those emissions are almost exclusively from lead entrenched in open 

areas and the installation of a new process for lead processing 

would not appear to affect those emissions. Moreover, we understand 

that the new hydrometallurgical process won’t be operational until 

sometime after the compliance date for the work practice standards 

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

or in part the fugitive emissions addressed through the work 

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

absence of being able to achieve the necessary reductions within the 

compliance period. We note that our determination here does not 
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preclude Doe Run from submitting additional information that may 

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

which we could take further action in a separate rulemaking.

As to the concerns the commenter raises about this situation 

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

that the maximum compliance period for standards issued pursuant to 

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

information that supports a legal basis for providing a longer 

period for compliance for the refining and furnace area stacks and 

for fugitive emissions.

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

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

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

the only stationary source creating the Jefferson County lead 

nonattainment area and the reductions required under the rule will 

help bring the area into attainment with the lead NAAQS. However, 

this regulation does not preempt the SIP process; the State of 

Missouri is still required to submit a state implementation plan 

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

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

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

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

CAA requires areas to attain the various NAAQS as expeditiously as 

Comment [NET27]: Accepted OMB’s revised 

language clarifying that Doe Run is the only source 

responsible for non-attainment.
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practicable, but no later than specified dates. For the 2008 lead 

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

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

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

2008 lead NAAQS earlier than December 31, 2015.

Comment: One commenter stated that the proposed emission standards 

and ambient standard had negative implications for determining

compliance under the proposed two-year compliance period and the 

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

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

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

pounds per ton produced while the other two new numerical standards 

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

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

The commenter stated that the three proposed numerical 

standards present a confusing regulatory regime as to which standard 

ultimately controls for determining compliance. If, for example, Doe 

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

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

operations, would it be in compliance? 

Of the three numerical standards, the commenter stated that 

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

and even that is unclear. The 0.91 tpy standard is derived from the 
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Lead NAAQS risk analysis. Despite this starting point, this standard 

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

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

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

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

to which portion fits under what statutory authority, this single 

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

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

than an ample margin of safety. 

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

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

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

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

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

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

replace the 1.0 lb/ton limit in the original MACT rule and will 

apply to the same sources subject to the limit in the original MACT 

rule. This change should alleviate the regulatory confusion that 

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

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

technology review requirements of the Act. As provided in the 

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

emission stacks separately to determine whether additional controls 
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are necessary under section 112(f) or 112(d)(6) and a plant-wide 

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

note that the monitoring requirement is primarily for the purpose of 

ensuring that fugitive emissions are appropriately addressed under 

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

ensure that fugitive emissions are controlled to an extent that they 

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

of safety. 

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

Comment: One commenter stated that the modification to the 

applicability provision does not comport with how smelting is 

defined and used and that the source category listing was intended 

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

several issues supporting this position:

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

Smelting source category,” describes and limits “any facility” to 

mean those involving smelting; and the “includes, but is not limited 

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

to “the following smelting processes.” 

• The list of processes identified all involve pyrometallurgical 

activities: sintering process, blast furnace, electric smelting 

furnace, reverberatory furnace, slag fuming furnace, drossing 

kettles, and dross reverberatory furnace.

Comment [A28]: For fenceline monitoring in 

another RTR package, EPA sets the monitoring level 

at 2x the RfC. Yet here it is set at the NAAQS. Why 

not allow 2x the NAAQS for consistency? Also, 

why not consider 10x the NAAQS? These types of 

inconsistencies between packages may be a a 

concern for EPA. 

Comment [M29]: We believe that it is 

appropriate to set this value at the NAAQS. We do 

not want to be in contradiction with other parts of the 

Agency that have clearly stated that lead 

concentrations above the NAAQS are not sufficient 

to protect public health with an adequate margin of 

safety.
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• The plain meaning of that language evidences intent to cover 

any and all types of pyrometallurgical processes for producing lead

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

production processes. 

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

company it keeps to justify an expansive reading goes well beyond 

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

The commenter also stated that the proposed change in 

applicability is inconsistent with the statutory structure for 

formulating source categories: “To the extent practicable, the 

categories and subcategories listed under this subsection shall be 

consistent with the list of source categories established pursuant 

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

commenter cited several instances in the statute where Primary Lead 

Smelting is referred to as a pyrometallurgical process. In 

summation, the commenter states that the statutory directive of CAA 

§section 112(c)(1) to assure consistency between a source category 

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

demonstrates that the statutory and regulatory use of “primary lead 

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

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

originally formulated primary lead smelting source category has a 

“broader definition” is inconsistent with the original source 
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category language and the pyro-oriented definitions applied to 

primary lead smelting/smelter found throughout the statute and 

regulations.

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

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

major source would be present. The new hydrometallurgical process 

bears no resemblance to the current pyrometallurgical process, other 

than feedstock and end product. The new process will have 

drastically reduced lead emissions and is presented as a minor 

source in the Doe Run Air Construction Permit Application for the 

New Lead Technology submitted to the Missouri Department of Natural 

Resources. 

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

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

that the source category listing for primary lead was not issued 

consistent with the requirements of section 112(c)(1), such claim is 

untimely. We disagree with the commenter that the source category 

description must be read to be limited to pyrometallurgical 

processes. The source category description was intended to include 

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

evidenced by the first sentence of the category description. While 

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

hydrometallurgical process described by the commenter did not exist, 

Comment [A30]: Can we discuss the permitting 

steps for the new facility and the “once in, always 

in” policy referenced below? 

Comment [NET31]: In what way were you 

thinking the permit process should be described? As 

I understand it, at this point, they’ve applied for a 

construction permit but that’s it. If you have any 

specifics as to the type of description you’d like to 

see, I’d be happy to look at getting some more 

clarifying language for you.

The next comment response includes our position re: 

the once in always in policy.
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the language left open the possibility that other lead metal 

production processes might be developed in the future and would be 

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

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

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

process. We maintain that primary lead processing facilities using 

such a process should still be subject to the NESHAP. 

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

that the new lead production processes should be listed as area 

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

finding" for including a hydrometallurgical lead production process 

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

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

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

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

either Doe Run’s new lead production process or the entire Doe Run 

facility after the new process is operational would or could emit 

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

category and the proposed rule offers no documented evidence that 

Doe Run’s hydrometallurgical lead production process or the 

Herculaneum facility after the new process becomes operational would 

constitute a major source. The commenter contended that neither the 

new process nor the entire Herculaneum facility would be a major 
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source. Plant-wide emissions at Doe Run’s facility after the new 

process becomes operational are estimated to approximate 0.65 tpy. 

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

lead production process cannot be treated as a major source 

category.

Response: Based on the revised applicability definition, the Doe Run 

facility remains subject to the Primary Lead Processing NESHAP so 

long as it continues to produce lead metal from ore concentrates. It 

is our position that once a major source is required to install 

controls or take other measures to comply with a MACT standard, it 

should not be able to substitute different controls or measures that 

happen to bring the source below major source levels to avoid 

compliance with a standard after the compliance date. Otherwise, a 

facility could backslide from MACT control levels by escaping 

applicability of the MACT standards and increasing emissions. 

Therefore, the Doe Run Herculaneum facility will continue to be 

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

emission standards and work practice standards promulgated in this 

action apply to the source in its current form as a 

pyrometallurgical processing facility. To the extent any of these 

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

construction of any new hydrometallurgical process, the emission 

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

Comment [NET32]: Added clarifying language.

Comment [A33]: Please explain this – on what 

basis is this statement being made? 

Comment [NET34]: This is an EPA policy based 

on the Agency’s interpretation of how Congress 

intended section 112 of the CAA to be implemented. 

It is discussed in the memo that I sent over to 

Cortney on the afternoon of 10/26.
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elsewhere, a new hydrometallurgical process is not subject to an 

emission limit under the existing MACT standard; we would consider 

an appropriate emission limit for the hydrometallurgical process 

once that process is a demonstrated technology.

Comment: Another commenter stated that the EPA appropriately 

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

new type of facility.

Response: We agree with this comment.

Comment: Two commenters stated that the EPA cannot use section 

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

type of standard is not an “emission standard.”

The commenters stated that the NAAQS does not fit within the 

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

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

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

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

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

of “standards” elsewhere in the subsection means “emission 

standard.” Likewise, §section 112(d)(6) gives the Administrator 

authority to revise “emission standards.” Both subsections limit the 

EPA’s rule-promulgating authority to setting “emission standards.”

According to commenters, Congress defined “emission standard” 

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

Comment [A35]: What authority would be used 

to set this standard?

Comment [NET36]: A standard to be included in 

this standard could be proposed under section 

112(d)(6) as a “development in processes, practices, 

or control technologies” if that limit were to replace 

the limit that applies to pyrometallurgical process. 

Alternatively, if the standard were to apply to the 

hydrometallurgical process and the emission 

standard included in this rule were to be left on the 

books, the limit for the hydro process could be 

proposed under section 112(d)(2) and (d)(3). That’s 

something that would have to be evaluated once the 

process is online and the Agency gets some 

emissions data.
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. Administrator which limits the quantity, rate or concentration of 

emissions of air pollutants on a continuous basis, including any 

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

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

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

read to allow a standard applicable to emissions from specific 

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

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

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

(“regulations prescribing a national primary ambient air quality 

standard . . . for each air pollutant”).

The commenters stated that the contrasting language highlights 

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

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

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

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

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

work practices, all of which are central to the §section 112(f)(2) 

mandate or on the practices, processes, and control technologies 

related to sources central to §section 112(d)(6). Further, a NAAQS 

limits ambient air lead without regard to source category or types 

of sources, while the MACT standards are particularized to control 

emissions at specific sources. Thus, the primary lead smelting 
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emission standards differ from the secondary lead smelting emission 

standards, but the same lead ambient air standards apply throughout 

the country without regard to such distinctions. In short, the lead 

NAAQS does not fit the meaning of “emission standard” as used in 

§section 112 and therefore cannot be properly used as the MACT 

standard here.

One commenter stated further that this error is not cured by 

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

. . . shall discharge or cause to be discharged into the atmosphere 

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

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

approved by the Administrator.” As such, proposed §section

63.1544(a) measures ambient air levels for compliance 

(“concentration of lead in air . . . at locations”) in what appears 

to match the source monitoring of ambient air required for the Lead 

NAAQS. See 73 FR at 67052, §section 50.16(a) and at 67059, §section

58.10; see also 76 FR at 9436/1 (proposing that compliance “be 

demonstrated using a compliance monitoring system”). As such, 

proposed §section 63.1544(a) does not limit the quantity, rate, or 

concentration of emissions from a specified source or take into 

account developments in practices, processes, and control 

technologies. Compare 40 C.F.R. §section 63.1544(a)(2010) (requiring 

“manual that describes in detail the measures that will be put in 
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place to control fugitive dust emissions from the sources”). 

Measuring ambient air at locations presumably near the source does 

not fall within the standards allowed by CAA §section 112, and, in 

any event, is redundant to the same monitoring and limitations

already established under the Lead NAAQS. Consequently, the proposed 

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

therefore cannot be adopted.

One commenter stated that the proposal requests comments on a 

work practices standard operating procedure (SOP) alternative to 

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

not an emission standard under Section 112, the alternative SOP 

proposal is consistent with the MACT directive that emission 

reductions be tied to specific sources.

One commenter stated that the proposed ambient lead standard is 

procedurally flawed because the EPA fails to explain the legal basis 

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

legal authority is of central relevance to this aspect of the 

proposal and the failure to clearly describe the legal basis for the 

standard violates the EPA’s obligation under §section 307(d)(3)(C) 

to set forth the “major legal interpretations” that underlie the 

proposal.

Response: The commenters mistake the purpose of the fenceline 

monitoring requirement in the proposed rule. The proposed rule 
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established emissions standards from the main, furnace area, and 

refinery operations stacks and further provided that fugitive 

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

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

fenceline monitoring requirement to ensure that the work practice 

standards adequately address fugitive emissions consistent with the 

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

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

the applicable standards for addressing fugitive emissions, similar 

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

standards applicable to point source emissions. The facility must 

use work practice standards to reduce fugitive emissions to protect 

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

environmental effects. The fenceline monitoring requirement is a 

method for ensuring compliance with the work practice standards to 

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

We understand that the draft regulatory text from the proposed 

rule may have contributed to the commenters’ confusion on this 

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

make clear that the applicable standard is the requirement to adopt 

work practice standards and that the fenceline monitoring 

requirement is a tool to help ensure compliance. See section 63.1544 

of the regulatory text.

Comment [A37]: Please include a crossreference to the CFR. 

Comment [NET38]: Added the cross-reference
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However, even if this were not the case, the EPA could adopt a 

performance standard using the lead NAAQS as the measure of 

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

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

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

measured at the fenceline, would be limited to the amount 

established by the NAAQS.

We disagree with the suggestion that we do not provide the 

legal basis for our proposed rule. The preamble clearly explains 

that we are addressing residual risk for this source category under 

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

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

9414 for a discussion of the statutory authority underlying the 

proposed revisions to the standard.) With regard to fugitive 

emissions, we are establishing a requirement for work practice 

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

standard because these fugitive emissions, which are predominantly 

from materials handling and roadways cannot be captured and vented 

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

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

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

that regime and does not allow supplemental (or supplanting) 

regulation of them under NESHAP. The commenter cited CAA §section

Comment [A39]: This is confusing. How would 

a facility know how to limit their emissions in order 

to meet the fenceline requirement? There is a lag 

and dilution effect associated with a fenceline 

monitor. 

Comment [NET40]: In this hypothetical 

situation, the facility would undertake a root-cause 

analysis to determine what fugitive dust source was 

responsible. Corrective action would follow and the 

facility would receive feedback with respect to the 

effectiveness of the corrective action in the form of 

subsequent monitor data. This is how things are 

typically done in SIP development.
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112(b)(2) that states in relevant part: “No air pollutant which is 

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

under this section” with certain exceptions not relevant here. 

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

Also, CAA §section 112(b)(7) removes elemental lead from 

consideration as a HAP. According to the commenter, the prohibition 

is not only clear, but also expansive: the statute “unqualifiedly 

prohibits listing a criteria pollutant as a HAP, that is, regardless 

of the reason.” Nat’l Lime Ass’n v. EPA, 233 F.3d 625, 638 (D.C. 

Cir. 2000).

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

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

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

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

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

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

we did when we established the original MACT standard for primary 

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

processing is lead compounds with elemental lead present only in 

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

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

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

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

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

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

Comment [A41]: How does EPA respond to the 

commenter’s point that the Lead NAAQS already 

regulates lead compounds: “The national primary 

and secondary ambient air quality standards for lead 

(Pb) and its compounds are 0.15 micrograms per 

cubic meter over a 3-month period, measured in the 

ambient area as Pb” (73 FR 66964, 67052).

Comment [NET42]: As we discussed in our call 

on 10/26, the lead emitted from this facility is the 

listed HAP, lead compounds. See the list of 

references in the footnote on the next page. Since 

lead compounds are a listed HAP in section 112, we 

are required to regulate them in this rulemaking. The 

facility did not provide any data indicating the lead 

emitted from their facility is not lead compounds. 

Additionally, our review of the literature indicated 

that the lead emitted is the listed HAP, lead 

compounds rather than elemental lead.
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this. Thus, we disagree with the commenter that we are attempting to 

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

The National Lime opinion cited by the commenters addressed a 

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

issue was whether EPA could use a NAAQS pollutant (particulate 

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

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

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

court rejected the argument by the National Lime Association that 

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

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

door” in this rulemaking.

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

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

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

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

Specifically, the commenter argues that:

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

it must consider the ongoing legality and 

effectiveness of the existing standard. 

Explicitly, in the current rulemaking EPA must 

“review, and revise as necessary” the existing 

 

Brémard, C., Laureyns, J., Merlin, J.C., Wignacourt, J.P. (1999). Environmental Science and Technology, Vol. 33, p. 1334-

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

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

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

Vol. 14:10, p. 1240-1244.
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MACT standard. 42 U.S.C. §section 7412(d)(6). It 

is clearly “necessary” for EPA to close 

inherently unlawful gaps in the original MACT, by 

setting a standard for an uncontrolled HAP. 

Indeed, EPA has recognized the need and done this 

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

rulemaking for Marine Tank Vessel Loading 

Operations and Group I Polymers and Resins where 

it proposed a standard for previously 

uncontrolled subcategories of these sources. See 

Proposed Rule, 75 Fed. Reg. 65,068, 65,115, 

65,106 (Oct. 21, 2010). EPA has no legal basis 

for failing to set a MACT standard now for the 

uncontrolled HAPs for the primary lead source 

category."

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

mandates that EPA must correct any deficiency in an underlying MACT 

standard when it conducts the “technology review” under that 

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

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

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

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

provision, which focuses on the review of developments that have 

occurred since the time of the original promulgation of the MACT 

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

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

recent rulemakings, we have chosen to fix underlying defects in 

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

provisions that directly govern the initial promulgation of MACT 

standards (see National Emission Standards for Hazardous Air 
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Pollutants From Petroleum Refineries, October 28, 2009, 74 FR 55670; 

and National Emission Standards for Hazardous Air Pollutants: Group 

I Polymers and Resins; Marine Tank Vessel Loading Operations; 

Pharmaceuticals Production; and the Printing and Publishing 

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

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

We believe that our approach is reasonable because using those 

provisions ensures that the process and considerations are those 

associated with initially establishing a MACT standard, and it is 

reasonable to make corrections following the process that would have 

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

original promulgation. 

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

petition and their additional comments on this proposed rulemaking, 

we agree that the Primary Lead Smelting NESHAP should have included 

an emission standard for organic HAP. We have evaluated available 

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

emission standard for organic HAP that is representative of current 

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

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

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

petition with respect to the issue of setting a standard or 

standards for organic HAP and will address that petition once we 
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have gathered the necessary data.

C. Primary Lead Processing Risk Assessment

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

account for cumulative risk and that there is no rational or 

scientific basis to dismiss consideration of the cumulative risk of 

exposures to HAPs due to uncertainties. The commenter urged that 

these uncertainties require protective action rather than inaction. 

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

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

as well as perform a sensitivity analysis to identify the major 

uncertainties in both the human health and ecological risk 

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

scientific experts have developed, and are in the process of 

developing, cutting edge methods to perform these assessments and 

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

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

rely on the significant information already available and also use 

the current and future RTR rulemakings to further advance this 

process.

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

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

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

from the National-Scale Air Toxics Assessments (NATA) would allow a 
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defensible estimate of what might be expected from other sources.

Response: We disagree with the commenter that our risk assessments 

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

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

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

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

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

cumulative in that it considers all emission points within the 

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

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

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

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

the present rulemaking, our consideration of cumulative risks for 

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

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

We further disagree with the commenter’s assertion that a 

comprehensive quantitative assessment of risks from all sources 

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

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

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

quantitative risk information necessary to inform RTR regulatory 

decisions, the EPA conducts a comprehensive assessment of the risks 
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associated with exposure to the HAPs emitted by the source category 

(i.e., those emissions that can actually be affected by the specific 

rulemaking) and supplements that with additional information about 

other possible concurrent and relevant risks that is readily 

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

emissions that are outside the scope of the particular rulemaking 

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

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

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

have very little additional risk information that can be considered. 

In all cases, however, when we consider additional information about 

risks, we also consider its attendant uncertainties, and information 

which carries significant uncertainties generally carries much less 

weight in the overall regulatory decision.

All of the quantitative risk assessment information about HAP 

emissions from the source category under consideration is also 

considered in the manner prescribed by the decision framework set 

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

Benzene decision framework), and this means that the general 

guidelines of risk acceptability have been developed in a way that 

they already take into account the impossibility of accurately 

quantifying the health risks posed by outside forces on every 

individual in the population. They do this by noting that the 
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guidelines apply in “the world in which we live,” a world which is 

acknowledged to be “not risk-free,” but rather a world which is full 

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

acknowledgment allows the EPA to make risk-based decisions by 

focusing on the risks associated with the emissions that are 

themselves the subject of regulation being considered, and not get 

distracted by the daunting task of assessing all the other 

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

be impacted by the regulation in question anyway.

Comment: Two commenters took issue with the modeling methodology 

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

on a number of concerns. 

One commenter stated that the RTR modeling characterized the 

maximum air lead concentrations near the facility to be fifty times 

the 2008 NAAQS which is inconsistent with both recent air quality 

monitoring data and Missouri's 2007 attainment demonstration 

modeling and stated that the proposed RTR modeling overestimated the 

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

commenter stated that the inaccuracies of the EPA’s proposed 

modeling analysis will be in conflict with future baseline and 

attainment demonstration modeling based on more accurate data, 

especially since the RTR proposes to correlate the MACT standard 

with the 2008 NAAQS. The commenter recommended that the EPA remodel 
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this facility using higher quality input data that are more 

representative of current operations at the Herculaneum facility, to 

obtain results that better reflect the actual monitored three-month 

lead concentrations. Alternately, the commenter stated that the EPA 

should either defer to appropriate air quality monitoring 

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

attainment demonstration as the basis for this RTR. Some commenters 

also suggested using AERMOD modeling followed by LEADPOST, rather 

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

lead concentrations. 

Two commenters identified specific issues with regard to the 

modeling approach and input data including:

• The ratio of modeled results to monitored data should not 

exceed a factor of two. The commenter provided specific corrections 

and analysis of data.

• The NAAQS attainment demonstration model developed by the State 

of Missouri and the RTR modeling, although conducted for different 

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

the same geographic location. Therefore, the output of both 

dispersion models, whether for residual risk assessment or SIP 

development, should reflect the maximum ambient air lead 

concentration. The commenter stated that any data limitations should 

be addressed with input from the commenter. 
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• Improvements from the 2007 SIP for the fugitive emissions from 

the sinter plant and blast furnace building do not appear to be 

reflected in the run script of the model, resulting in 

concentrations up to fifty times the NAAQS. The commenter stated 

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

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

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

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

basis for the risk assessment.

• The EPA did not provide a modeling protocol for their 

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

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

complete, replicable public review of the model and assessment of 

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

specific modeling parameters and data elements that were not 

correctly applied during the proposal modeling run which could have 

significantly affected the results including model control options,

run script parameters, volume sources modeled as point sources, 

inaccurate fenceline/boundary locations, incorrect elevations for 

sources and receptors, and old census data information for receptor 

centroids.

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

detailed site-specific meteorological data, as well as updated 
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facility boundary and other information provided by Doe Run in 

comments on the proposed rule, we have remodeled the facility with 

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

estimate monthly lead concentrations, and we used the building and 

particle data submitted by one commenter to model building downwash 

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

month rolling averages. In addition, using the updated facility 

boundary information, the EPA also removed census blocks that would 

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

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

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

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

modeling effort are similar to results submitted by the Doe Run 

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

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

Moreover, the EPA notes that a comparison of modeled lead 

concentrations at the sites of six lead monitors are within 50 

percent of measured concentrations at those monitors. These results 

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

its public comments. 

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

documentation needed to reproduce the modeling that was performed 

for the proposal risk assessment.
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Comment: With respect to using the NAAQS to evaluate potential 

multipathway risks from lead, one commenter stated that the risk 

assessment used to set the NAAQS was based on quantitative studies 

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

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

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

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

of a risk assessment that studied children only. 

Response: The lead NAAQS was a public health policy judgment 

considering the available health evidence and risk analyses as well 

as the uncertainties associated with the health evidence and risk 

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

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

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

concentration not to exceed a level of 0.15 μg/m3

. This standard was 

set to protect public health, including the health of sensitive 

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

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

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

safety regardless of the age of the individuals living in a 

particular area. 

Comment: One commenter stated that rather than finalizing this 
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proposal as it stands, the best available science directs the EPA to 

set a residual risk standard that incorporates protective health 

benchmarks and assures that children living near the facility will

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

points. This includes protecting children against a blood lead level 

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

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

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

because lead persists in the environment, resulting in reservoirs in 

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

this source category promptly and in a precautionary manner. The 

commenter stated that the EPA should consider requiring zero lead 

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

ensure that the ambient air concentration for lead in the local 

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

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

Children’s Health Protection Advisory Committee had recommended for 

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

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

safety.” 

Response: In order to assess multipathway risks associated with 

emissions of lead, the EPA compared modeled rolling three month 

average lead concentrations estimated from emissions from the one 
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source in this category to the NAAQS for lead. As noted above, we 

believe that this is a reasonable approach given that the NAAQS is a 

health based standard set to protect the public health, including 

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

adequate margin of safety. Moreover, the risk assessment supporting 

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

and secondary lead smelting operations. While we conclude that the 

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

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

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

analysis, we examined whether there were additional cost effective 

controls available to further protect public health including 

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

elsewhere in this notice and other supporting documents available in 

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

effective controls that would provide further risk reductions. 

With respect to the California benchmark for protecting 

children, the EPA has a hierarchy of appropriate health benchmark 

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

derived health benchmarks than those from other agencies 

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

For the reasons provided above, we believe that the lead NAAQS level 
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establishes an appropriate benchmark for addressing the acceptable 

level of risk and we disagree with the commenter that we should 

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

month average.6 

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

dozen other hazardous air pollutants, including cadmium and arsenic, 

one commenter stated that the EPA should determine that this health 

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

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

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

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

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

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

emissions.

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

to follow the benzene decision framework for determining 

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

million is generally considered acceptable, although this is not a 

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

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

acceptable, we then considered whether there were additional cost-

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

EPA-HQ-OAR-2006-0735-5204.
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effective controls that would further reduce risk from the other HAP 

emitted in order to provide an ample margin of safety. Because the 

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

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

additional cost effective controls and that the acceptable level of 

HAP emissions also provided an ample margin of safety. 

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

NAAQS assessment instead of a multi-pathway risk assessment because 

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

the lead NAAQS requires an adequate margin of safety while a 

residual risk standard requires an ample margin of safety. The 

commenter stated that a residual risk standard should provide a 

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

commenter noted that the NAAQS is set to protect sensitive 

populations while residual risk rules are set to protect the 

greatest number of individuals possible from unacceptable risk. The 

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

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

Response: We disagree with the commenter that the lead NAAQS 

assessment should not be considered as part of our residual risk 

analysis because it provides an inappropriate level of protection. 

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

the health of sensitive populations, most critical for lead, the 
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health of children. That does not suggest that non-sensitive 

populations are not protected, but rather that the NAAQS is set at a 

level that will not only protect the general population but also 

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

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

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

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

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

risk decision process, the EPA then considered whether there were 

additional controls that might further reduce risk to achieve an 

ample margin of safety considering cost and feasibility. There were 

no additional cost-effective controls beyond those that would need 

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

the three emissions points (fugitive dust emissions, the furnace 

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

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

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

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

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

could reduce the main stack emissions beyond those that are achieved 

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

by the current level of control for the main stack. A more detailed 

presentation of the economic analysis of additional controls for the 
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refining, furnace area, and main stacks can be found in the 

technical support document, which is available in the docket.

Comment: One commenter stated that the EPA has not appropriately 

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

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

commenter, using the NAAQS to assess ecological risk is problematic 

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

anticipated to adversely affect human health, they also are not 

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

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

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

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

either to wildlife or to natural resources in the environment either 

from inhalation or air deposition of HAP emissions, exacerbated by 

persistence and bioaccumulation. As the EPA’s own Scientific 

Advisory Board has stated: “The assumption that ecological receptors 

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

May 2010 at 48. 

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

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

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

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

appropriate to assume that exposure levels not expected to harm 
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humans are also not expected to harm ecological receptors. 

Although the ecological effects of lead are well documented, 

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

review linking various ecological effects to specific levels of lead 

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

sufficient basis for establishing a separate secondary standard, but 

that revising the secondary standard to be equal to the revised 

primary standard would provide substantial additional protection to 

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

appropriate to consider the secondary lead NAAQS when evaluating the 

potential for adverse environmental effects. 

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

the secondary NAAQS as a benchmark to determine whether there will 

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

evaluate ecologic risks is inappropriate. The commenter states that 

the EPA should recognize that the establishment of the Secondary 

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

management decision, rather than a decision quantitatively founded 

in risk assessment. The commenter cited that in establishing the 

lead NAAQS, the EPA introduced its approach by describing the 

“substantial limitations in the evidence, especially the lack of 

evidence linking various effects to specific levels of ambient Pb” 

(US EPA, 2008. P. 67007), and ultimately concluded that the 
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secondary lead NAAQS should be set equal to the primary lead NAAQS. 

In contrast, in this proposed rule, the EPA concludes that 

“ambient lead concentrations above the lead NAAQS indicates 

potential for adverse environmental effects” (76 FR 9421). 

Response: The secondary lead NAAQS was set to protect against 

adverse welfare effects (including adverse environmental effects) 

and has the same averaging time, form, and level as the primary 

standard. Thus, we find it appropriate to consider the secondary 

lead NAAQS when considering the potential for adverse environmental 

effects. The commenter is correct that we stated in the proposed 

rule that “ambient lead concentrations above the lead NAAQS 

indicates potential for adverse environmental effects.” This 

statement is entirely consistent with the idea that the secondary

lead NAAQS was set at a level above which there may be adverse 

environmental effects but does not support a conclusion that there 

are adverse environmental effects below that level that must be 

addressed as part of this residual risk determination. As we have 

noted previously, there are not sufficient data supporting that a 

lower level is necessary to protect against an environmental risk.

Comment: One commenter stated that in evaluating potential 

multipathway risks from PB-HAP other than lead, the EPA used de 

minimis emission rates to screen for potentially significant multipathway impacts, but for lead, this method was abandoned. The 
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commenter disagrees with this approach, stating, “This comparison 

mirrors NAAQS source monitoring for attainment purposes in its use 

of the national ambient air lead level as the benchmark. As such, it 

is not a proper surrogate for “facility-level de minimis emission 

rates” used as the chronic reference benchmarks for CAA §section 112

risk assessments.” 

Response: The EPA disagrees that comparing modeled 3-month rolling 

average lead concentrations to the NAAQS for lead mirrors source 

monitoring for NAAQS attainment purposes and that this approach is 

not a proper surrogate for facility-level de minimis emission rates 

used as the chronic reference benchmarks for CAA §section 112 risk 

assessments. In general, determining attainment for the lead NAAQS 

is based on aggregate ambient monitoring of all potential sources of 

lead in a given area. In contrast, the Primary Lead Smelting Risk 

Assessment and Preamble clearly state that 3-month rolling average 

lead concentrations are based on modeled lead concentrations from 

lead emissions from the one facility in the source category. 76 FR 

9421. Thus, for example, while for NAAQS attainment purposes ambient 

lead concentrations resulting from lead haul roads outside the 

facility boundary would contribute to the overall 3-month rolling 

average ambient lead concentration measured at a nearby ambient lead 

monitor, for purposes of the risk assessment to support this 

rulemaking, these types of offsite emission sources were not 
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included when modeling 3-month rolling lead concentrations (i.e., 

only emission sources from within the facility boundary were used as 

inputs into the dispersion model to estimate resulting modeled 3-

month average lead concentrations). 

The NAAQS for lead was set to protect, with an adequate margin 

of safety, human health, including the health of children and other 

at-risk populations, against an array of adverse health effects, 

most notably including neurological effects, particularly 

neurobehavioral and neurocognitive effects, in children (73 FR 

67007). In developing the NAAQS for lead, because of the multipathway, multi-media impacts of lead, the risk assessment supporting 

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

and secondary lead smelting operations. It also considered 

background lead exposures from other sources (like contaminated 

drinking water and exposure to lead-based paints). The EPA believes 

that the lead NAAQS is a reasonable benchmark to evaluate the 

potential for multipathway health effects from lead.

Finally, as noted in the risk assessment document, there is no 

RfD or other comparable chronic health benchmark value for lead 

compounds. That is, in 1988, the EPA’s IRIS program reviewed the 

health effects data regarding lead and its inorganic compounds and 

determined that it would be inappropriate to develop an RfD for 
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these compounds, saying, “A great deal of information on the health 

effects of lead has been obtained through decades of medical 

observation and scientific research. This information has been 

assessed in the development of air and water quality criteria by the 

Agency's Office of Health and Environmental Assessment (OHEA) in 

support of regulatory decision-making by the Office of Air Quality 

Planning and Standards (OAQPS) and by the Office of Drinking Water 

(ODW). By comparison to most other environmental toxicants, the 

degree of uncertainty about the health effects of lead is quite low. 

It appears that some of these effects, particularly changes in the 

levels of certain blood enzymes and in aspects of children's 

neurobehavioral development, may occur at blood lead levels so low 

as to be essentially without a threshold. The agency's RfD Work

Group discussed inorganic lead (and lead compounds) at two meetings 

(07/08/1985 and 07/22/1985) and considered it inappropriate to 

develop an RfD for inorganic lead.” The EPA’s IRIS assessment for 

Lead and compounds (inorganic) (CASRN 7439-92-1), 

http://www.epa.gov/iris/subst/0277.htm.

Comment: One commenter stated that the EPA must include a plain 

language statement of health risks and benefits of the proposed 

rule. As part of its rulemaking proposal, the EPA should include a 

plain statement of the health impacts and risks at issue. For 

example, the commenter stated that the MIR and chronic and risk 
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numbers are not easily understandable by the general public; the IQ 

point losses at stake or how it is setting a standard to address 

these are not discussed, and the types of cancer or the nature of 

the health disorders or other adverse effects that most of these 

types of HAP emissions present to the public are not discussed. The 

commenter stated that this type of “[e]xpanded discussion is 

important to understanding the ‘real-world’ risk, including dealing 

with health disparities.” SAB May 2010 at 50. 

A full elaboration of the types of health impacts at issue 

here, ranging from significant IQ loss (due to lead emissions), to a 

high lifetime cancer risk (from non-lead emissions), for this 

particular community, is needed to inform the EPA’s and the public’s 

consideration of what level of risk is acceptable or unacceptable, 

and what standard is required to provide an ample margin of safety.

Response: The EPA strives to communicate its health and risk 

information to the public in a manner that is concise, informative, 

and readily understandable. In the risk assessment document, we 

discuss the various metrics used to characterize risk associated 

with the source category (e.g., see section 2.3 of the risk 

assessment document for a discussion of the MIR). Moreover, while 

the commenter is correct that we do not discuss in detail the 

neurological effects associated with exposure to lead (e.g., loss of 

IQ points in children), we do reference the final lead NAAQS 
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decision, which does discuss in detail the health effects associated 

with lead exposure. With regard to how the proposed controls limit 

the health risks associated with lead exposure, we noted in the 

preamble that the proposed controls would ensure that the facility’s 

contribution to ambient concentrations of lead were at or below the 

NAAQS for lead and that this represents an acceptable level of risk 

since the lead NAAQS was set to protect public health, including the 

health of sensitive populations (e.g., children), from the adverse 

health effects associated with lead exposure. In addition, as 

discussed previously, we concluded that the same level of controls 

would also provide an ample margin of safety.

With regard to discussing specific types of cancers potentially 

associated with exposure to a given HAP, we note that the cancer 

unit risk estimates used in the risk assessment are not associated 

with specific types of cancers, but rather with the risk of cancer 

in general. Moreover, since many of the cancer studies the unit risk 

estimates take into account are animal studies, there is appreciable 

uncertainty as to whether the same types of cancers would be seen in 

humans. Thus, we find it appropriate to express the results of our 

cancer assessment in terms of general cancer risk. 

VI. Impacts of the Final Rule

The revisions to the Primary Lead Processing MACT standard will 

ensure that emissions from the one source in this source category do 
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not present an unacceptable level of risk and will also provide an 

ample margin of safety. The estimated reductions include a reduction 

in fugitive dust emissions of lead and as much as 10 tons per year of 

lead from the furnace area and refining operations stacks. These 

controls will also reduce emissions of other HAP emitted from the 

facility. The costs of controls were not directly considered in the 

decision to require work practice standards and fenceline compliance 

monitoring to address fugitive emissions or to add an emission 

standard for furnace area and refining emissions because these

requirements are necessary to bring risk to an acceptable level.

However, as an example the cost for paving all unpaved roads at the 

facility to control fugitive emissions would be around $800,000. The 

EPA evaluated control practices and technology and associated costs 

in determining that the same requirements needed to achieve 

acceptable risks would also provide an ample margin of safety with 

regard to fugitive dust emissions and emissions from the furnace area 

and refining stacks. In addition, we considered other available 

practices, processes and control technologies. For the same reason we 

concluded that no additional controls were necessary to provide an 

ample margin of safety for the fugitive dust and refining and furnace 

area stacks, we concluded that there were no additional cost 

effective developments in practices, processes or control 

technologies for those emission sources. 
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VII. Statutory and Executive Order Reviews

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

Executive Order 13563: Improving Regulation and Regulatory Review

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 

action is a “significant regulatory action.” This action is a 

significant regulatory action because it raises novel legal and 

policy issues. Accordingly, the EPA submitted this action to the 

Office of Management and Budget (OMB) for review under Executive 

Order 12866 and Executive Order 13563 (76 FR 3821, January 21, 2011), 

and any changes made in response to OMB recommendations have been 

documented in the docket for this action.

B. Paperwork Reduction Act

The Office of Management and Budget (OMB) has approved the 

information collection requirements contained in this rule under the 

provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and 

has assigned OMB control number 2060-0414. 

The information requirements are based on notification, 

recordkeeping, and reporting requirements in the NESHAP General 

Provisions (40 CFR part 63, subpart A), which are mandatory for all 

operators subject to national emission standards. These recordkeeping 

and reporting requirements are specifically authorized by section 114 

of the CAA (42 U.S.C. 7414). All information submitted to the EPA

pursuant to the recordkeeping and reporting requirements for which a 
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claim of confidentiality is made is safeguarded according to agency 

policies set forth in 40 CFR part 2, subpart B.

This final rule includes new paperwork requirements for 

monitoring for lead concentrations in air and increased frequency for 

stack testing as described in 40 CFR 63.1547(k) (compliance 

monitoring) and 40 CFR 63.1546 (stack testing). Although these are 

additional requirements under the final rule, they are consistent 

with existing monitoring and testing currently conducted by the 

facility to meet MACT and SIP requirements and would not constitute 

an undue burden to the facility.

When a malfunction occurs, sources must report them according to 

the applicable reporting requirements of 40 CFR part 63, subpart TTT.

An affirmative defense to civil penalties for exceedances of emission 

limits that are caused by malfunctions is available to a source if it 

can demonstrate that certain criteria and requirements are satisfied.

The criteria ensure that the affirmative defense is available only 

where the event that causes an exceedance of the emission limit meets 

the narrow definition of malfunction in 40 CFR 63.2 (sudden, 

infrequent, not reasonable preventable, and not caused by poor 

maintenance and or careless operation) and where the source took 

necessary actions to minimize emissions. In addition, the source must 

meet certain notification and reporting requirements. For example, 

the source must prepare a written root cause analysis and submit a 
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written report to the Administrator documenting that it has met the 

conditions and requirements for assertion of the affirmative defense.

The EPA is adding affirmative defense to the estimate of burden 

in the ICR. To provide the public with an estimate of the relative 

magnitude of the burden associated with an assertion of the 

affirmative defense position adopted by a source, the EPA has 

provided administrative adjustments to the ICR that show what the 

notification, recordkeeping, and reporting requirements associated 

with the assertion of the affirmative defense might entail. The EPA’s 

estimate for the required notification, reports, and records, 

including the root cause analysis, totals $3,141, and is based on the 

time and effort required of a source to review relevant data, 

interview plant employees, and document the events surrounding a 

malfunction that has caused an exceedance of an emission limit. The 

estimate also includes time to produce and retain the record and 

reports for submission to the EPA. The EPA provides this illustrative 

estimate of this burden, because these costs are only incurred if 

there has been a violation, and a source chooses to take advantage of 

the affirmative defense.

Given the variety of circumstances under which malfunctions 

could occur, as well as differences among sources' operation and 

maintenance practices, we cannot reliably predict the severity and 

frequency of malfunction-related excess emissions events for a
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particular source. It is important to note that the EPA has no basis 

currently for estimating the number of malfunctions that would 

qualify for an affirmative defense. Current historical records would 

be an inappropriate basis, as source owners or operators previously 

operated their facilities in recognition that they were exempt from 

the requirement to comply with emissions standards during 

malfunctions. Of the number of excess emission events reported by 

source operators, only a small number would be expected to result 

from a malfunction (based on the definition above), and only a subset 

of excess emissions caused by malfunctions would result in the source 

choosing to assert the affirmative defense. Thus, we believe the 

number of instances in which source operators might be expected to 

avail themselves of the affirmative defense will be extremely small.

For this reason, we estimate no more than 2 or 3 such occurrences for 

all sources subject to 40 CFR part 63, subpart TTT over the 3-year 

period covered by this ICR. We expect to gather information on such 

events in the future, and will revise this estimate as better 

information becomes available.

For the Primary Lead Processing MACT standard, the ICR document 

prepared by the EPA, which has been revised to include the amendments 

to the standards, has been assigned the EPA ICR number 1856.0708.

Burden changes associated with these amendments result from the 

reporting and recordkeeping requirements of the affirmative defense 
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provisions and the lead concentration in air limit added to the rule.

The change in respondents’ annual reporting and recordkeeping burden 

associated with these amendments for this collection (averaged over 

the first 3 years after the effective date of the standards) is 

estimated to be 30 labor hours at a cost of $3,141 per year for the 

affirmative defense reporting and recordkeeping provisions and 1,313

labor hours at a cost of $461,640 per year for the lead concentration 

in air limit reporting and recordkeeping provisions. There will be no 

capital costs associated with the information collection requirements 

of the final rule. There is no estimated change in annual burden to 

the Federal government for these amendments. Burden is defined at 5 

CFR 1320.3(b)

An agency may not conduct or sponsor, and a person is not 

required to respond to, a collection of information unless it 

displays a currently valid OMB control number. The OMB control 

numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. 

In addition, EPA is amending the table in 40 CFR part 9 of currently 

approved OMB control numbers for various regulations to list the 

regulatory citations for the information requirements contained in 

this final rule.

C. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) generally requires an 

agency to prepare a regulatory flexibility analysis of any rule 
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subject to notice and comment rulemaking requirements under the 

Administrative Procedure Act, or any other statute, unless the agency 

certifies that the rule will not have a significant economic impact 

on a substantial number of small entities. Small entities include 

small businesses, small organizations, and small governmental 

jurisdictions.

For purposes of assessing the impact of these final rules on 

small entities, small entity is defined as: (1) a small business as 

defined by the Small Business Administration’s regulations at 13 CFR 

121.201; (2) a small governmental jurisdiction that is a government 

of a city, county, town, school district, or special district with a 

population of less than 50,000; and (3) a small organization that is 

any not-for-profit enterprise which is independently owned and 

operated and is not dominant in its field.

After considering the economic impacts of these final rules on 

small entities, I certify that this action will not have a 

significant economic impact on a substantial number of small 

entities. This final action will not impose any requirements on small 

entities. The costs associated with the new requirements in these 

final rules are not expected to present an undue burden to this 

industry as discussed above. 

D. Unfunded Mandates Reform Act 

This action contains no Federal mandates under the provisions of 
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Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 

1531-1538 for State, local, or tribal governments or the private 

sector. The action imposes no enforceable duty on any State, local 

or tribal governments or the private sector. Therefore, this action 

is not subject to the requirements of sections 202 or 205 of the 

UMRA.

These rules are also not subject to the regulatory requirements 

that might significantly or uniquely affect small governments. They 

contain no requirements that apply to such governments or impose 

obligations upon them.

E. Executive Order 13132: Federalism

This action does not have federalism implications. It will not 

have substantial direct effects on the States, on the relationship 

between the national government and the States, or on the 

distribution of power and responsibilities among the various levels 

of government, as specified in Executive Order 13132. These final 

rules primarily affect private industry, and do not impose 

significant economic costs on State or local governments. Thus, 

Executive Order 13132 does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian 

Tribal Governments

This action does not have tribal implications, as specified in 

Executive Order 13175 (65 FR 67249, November 9, 2000). It will not 
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have substantial direct effect on tribal governments, on the 

relationship between the Federal government and Indian tribes, or on 

the distribution of power and responsibilities between the Federal 

government and Indian tribes, as specified in Executive Order 13175.

Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental 

Health Risks and Safety Risks

This action is not subject to Executive Order 13045 (62 FR

19885, April 23, 1997), because it is not economically significant as 

defined in Executive Order 12866. However, the agency does believe 

there is a disproportionate risk to children. Modeled ambient air 

lead concentrations from the one facility in this source category are 

in excess of the NAAQS for lead, which was set to “provide increased 

protection for children and other at-risk populations against an 

array of adverse health effects, most notably including neurological 

effects in children, including neurocognitive and neurobehavioral 

effects.” 73 FR 67007. However, the control measures promulgated in 

this notice will result in lead concentration levels that are in 

compliance with the lead NAAQS, thereby mitigating the risk of 

adverse health effects to children.

H. Executive Order 13211: Actions Concerning Regulations That 

Significantly Affect Energy Supply, Distribution, or Use

This action is not a “significant energy action” as defined in
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Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not 

likely to have a significant adverse energy effect on the supply, 

distribution, or use of energy. This action will not create any new 

requirements for sources in the energy supply, distribution, or use 

sectors. Further, we have concluded that these final rules are not 

likely to have any adverse energy effects.

I. National Technology Transfer and Advancement Act

Section 12(d) of the National Technology Transfer and 

Advancement Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 

U.S.C. 272 note) directs the EPA to use voluntary consensus standards 

(VCS) in its regulatory activities, unless to do so would be 

inconsistent with applicable law or otherwise impractical. VCS are 

technical standards (e.g., materials specifications, test methods, 

sampling procedures, and business practices) that are developed or 

adopted by VCS bodies. NTTAA directs the EPA to provide Congress, 

through OMB, explanations when the agency decides not to use 

available and applicable VCS. 

This action does not involve technical standards. Therefore, the 

EPA did not consider the use of any VCS.

J. Executive Order 12898: Federal Actions To Address Environmental 

Justice in Minority Populations and Low-Income Populations

Executive Order 12898 (59 FR 7629, February 16, 1994) 

establishes Federal executive policy on environmental justice. Its 
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main provision directs Federal agencies, to the greatest extent 

practicable and permitted by law, to make environmental justice part 

of their mission by identifying and addressing, as appropriate, 

disproportionately high and adverse human health or environmental 

effects of their programs, policies, and activities on minority 

populations and low-income populations in the United States.

The EPA has determined that this final rule will not have 

disproportionately high and adverse human health or environmental 

effects on minority or low-income populations, because it does not 

decrease the level of protection provided to human health or the 

environment, but in fact decreases emissions of lead. To examine the 

potential for any environmental justice issues that might be 

associated with this rule, we evaluated the distributions of HAPrelated cancer and non-cancer risks across different social, 

demographic, and economic groups within the populations living near 

the one facility that is currently operating in this source category.

Our analyses also show that, although there is potential for an 

adverse environmental and human health effects from emission of lead, 

it does not indicate any significant potential for disparate impacts 

to the specific demographic groups analyzed.

The rule would require additional control measures to address 

the identified environmental and health risks and would therefore, 

decrease risks to any populations exposed to these sources.
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K. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801, et seq., as added by 

the Small Business Regulatory Enforcement Fairness Act of 1996, 

generally provides that, before a rule may take effect, the agency 

promulgating the rule must submit a rule report, which includes a 

copy of the rule, to each House of the Congress and to the 

Comptroller General of the United States. The EPA will submit a 

report containing this final rule and other required information to 

the United States Senate, the United States House of Representatives, 

and the Comptroller General of the United States prior to publication 

of the final rule in the Federal Register. A major rule cannot take 

effect until 60 days after it is published in the Federal Register.

This action is not a “major rule” as defined by 5 U.S.C. 804(2). The 

final rules will be effective on [INSERT DATE OF PUBLICATION].
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List of Subjects for 40 CFR Part 63

Environmental protection, Administrative practice and 

procedures, Air pollution control, Hazardous substances, 

Intergovernmental relations, Reporting and recordkeeping 

requirements.

______________

Dated: XXXXX XX, 2011.

________________________

Lisa P. Jackson,

Administrator.
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For the reasons stated in the preamble, the Environmental 

Protection Agency proposes to amend title 40, chapter I, of the 

Code of Federal Regulations as follows:

PART 63-–[AMENDED]

1. The authority citation for part 63 continues to read 

as follows:

Authority: 42 U.S.C. 7401, et seq.

Subpart TTT—[AMENDED]

§63.1541 Applicability.

(a) The provisions of this subpart apply to any facility 

engaged in producing lead metal from ore concentrates. The 

category includes, but is not limited to, the following smelting 

processes: sintering, reduction, preliminary treatment, refining 

and casting operations, process fugitive sources, and fugitive 

dust sources. The sinter process includes an updraft or 

downdraft sintering machine. The reduction process includes the 

blast furnace, electric smelting furnace with a converter or 

reverberatory furnace, and slag fuming furnace process units.

The preliminary treatment process includes the drossing kettles 

and dross reverberatory furnace process units. The refining 

process includes the refinery process unit. The provisions of 

this subpart do not apply to secondary lead smelters, lead 

refiners, or lead remelters.
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(b) Table 1 of this subpart specifies the provisions of 

subpart A of this part that apply and those that do not apply to 

owners and operators of primary lead processors.

3. Section 63.1542 is amended by adding a definition for 

“Affirmative defense,” “Lead refiner,” “Lead remelter,” “Primary 

lead processor,” and “Secondary lead smelter;” deleting the 

definition of “Primary lead smelter;” and revising the 

definitions of ”Fugitive dust source,” “Furnace area,” 

“Malfunction,” “Materials storage and handling area,” “Plant 

roadway,” “Process fugitive source,” “Refining and casting 

area,” “Sinter machine area,” and “Tapping location” to read as 

follows:

§63.1542 Definitions.

* * * * *

 Affirmative defense means, in the context of an enforcement 

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

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

merits of which are independently and objectively evaluated in a 

judicial or administrative proceeding.

* * * * *

 Fugitive dust source means a stationary source of hazardous 

air pollutant emissions at a primary lead processor resulting 

from the handling, storage, transfer, or other management of 

lead-bearing materials where the source is not part of a 
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specific process, process vent, or stack. Fugitive dust sources 

include roadways, storage piles, materials handling transfer 

points, and materials transport areas.

 Furnace area means any area of a primary lead processor in 

which a blast furnace or dross furnace is located.

 Lead refiner means any facility that refines lead metal that 

is not located at a primary lead processor.

 Lead remelter means any facility that remelts lead metal 

that is not located at a primary lead processor. 

 Malfunction means any sudden, infrequent, and not reasonably 

preventable failure of air pollution control and monitoring 

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

normal or usual manner which causes, or has the potential to 

cause, the emission limitations in an applicable standard to be 

exceeded. Failures that are caused in part by poor maintenance 

or careless operation are not malfunctions.

 Materials storage and handling area means any area of a 

primary lead processor in which lead-bearing materials 

(including ore concentrate, sinter, granulated lead, dross, 

slag, and flue dust) are stored or handled between process 

steps, including areas in which materials are stored in piles, 

bins, or tubs, and areas in which material is prepared for 

charging to a sinter machine or smelting furnace or other lead

processing operation.
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* * * * *

 Plant roadway means any area of a primary lead processor 

that is subject to vehicle traffic, including traffic by 

forklifts, front-end loaders, or vehicles carrying ore 

concentrates or cast lead ingots. Excluded from this definition 

are employee and visitor parking areas, provided they are not 

subject to traffic by vehicles carrying lead-bearing materials. 

 Primary lead processor means any facility engaged in the 

production of lead metal from lead sulfide ore concentrates 

through the use of pyrometallurgical or other techniques.

 Process fugitive source means a source of hazardous air 

pollutant emissions at a primary lead processor that is 

associated with lead smelting, processing or refining but is not 

the primary exhaust stream and is not a fugitive dust source. 

Process fugitive sources include sinter machine charging 

locations, sinter machine discharge locations, sinter crushing 

and sizing equipment, furnace charging locations, furnace taps, 

and drossing kettle and refining kettle charging or tapping 

locations.

 Refining and casting area means any area of a primary lead 

processor in which drossing or refining operations occur, or 

casting operations occur.

 Secondary lead smelter means any facility at which leadbearing scrap material, primarily, but not limited to, lead-acid 
Page 104 of 137

batteries, is recycled into elemental lead or lead alloys by 

smelting.

* * * * *

 Sinter machine area means any area of a primary lead 

processor where a sinter machine, or sinter crushing and sizing 

equipment is located.

* * * * *

 Tapping location means the opening through which lead and 

slag are removed from the furnace.

4. Section 63.1543 is revised to read as follows:

§63.1543 Standards for process and process fugitive sources.

(a) No owner or operator of any existing, new, or 

reconstructed primary lead processor shall discharge or cause to 

be discharged into the atmosphere lead compounds in excess of 

0.97 pounds per ton of lead metal produced from the aggregation 

of emissions discharged from air pollution control devices used 

to control emissions from the sources listed in paragraphs 

(a)(1) through (a)(9) of this section.

(1) Sinter machine;

(2) Blast furnace;

(3) Dross furnace;

(4) Dross furnace charging location;

(5) Blast furnace and dross furnace tapping location;
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(6) Sinter machine charging location;

(7) Sinter machine discharge end;

(8) Sinter crushing and sizing equipment; and

(9) Sinter machine area.

(b) No owner or operator of any existing, new, or 

reconstructed primary lead processor shall discharge or cause to 

be discharged into the atmosphere lead compounds in excess of 

1.2 tons per year from the aggregation of the air pollution 

control devices used to control emissions from furnace area and 

refining and casting operations.

(c) The process fugitive sources listed in paragraphs 

(a)(4) through (a)(8) of this section must be equipped with a 

hood and must be ventilated to a baghouse or equivalent control 

device. The hood design and ventilation rate must be consistent 

with American Conference of Governmental Industrial Hygienists 

recommended practices.

(d) The sinter machine area must be enclosed in a building 

that is ventilated to a baghouse or equivalent control device at 

a rate that maintains a positive in-draft through any doorway 

opening.

(e) Except as provided in paragraph (f) of this section, 

following the initial tests to demonstrate compliance with 

paragraphs (a) and (b) of this section, the owner or operator of 

a primary lead processor must conduct compliance tests for lead 
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compounds on an quarterly basis (no later than 100 days 

following any previous compliance test).

(f) If the 12 most recent compliance tests demonstrate 

compliance with the emission limit specified in paragraphs (a) 

and (b) of this section, the owner or operator of a primary lead 

processor shall be allowed up to 12 calendar months from the 

last compliance test to conduct the next compliance test for 

lead compounds.

(g) The owner or operator of a primary lead processor must 

maintain and operate each baghouse used to control emissions 

from the sources listed in paragraphs (a)(1) through (a)(9) and 

(b) of this section such that the alarm on a bag leak detection 

system required under §63.1547(c)(8) does not sound for more 

than five percent of the total operating time in a 6-month 

reporting period.

(h) The owner or operator of a primary lead processor must 

record the date and time of a bag leak detection system alarm 

and initiate procedures to determine the cause of the alarm 

according to the corrective action plan required under 

§63.1547(f) within 1 hour of the alarm. The cause of the alarm 

must be corrected as soon as practicable.

(i) At all times, the owner or operator must operate and 

maintain any affected source, including associated air pollution 
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control equipment and monitoring equipment, in a manner 

consistent with safety and good air pollution control practices 

for minimizing emissions. Determination of whether such 

operation and maintenance procedures are being used will be 

based on information available to the Administrator which may 

include, but is not limited to, monitoring results, review of 

operation and maintenance procedures, review of operation and 

maintenance records, and inspection of the source.

5. Section 63.1544 is revised to read as follows:

§63.1544 Standards for fugitive dust sources.

(a) Each owner or operator of any existing, new or 

reconstructed primary lead processor must adopt and implement 

work practice standards or other measures to reduce fugitive 

dust emissions sufficient to ensure that lead levels in the air 

at the fenceline do not exceed 0.15 μg/m3 on a 3-month rolling 

average.

(b) Consistent with the requirements in section 

63.1547(k), each owner or operator of any existing, new or 

reconstructed primary lead processor must establish a monitoring 

network at locations approved by the Administrator to ensure 

compliance with the requirements of paragraph (a). 

(c) At all times, the owner or operator must operate and 

maintain any affected source, including associated air pollution 
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control equipment and monitoring equipment, in a manner 

consistent with safety and good air pollution control practices 

for minimizing emissions. Determination of whether such 

operation and maintenance procedures are being used will be 

based on information available to the Administrator which may

include, but is not limited to, monitoring results, review of 

operation and maintenance procedures, review of operation and 

maintenance records, and inspection of the source.

6. Section 63.1545 is revised to read as follows:

§63.1545 Compliance dates.

(a) Each owner or operator of an existing primary lead 

processor must achieve compliance with the requirements in 

§16.1543(a) no later than [INSERT DATE 60 DAYS FROM THE DATE OF 

PUBLICATION OF THESE AMENDMENTS IN THE FEDERAL REGISTER]. Each 

owner or operator of an existing primary lead processor must 

achieve compliance with the requirements in § 63.1543(b), §

63.1543(e), and § 63.1544 of this subpart no later than [INSERT 

DATE TWO YEARS FROM THE DATE OF PUBLICATION OF THESE AMENDMENTS 

IN THE FEDERAL REGISTER].

(b) Each owner or operator of a new primary lead processor

must achieve compliance with the requirements of this subpart no 

later than [INSERT DATE 60 DAYS AFTER PUBLICATION OF THESE 

AMENDMENTS IN THE FERERAL REGISTER] or startup, whichever is 

later.
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(c) Prior to the dates specified in §63.1545(a), each owner 

or operator of an existing primary lead processor must continue 

to comply with the requirements of §63.1543 and §63.1544 as 

promulgated in the June 4, 1999 NESHAP for Primary Lead 

Smelting.

(d) Each owner or operator of an existing primary lead 

processor must comply with the requirements of 63.1547(g)(1), 

63.1547(g)(2), 63.1551, and the revisions to Table 1 of Subpart 

TTT of Part 63 on [INSERT DATE OF PUBLICATION OF THESE 

AMENDMENTS IN THE FEDERAL REGISTER].

7. Section 63.1546 is revised to read as follows:

§63.1546 Performance testing.

(a) The following procedures must be used to determine 

quarterly compliance with the emissions standard for lead 

compounds under §63.1543(a) and (b) for existing sources:

(1) Each owner or operator of existing sources listed in 

§63.1543(a)(1) through (9) and (b) must determine the lead 

compound emissions rate, in units of pounds of lead per hour 

according to the following test methods in appendix A of part 60 

of this chapter:

(i) Method 1 must be used to select the sampling port 

location and the number of traverse points.

(ii) Method 2, 2F, 2G must be used to measure volumetric 

flow rate.
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(iii) Method 3, 3A, 3B must be used for gas analysis.

(iv) Method 4 must be used to determine moisture content of 

the stack gas.

(v) Method 12 or Method 29 must be used to determine lead 

emissions rate of the stack gas.

(2) A performance test shall consist of at least three 

runs. For each test run with Method 12 or Method 29, the minimum 

sample time must be 60 minutes and the minimum volume must be 1 

dry standard cubic meter (35 dry standard cubic feet).

(3) Performance tests shall be completed quarterly, once 

every 3 months, to determine compliance.

(4) The lead emission rate in pounds per quarter is 

calculated by multiplying the quarterly lead emission rate in 

pounds per hour by the quarterly plant operating time, in hours 

as shown in Equation 1:

(Eq. 1)

Where: 

EPb = quarterly lead emissions, pounds per quarter;

ERPb = quarterly lead emissions rate, pounds per hour; and

QPOT = quarterly plant operating time, hours per quarter.

(5) The lead production rate, in units of tons per 

quarter, must be determined based on production data for the 

previous quarter according to the procedures detailed in 

paragraphs (a)(5)(i) through (iv) of this section:
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(i) Total lead products production multiplied by the 

fractional lead content must be determined in units of tons.

(ii) Total copper matte production multiplied by the 

fractional lead content must be determined in units of tons.

(iii) Total copper speiss production multiplied by the 

fractional lead content must be determined in units of tons.

(iv) Total quarterly lead production must be determined by 

summing the values obtained in paragraphs (a)(5)(i) through 

(a)(5)(iii) of this section.

(6) To determine compliance with the production-based lead 

compound emission rate in §63.1543(a), the quarterly productionbased lead compound emission rate, in units of pounds of lead 

emissions per ton of lead produced, is calculated as shown in 

Equation 2 by dividing lead emissions by lead production.

(Eq. 2)

Where :

CEPb = quarterly production-based lead compound emission 

rate, in units of pounds of lead emissions per ton of lead 

produced;

EPb = quarterly lead emissions, pounds per quarter; and

PPb = quarterly lead production, tons per quarter.

(7) To determine quarterly compliance with the emissions 

standard for lead compounds under §63.1543(b), sum the lead 
Page 112 of 137

compound emission rates for the current and previous three 

quarters for the sources in §63.1543 (b), as determined in 

accordance with paragraphs (a)(1) through (a)(4) of this 

section.

(b) Owner and operators must perform an initial compliance 

test to demonstrate compliance with the sinter building in-draft 

requirements of §63.1543(d) at each doorway opening in 

accordance with paragraphs (b)(1) through (b)(4) of this 

section.

(1) Use a propeller anemometer or equivalent device.

(2) Determine doorway in-draft by placing the anemometer in 

the plane of the doorway opening near its center.

(3) Determine doorway in-draft for each doorway that is 

open during normal operation with all remaining doorways in 

their customary position during normal operation.

(4) Do not determine doorway in-draft when ambient wind 

speed exceeds 2 meters per second.

(c) Performance tests shall be conducted under such 

conditions as the Administrator specifies to the owner or 

operator based on representative performance of the affected 

source for the period being tested. Upon request, the owner or 

operator shall make available to the Administrator such records 

as may be necessary to determine the conditions of performance 

tests.
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8. Section 63.1547 is revised to read as follows:

§63.1547 Monitoring requirements.

(a) Owners and operators of primary lead processors must 

prepare, and at all times operate according to, a standard 

operating procedures manual that describes in detail the 

procedures for inspection, maintenance, and bag leak detection 

and corrective action for all baghouses that are used to control 

process, process fugitive, or fugitive dust emissions from any 

source subject to the lead emission standards in §§63.1543 and 

63.1544, including those used to control emissions from general 

ventilation systems.

(b) The standard operating procedures manual for baghouses 

required by paragraph (a) of this section must be submitted to 

the Administrator or delegated authority for review and 

approval.

(c) The procedures specified in the standard operating 

procedures manual for inspections and routine maintenance must, 

at a minimum, include the requirements of paragraphs (c)(1) 

through (c)(8) of this section.

(1) Weekly confirmation that dust is being removed from 

hoppers through visual inspection or equivalent means of 

ensuring the proper functioning of removal mechanisms.

(2) Daily check of compressed air supply for pulse-jet 

baghouses.
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(3) An appropriate methodology for monitoring cleaning 

cycles to ensure proper operation.

(4) Monthly check of bag cleaning mechanisms for proper 

functioning through visual inspection or equivalent means.

(5) Quarterly visual check of bag tension on reverse air 

and shaker-type baghouses to ensure that bags are not kinked 

(kneed or bent) or laying on their sides. Such checks are not 

required for shaker-type baghouses using self-tensioning (spring 

loaded) devices.

(6) Quarterly confirmation of the physical integrity of the

baghouse through visual inspection of the baghouse interior for 

air leaks.

(7) Quarterly inspection of fans for wear, material 

buildup, and corrosion through visual inspection, vibration 

detectors, or equivalent means.

(8) Except as provided in paragraph (h) of this section, 

continuous operation of a bag leak detection system.

(d) The procedures specified in the standard operating 

procedures manual for maintenance must, at a minimum, include a 

preventative maintenance schedule that is consistent with the 

baghouse manufacturer's instructions for routine and long-term 

maintenance.
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(e) The bag leak detection system required by paragraph 

(c)(8) of this section must meet the specifications and 

requirements of (e)(1) through (e)(8) of this section.

(1) The bag leak detection system must be certified by the 

manufacturer to be capable of detecting particulate matter 

emissions at concentrations of 10 milligram per actual cubic 

meter (0.0044 grains per actual cubic foot) or less.

(2) The bag leak detection system sensor must provide 

output of relative particulate matter loadings, and the owner or 

operator must continuously record the output from the bag leak 

detection system.

(3) The bag leak detection system must be equipped with an 

alarm system that will sound when an increase in relative 

particulate loading is detected over a preset level, and the 

alarm must be located such that it can be heard or otherwise 

determined by the appropriate plant personnel.

(4) Each bag leak detection system that works based on the 

triboelectric effect must be installed, calibrated, and 

maintained in a manner consistent with guidance provided in the 

U.S. Environmental Protection Agency guidance document ”Fabric 

Filter Bag Leak Detection Guidance” (EPA-454/R-98-015). Other 

bag leak detection systems must be installed, calibrated, and 

maintained in a manner consistent with the manufacturer's 

written specifications and recommendations.
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(5) The initial adjustment of the system must, at a 

minimum, consist of establishing the baseline output by 

adjusting the sensitivity (range) and the averaging period of 

the device, and establishing the alarm set points and the alarm 

delay time.

(6) Following initial adjustment, the owner or operator 

must not adjust the sensitivity or range, averaging period, 

alarm set points, or alarm delay time, except as detailed in the 

approved SOP required under paragraph (a) of this section. In no 

event shall the sensitivity be increased by more than 100 

percent or decreased more than 50 percent over a 365-day period 

unless a responsible official certifies that the baghouse has 

been inspected and found to be in good operating condition.

(7) For negative pressure, induced air baghouses, and 

positive pressure baghouses that are discharged to the 

atmosphere through a stack, the bag leak detector must be 

installed downstream of the baghouse and upstream of any wet 

acid gas scrubber.

(8) Where multiple detectors are required, the system's 

instrumentation and alarm may be shared among detectors.

(f) The standard operating procedures manual required by 

paragraph (a) of this section must include a corrective action 

plan that specifies the procedures to be followed in the event 

of a bag leak detection system alarm. The corrective action plan 
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must include at a minimum, procedures to be used to determine 

the cause of an alarm, as well as actions to be taken to 

minimize emissions, which may include, but are not limited to, 

the following.

(1) Inspecting the baghouse for air leaks, torn or broken 

bags or filter media, or any other condition that may cause an 

increase in emissions.

(2) Sealing off defective bags or filter media.

(3) Replacing defective bags or filter media, or otherwise 

repairing the control device.

(4) Sealing off a defective baghouse compartment.

(5) Cleaning the bag leak detection system probe, or 

otherwise repairing or maintaining the bag leak detection 

system.

(6) Shutting down the process producing the particulate 

emissions.

(g) The percentage of total operating time the alarm on the 

bag leak detection system sounds in a 6-month reporting period 

must be calculated in order to determine compliance with the 

five percent operating limit in §63.1543(h). The percentage of 

time the alarm on the bag leak detection system sounds must be 

determined according to paragraphs (g)(1) through (g)(3) of this 

section.
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(1) For each alarm where the owner or operator initiates 

procedures to determine the cause of an alarm within 1 hour of 

the alarm, 1 hour of alarm time must be counted.

(2) For each alarm where the owner or operator does not 

initiate procedures to determine the cause of the alarm within 1 

hour of the alarm, alarm time will be counted as the actual 

amount of time taken by the owner or operator to initiate 

procedures to determine the cause of the alarm.

(3) The percentage of time the alarm on the bag leak 

detection system sounds must be calculated as the ratio of the 

sum of alarm times to the total operating time multiplied by 

100.

(h) Baghouses equipped with HEPA filters as a secondary 

filter used to control process or process fugitive sources 

subject to the lead emission standards in §63.1543 are exempt 

from the requirement in paragraph (c)(8) of this section to be 

equipped with a bag leak detector. The owner or operator of an 

affected source that uses a HEPA filter must monitor and record 

the pressure drop across the HEPA filter system daily. If the 

pressure drop is outside the limit(s) specified by the filter 

manufacturer, the owner or operator must take appropriate 

corrective measures, which may include, but not be limited to, 

the following:
Page 119 of 137

(1) Inspecting the filter and filter housing for air leaks 

and torn or broken filters.

(2) Replacing defective filter media, or otherwise 

repairing the control device.

(3) Sealing off a defective control device by routing air 

to other comparable control devices.

(4) Shutting down the process producing the particulate 

emissions.

(i) Owners and operators must monitor sinter machine 

building in-draft to demonstrate continued compliance with the 

operating standard specified in §63.1543(d) in accordance with 

either paragraph (i)(1), (i)(2), or (i)(3) of this section.

(1) Owners and operators must check and record on a daily 

basis doorway in-draft at each doorway in accordance with the 

methodology specified in §63.1546(b).

(2) Owners and operators must establish and maintain 

baseline ventilation parameters which result in a positive indraft according to paragraphs (i)(2)(i) through (i)(2)(iv) of 

this section.

(i) Owners and operators must install, calibrate, maintain, 

and operate a monitoring device that continuously records the 

volumetric flow rate through each separately ducted hood; or 

install, calibrate, maintain, and operate a monitoring device 

that continuously records the volumetric flow rate at the 
Page 120 of 137

control device inlet of each exhaust system ventilating the 

building. The flow rate monitoring device(s) can be installed in 

any location in the exhaust duct such that reproducible flow 

rate measurements will result. The flow rate monitoring 

device(s) must have an accuracy of plus or minus 10 percent over 

the normal process operating range and must be calibrated 

according to manufacturer's instructions.

(ii) During the initial demonstration of sinter building 

in-draft, and at any time the owner or operator wishes to reestablish the baseline ventilation parameters, the owner or 

operator must continuously record the volumetric flow rate 

through each separately ducted hood, or continuously record the 

volumetric flow rate at the control device inlet of each exhaust 

system ventilating the building and record exhaust system damper 

positions. The owner or operator must determine the average 

volumetric flow rate(s) corresponding to the period of time the 

in-draft compliance determinations are being conducted.

(iii) The owner or operator must maintain the volumetric 

flow rate(s) at or above the value(s) established during the 

most recent in-draft determination at all times the sinter 

machine is in operation. Volumetric flow rate(s) must be 

calculated as a 15-minute average.

(iv) If the volumetric flow rate is monitored at the 

control device inlet, the owner or operator must check and 
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record damper positions daily to ensure they are in the 

positions they were in during the most recent in-draft 

determination.

(3) An owner or operator may request an alternative 

monitoring method by following the procedures and requirements 

in §63.8(f) of the General Provisions.

(j) Each owner or operator of new or modified sources 

listed under §63.1543 (a)(1) through (a)(9) and (b) must 

install, calibrate, maintain, and operate a continuous emission 

monitoring system (CEMS) for measuring lead emissions and a 

continuous emission rate monitoring system (CERMS)subject to 

Performance Specification 6 of Appendix B to part 60.

(1) Each owner or operator of a source subject to the 

emissions limits for lead compounds under §63.1543(a)and (b) 

must install a CEMS for measuring lead emissions within 180 days 

of promulgation of performance specifications for lead CEMS.

(i) Prior to promulgation of performance specifications for 

CEMS used to measure lead concentrations, an owner or operator 

must use the procedure described in §63.1546 (a)(1) through 

(a)(7) of this section to determine compliance. 

(2) If a CEMS used to measure lead emissions is applicable, 

the owner or operator must install a CERMS with a sensor in a 

location that provides representative measurement of the exhaust 

gas flow rate at the sampling location of the CEMS used to 
Page 122 of 137

measure lead emissions, taking into account the manufacturer’s 

recommendations. The flow rate sensor is that portion of the 

system that senses the volumetric flow rate and generates an 

output proportional to that flow rate.

(i) The CERMS must be designed to measure the exhaust gas 

flow rate over a range that extends from a value of at least 20 

percent less than the lowest expected exhaust flow rate to a 

value of at least 20 percent greater than the highest expected 

exhaust gas flow rate. 

(ii) The CERMS must be equipped with a data acquisition and 

recording system that is capable of recording values over the 

entire range specified in paragraph (b)(2)(i) of this section. 

(iii) Each owner or operator must perform an initial 

relative accuracy test of the CERMS in accordance with the 

applicable Performance Specification in Appendix B to part 60 of 

the chapter. 

(iv) Each owner or operator must operate the CERMS and 

record data during all periods of operation of the affected 

facility including periods of startup, shutdown, and 

malfunction, except for periods of monitoring system 

malfunctions, repairs associated with monitoring system 

malfunctions, and required monitoring system quality assurance 

or quality control activities (including, as applicable, 

calibration checks and required zero and span adjustments.
Page 123 of 137

(3) Each owner or operator must calculate the lead 

emissions rate in tons per year by summing all hours of CEMS 

data for a year to determine compliance with 63.1543 (b).

(i) When the CERMS are unable to provide quality assured 

data the following applies:

(A) When data are not available for periods of up to 48 

hours, the highest recorded hourly emission rate from the 

previous 24 hours must be used.

(B) When data are not available for 48 or more hours, the 

maximum daily emission rate based on the previous 30 days must 

be used.

(k) The owner or operator of each source subject to 

§63.1544(a) must operate a continuous monitoring system for the 

measurement of lead compound concentrations in air.

(1) The owner or operator must operate compliance monitors 

sufficient in number, location, and frequency of sample 

collection to detect expected maximum concentrations of lead 

compounds in air due to emissions from the affected source(s) in 

accordance with a written plan as described in (k)(2) of this 

paragraph and approved by the Administrator. The plan must 

include descriptions of the sampling and analytical methods 

used. The plan may take into consideration existing monitoring 

being conducted under a state monitoring plan in accordance with 

Part 58.
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(2) The owner or operator must submit a written plan 

describing and explaining the basis for the design and adequacy 

of the compliance monitoring network, the sampling, analytical, 

and quality assurance procedures, and any other related 

procedures, and the justification for any seasonal, background, 

or other data adjustments within 45 days after the effective 

date of this subpart. 

(3) The Administrator at any time may require changes in, 

or expansion of, the monitoring program, including additional 

sampling and analytical protocols and network design.

(l) If all rolling three-month average concentrations of 

lead in air measured by the compliance monitoring system are 

less than [50 percent] of the lead concentration in air limit in 

§63.1544(a) for three consecutive years, the owner or operator 

may submit a revised plan to reduce the monitoring sampling and 

analysis frequency (e.g., from daily to weekly).

For any subsequent period, if any rolling three-month 

average lead concentration in air measured at any monitor in the 

monitoring system exceeds [50 percent] of the concentration 

limit in §63.1544(a), the owner or operator must resume 

monitoring pursuant to paragraph (k)(1) at all monitors until 

another three consecutive years of lead concentration in air 
Page 125 of 137

measurements less than [50 percent] of the lead concentration in 

air limit is demonstrated.

9. Section 63.1548 is revised to read as follows:

§63.1548 Notification requirements.

(a) The owner or operator of a primary lead processor must 

comply with the notification requirements of §63.9 of subpart A, 

General Provisions as specified in Table 1 of this subpart.

(b) The owner or operator of a primary lead processor must 

submit the standard operating procedures manual for baghouses 

required under §63.1547(a) to the Administrator or delegated 

authority along with a notification that the primary lead 

processor is seeking review and approval of the manual and 

procedures. Owners or operators of existing primary lead 

processors must submit this notification no later than November 

6, 2000. The owner or operator of a primary lead processor that 

commences construction or reconstruction after April 17, 1998, 

must submit this notification no later than 180 days before 

startup of the constructed or reconstructed primary lead 

processor, but no sooner than September 2, 1999.

(c) The owner or operator of a primary lead processor must 

submit the compliance monitoring network plan required under 

§63.1547(k)(2) to the Administrator or delegated authority along 

with a notification that the primary lead processor is seeking 

review and approval of the plan. Owners or operators of existing 
Page 126 of 137

primary lead processors must submit this notification no later 

than 45 days after promulgation of this subpart. The owner or 

operator of a new, reconstructed, or modified primary lead 

processor must submit this notification no later than 180 days 

before startup of the constructed or reconstructed primary lead 

processor.

10. Section 63.1549 is revised to read as follows:

§63.1549 Recordkeeping and reporting requirements.

(a) The owner or operator of a primary lead processor must 

comply with the recordkeeping requirements of §63.10 of subpart 

A, General Provisions as specified in Table 1 of this subpart.

(b) In addition to the general records required by 

paragraph (a) of this section, each owner or operator of a 

primary lead processor must maintain for a period of 5 years, 

records of the information listed in paragraphs (b)(1) through 

(b)(10) of this section.

(1) Production records of the weight and lead content of 

lead products, copper matte, and copper speiss.

(2) Records of the bag leak detection system output.

(3) An identification of the date and time of all bag leak 

detection system alarms, the time that procedures to determine 

the cause of the alarm were initiated, the cause of the alarm, 

an explanation of the actions taken, and the date and time the 

cause of the alarm was corrected.
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(4) Any recordkeeping required as part of the requirements 

described in the compliance monitoring system plan required 

under §63.1547(k)(2).

(5) Any recordkeeping required as part of the practices 

described in the standard operating procedures manual for 

baghouses required under §63.1547(a).

(6) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(1), the records of the daily doorway in-draft 

checks, an identification of the periods when there was not a 

positive in-draft, and an explanation of the corrective actions 

taken.

(7) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(2), the records of the output from the continuous 

volumetric flow monitor(s), an identification of the periods 

when the 15-minute volumetric flow rate dropped below the 

minimum established during the most recent in-draft 

determination, and an explanation of the corrective actions 

taken.

(8) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 
Page 128 of 137

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(2), and volumetric flow rate is monitored at the 

baghouse inlet, records of the daily checks of damper positions, 

an identification of the days that the damper positions were not 

in the positions established during the most recent in-draft 

determination, and an explanation of the corrective actions 

taken.

(9) Records of the occurrence and duration of each 

malfunction of operation (i.e., process equipment) or the air 

pollution control equipment and monitoring equipment. 

(10) Records of actions taken during periods of malfunction 

to minimize emissions in accordance with §§63.1543(i) and 

63.1544(e), including corrective actions to restore 

malfunctioning process and air pollution control and monitoring 

equipment to its normal or usual manner of operation. 

(c) Records for the most recent 2 years of operation must 

be maintained on site. Records for the previous 3 years may be 

maintained off site.

(d) The owner or operator of a primary lead processor must 

comply with the reporting requirements of §63.10 of subpart A, 

General Provisions as specified in Table 1 of this subpart.

(e) In addition to the information required under §63.10 of 

the General Provisions, the owner or operator must provide semi-
Page 129 of 137

annual reports containing the information specified in 

paragraphs (e)(1) through (e)(9) of this section to the 

Administrator or designated authority.

(1) The reports must include records of all alarms from the 

bag leak detection system specified in §63.1547(e).

(2) The reports must include a description of the actions 

taken following each bag leak detection system alarm pursuant to 

§63.1547(f).

(3) The reports must include a calculation of the 

percentage of time the alarm on the bag leak detection system 

sounded during the reporting period pursuant to §63.1547(g).

(4) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(1), the reports must contain an identification of 

the periods when there was not a positive in-draft, and an 

explanation of the corrective actions taken.

(5) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(2), the reports must contain an identification of 

the periods when the 15-minute volumetric flow rate(s) dropped 

below the minimum established during the most recent in-draft 
Page 130 of 137

determination, and an explanation of the corrective actions 

taken.

(6) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(2), and volumetric flow rate is monitored at the 

baghouse inlet, the reports must contain an identification of 

the days that the damper positions were not in the positions 

established during the most recent in-draft determination, and 

an explanation of the corrective actions taken. 

(7) The reports must contain a summary of the records 

maintained as part of the practices described in the standard 

operating procedures manual for baghouses required under 

§63.1547(a), including an explanation of the periods when the 

procedures were not followed and the corrective actions taken.

(8) The reports must contain a summary of the compliance 

monitoring results for the required reporting period, including 

an explanation of any periods when the procedures outlined in 

the compliance monitoring system plan required by §63.1547(k)(2) 

were not followed and the corrective actions taken.

(9) If there was a malfunction during the reporting period, 

the report shall also include the number, duration, and a brief 

description for each type of malfunction which occurred during 

the reporting period and which caused or may have caused any 
Page 131 of 137

applicable emission limitation to be exceeded. The report must 

also include a description of actions taken by an owner or 

operator during a malfunction of an affected source to minimize 

emissions in accordance with §§63.1543(i) and 63.1544(b), 

including actions taken to correct a malfunction.

11. Section 63.1550 is revised to read as follows:

§63.1550 Delegation of authority.

(a) In delegating implementation and enforcement authority 

to a State under section 112(l) of the act, the authorities 

contained in paragraph (b) of this section must be retained by 

the Administrator and not transferred to a State.

(b) Authorities which will not be delegated to States: no

restrictions.

12. Section 63.1551 is added to read as follows:

§63.1551 Affirmative defense for exceedance of emission limit 

during malfunction.

In response to an action to enforce the standards set forth 

in this subpart you may assert an affirmative defense to a claim 

for civil penalties for exceedances of such standards that are 

caused by malfunction, as defined at 40 CFR 63.2. Appropriate 

penalties may be assessed, however, if you fail to meet your 

burden of proving all of the requirements in the affirmative 

defense. The affirmative defense shall not be available for 

claims for injunctive relief.
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(a) To establish the affirmative defense in any action to 

enforce such a limit, you must timely meet the notification 

requirements in paragraph (b) of this section, and must prove by 

a preponderance of evidence that:

(1) The excess emissions: 

(i) Were caused by a sudden, infrequent, and unavoidable 

failure of air pollution control and monitoring equipment, 

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

manner, and 

(ii) Could not have been prevented through careful 

planning, proper design or better operation and maintenance 

practices; and

 (iii) Did not stem from any activity or event that could 

have been foreseen and avoided, or planned for; and

(iv) Were not part of a recurring pattern indicative of 

inadequate design, operation, or maintenance; and

(2) Repairs were made as expeditiously as possible when 

the applicable emission limitations were being exceeded. Offshift and overtime labor were used, to the extent practicable to 

make these repairs; and

 (3) The frequency, amount and duration of the excess 

emissions (including any bypass) were minimized to the maximum 
Page 133 of 137

extent practicable during periods of such emissions; and

 (4) If the excess emissions resulted from a bypass of 

control equipment or a process, then the bypass was unavoidable 

to prevent loss of life, personal injury, or severe property 

damage; and

 (5) All possible steps were taken to minimize the impact of 

the excess emissions on ambient air quality, the environment and 

human health; and

 (6) All emissions monitoring and control systems were kept 

in operation if at all possible, consistent with safety and good 

air pollution control practices; and

 (7) All of the actions in response to the excess emissions 

were documented by properly signed, contemporaneous operating 

logs; and

(8) At all times, the facility was operated in a manner 

consistent with good practices for minimizing emissions; and

(9) A written root cause analysis has been prepared, the 

purpose of which is to determine, correct, and eliminate the 

primary causes of the malfunction and the excess emissions 

resulting from the malfunction event at issue. The analysis 

shall also specify, using best monitoring methods and 

engineering judgment, the amount of excess emissions that were 

the result of the malfunction. 
Page 134 of 137

(b) Notification. The owner or operator of the facility 

experiencing an exceedance of its emission limit(s) during a 

malfunction shall notify the Administrator by telephone or 

facsimile (FAX) transmission as soon as possible, but no later 

than two business days after the initial occurrence of the 

malfunction, if it wishes to avail itself of an affirmative 

defense to civil penalties for that malfunction. The owner or 

operator seeking to assert an affirmative defense shall also 

submit a written report to the Administrator within 45 days of 

the initial occurrence of the exceedance of the standards in 

this subpart to demonstrate, with all necessary supporting 

documentation, that it has met the requirements set forth in 

paragraph (a) of this section. The owner or operator may seek 

an extension of this deadline for up to 30 additional days by 

submitting a written request to the Administrator before the 

expiration of the 45 day period. Until a request for an 

extension has been approved by the Administrator, the owner or 

operator is subject to the requirement to submit such report 

within 45 days of the initial occurrence of the exceedance. 

12. Table 1 to Subpart TTT of Part 63 is revised to read as 

follows:

Table 1 of Subpart TTT – General Provisions Applicability to 

Subpart TTT
Page 135 of 137

Reference

Applies 

to 

subpart 

TTT Comment

* * * * * * *

63.6(a), (b), (c) Yes

63.6 (d) No Section reserved.

63.6(e)(1)(i) No See 63.1543(i) 

and 63.1544(b) 

for general duty 

requirement. 

63.6(e)(1)(ii) No

63.6(e)(1)(iii) Yes

63.6(e)(2) No Section reserved.

63.6(e)(3) No

63.6(f)(1) No

63.6(g) Yes

63.6(h) No No opacity limits 

in rule.

63.6(i) Yes

63.6(j) Yes

§63.7(a)-(d) Yes
Page 136 of 137

§63.7(e)(1) No See 63.1546(c). 

§63.7(e)(2)-(e)(4) Yes

63.7(f), (g), (h) Yes

63.8(a)-(b) Yes

63.8(c)(1)(i) No

63.8(c)(1)(ii) Yes

63.8(c)(1)(iii) No

63.8(c)(2)-(d)(2) Yes

63.8(d)(3) Yes, 

except 

for last 

sentence

63.8(e)-(g) Yes

63.9(a),(b),(c),(e),(g),(h)(1)through 

(3), (h)(5) and (6), (i) and (j)

Yes

63.9(f) No

63.9(h)(4) No Reserved

63.10(b)(2)(i) No

63.10(b)(2)(ii) No See 63.1549(b)(9) 

and (10) for 

recordkeeping of 

occurrence and 
Page 137 of 137

duration of 

malfunctions and 

recordkeeping of 

actions taken 

during 

malfunction. 

63.10(b)(2)(iii) Yes

63.10(b)(2)(iv)-(b)(2)(v) No

63.10(b)(2)(vi)-(b)(2)(xiv) Yes

63.(10)(b)(3) Yes

63.10(c)(1)-(9) Yes

63.10(c)(10)-(11) No See 63.1549(b)(9) 

and (10) for 

recordkeeping of 

malfunctions. 

63.10(c)(12)-(c)(14) Yes

63.10(c)(15) No

63.10(d)(1)-(4) Yes

63.10(d)(5) No See 63.1549(e)(9) 

for reporting of 

malfunctions.

63.10(e)-((f) Yes

* * * * * * *
Summary of Interagency Working Comments on Draft Language under 

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EO12866 NESHAP_Primary Lead Processing Final 2060AQ43_20111005.doc

6560-50-P

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA–HQ–OAR–2004–0305; FRL-XXXX-X]

RIN 2060–AQ43

National Emission Standards for Hazardous Air Pollutant Emissions for 

Primary Lead Processing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This action finalizes the residual risk and technology 

review conducted for the Primary Lead Processing source category

regulated under national emission standards for hazardous air 

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

that include revision of the rule’s title and applicability 

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

modification and addition of testing and monitoring and related 

notification, recordkeeping, and reporting requirements, including 

the addition of a requirement to monitor the lead concentration in 

the air. It also finalizes revisions to the regulatory provisions 

related to emissions during periods of startup, shutdown, and 

malfunction and makes minor non-substantive changes to the rule.

DATES: This final action is effective on [INSERT DATE OF 

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

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

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

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

business information (CBI) or other information whose disclosure is 

restricted by statute. Certain other material, such as copyrighted 

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

available only in hard copy form. Publicly available docket materials 

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

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

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

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

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

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

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

1742.

FOR FURTHER INFORMATION CONTACT: For questions about this final 

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

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

Protection Agency, Research Triangle Park, NC 27711; telephone 

number: (919) 541–0483; fax number: (919) 541-3207; and email 

address: topham.nathan@epa.gov. For additional contact information, 

see the following SUPPLEMENTARY INFORMATION section.
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SUPPLEMENTARY INFORMATION:

For specific information regarding the modeling methodology, 

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

Standards, Health and Environmental Impacts Division, Air Toxics 

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

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

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

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

this NESHAP to a particular entity, contact the appropriate person 

listed in Table 1 to this preamble.

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

Action

NESHAP for: OECA Contact1 OAQPS Contact2

Primary Lead 

Processing 

Maria Malave, (202) 

564-7027, 

malave.maria@epa.gov

Nathan Topham

(919) 541-0483

topham.nathan@epa.gov

1 EPA’s Office of Enforcement and Compliance Assurance. 

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

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

the EPA proposed revisions to the Primary Lead Smelting NESHAP based 

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

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

revisions for the rule. Some of the significant comments and our 

responses are summarized in this preamble; a summary of the other 

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

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

in this action is available in the docket.

Organization of This Document. The following outline is provided to 

aid in locating information in the preamble.

I. General Information

A. Does this action apply to me?

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

C. Judicial Review

II. Background 

III. Summary of the Final Rule

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

Processing source category?

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

and malfunction?

 C. What are the effective and compliance dates of the 

standards?

IV. Summary of Significant Changes Since Proposal

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

of the Clean Air Act

 B. Changes to the Technology Review Performed Under Section 

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

 C. Other Changes Since Proposal

V. Summary of Significant Comments and Responses

A. Timeline for Compliance

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

C. Primary Lead Processing Risk Assessment

VI. Impacts of the Final Rule

VII.Statutory and Executive Order Reviews

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

Executive Order 13563: Improving Regulation and Regulatory 

Review

B. Paperwork Reduction Act 

C. Regulatory Flexibility Act 

D. Unfunded Mandates Reform Act 

E. Executive Order 13132: Federalism 

F. Executive Order 13175: Consultation and Coordination With

Indian Tribal Governments 

G. Executive Order 13045: Protection of Children From

Environmental Health Risks and Safety Risks

H. Executive Order 13211: Actions Concerning Regulations That 

Significantly Affect Energy Supply, Distribution, or Use
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I. National Technology Transfer and Advancement Act 

J. Executive Order 12898: Federal Actions to Address 

Environmental Justice in Minority Populations and Low-Income

Populations

K. Congressional Review Act

I. General Information

A. Does this action apply to me?

Regulated Entities. Categories and entities potentially regulated by 

this action include: 

Table 2 – NESHAP and Industrial Source Categories Affected By 

This Final Action

NESHAP and Source Category NAICS1 Code MACT2

Code

Primary Lead Processing 331419 0204

1 North American Industry Classification System

2 Maximum Achievable Control Technology

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

guide for readers regarding entities likely to be affected by the 

final action for the source category listed. To determine whether 

your facility would be affected, you should examine the applicability 

criteria in the appropriate national emission standards for hazardous 

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

report published by the EPA in 1992, the Primary Lead Smelting source 

category is defined as any facility engaged in producing lead metal 

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

smelting processes: sintering, reduction, preliminary treatment, and 
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refining operations.1 To be consistent with the 1992 listing, the EPA

is revising the applicability of the Primary Lead Smelting NESHAP to 

apply to any facility that produces lead metal from lead ore 

concentrates and is changing the title of the rule to reference 

Primary Lead Processing. For clarification purposes, all reference to 

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

hazardous air pollutant) and all reference to lead production means 

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

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

If you have any questions regarding the applicability of any 

aspect of the Primary Lead Processing NESHAP, please contact the 

appropriate person listed in Table 1 of this preamble in the 

preceding FOR FURTHER INFORMATION CONTACT section.

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

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

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

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

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

policy and guidance page for newly proposed and promulgated rules at 

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

provides information and technology exchange in various areas of air 

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

July, 1992.
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pollution control.

Additional information is available on the residual risk and 

technology review (RTR) web page at 

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

includes source category descriptions and detailed emissions and 

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

C. Judicial Review. 

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

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

the United States Court of Appeals for the District of Columbia 

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

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

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

proceedings brought by the EPA to enforce the requirements.

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

objection to a rule or procedure which was raised with reasonable 

specificity during the period for public comment (including any 

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

also provides a mechanism for us to convene a proceeding for 

reconsideration, “[i]f the person raising an objection can 

demonstrate to the EPA that it was impracticable to raise such 

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

for such objection arose after the period for public comment (but 
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within the time specified for judicial review) and if such objection 

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

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

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

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

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

preceding FOR FURTHER INFORMATION CONTACT section, and the Associate 

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

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

NW, Washington, DC 20460.

II. Background 

Section 112 of the CAA establishes a two-stage regulatory 

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

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

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

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

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

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

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

major sources, these technology-based standards must reflect the 

maximum degree of emission reductions of HAP achievable (after

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

environmental impacts) and are commonly referred to as maximum 
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achievable control technology (MACT) standards.

For MACT standards, the statute specifies certain minimum 

stringency requirements, which are referred to as floor requirements

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

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

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

controlled similar source. The MACT standards for existing sources 

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

less stringent than the average emission limitation achieved by the 

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

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

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

must also consider control options that are more stringent than the 

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

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

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

environmental impacts, and energy requirements. In promulgating MACT 

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

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

that reduce the volume of or eliminate HAP emissions through process 

changes, substitution of materials, or other modifications; enclose 

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

treat HAP when released from a process, stack, storage, or fugitive 
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emissions point; and/or are design, equipment, work practice, or 

operational standards.

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

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

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

revise them “as necessary (taking into account developments in 

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

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

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

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

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

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

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

adopt standards equal to existing MACT standards if the EPA

determines that the existing standards are sufficiently protective.

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

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

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

Subpart TTT, that took into consideration the residual risk and 

technology review (RTR) analyses for that source category. This 

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

provisions of CAA section 112 for the Primary Lead Processing source 
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category. Specifically, as a result of our analyses, we are revising 

the requirements of the NESHAP to ensure public health and the 

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

emission reductions are consistent with what is economically and 

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

taking the following actions:

• Revising the requirements in the NESHAP related to emissions 

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

• Revising the title of the rule and amending the applicability 

section consistent with the definition of the source category 

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

facility processing lead ore concentrate to produce lead metal.

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

definition of “primary lead processor” and adding definitions of 

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

remelters.”

• Incorporating the use of plain language into the rule.

• Addressing technical and editorial corrections in the rule.

• Responding to the January 2009 petition for rulemaking from the 

Natural Resources Defense Council (NRDC) that the original 

primary lead NESHAP should have included an emission standard 

for organic HAP and announcing our intention to collect 

additional data needed to develop a standard for organic HAP.
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We note that the Doe Run Herculaneum Smelter, the only facility 

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

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

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

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

will achieve drastic reductions in lead emissions and will provide 

substantial environmental and public health benefits. The Herculaneum 

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

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

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

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

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

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

III. Summary of the Final Rule

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

source category?

The National Emission Standards for Hazardous Air Pollutant 

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

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

lead processing industry consists of facilities that produce lead 

metal from ore concentrates. The source category covered by this MACT 

standard currently includes only one operating facility, The Doe Run 

Company in Herculaneum, Missouri.
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For the reasons provided in the proposed rule and in the support 

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

with this source category are unacceptable and are therefore 

promulgating requirements to reduce the risk to an acceptable level. 

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

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

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

concluded that there are no additional cost-effective controls 

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

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

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

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

existing MACT standard to include: 

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

refining operation stacks, combined.2

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

address fugitive emissions to ensure emissions do not present an 

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

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

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

that such fugitive emissions are adequately addressed.

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

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

of maximum lead impact.
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To satisfy section 112(d)(6) of the CAA, we are, therefore,

revising the existing MACT standard to include a reduction of the 

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

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

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

developments in practices, processes, or control technologies since 

promulgation of the MACT standards demonstrate that the facility can 

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

section 112(d)(6). 

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

of the CAA, we are promulgating the following:

• The revision of the applicability section of the rule consistent 

with the definition of the source category adopted in 1992, 

subpart TTT which applies to any facility that produces lead metal

from lead concentrate ore. 

• Changes to the Primary Lead Processing MACT standards to eliminate 

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

subpart TTT to indicate that several requirements of the 40 CFR 

part 63 General Provisions related to periods of SSM do not apply.

We are adding provisions to the Primary Lead Processing MACT 

standards requiring sources to operate in a manner that minimizes 

emissions, removing the SSM plan requirement, clarifying the 

required conditions for performance tests, and revising the SSM–
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associated recordkeeping and reporting requirements to require 

reporting and recordkeeping for periods of malfunction. We are 

also adding provisions to provide an affirmative defense against 

civil penalties for exceedances of emission standards caused by 

malfunctions, as well as criteria for establishing the affirmative 

defense.

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

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

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

definition of “primary lead processor” and adding definitions of 

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

These revisions to the Primary Lead Processing MACT standard are 

expected to result in lead emissions reductions and increased 

compliance costs to the industry. No economic impacts on small 

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

have determined that the one facility in this source category can 

meet the applicable emissions standards at all times, including 

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

standards.

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

malfunction?

The United States Court of Appeals for the District of Columbia 

Circuit vacated portions of two provisions in the EPA’s CAA Section 
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112 regulations governing the emissions of HAP during periods of 

startup, shutdown, and malfunction (SSM). Sierra Club v. EPA, 551 

F.3d 1019 (D.C. Cir. 2008), cert. denied, 130 S. Ct. 1735 (U.S. 

2010). Specifically, the Court vacated the SSM exemption contained in 

40 CFR 63.6(f)(1) and 40 CFR 63.6(h)(1), that are part of a 

regulation, commonly referred to as the “General Provisions Rule,” 

that the EPA promulgated under section 112 of the CAA. When 

incorporated into CAA Section 112(d) regulations for specific source 

categories, these two provisions exempt sources from the requirement 

to comply with the otherwise applicable CAA section 112(d) emission 

standard during periods of SSM.

We have eliminated the SSM exemption in this rule. Consistent 

with Sierra Club v. EPA, the EPA has established standards in this 

rule that apply at all times. We have also revised Table 1 (the 

General Provisions table) in several respects. For example, we have 

eliminated that incorporation of the General Provisions’ requirement 

that the source develop an SSM plan. We have also eliminated or 

revised certain recordkeeping and reporting that related to the SSM 

exemption. The EPA has attempted to ensure that we have not included 

in the regulatory language any provisions that are inappropriate, 

unnecessary, or redundant in the absence of the SSM exemption.

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

into account startup and shutdown periods and, for the reasons 
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explained below, has not established different standards for those 

periods. Information on periods of startup and shutdown in the 

industry indicate that emissions during these periods do not 

increase. Furthermore, all processes are controlled by either control 

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

affected by startup or shutdown. Also, compliance with the standards

requires averaging of emissions over three month periods, which 

accounts for the variability of emissions that may result during 

periods of startup and shutdown. Therefore, separate standards for 

periods of startup and shutdown are not being promulgated.

Periods of startup, normal operations, and shutdown are all 

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

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

reasonably preventable failure of air pollution control and 

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

normal or usual manner * * * ’’(40 CFR 63.2). The EPA has determined 

that CAA section 112 does not require that emissions that occur 

during periods of malfunction be factored into development of CAA 

section 112 standards. Under section 112, emission standards for new 

sources must be no less stringent than the level “achieved” by the 

best controlled similar source and for existing sources generally 

must be no less stringent than the average emission limitation 

“achieved” by the best performing 12 percent of sources in the 
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category. There is nothing in section 112 that directs the Agency to 

consider malfunctions in determining the level “achieved” by the best 

performing or best controlled sources when setting emission 

standards. Moreover, while the EPA accounts for variability in 

setting emissions standards consistent with the section 112 caselaw, 

nothing in that caselaw requires the Agency to consider malfunctions 

as part of that analysis. Section 112 uses the concept of “best 

controlled” and “best performing” unit in defining the level of 

stringency that section 112 performance standards must meet. Applying 

the concept of “best controlled” or “best performing” to a unit that 

is malfunctioning presents significant difficulties, as malfunctions 

are sudden and unexpected events.

Further, accounting for malfunctions would be difficult, if not 

impossible, given the myriad 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) (EPA typically has wide latitude in determining the 

extent of data-gathering necessary to solve a problem. We generally 

defer to an agency's decision to proceed on the basis of imperfect 

scientific information, rather than to "invest the resources to 
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conduct the perfect study."). See also, Weyerhaeuser v Costle, 590 

F.2d 1011, 1058 (D.C. Cir. 1978) (“ In the nature of things, no 

general limit, individual permit, or even any upset provision can 

anticipate all upset situations. After a certain point, the 

transgression of regulatory limits caused by ‘uncontrollable acts of 

third parties,’ such as strikes, sabotage, operator intoxication or 

insanity, and a variety of other eventualities, must be a matter for 

the administrative exercise of case-by-case enforcement discretion, 

not for specification in advance by regulation.”). In addition, the 

goal of a best controlled or best performing source is to operate in 

such a way as to avoid malfunctions of the source and accounting for 

malfunctions could lead to standards that are significantly less 

stringent than levels that are achieved by a well-performing nonmalfunctioning source. The EPA’s approach to malfunctions is 

consistent with section 112 and is a reasonable interpretation of the 

statute. 

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

CAA section 112(d) standards as a result of a malfunction event, the

EPA would determine an appropriate response based on, among other 

things, the good faith efforts of the source to minimize emissions 

during malfunction periods, including preventative and corrective 

actions, as well as root cause analyses to ascertain and rectify 

excess emissions. The EPA would also consider whether the source's 
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failure to comply with the CAA section 112(d) standard was, in fact, 

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

“caused in part by poor maintenance or careless operation.” 40 C.F.R. 

63.2 (definition of malfunction).

Finally, the EPA recognizes that even equipment that is properly 

designed and maintained can sometimes fail and that such failure can 

sometimes cause an exceedance of the relevant emission standard. 

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

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

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

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

adding to the final rule an affirmative defense to civil penalties 

for exceedances of emission limits that are caused by malfunctions. 

See 40 CFR 63.1542 Primary Lead Processing (defining “affirmative 

defense” to mean, in the context of an enforcement proceeding, a 

response or defense put forward by a defendant, regarding which the 

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

independently and objectively evaluated in a judicial or 

administrative proceeding.). We also have added other regulatory 

provisions to specify the elements that are necessary to establish 

this affirmative defense; the source must prove by a preponderance of 

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

Primary Lead Processing. (See 40 C.F.R. 22.24). The criteria ensure 
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that the affirmative defense is available only where the event that 

causes an exceedance of the emission limit meets the narrow 

definition of malfunction in 40 C.F.R. 63.2 (sudden, infrequent, not 

reasonable preventable and not caused by poor maintenance and or 

careless operation). For example, to successfully assert the 

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

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

infrequent, and unavoidable failure of air pollution control and 

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

normal or usual manner....” The criteria also are designed to ensure 

that steps are taken to correct the malfunction, to minimize 

emissions in accordance with section 63.1543(i) and 63.1544(e), and 

to prevent future malfunctions. For example, the source must prove by 

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

expeditiously as possible when the applicable emission limitations 

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

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

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

proceeding, the Administrator may challenge the assertion of the 

affirmative defense and, if the respondent has not met its burden of 

proving all of the requirements in the affirmative defense, 

appropriate penalties may be assessed in accordance with Section 113 

of the Clean Air Act (see also 40 C.F.R. Part 22.27). 
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The EPA included an affirmative defense in the final rule in an 

attempt to balance a tension, inherent in many types of air 

regulation, to ensure adequate compliance while simultaneously 

recognizing that despite the most diligent of efforts, emission 

limits may be exceeded under circumstances beyond the control of the 

source. The EPA must establish emission standards that “limit the 

quantity, rate, or concentration of emissions of air pollutants on a 

continuous basis.” 42 U.S.C. section 7602(k)(defining “emission 

limitation and emission standard”). See generally Sierra Club v. EPA, 

551 F.3d 1019, 1021 (D.C. Cir. 2008) Thus, the EPA is required to 

ensure that section 112 emissions limitations are continuous. The 

affirmative defense for malfunction events meets this requirement by 

ensuring that even where there is a malfunction, the emission 

limitation is still enforceable through injunctive relief. While 

“continuous” limitations, on the one hand, are required, there is 

also caselaw indicating that in many situations it is appropriate for 

the EPA to account for the practical realities of technology. For 

example, in Essex Chemical v. Ruckelshaus, 486 F.2d 427, 433 (D.C. 

Cir. 1973), the D.C. Circuit acknowledged that in setting standards 

under CAA section 111 “variant provisions” such as provisions 

allowing for upsets during startup, shutdown and equipment 

malfunction “appear necessary to preserve the reasonableness of the 

standards as a whole and that the record does not support the ‘never 
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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 EPA’s view that a system that incorporates some level of 

flexibility is reasonable. The affirmative defense simply provides 

for a defense to civil penalties for excess emissions that are proven 

to be beyond the control of the source. By incorporating an 

affirmative defense, the EPA has formalized its approach to upset 

events. In a Clean Water Act setting, the Ninth Circuit required this 

type of formalized approach when regulating “upsets beyond the 

control of the permit holder.” Marathon Oil Co. v. EPA, 564 F.2d 

1253, 1272-73 (9th Cir. 1977). But see, Weyerhaeuser Co. v. Costle, 

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

approach is adequate). The affirmative defense provisions give the 

EPA the flexibility to both ensure that its emission limitations are 

“continuous” as required by 42 U.S.C. section 7602(k), and account 

for unplanned upsets and thus support the reasonableness of the 

standard as a whole.

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

The revisions to the MACT standards being promulgated in this action 

are effective on [INSERT DATE OF PUBLICATION]. For the MACT 

standards being addressed in this action, the compliance date for 
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the revised SSM requirements is the effective date of the standards, 

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

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

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

furnace area stack emission limits and the requirement to adopt work 

practice standards to address fugitive emissions and to ensure 

compliance using monitoring of the lead concentration in air limit 

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

YEARS FROM DATE OF PUBLICATION].

IV. Summary of Significant Changes Since Proposal

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

the Clean Air Act

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

proposed rulemaking: National Emission Standards for Hazardous Air 

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

presented a number of options for additional controls on the primary 

lead smelting source category, which currently includes only one

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

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

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

results presented in the draft document: Draft Residual Risk 

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

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

substantially updated emissions, meteorological, facility boundary, 

as well as other relevant information bearing on the risk assessment 

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

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

its analyses to reflect the information received during the public 

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

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

Assessment for the Primary Lead Smelting Source Category” which is 

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

discussion of the updated emissions information used in the final 

risk assessment can be found in the Technical Support Document for 

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

rulemaking.

Table 3 presents the results of the final baseline risk 

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

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

approximately 1,550 people may be exposed to lead concentrations 

above the NAAQS. Results indicate that emissions from the refining 

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

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

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

beyond the fenceline of the facility because emissions are highly 

dispersed due to the height of the main stack. 

Table 3 - Summary of Lead Concentrations Relative to the NAAQS Based 

on Estimated Actual 2009 Emissions

Emission Point

2009 

Emissions 

(tpy)

Maximum Modeled 3-

Month Average Lead 

Concentration

(μg/m3)

Offsite Impact3

Main stack1 68.3 0.13 0.85 times the NAAQS

Refining stacks2 9.1 1.16 7.7 times the NAAQS

Furnace area stack:

(controlled blast and 

drossing fugitives)

2.5 0.31 2 times the NAAQS

Fugitive dust 1.0 0.17 1.1 times the NAAQS

1

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

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

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

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

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

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

3 For a given emission point, the model receptor location with the highest modeled 

3-month ambient lead concentration was determined. This highest 3-month ambient 

lead concentration was then divided by the NAAQS (0.15 μg/m3

) for lead to determine 

the maximum offsite impact for a given emission point.

Consistent with the risk assessment to support the proposed 

rulemaking, the risk assessment to support the final rulemaking also 

indicates that risks are unacceptable. This decision considers all 

the risk estimates presented in the risk assessment document, but is

primarily based on lead emissions from the furnace area stack and the 

refining operations stacks. We note that while the risk assessment

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

which we think an unacceptable risk is presented to the public.
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supporting the proposed rulemaking estimated that a combined emission 

limit for the furnace area and refining operations should be set at 

0.91 tons of lead per year to ensure that risks are acceptable, the 

updated risk assessment estimates that a combined emission limit of 

1.2 tons of lead per year will ensure that ambient lead 

concentrations from those emission points do not result in lead 

levels in the ambient air above the level of the NAAQS for lead, 

thereby resulting in acceptable lead risk. In our ample margin of 

safety analysis, we identified no cost-effective controls that are 

capable of achieving emission levels below 1.2 tons per year, as 

described in the technical support document. Thus, EPA is 

promulgating a combined lead emission limit for the furnace area and 

refining operations stacks at 1.2 tons per year.4 The risk assessment 

also identified potential ambient air concentrations above the level 

of the NAAQS resulting from fugitive emissions. Therefore, we are 

finalizing the requirement for work practice standards and monitoring 

of lead in ambient air to demonstrate that the work practices yield 

fenceline concentrations below 0.15 μg/m3

.

In addition to the updated lead risk assessment results 

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

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

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

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

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

respect to our updated cancer risk assessment, we estimate that the 

maximum individual risk (MIR) of cancer is 20 in a million (as 

compared to 30 in a million based on the risk assessment to support 

the proposed rule), and that the cancer incidence is 0.008, or 1 

excess cancer case every 125 years (as compared to 0.0008 based on 

the risk assessment to support the proposed rule). In addition, the 

refined worst-case acute hazard quotient (HQ) value is 2.0 (based on 

the REL for arsenic), driven by arsenic emissions from the main stack

(as compared to 0.6 based on the REL for arsenic and driven by 

arsenic fugitive dust emissions as indicated by the risk assessment 

to support the proposed rule). Finally, while the worst-case 

multipathway screen to support the proposed rule indicated that no 

non-lead PB-HAP exceeded screening levels for potential multipathway 

effects, in the risk assessment to support the final rulemaking, the 

worst-case multipathway screening level was exceeded with respect to 

cadmium emissions. This is the result of the revised emissions 

information provided by the company during the comment period, which 

indicated higher cadmium emissions from the main stack than were 

assumed for purposes of the risk assessment performed for the 

proposed rule.

In considering the updated non-lead risk results presented 

above, we note that while cancer incidence increased in our updated 
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risk assessment, cancer incidence remains very low with 1 excess 

cancer case being estimated every 125 years. 

With respect to the worst-case acute HQ value of 2 based on the 

REL for arsenic due to emissions from the main stack, we note that 

this is a conservative, worst-case analysis of the potential for

acute health effects. We also note that in contrast to the risk 

analysis to support the proposed rulemaking, the final risk analysis 

modeled the main stack at the good engineering practice (GEP) stack 

height of 330 feet rather than the actual stack height of 550 feet.

Thus it is very likely that the maximum potential worst-case HQ value 

is significantly lower than 2.

Finally, with respect to the exceedence of the worst-case 

multipathway screening level for cadmium, we note that this only 

indicates the potential for cadmium exposures above the chronic 

noncancer reference dose (RfD) for cadmium. That is, while in 

general, emission rates below the worst-case multipathway screening 

level indicate no significant potential for multipathway related 

health effects, emission levels above this worst-case screening level 

only indicate the potential for multipathway-related health risks of 

concern based on a worst-case scenario. We were not able to refine 

our multi-pathway analysis beyond the worst-case screening 

assessment. As a result, based on worst case screening, we cannot

state whether or not there are going to be multipathway risks at true 
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exposure levels, we can only say that there are risks using worst 

case modeling. However, due to the highly conservative nature of this 

screening assessment and the uncertainties related to the results, we 

have concluded that, after implementation of the controls needed to 

reduce lead levels to the NAAQS, risks will be acceptable, 

considering the combination of potential multipathway risks, cancer 

risks, chronic non-cancer risks, and acute non-cancer risks. We also 

reviewed whether there were cost-effective controls that could 

further reduce risks as part of our ample margin of safety analysis. 

The controls we are requiring to address lead emissions also reduce 

emissions of non-lead HAP. We were unable to identify any technically 

feasible cost effective additional controls that would further reduce 

emissions of lead and non-lead HAP. We are therefore determining that 

the standard we are promulgating today provides an ample margin of 

safety to protect public health.

In summary, the final rule includes an emission standard of 1.2 

tons per year of lead emissions from refining and furnace area 

stacks, combined. The standard also includes a requirement for the 

facility to employ work practice standards to minimize fugitive 

emissions with ambient monitoring to ensure those work practices are 

effective. These standards will ensure risks are acceptable and 

public health is protected with an ample margin of safety and that 
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there is not an adverse environmental effect from HAP emissions from 

the one lead processing facility in this source category.

B. Changes to the Technology Review Performed Under Section 112(d)(6)

of the Clean Air Act

In the proposed rule, the main stack was subject to an emission 

limit of 0.22 pounds of lead per ton of lead produced based on our 

section 112(d)(6) technology review. That proposed limit was based on 

information that in practice the source had significantly lower 

emissions than the emission limit of 1 pound of lead per ton of lead 

produced required in the 1999 MACT standard. In comments on the 

proposed rule, The Doe Run Company indicated that the proposed 

emission limit under Section 112(d)(6) could not be met and that the 

data on which that emission limit was based were not accurate. The 

facility provided a 2009 stack test for the main stack that indicated 

that emissions at the facility are significantly higher than we 

assumed as the basis for the proposed limit. For purposes of our 

analysis for the final rule, the EPA recalculated the emissions 

performance achieved for the main stack as demonstrated by the 2009 

and 2008 stack tests and considered an estimate of emission 

variability in order to determine whether it was appropriate to 

revise the emission limit based on what the source was able to 

achieve in practice. Based on the revised analysis, we are 
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establishing an emission limit for the main stack of 0.97 pounds of 

lead per ton of lead produced. 

We have also changed the compliance date for the main stack to 

reflect compliance “as expeditiously as possible” under section 

112(i)(3) of the CAA. The compliance date for the 0.97 lb/ton limit 

is 60 days from the date of publication of the final rule.

C. Other Changes Since Proposal

The EPA has decided not to include the refining and furnace area 

emissions as part of a facility wide emission limit as was proposed. 

We received comments from Doe Run on the proposed rule that inclusion 

of these sources in the production based emission limit in section 

63.1543(a) was not necessary to achieve acceptable risk and that 

these sources would simultaneously be required to comply with the 

standard for refining and furnace area emissions proposed under 

section 112(f) and the production based limit proposed under section 

112(d)(6). We agree with the commenters and we are establishing a 

separate emission limit of 1.2 tons per year of lead emissions that 

applies to the combined emissions of the refining and furnace area 

stacks. The emission standard limits the combined emissions from 

these two stacks because the revised risk assessment indicated that 

the location of maximum impact for these two stacks overlapped at the 

same receptor. A production based emission limit will continue to 

apply to sources in section 63.1543(a)(1)-(9).
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In recent rules promulgated under section 112 and 129, the EPA 

has revised certain terms and conditions of the affirmative defense 

in response to concerns raised by various commenters. The EPA is 

adopting those same revisions in this rule. Specifically, the EPA is

revising the affirmative defense language to delete “short” from

63.1551(a)(1)(i), because other criteria in the affirmative defense 

require that the source assure that the duration of the excess 

emissions “were minimized to the maximum extent practicable.” EPA is 

also deleting the term “severe” in the phrase “severe personal 

injury” in 63.1551(a)(4) because we do not think it is appropriate to 

make the affirmative defense available only when bypass was 

unavoidable to prevent severe personal injury. In addition, the EPA 

is revising 63.1551(a)(6) to add “consistent with good air pollution 

control practice for minimizing emissions.” EPA is also revising the 

language of 63.1551(a)(9) to clarify that the purpose of the root 

cause analysis is to determine, correct, and eliminate the primary 

cause of the malfunction. The root cause analysis itself does not 

necessarily require that the cause be determined, corrected or 

eliminated. However, in most cases, the EPA believes that a properly 

conducted root cause analysis will have such results. In addition,

the EPA is revising 63.1551(b) to state that a written report must be 

submitted within 45 days of the initial occurrence of the malfunction 
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and that the source may seek an extension of up to an additional 30 

days. 

V. Summary of Significant Comments and Responses

In the proposed action, we requested public comments on all 

aspects of the proposal, including our residual risk reviews and 

resulting proposed standards, our technology reviews and resulting 

proposed standard, and our proposed amendments to delete the startup 

and shutdown exemptions and the malfunction exemption and to 

establish an affirmative defense for malfunctions. 

We received written comments from 16 commenters. Our responses 

to some of the significant public comments are provided below. A 

response to the comments that are not in the preamble has been placed 

in the docket. See Summary of Public Comments and Responses for 

Primary Lead Processing NESHAP (October 2011), for summaries of other 

comments and our responses to them.

A. Timeline for Compliance

Comment: Two commenters opposed the compliance timing and supported 

extending the compliance date beyond two years for several reasons. 

One commenter stated that according to the time line in the proposed 

rule, the facility will operate in its current form for only a few 

months after the compliance date of the rule. This creates a dilemma 

for the State and facility in terms of implementation, planning, 

resources and compliance. The commenter suggested that the 
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implementation and attainment schedules for this MACT rule should

correspond to those of the 2008 NAAQS. 

One commenter identified three provisions they suggest could be 

used to allow more than 2 years for compliance: (1) 112(i)(3)(A) 

establishes 3 years for compliance for section 112 standards, (2) 

112(i)(5) allows exemption for up to 6 years for facilities 

demonstrating 90 percent reduction in HAP prior to first proposal of 

a section 112(d) standard, and (3) 112(h)(3) allows an alternative 

means of compliance in some circumstances. The commenter stated that 

the import of the underlying statutory authority relates to the 

compliance period for existing sources. Under the EPA practice, a 

three-year compliance period applies to section 112(d) MACT 

standards, while a two-year period applies to section 112(f) 

standards. Although the EPA seems to have reflexively applied the 

section 112(f) period, this approach is not foreordained in the 

present circumstances. Specifically, section 112(i)(3)(A), which 

allows a three-year compliance period for any section 112 standard, 

merits consideration in light of the various proposed MACT 

standards, including a plant-wide section 112(d)(6) standard. With 

regard to the authority under section 112(i)(5), the commenter 

states that emissions have been reduced from 140 tons in the year 

2000 to less than 14 tons in 2009, representing a decrease of over 

90%. With regard to section 112(h)(3), the commenter believes that
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the two year compliance period has serious adverse economic effects 

on the company and the new hydrometallurgical process can be 

considered an alternative means of emission limitation. 

The commenter also stated that the circumstances of this case 

present a unique challenge in determining an appropriate compliance 

deadline for a new primary lead smelting MACT standard. The 

commenter stated that there were several differences from the 

typical MACT rulemaking: instead of multiple sources within a 

category, there is only one facility in the category; by virtue of a 

federally enforceable consent decree, the facility must terminate 

its present operations by April 30, 2014; and assuming a final rule 

issues on October 31, 2011, and a two-year compliance deadline, the 

compliance period would be at most six months prior to stoppage of 

many of the current operations. If forced to achieve compliance that 

would last only for such a short period, the facility would face 

severe economic hardship that could jeopardize its ability to 

finance and to build a new hydrometallurgical lead production 

process that would largely eliminate lead emissions. These 

circumstances raise questions as to the legal necessity as well as 

the feasibility and practicality of implementing a two-year 

compliance deadline.

Further, it was incorrectly assumed that a two-year compliance 

period is consistent with the schedule of required actions contained 
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in the Consent Decree, when the opposite is true. Requiring MACT 

standard compliance six months before the required termination of 

Doe Run’s existing lead smelting seriously erodes several Consent 

Decree goals: introducing a new hydrometallurgical lead production 

process that minimizes lead emissions, assuring continued primary 

lead production in the United States, and promoting the development 

of the most technologically advanced lead production process in the 

world. 

Finally, the commenter stated that the primary lead RTR 

proposal effectively accelerates the compliance date for the lead 

NAAQS for the Doe Run facility. According to the commenter a twoyear compliance timeframe relies, in part, on the various steps that 

must be undertaken to implement a plan to monitor lead concentration 

in air. But this reliance is also misplaced because it requires Doe 

Run to comply with the new Lead NAAQS in 2013, or more than two 

years before the Lead NAAQS itself requires compliance. No statutory 

authority supports such accelerated compliance for the lead NAAQS or 

preemption of the SIP process. In short, the two-year timeframe 

rests on faulty grounds: factually, it is inconsistent with the 

Consent Decree requirements, and legally, it unlawfully attempts to 

speed up the previously-established compliance timeframe for the 

lead NAAQS.

Response: Section 112(i)(3) establishes the compliance timeframe for 
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any standard issued under section 112 for existing sources and 

provides that the compliance date shall be as expeditiously as 

practicable but no later than 3 years following the effective date 

of the standard. Section 112(f)(4), however, expressly provides 

more specific requirements for standards issued under section 112(f)

and thus for section 112(f) standards those more prescriptive 

requirements govern in place of the compliance requirements in 

section 112(i)(3). Specifically, section 112(f)(4) provides that a 

source cannot emit an air pollutant in violation of a standard 

issued under subsection (f) except that the standard will not apply 

until 90 days after its effective date. It also provides that the 

Administrator may grant a waiver for a period of up to 2 years from 

the effective date if necessary for the installation of controls and 

if measures will be taken in the interim to ensure public health is 

protected from imminent endangerment. Thus, for purposes of 

standards applicable to the furnace and refinery area emissions and 

for fugitive emissions, which were issued under section 112(f), the 

compliance period may not exceed two years from the effective date 

of the standard.

The main stack emission limit, proposed under 112(d)(6), is 

subject to the section 112(i)(3) compliance provisions. We are 

establishing an emission standard of 0.97 lb Pb/ton of lead produced 

that would replace the existing standard of 1 lb Pb/ton of lead 
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produced. This standard is based on the level of emissions that the 

source is already achieving in practice and thus no additional 

controls would be needed to meet that emission limit for the main 

stack. For that reason, we are requiring compliance with the new 

limit for the main stack within 60 days of the effective date of 

this final rule as this timeframe constitutes compliance “as 

expeditiously as practicable.”

Concerning section 112(i)(5), the provision only applies to 

standards promulgated pursuant to section 112(d) (and not 112(f)) 

and also only where a source achieves a 90% reduction (95% in the 

case of HAPs that are particulate matter) prior to the proposal of 

the section 112(d) standard. Thus, this provision does not apply to 

the standards established under 112(f) in this final rule. With 

regard to the emission standard proposed for the main stack, stack 

test data indicate that the main stack emissions are substantially 

higher than the 14 tons per year value cited by the commenter. Based 

on performance test data, the facility has not achieved the 

reductions in emissions required to apply the alternative compliance 

dates in section 112(i)(5).

Section 112(h)(3) allows the Administrator through notice and 

comment rulemaking to accept an alternative means of emission limit 

in place of a work practice standard established under 112(h)(1) if 

the owner or operator of a source establishes that such alternative 
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means will achieve reductions at least equivalent to those that 

would be achieved by the work practice standard. It is unclear 

precisely what the commenter is suggesting with regard to this 

provision. However, it seems they may be suggesting that the new 

hydrometallurgical process that they plan to install after they 

close the pyrometallurgical processes should be considered an 

alternative means of compliance with the work practice standard. It 

is unclear how this process would address the emissions covered by 

the work practice standard requirement we are establishing which is 

intended to address current fugitive emissions from the facility. 

Those emissions are almost exclusively from lead entrenched in open 

areas and the installation of a new process for lead processing 

would not appear to affect those emissions. Moreover, we understand 

that the new hydrometallurgical process won’t be operational until 

sometime after the compliance date for the work practice standards 

we are requiring. Thus, even if that process would address in whole 

or in part the fugitive emissions addressed through the work 

practice standards, it would not be an appropriate substitute in the 

absence of being able to achieve the necessary reductions within the 

compliance period. We note that our determination here does not 

preclude Doe Run from submitting additional information that may 

further support a demonstration under section 112(h)(3) and for 

which we could take further action in a separate rulemaking.
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As to the concerns the commenter raises about this situation 

being unique, we do not disagree. However, the statute is clear 

that the maximum compliance period for standards issued pursuant to 

section 112(f) is two years. The commenter submits no facts or 

information that supports a legal basis for providing a longer 

period for compliance for the refining and furnace area stacks and 

for fugitive emissions.

Finally, we note that the Lead NAAQS does not apply to a 

specific facility but rather is a level that must be met within the 

designated nonattainment area. However, we recognize that Doe Run is 

the only stationary source creating the Jefferson County lead 

nonattainment area and the reductions required under the rule will 

help bring the area into attainment with the lead NAAQS. However, 

this regulation does not preempt the SIP process; the State of 

Missouri is still required to submit a state implementation plan 

demonstrating how the area will attain and maintain the lead NAAQS. 

In doing so, the State may rely on any reductions required under 

this regulation. Finally, we note that this regulation does not 

“speed up” the compliance timeframe for meeting the Lead NAAQS. The 

CAA requires areas to attain the various NAAQS as expeditiously as 

practicable, but no later than specified dates. For the 2008 lead 

NAAQS, areas are required to attain the standard as expeditiously as 

practicable, but no later than December 31, 2015. The Act not only 
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contemplates but requires, if practicable, for areas to attain the 

2008 lead NAAQS earlier than December 31, 2015.

Comment: One commenter stated that the proposed emission standards 

and ambient standard had negative implications for determining

compliance under the proposed two-year compliance period and the 

“plantwide reductions” that are “required under section 112(f)(2).” 

76 FR at 9437/1. According to the commenter, the only plant-wide 

reduction proposed in the rule is the plant wide limit of 0.22 

pounds per ton produced while the other two new numerical standards 

are the 0.91 tpy limit for furnace area and refining and casting 

operations and the 0.15 μg/m3 limit for ambient lead concentrations.

The commenter stated that the three proposed numerical 

standards present a confusing regulatory regime as to which standard 

ultimately controls for determining compliance. If, for example, Doe 

Run achieves an aggregate emission of 0.22 lb/ton on a facility wide 

basis but exceeds 0.91 TPY for its furnace and refining and casting 

operations, would it be in compliance? 

Of the three numerical standards, the commenter stated that 

only the 0.91 tpy limit can arguably be linked to Section 112(f), 

and even that is unclear. The 0.91 tpy standard is derived from the 

Lead NAAQS risk analysis. Despite this starting point, this standard 

is subsumed in the proposed 0.22 lb/ton plant-wide limit which arose 

under the section 112(d)(6) technology review, adjusted for 
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“variability in the operations and emissions.” While an effort is 

made to differentiate the components of the 0.22 lb/ton standard as 

to which portion fits under what statutory authority, this single 

plant-wide emission standard rests on the section 112(d)(6) review. 

Although not explicitly stated, this plant-wide standard offers more 

than an ample margin of safety. 

Response: We have decided not to include a facility-wide limit that 

would include the refining and furnace area stacks as well as to the 

main stack. Instead, the 1.2 tpy emissions standard we are 

promulgating under section 112(f) will apply to combined emissions

from the refining and furnace area stacks. The 0.97 lb/ton emission

standard that we are promulgating pursuant to section 112(d)(6) will 

replace the 1.0 lb/ton limit in the original MACT rule and will 

apply to the same sources subject to the limit in the original MACT 

rule. This change should alleviate the regulatory confusion that 

could arise over the limits in the proposal. Furthermore, we believe 

a plant-wide limit is not necessary to address the residual risk and 

technology review requirements of the Act. As provided in the 

preamble to the proposed and final rules, we evaluated each of the 

emission stacks separately to determine whether additional controls 

are necessary under section 112(f) or 112(d)(6) and a plant-wide 

limit is not needed under either of those statutory requirements. We 

note that the monitoring requirement is primarily for the purpose of 
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ensuring that fugitive emissions are appropriately addressed under 

section 112(f). The fenceline ambient monitoring requirement will 

ensure that fugitive emissions are controlled to an extent that they 

do not present an unacceptable risk and also provide an ample margin 

of safety. 

B. The EPA’s Authority Under Section 112 of the Clean Air Act

Comment: One commenter stated that the modification to the 

applicability provision does not comport with how smelting is 

defined and used and that the source category listing was intended 

to cover smelting only, not other processes. The commenter lists 

several issues supporting this position:

• The opening phrase of the first sentence “The Primary Lead 

Smelting source category,” describes and limits “any facility” to 

mean those involving smelting; and the “includes, but is not limited 

to” language does not apply to any lead producing process, but only 

to “the following smelting processes.” 

• The list of processes identified all involve pyrometallurgical 

activities: sintering process, blast furnace, electric smelting 

furnace, reverberatory furnace, slag fuming furnace, drossing 

kettles, and dross reverberatory furnace.

• The plain meaning of that language evidences intent to cover 

any and all types of pyrometallurgical processes for producing lead

but shows no attempt to encompass other, as yet unknown, lead 
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production processes. 

• Isolating the phrase “including, not limited to” from the 

company it keeps to justify an expansive reading goes well beyond 

the meaning of the listing as a whole and thus cannot stand.

The commenter also stated that the proposed change in 

applicability is inconsistent with the statutory structure for 

formulating source categories: “To the extent practicable, the 

categories and subcategories listed under this subsection shall be 

consistent with the list of source categories established pursuant 

to section 7411 of this title and part C of this subchapter.” The 

commenter cited several instances in the statute where Primary Lead 

Smelting is referred to as a pyrometallurgical process. In 

summation, the commenter states that the statutory directive of CAA 

section 112(c)(1) to assure consistency between a source category 

definition and how the same terms are used in other parts of the Act 

demonstrates that the statutory and regulatory use of “primary lead 

smelting” and “primary lead smelter” was consistently designed to 

cover only pyrometallurgical processes. The EPA’s assertion that the 

originally formulated primary lead smelting source category has a 

“broader definition” is inconsistent with the original source 

category language and the pyro-oriented definitions applied to 

primary lead smelting/smelter found throughout the statute and 

regulations.
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The commenter also stated that the EPA’s effort to recast the 

primary lead smelting category is barred by the failure to show a 

major source would be present. The new hydrometallurgical process 

bears no resemblance to the current pyrometallurgical process, other 

than feedstock and end product. The new process will have 

drastically reduced lead emissions and is presented as a minor 

source in the Doe Run Air Construction Permit Application for the 

New Lead Technology submitted to the Missouri Department of Natural 

Resources. 

Response: Section 112(c)(1) describes the process for creating the 

source category list. To the extent that the commenter is concerned 

that the source category listing for primary lead was not issued 

consistent with the requirements of section 112(c)(1), such claim is 

untimely. We disagree with the commenter that the source category 

description must be read to be limited to pyrometallurgical 

processes. The source category description was intended to include 

all processes used to produce lead metal from ore concentrates, as 

evidenced by the first sentence of the category description. While 

it is true that at the time of the source category listing, the 

hydrometallurgical process described by the commenter did not exist, 

the language left open the possibility that other lead metal 

production processes might be developed in the future and would be 

covered under the source category listing. As noted in the response 
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to comments, if a new process such as the hydrometallurgical process 

is developed, EPA would consider what standard should apply to such 

process. We maintain that primary lead processing facilities using 

such a process should still be subject to the NESHAP. 

Comment: A commenter stated that the proposed rule does not suggest 

that the new lead production processes should be listed as area 

sources. If the EPA could make the necessary "adverse effects 

finding" for including a hydrometallurgical lead production process 

as an area source, a separate NESHAP would be required for a new 

area source. The EPA lacks authority to subsume a new area source 

into the Primary Lead Smelting major source category, as it would 

require in the proposed rule. Therefore, the EPA must show that 

either Doe Run’s new lead production process or the entire Doe Run 

facility after the new process is operational would or could emit 

more than 10 tpy of lead if the facility is to remain a major source 

category and the proposed rule offers no documented evidence that 

Doe Run’s hydrometallurgical lead production process or the 

Herculaneum facility after the new process becomes operational would 

constitute a major source. The commenter contended that neither the 

new process nor the entire Herculaneum facility would be a major 

source. Plant-wide emissions at Doe Run’s facility after the new 

process becomes operational are estimated to approximate 0.65 tpy. 

Absent the presence of a major source at Doe Run’s facility, the new 
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lead production process cannot be treated as a major source 

category.

Response: Based on the revised applicability definition, the Doe Run 

facility remains subject to the Primary Lead Processing NESHAP so 

long as it continues to produce lead metal from ore concentrates. It 

is our position that once a major source is required to install 

controls or take other measures to comply with a MACT standard, it 

should not be able to substitute different controls or measures that 

happen to bring the source below major source levels to avoid 

compliance with a standard after the compliance date. Otherwise, a 

facility could backslide from MACT control levels by escaping 

applicability of the MACT standards and increasing emissions. 

Therefore, the Doe Run Herculaneum facility will continue to be 

treated as a major source of HAP emissions. We note that the 

emission standards and work practice standards promulgated in this 

action apply to the source in its current form as a 

pyrometallurgical processing facility. To the extent any of these 

processes remain in place, such as the refining operation, after 

construction of any new hydrometallurgical process, the emission 

limit applicable to that process would continue to apply. As noted 

elsewhere, a new hydrometallurgical process is not subject to an 

emission limit under the existing MACT standard; we would consider 

an appropriate emission limit for the hydrometallurgical process 
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once that process is a demonstrated technology.

Comment: Another commenter stated that the EPA appropriately 

proposes to update the applicability of the MACT to cover Doe Run’s 

new type of facility.

Response: We agree with this comment.

Comment: Two commenters stated that the EPA cannot use section 

112(f) authority to establish an ambient air standard because this 

type of standard is not an “emission standard.”

The commenters stated that the NAAQS does not fit within the 

meaning of “emission standard” as used in CAA sections 112(d)(6) or 

(f)(2), the EPA’s stated authority for the proposed rule. Section 

112(f)(2) is entitled “Emission standards” and the second sentence, 

where the “ample margin of safety” factor is found, has “emission 

standard” as its subject; these specific references clarify the use 

of “standards” elsewhere in the subsection means “emission 

standard.” Likewise, section 112(d)(6) gives the Administrator 

authority to revise “emission standards.” Both subsections limit the 

EPA’s rule-promulgating authority to setting “emission standards.”

According to commenters, Congress defined “emission standard” 

in CAA section 302(k) to “mean a requirement established by the . . 

. Administrator which limits the quantity, rate or concentration of 

emissions of air pollutants on a continuous basis, including any 

requirement relating to the operation or maintenance of a source . . 
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. and any design, equipment, work practice or operational standard 

promulgated under this chapter.” The language can only be reasonably 

read to allow a standard applicable to emissions from specific 

source(s). The lead (or any other) NAAQS, by definition, is not 

targeted to specific source(s), but applies generally to the 

national ambient air. See, e.g., CAA section 109(a)(1)(A) 

(“regulations prescribing a national primary ambient air quality 

standard . . . for each air pollutant”).

The commenters stated that the contrasting language highlights 

that the lead NAAQS does not qualify as an emission standard within 

the meaning of section 112. The NAAQS addresses ambient air rather 

than emissions from a source, and as a result the NAAQS does not put 

any limits on the quantity, rate, or concentration of emissions from 

a particular source or on its operation, maintenance, design, or 

work practices, all of which are central to the section 112(f)(2) 

mandate or on the practices, processes, and control technologies 

related to sources central to section 112(d)(6). Further, a NAAQS 

limits ambient air lead without regard to source category or types 

of sources, while the MACT standards are particularized to control 

emissions at specific sources. Thus, the primary lead smelting 

emission standards differ from the secondary lead smelting emission 

standards, but the same lead ambient air standards apply throughout 

the country without regard to such distinctions. In short, the lead 
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NAAQS does not fit the meaning of “emission standard” as used in 

section 112 and therefore cannot be properly used as the MACT 

standard here.

One commenter stated further that this error is not cured by 

the wording of proposed section 63.1544(a), which states: “No owner 

. . . shall discharge or cause to be discharged into the atmosphere 

lead compounds that cause the concentration of lead in air to exceed 

0.15 μg/m3 on a 3-month rolling average measured at locations 

approved by the Administrator.” As such, proposed section 63.1544(a) 

measures ambient air levels for compliance (“concentration of lead 

in air . . . at locations”) in what appears to match the source 

monitoring of ambient air required for the Lead NAAQS. See 73 FR at 

67052, section 50.16(a) and at 67059, section 58.10; see also 76 FR 

at 9436/1 (proposing that compliance “be demonstrated using a 

compliance monitoring system”). As such, proposed section 63.1544(a) 

does not limit the quantity, rate, or concentration of emissions 

from a specified source or take into account developments in 

practices, processes, and control technologies. Compare 40 C.F.R. 

section 63.1544(a)(2010) (requiring “manual that describes in detail 

the measures that will be put in place to control fugitive dust 

emissions from the sources”). Measuring ambient air at locations 

presumably near the source does not fall within the standards 

allowed by CAA section 112, and, in any event, is redundant to the 
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same monitoring and limitations already established under the Lead 

NAAQS. Consequently, the proposed rule exceeds the statutory 

authority granted by section 112, and therefore cannot be adopted.

One commenter stated that the proposal requests comments on a 

work practices standard operating procedure (SOP) alternative to 

ambient air monitoring. As opposed to using the Lead NAAQS, which is 

not an emission standard under Section 112, the alternative SOP 

proposal is consistent with the MACT directive that emission 

reductions be tied to specific sources.

One commenter stated that the proposed ambient lead standard is 

procedurally flawed because the EPA fails to explain the legal basis 

for imposing such a standard under section 112(f). The agency’s 

legal authority is of central relevance to this aspect of the 

proposal and the failure to clearly describe the legal basis for the 

standard violates the EPA’s obligation under section 307(d)(3)(C) to 

set forth the “major legal interpretations” that underlie the 

proposal.

Response: The commenters mistake the purpose of the fenceline 

monitoring requirement in the proposed rule. The proposed rule 

established emissions standards from the main, furnace area, and 

refinery operations stacks and further provided that fugitive 

emissions would need to be addressed by work practice standards (as 

is allowed under section 112(h)(1)). Finally, it established a 
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fenceline monitoring requirement to ensure that the work practice 

standards adequately address fugitive emissions consistent with the 

requirements of section 112(f). Thus the fenceline monitoring is not 

an emission standard, but rather a method to ensure compliance with 

the applicable standards for addressing fugitive emissions, similar 

to how a stack test might be used to ensure compliance with emission 

standards applicable to point source emissions. The facility must 

use work practice standards to reduce fugitive emissions to protect 

public health with an ample margin of safety, and to avoid adverse 

environmental effects. The fenceline monitoring requirement is a 

method for ensuring compliance with the work practice standards to 

provide the protection required under CAA section 112(f)(2). 

We understand that the draft regulatory text from the proposed 

rule may have contributed to the commenters’ confusion on this 

issue. We have modified the regulatory text for the final rule to 

make clear that the applicable standard is the requirement to adopt 

work practice standards and that the fenceline monitoring 

requirement is a tool to help ensure compliance. See section 63.1544 

of the regulatory text.

However, even if this were not the case, the EPA could adopt a 

performance standard using the lead NAAQS as the measure of 

performance for a source to achieve. Such a standard would “limi[t] 

the quantity, rate, or concentration of emission of [lead] on a 
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continuous basis” (CAA 302 k) since a source’s lead emissions, 

measured at the fenceline, would be limited to the amount 

established by the NAAQS.

We disagree with the suggestion that we do not provide the 

legal basis for our proposed rule. The preamble clearly explains 

that we are addressing residual risk for this source category under 

section 112(f) and clearly explains the rationale for the proposed 

rule and the basis for the proposed requirements. (See 76 FR 9412-

9414 for a discussion of the statutory authority underlying the 

proposed revisions to the standard.) With regard to fugitive 

emissions, we are establishing a requirement for work practice 

standards consistent with section 112(h)(1) in lieu of an emission 

standard because these fugitive emissions, which are predominantly 

from materials handling and roadways cannot be captured and vented 

to a stack for which we could establish an emission limit.

Comment: One commenter stated that the CAA limits the EPA’s ability 

to regulate pollutants subject to NAAQS (“criteria pollutants”) to 

that regime and does not allow supplemental (or supplanting) 

regulation of them under NESHAP. The commenter cited CAA section

112(b)(2) that states in relevant part: “No air pollutant which is 

listed under section 7408(a) of this title may be added to the list 

under this section” with certain exceptions not relevant here. 

Section 7408(a) provides the statutory authority for setting NAAQS. 
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Also, CAA section 112(b)(7) removes elemental lead from 

consideration as a HAP. According to the commenter, the prohibition 

is not only clear, but also expansive: the statute “unqualifiedly 

prohibits listing a criteria pollutant as a HAP, that is, regardless 

of the reason.” Nat’l Lime Ass’n v. EPA, 233 F.3d 625, 638 (D.C. 

Cir. 2000).

Response: As we recognized in the preamble to the proposed rule, 

under section 112(b)(7) elemental lead may not be listed as a HAP 

under section 112 and the references to “lead” in the proposed rule 

referred to “lead compounds” which are expressly listed as a HAP in 

CAA section 112(b)(1). 76 FR 9412. Because lead compounds are a 

listed HAP, we are required to regulate them under section 112, as 

we did when we established the original MACT standard for primary 

lead in 1999. 64 FR 30194. The lead emitted from primary lead 

processing is lead compounds with elemental lead present only in 

trace amounts.5 The commenter did not provide any data to refute 

this. Thus, we disagree with the commenter that we are attempting to 

 5 Harrison, R.M. and Williams, C.R. (1981). Environmental Science and Technology, Vol. 15:10, p. 1197-1204.; Ohmsen, 

G.S.(2001). Journal of the Air and Waste Management Association, Vol. 51, p. 1443-1451.; Uzu, G., Sobanska, S., Sarret, G., 

Sauvain, J.J., Pradère, P., and Dumat, C. (2011). Journal of Hazardous Materials, Vol. 186, p. 1018-1027.; Spear, T.M., Svee, 

W., Vincent, J.H., and Stanisich, N. (1998). Environmental Health Perspectives, Vol. 106:9, p. 565-571.; Czaplicka, M., and 

Buzek, Ł. (2011). Water, Air, & Soil Pollution, Vol. 218, p. 157-163.; Sobanska, S., Ricq, N., Laboudigue, A., Guillermo, R., 

Brémard, C., Laureyns, J., Merlin, J.C., Wignacourt, J.P. (1999). Environmental Science and Technology, Vol. 33, p. 1334-

1339.; Harrison, R.M. and Williams, C.R. (1983). The Science of the Total Environment, Vol. 31, p. 129-140.; Batonneau, Y., 

Bremard, C., Gengembre, L., Laureyns, J., Maguer, A.L., Maguer, D.L., Perdrix, E., and Sobanska, S. (2004). Environmental 

Science and Technology, Vol. 38, p. 5281-5289.; Foster, R.L. and Lott, P.F. (1980). Environmental Science and Technology, 

Vol. 14:10, p. 1240-1244.
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regulate in contravention of section 112(b)(7) in this action.

The National Lime opinion cited by the commenters addressed a 

different issue than the one being at issue here. In that case, the 

issue was whether EPA could use a NAAQS pollutant (particulate 

matter) as a surrogate for HAP metal emissions. While certain HAP 

listed in 112(b)(1) are considered particulate matter, “particulate 

matter” is not listed on the 112(b)(1) list. In that case, the 

court rejected the argument by the National Lime Association that 

EPA was regulating particulate matter “through the back door.” In 

the present situation, EPA is not regulating lead “through the back 

door” in this rulemaking.

Comment: One commenter stated that the EPA unlawfully refused to set 

a standard for organic HAP. According to the commenter, the EPA 

must set an emission standard for the organic HAP listed on the 

section 112(b)(1) list that this source category emits. 

Specifically, the commenter argues that:

"[w]hen EPA performs a section 112(d)(6) review, 

it must consider the ongoing legality and 

effectiveness of the existing standard. 

Explicitly, in the current rulemaking EPA must 

“review, and revise as necessary” the existing 

MACT standard. 42 U.S.C. section 7412(d)(6). It 

is clearly “necessary” for EPA to close 

inherently unlawful gaps in the original MACT, by 

setting a standard for an uncontrolled HAP. 

Indeed, EPA has recognized the need and done this 

during its section 112(d)(6) review in its recent 

rulemaking for Marine Tank Vessel Loading 

Operations and Group I Polymers and Resins where 

it proposed a standard for previously 
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uncontrolled subcategories of these sources. See 

Proposed Rule, 75 Fed. Reg. 65,068, 65,115, 

65,106 (Oct. 21, 2010). EPA has no legal basis 

for failing to set a MACT standard now for the 

uncontrolled HAPs for the primary lead source 

category."

Response: We disagree with the commenter that section 112(d)(6) 

mandates that EPA must correct any deficiency in an underlying MACT 

standard when it conducts the “technology review” under that 

section. We believe that section 112 does not expressly address this 

issue, and EPA has discretion in determining how to address a 

purported flaw in a promulgated standard. The "as necessary" 

language cited by the commenter must be read in the context of the 

provision, which focuses on the review of developments that have 

occurred since the time of the original promulgation of the MACT 

standard and thus should not be read as a mandate to correct flaws 

that existed at the time of the original promulgation. In several 

recent rulemakings, we have chosen to fix underlying defects in 

existing MACT standards under sections 112(d)(2) and (3), the 

provisions that directly govern the initial promulgation of MACT 

standards (see National Emission Standards for Hazardous Air 

Pollutants From Petroleum Refineries, October 28, 2009, 74 FR 55670; 

and National Emission Standards for Hazardous Air Pollutants: Group 

I Polymers and Resins; Marine Tank Vessel Loading Operations; 

Pharmaceuticals Production; and the Printing and Publishing 

Industry, April 21, 2011, 76 FR 22566). (We note that the commenter 
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incorrectly states that we revised those standards under 112(d)(6)). 

We believe that our approach is reasonable because using those 

provisions ensures that the process and considerations are those 

associated with initially establishing a MACT standard, and it is 

reasonable to make corrections following the process that would have 

been followed if we had not made an error at the time of the 

original promulgation. 

Nevertheless, based on our review of the commenter's 2009 

petition and their additional comments on this proposed rulemaking, 

we agree that the Primary Lead Smelting NESHAP should have included 

an emission standard for organic HAP. We have evaluated available 

data and believe that we need additional data in order to set an 

emission standard for organic HAP that is representative of current 

operations and emissions. We intend to collect the needed data and 

propose a MACT emission standard under section 112(d)(2) & (3) of 

the CAA. Accordingly, we are not taking final action on the 2009 

petition with respect to the issue of setting a standard or 

standards for organic HAP and will address that petition once we 

have gathered the necessary data.

C. Primary Lead Processing Risk Assessment

Comment: One commenter stated that the EPA failed to consider or 

account for cumulative risk and that there is no rational or 

scientific basis to dismiss consideration of the cumulative risk of 
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exposures to HAPs due to uncertainties. The commenter urged that 

these uncertainties require protective action rather than inaction. 

The commenter stated that the EPA’s Science Advisory Board (SAB) in 

May 2010 urged the EPA to use the RTR rulemaking process to do this 

as well as perform a sensitivity analysis to identify the major 

uncertainties in both the human health and ecological risk 

assessments. According to the commenter, the SAB and numerous other 

scientific experts have developed, and are in the process of 

developing, cutting edge methods to perform these assessments and 

that the EPA, as the lead environmental agency of the United States, 

has a responsibility to show leadership in this process. It should 

rely on the significant information already available and also use 

the current and future RTR rulemakings to further advance this

process.

The commenter stated that it could be done on a site-specific 

basis or for the industry as a whole. Uncertainty in estimates of 

HAP in ambient air has been characterized, so the data available 

from the National-Scale Air Toxics Assessments (NATA) would allow a 

defensible estimate of what might be expected from other sources.

Response: We disagree with the commenter that our risk assessments 

do not consider cumulative risk. We note that our assessment of 

cancer risks is, in fact, cumulative, summing the risks associated 

with all carcinogens emitted by the facility. Similarly, the use of 
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the target organ specific hazard index (TOSHI) for chronic noncancer effects evaluates the cumulative effects of HAP on a given 

target organ. Further, our assessment for Primary Lead Processing is 

cumulative in that it considers all emission points within the 

fenceline (since they are all covered by the MACT). Moreover, the 

level of the lead NAAQS, which we used as the metric for defining 

unacceptable risk, was set based on all air-related exposures in its 

derivation and thus is also a cumulative standard. We note that for 

the present rulemaking, our consideration of cumulative risks for 

the Doe Run facility is the same as that for the industry as a whole 

since Doe Run is the only facility within the source category.

We further disagree with the commenter’s assertion that a 

comprehensive quantitative assessment of risks from all sources 

outside the source category is required under the statute. If such 

were in fact the case, the task of completing such a requirement 

would take an interminable length of time. Instead, to provide the 

quantitative risk information necessary to inform RTR regulatory 

decisions, the EPA conducts a comprehensive assessment of the risks 

associated with exposure to the HAPs emitted by the source category 

(i.e., those emissions that can actually be affected by the specific 

rulemaking) and supplements that with additional information about 

other possible concurrent and relevant risks that is readily 

available. In some cases, we have additional information about HAP 
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emissions that are outside the scope of the particular rulemaking 

but within the boundaries of the subject facilities. In other cases, 

we may have ambient HAP monitoring data that can be considered as 

part of the regulatory decision-making. In still other cases, we may 

have very little additional risk information that can be considered. 

In all cases, however, when we consider additional information about 

risks, we also consider its attendant uncertainties, and information 

which carries significant uncertainties generally carries much less 

weight in the overall regulatory decision.

All of the quantitative risk assessment information about HAP 

emissions from the source category under consideration is also 

considered in the manner prescribed by the decision framework set 

forth by the CAA for residual risk decision-making (i.e., the 

Benzene decision framework), and this means that the general 

guidelines of risk acceptability have been developed in a way that 

they already take into account the impossibility of accurately 

quantifying the health risks posed by outside forces on every 

individual in the population. They do this by noting that the 

guidelines apply in “the world in which we live,” a world which is 

acknowledged to be “not risk-free,” but rather a world which is full 

of risks, many of which can simply not be quantified. This 

acknowledgment allows the EPA to make risk-based decisions by 

focusing on the risks associated with the emissions that are 
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themselves the subject of regulation being considered, and not get 

distracted by the daunting task of assessing all the other 

concurrent potential risks that may or may not be relevant and can’t 

be impacted by the regulation in question anyway.

Comment: Two commenters took issue with the modeling methodology 

used for the RTR proposal and disagreed with the risk results based 

on a number of concerns. 

One commenter stated that the RTR modeling characterized the 

maximum air lead concentrations near the facility to be fifty times 

the 2008 NAAQS which is inconsistent with both recent air quality 

monitoring data and Missouri's 2007 attainment demonstration 

modeling and stated that the proposed RTR modeling overestimated the 

maximum air lead concentration by at least a factor of five. The 

commenter stated that the inaccuracies of the EPA’s proposed 

modeling analysis will be in conflict with future baseline and 

attainment demonstration modeling based on more accurate data, 

especially since the RTR proposes to correlate the MACT standard 

with the 2008 NAAQS. The commenter recommended that the EPA remodel 

this facility using higher quality input data that are more 

representative of current operations at the Herculaneum facility, to 

obtain results that better reflect the actual monitored three-month 

lead concentrations. Alternately, the commenter stated that the EPA 

should either defer to appropriate air quality monitoring 
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information or to the modeling run used for the 2007 SIP revision 

attainment demonstration as the basis for this RTR. Some commenters 

also suggested using AERMOD modeling followed by LEADPOST, rather 

than using HEM-3 to ultimately calculate 3-month rolling average 

lead concentrations. 

Two commenters identified specific issues with regard to the 

modeling approach and input data including:

• The ratio of modeled results to monitored data should not 

exceed a factor of two. The commenter provided specific corrections 

and analysis of data.

• The NAAQS attainment demonstration model developed by the State 

of Missouri and the RTR modeling, although conducted for different 

purposes, are both based on compliance with the same standard for 

the same geographic location. Therefore, the output of both 

dispersion models, whether for residual risk assessment or SIP 

development, should reflect the maximum ambient air lead 

concentration. The commenter stated that any data limitations should 

be addressed with input from the commenter. 

• Improvements from the 2007 SIP for the fugitive emissions from 

the sinter plant and blast furnace building do not appear to be 

reflected in the run script of the model, resulting in 

concentrations up to fifty times the NAAQS. The commenter stated 

that actual monitoring data from 2010 show a maximum three-month 
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average ambient air concentration of 1.12 μg/m3 at the Main Street 

site. This actual monitored value is in line with the MDNR modeled 

estimate from the 2007 SIP revision and is recommended to be the 

basis for the risk assessment.

• The EPA did not provide a modeling protocol for their 

dispersion modeling, or all of the modeling inputs, post processing 

and other data in the docket for public review. Therefore, a 

complete, replicable public review of the model and assessment of 

the proposed RTR could not be made. The commenter identified several 

specific modeling parameters and data elements that were not 

correctly applied during the proposal modeling run which could have 

significantly affected the results including model control options,

run script parameters, volume sources modeled as point sources, 

inaccurate fenceline/boundary locations, incorrect elevations for 

sources and receptors, and old census data information for receptor 

centroids.

Response: Because of the availability of newer emissions data, more 

detailed site-specific meteorological data, as well as updated 

facility boundary and other information provided by Doe Run in 

comments on the proposed rule, we have remodeled the facility with 

these newer data. We remodeled using AERMOD in the default mode to 

estimate monthly lead concentrations, and we used the building and 

particle data submitted by one commenter to model building downwash 
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and plume depletion. We used the LEADPOST processor to calculate 3-

month rolling averages. In addition, using the updated facility 

boundary information, the EPA also removed census blocks that would 

now be considered onsite. The methods and results of this modeling 

effort can be found in the document: Residual Risk Assessment for 

the Primary Lead Smelting Source Category, which is available in the 

docket for this rulemaking. The EPA notes that the results of this 

modeling effort are similar to results submitted by the Doe Run 

Company to the State as part of a SIP (this Doe Run modeling effort 

was also submitted to the EPA as part of its public comments). 

Moreover, the EPA notes that a comparison of modeled lead 

concentrations at the sites of six lead monitors are within 50 

percent of measured concentrations at those monitors. These results 

are similar to a model-to-monitor comparison submitted by Doe Run in 

its public comments. 

We note that the docket included all of the input files and 

documentation needed to reproduce the modeling that was performed 

for the proposal risk assessment.

Comment: With respect to using the NAAQS to evaluate potential 

multipathway risks from lead, one commenter stated that the risk 

assessment used to set the NAAQS was based on quantitative studies 

of young children and that while “the Lead NAAQS obviously applies 

to all ages, that was a qualitative risk management decision made as 
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a matter of policy” and that “the task at hand is to provide a 

quantitative risk assessment of the maximum non-adverse facilitylevel emissions rate for all ages, which cannot be done on the basis 

of a risk assessment that studied children only. 

Response: The lead NAAQS was a public health policy judgment 

considering the available health evidence and risk analyses as well 

as the uncertainties associated with the health evidence and risk 

analyses. We disagree with the commenter that the lead NAAQS cannot 

be used in a quantitative manner. The review of the lead NAAQS 

clearly resulted in a quantitative standard: 3-month maximum lead 

concentration not to exceed a level of 0.15 μg/m3

. This standard was 

set to protect public health, including the health of sensitive 

populations, with an adequate margin of safety. As the commenter 

notes, the lead NAAQS applies in all areas of the United States and 

is meant to protect the public health with an adequate margin of 

safety regardless of the age of the individuals living in a 

particular area. 

Comment: One commenter stated that rather than finalizing this 

proposal as it stands, the best available science directs the EPA to 

set a residual risk standard that incorporates protective health 

benchmarks and assures that children living near the facility will

not face an unacceptable neurological effect, such as the loss of IQ 

points. This includes protecting children against a blood lead level 
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change of 1.0 μg/dL or more, a benchmark used by California for the 

blood lead level change that is associated with a child’s loss of 

one IQ point. Because there is no safe level of lead exposure and 

because lead persists in the environment, resulting in reservoirs in 

soils and dusts, the EPA has an obligation to control emissions from 

this source category promptly and in a precautionary manner. The 

commenter stated that the EPA should consider requiring zero lead 

emissions. At a minimum, the EPA should set a standard that would 

ensure that the ambient air concentration for lead in the local 

community does not exceed the level of 0.02 μg/m3 as a one-month 

average, in order to protect children. As this is the level the 

Children’s Health Protection Advisory Committee had recommended for 

the lead NAAQS, the EPA must also set additional protections beyond 

this ambient air limit in order to provide an “ample margin of 

safety.” 

Response: In order to assess multipathway risks associated with 

emissions of lead, the EPA compared modeled rolling three month 

average lead concentrations estimated from emissions from the one 

source in this category to the NAAQS for lead. As noted above, we 

believe that this is a reasonable approach given that the NAAQS is a 

health based standard set to protect the public health, including 

the health of sensitive sub-populations (such as children) with an 

adequate margin of safety. Moreover, the risk assessment supporting 
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the NAAQS considered direct inhalation exposures and indirect airrelated multi-pathway exposures from industrial sources like primary 

and secondary lead smelting operations. While we conclude that the 

level of the NAAQS presents an acceptable level of risk from lead in 

ambient air, and are requiring controls to ensure that the level of 

the NAAQS is not exceeded, as part of our “ample margin of safety” 

analysis, we examined whether there were additional cost effective 

controls available to further protect public health including 

monitoring at a level below 0.15 μg/m3. For the reasons explained 

elsewhere in this notice and other supporting documents available in 

the docket, we have determined that there are no additional cost 

effective controls that would provide further risk reductions. 

With respect to the California benchmark for protecting 

children, the EPA has a hierarchy of appropriate health benchmark 

values. In general, this hierarchy places greater weight on EPA 

derived health benchmarks than those from other agencies 

(http://www.epa.gov/ttn/atw/nata1999/99pdfs/healtheffectsinfo.pdf). 

For the reasons provided above, we believe that the lead NAAQS level 

establishes an appropriate benchmark for addressing the acceptable 

level of risk and we disagree with the commenter that we should 

instead use an ambient concentration of 0.02 μg/m3 based on a one 
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month average.6 

Comment: With regard to the source category’s emissions of two 

dozen other hazardous air pollutants, including cadmium and arsenic, 

one commenter stated that the EPA should determine that this health 

risk is also unacceptable. With thousands of people exposed to a 

lifetime risk of cancer above 1 in a million, and with at least 200 

exposed to a lifetime risk of up to 30 in a million, the EPA must 

recognize that this risk is too high for this local community. The 

EPA should set a standard that would reduce cancer risks to an 

acceptable level and ensure an ample margin of safety from non-lead 

emissions.

Response: With respect to cancer risk, section 112 provides for EPA

to follow the benzene decision framework for determining 

acceptability. Under that framework, cancer risk less than 100 in a

million is generally considered acceptable, although this is not a 

bright line and EPA examines a variety of health factors to make its 

determination. Once we concluded that the risk from non-lead HAP was 

acceptable, we then considered whether there were additional costeffective controls that would further reduce risk from the other HAP 

emitted in order to provide an ample margin of safety. Because the 

controls for other HAP were the same as the controls for lead, we 

 6 This level is well below the background ambient lead levels measured in the area during the SIP process. See docket ID 

EPA-HQ-OAR-2006-0735-5204.
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determined (for the same reason we did for lead) that there were no 

additional cost effective controls and that the acceptable level of 

HAP emissions also provided an ample margin of safety. 

Comment: One commenter stated that they oppose the use of the lead 

NAAQS assessment instead of a multi-pathway risk assessment because 

the lead NAAQS provides an inappropriate level of protection, i.e., 

the lead NAAQS requires an adequate margin of safety while a 

residual risk standard requires an ample margin of safety. The 

commenter stated that a residual risk standard should provide a 

level of protection that is higher than the NAAQS. Moreover, the 

commenter noted that the NAAQS is set to protect sensitive 

populations while residual risk rules are set to protect the 

greatest number of individuals possible from unacceptable risk. The 

proposed rule based on the lead NAAQS will not provide as high a 

level of protection as required by CAA section 112(f)(2). 

Response: We disagree with the commenter that the lead NAAQS 

assessment should not be considered as part of our residual risk 

analysis because it provides an inappropriate level of protection. 

The lead NAAQS is set at a level to protect public health, including 

the health of sensitive populations, most critical for lead, the 

health of children. That does not suggest that non-sensitive 

populations are not protected, but rather that the NAAQS is set at a 

level that will not only protect the general population but also 
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those who are more sensitive to lead exposures. In the proposed 

rule, the level of the NAAQS, which protects public health with an 

adequate margin of safety, was used to determine whether or not 

there was unacceptable risk. Once we determined a level of emissions 

that results in risks being acceptable, under the two-step residual 

risk decision process, the EPA then considered whether there were 

additional controls that might further reduce risk to achieve an 

ample margin of safety considering cost and feasibility. There were 

no additional cost-effective controls beyond those that would need 

to be implemented to ensure an acceptable level of risk. Thus, for 

the three emissions points (fugitive dust emissions, the furnace 

area stack, and the refinery stacks) for which we are requiring 

action to ensure an acceptable level of risk, we have concluded that

there are no additional cost-effective controls and that an ample 

margin of safety was provided by the same controls that ensured an 

acceptable level of risk. There are no cost effective controls that 

could reduce the main stack emissions beyond those that are achieved 

in practice. Therefore, an ample margin of safety will be provided 

by the current level of control for the main stack. A more detailed 

presentation of the economic analysis of additional controls for the 

refining, furnace area, and main stacks can be found in the 

technical support document, which is available in the docket.

Comment: One commenter stated that the EPA has not appropriately 
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accounted for or prevented environmental risks from lead or non-lead 

emissions as required by section 112(f)(2)(A). According to the 

commenter, using the NAAQS to assess ecological risk is problematic 

and EPA’s approach of assuming that “when exposure levels are not

anticipated to adversely affect human health, they also are not 

anticipated to adversely affect the environment,” 76 Fed. Reg. at 

9425, is illogical and unlawful. Further, based on the information 

the EPA has gathered about the local environment around the Doe Run 

facility, the EPA cannot assume that there would be no effects 

either to wildlife or to natural resources in the environment either 

from inhalation or air deposition of HAP emissions, exacerbated by 

persistence and bioaccumulation. As the EPA’s own Scientific 

Advisory Board has stated: “The assumption that ecological receptors 

will be protected if human health is protected is incorrect.” SAB 

May 2010 at 48. 

Response: The EPA is unaware of any data indicating a direct 

atmospheric impact of non-lead HAP emitted from this source category

on receptors such as plants, birds, and wildlife. Given that there 

is no information supporting that there is an effect, we find it 

appropriate to assume that exposure levels not expected to harm 

humans are also not expected to harm ecological receptors. 

Although the ecological effects of lead are well documented, 

there was a lack of evidence at the time of the last lead NAAQS 
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review linking various ecological effects to specific levels of lead 

in the air. It was determined that the evidence did not provide a 

sufficient basis for establishing a separate secondary standard, but 

that revising the secondary standard to be equal to the revised 

primary standard would provide substantial additional protection to 

ecological receptors from the effects of lead. Thus, we find it 

appropriate to consider the secondary lead NAAQS when evaluating the 

potential for adverse environmental effects. 

Comment: One commenter generally stated that the EPA must not use 

the secondary NAAQS as a benchmark to determine whether there will 

be environmental effects and that the use of the lead NAAQS to 

evaluate ecologic risks is inappropriate. The commenter states that 

the EPA should recognize that the establishment of the Secondary 

lead NAAQS at the same level of the Primary Lead NAAQS was a risk 

management decision, rather than a decision quantitatively founded 

in risk assessment. The commenter cited that in establishing the 

lead NAAQS, the EPA introduced its approach by describing the 

“substantial limitations in the evidence, especially the lack of 

evidence linking various effects to specific levels of ambient Pb” 

(US EPA, 2008. P. 67007), and ultimately concluded that the 

secondary lead NAAQS should be set equal to the primary lead NAAQS. 

In contrast, in this proposed rule, the EPA concludes that 

“ambient lead concentrations above the lead NAAQS indicates 
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potential for adverse environmental effects” (76 FR 9421). 

Response: The secondary lead NAAQS was set to protect against 

adverse welfare effects (including adverse environmental effects) 

and has the same averaging time, form, and level as the primary 

standard. Thus, we find it appropriate to consider the secondary 

lead NAAQS when considering the potential for adverse environmental 

effects. The commenter is correct that we stated in the proposed 

rule that “ambient lead concentrations above the lead NAAQS 

indicates potential for adverse environmental effects.” This 

statement is entirely consistent with the idea that the secondary

lead NAAQS was set at a level above which there may be adverse 

environmental effects but does not support a conclusion that there 

are adverse environmental effects below that level that must be 

addressed as part of this residual risk determination. As we have 

noted previously, there are not sufficient data supporting that a 

lower level is necessary to protect against an environmental risk.

Comment: One commenter stated that in evaluating potential 

multipathway risks from PB-HAP other than lead, the EPA used de 

minimis emission rates to screen for potentially significant multipathway impacts, but for lead, this method was abandoned. The 

commenter disagrees with this approach, stating, “This comparison 

mirrors NAAQS source monitoring for attainment purposes in its use 

of the national ambient air lead level as the benchmark. As such, it 
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is not a proper surrogate for “facility-level de minimis emission 

rates” used as the chronic reference benchmarks for CAA section 112

risk assessments.” 

Response: The EPA disagrees that comparing modeled 3-month rolling 

average lead concentrations to the NAAQS for lead mirrors source 

monitoring for NAAQS attainment purposes and that this approach is 

not a proper surrogate for facility-level de minimis emission rates 

used as the chronic reference benchmarks for CAA section 112 risk 

assessments. In general, determining attainment for the lead NAAQS 

is based on aggregate ambient monitoring of all potential sources of 

lead in a given area. In contrast, the Primary Lead Smelting Risk 

Assessment and Preamble clearly state that 3-month rolling average 

lead concentrations are based on modeled lead concentrations from 

lead emissions from the one facility in the source category. 76 FR 

9421. Thus, for example, while for NAAQS attainment purposes ambient 

lead concentrations resulting from lead haul roads outside the 

facility boundary would contribute to the overall 3-month rolling 

average ambient lead concentration measured at a nearby ambient lead 

monitor, for purposes of the risk assessment to support this 

rulemaking, these types of offsite emission sources were not 

included when modeling 3-month rolling lead concentrations (i.e., 

only emission sources from within the facility boundary were used as 

inputs into the dispersion model to estimate resulting modeled 3-
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month average lead concentrations). 

The NAAQS for lead was set to protect, with an adequate margin 

of safety, human health, including the health of children and other 

at-risk populations, against an array of adverse health effects, 

most notably including neurological effects, particularly 

neurobehavioral and neurocognitive effects, in children (73 FR 

67007). In developing the NAAQS for lead, because of the multipathway, multi-media impacts of lead, the risk assessment supporting 

the NAAQS considered direct inhalation exposures and indirect airrelated multi-pathway exposures from industrial sources like primary 

and secondary lead smelting operations. It also considered 

background lead exposures from other sources (like contaminated 

drinking water and exposure to lead-based paints). The EPA believes 

that the lead NAAQS is a reasonable benchmark to evaluate the 

potential for multipathway health effects from lead.

Finally, as noted in the risk assessment document, there is no 

RfD or other comparable chronic health benchmark value for lead 

compounds. That is, in 1988, the EPA’s IRIS program reviewed the 

health effects data regarding lead and its inorganic compounds and 

determined that it would be inappropriate to develop an RfD for 

these compounds, saying, “A great deal of information on the health 

effects of lead has been obtained through decades of medical 

observation and scientific research. This information has been 
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assessed in the development of air and water quality criteria by the 

Agency's Office of Health and Environmental Assessment (OHEA) in 

support of regulatory decision-making by the Office of Air Quality 

Planning and Standards (OAQPS) and by the Office of Drinking Water 

(ODW). By comparison to most other environmental toxicants, the 

degree of uncertainty about the health effects of lead is quite low. 

It appears that some of these effects, particularly changes in the 

levels of certain blood enzymes and in aspects of children's 

neurobehavioral development, may occur at blood lead levels so low 

as to be essentially without a threshold. The agency's RfD Work 

Group discussed inorganic lead (and lead compounds) at two meetings 

(07/08/1985 and 07/22/1985) and considered it inappropriate to 

develop an RfD for inorganic lead.” The EPA’s IRIS assessment for 

Lead and compounds (inorganic) (CASRN 7439-92-1), 

http://www.epa.gov/iris/subst/0277.htm.

Comment: One commenter stated that the EPA must include a plain 

language statement of health risks and benefits of the proposed 

rule. As part of its rulemaking proposal, the EPA should include a 

plain statement of the health impacts and risks at issue. For 

example, the commenter stated that the MIR and chronic and risk 

numbers are not easily understandable by the general public; the IQ 

point losses at stake or how it is setting a standard to address 

these are not discussed, and the types of cancer or the nature of 
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the health disorders or other adverse effects that most of these 

types of HAP emissions present to the public are not discussed. The 

commenter stated that this type of “[e]xpanded discussion is 

important to understanding the ‘real-world’ risk, including dealing 

with health disparities.” SAB May 2010 at 50. 

A full elaboration of the types of health impacts at issue 

here, ranging from significant IQ loss (due to lead emissions), to a 

high lifetime cancer risk (from non-lead emissions), for this 

particular community, is needed to inform the EPA’s and the public’s 

consideration of what level of risk is acceptable or unacceptable, 

and what standard is required to provide an ample margin of safety.

Response: The EPA strives to communicate its health and risk 

information to the public in a manner that is concise, informative, 

and readily understandable. In the risk assessment document, we 

discuss the various metrics used to characterize risk associated 

with the source category (e.g., see section 2.3 of the risk 

assessment document for a discussion of the MIR). Moreover, while 

the commenter is correct that we do not discuss in detail the 

neurological effects associated with exposure to lead (e.g., loss of 

IQ points in children), we do reference the final lead NAAQS 

decision, which does discuss in detail the health effects associated 

with lead exposure. With regard to how the proposed controls limit 

the health risks associated with lead exposure, we noted in the 
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preamble that the proposed controls would ensure that the facility’s 

contribution to ambient concentrations of lead were at or below the 

NAAQS for lead and that this represents an acceptable level of risk 

since the lead NAAQS was set to protect public health, including the 

health of sensitive populations (e.g., children), from the adverse 

health effects associated with lead exposure. In addition, as 

discussed previously, we concluded that the same level of controls 

would also provide an ample margin of safety.

With regard to discussing specific types of cancers potentially 

associated with exposure to a given HAP, we note that the cancer 

unit risk estimates used in the risk assessment are not associated 

with specific types of cancers, but rather with the risk of cancer 

in general. Moreover, since many of the cancer studies the unit risk 

estimates take into account are animal studies, there is appreciable 

uncertainty as to whether the same types of cancers would be seen in 

humans. Thus, we find it appropriate to express the results of our 

cancer assessment in terms of general cancer risk. 

VI. Impacts of the Final Rule

The revisions to the Primary Lead Processing MACT standard will 

ensure that emissions from the one source in this source category do 

not present an unacceptable level of risk and will also provide an 

ample margin of safety. The estimated reductions include a reduction 

in fugitive dust emissions of lead and as much as 10 tons per year of 
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lead from the furnace area and refining operations stacks. These 

controls will also reduce emissions of other HAP emitted from the 

facility. The costs of controls were not directly considered in the 

decision to require work practice standards and fenceline compliance 

monitoring to address fugitive emissions or to add an emission 

standard for furnace area and refining emissions because these

requirements are necessary to bring risk to an acceptable level.

However, as an example the cost for paving all unpaved roads at the 

facility to control fugitive emissions would be around $800,000. The 

EPA evaluated control practices and technology and associated costs 

in determining that the same requirements needed to achieve 

acceptable risks would also provide an ample margin of safety with 

regard to fugitive dust emissions and emissions from the furnace area 

and refining stacks. In addition, we considered other available 

practices, processes and control technologies. For the same reason we 

concluded that no additional controls were necessary to provide an 

ample margin of safety for the fugitive dust and refining and furnace 

area stacks, we concluded that there were no additional cost 

effective developments in practices, processes or control 

technologies for those emission sources. 

VII. Statutory and Executive Order Reviews

A. Executive Orders 12866: Regulatory Planning and Review, and 

Executive Order 13563: Improving Regulation and Regulatory Review
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Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 

action is a “significant regulatory action.” This action is a 

significant regulatory action because it raises novel legal and 

policy issues. Accordingly, the EPA submitted this action to the 

Office of Management and Budget (OMB) for review under Executive 

Order 12866 and Executive Order 13563 (76 FR 3821, January 21, 2011), 

and any changes made in response to OMB recommendations have been 

documented in the docket for this action.

B. Paperwork Reduction Act

The Office of Management and Budget (OMB) has approved the 

information collection requirements contained in this rule under the 

provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and 

has assigned OMB control number 2060-0414. 

The information requirements are based on notification, 

recordkeeping, and reporting requirements in the NESHAP General 

Provisions (40 CFR part 63, subpart A), which are mandatory for all 

operators subject to national emission standards. These recordkeeping 

and reporting requirements are specifically authorized by section 114 

of the CAA (42 U.S.C. 7414). All information submitted to the EPA

pursuant to the recordkeeping and reporting requirements for which a 

claim of confidentiality is made is safeguarded according to agency 

policies set forth in 40 CFR part 2, subpart B.

This final rule includes new paperwork requirements for 
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monitoring for lead concentrations in air and increased frequency for 

stack testing as described in 40 CFR 63.1547(k) (compliance 

monitoring) and 40 CFR 63.1546 (stack testing). Although these are 

additional requirements under the final rule, they are consistent 

with existing monitoring and testing currently conducted by the 

facility to meet MACT and SIP requirements and would not constitute 

an undue burden to the facility.

When a malfunction occurs, sources must report them according to 

the applicable reporting requirements of 40 CFR part 63, subpart TTT.

An affirmative defense to civil penalties for exceedances of emission 

limits that are caused by malfunctions is available to a source if it 

can demonstrate that certain criteria and requirements are satisfied.

The criteria ensure that the affirmative defense is available only 

where the event that causes an exceedance of the emission limit meets 

the narrow definition of malfunction in 40 CFR 63.2 (sudden, 

infrequent, not reasonable preventable, and not caused by poor 

maintenance and or careless operation) and where the source took 

necessary actions to minimize emissions. In addition, the source must 

meet certain notification and reporting requirements. For example, 

the source must prepare a written root cause analysis and submit a 

written report to the Administrator documenting that it has met the 

conditions and requirements for assertion of the affirmative defense.
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The EPA is adding affirmative defense to the estimate of burden 

in the ICR. To provide the public with an estimate of the relative 

magnitude of the burden associated with an assertion of the 

affirmative defense position adopted by a source, the EPA has 

provided administrative adjustments to the ICR that show what the 

notification, recordkeeping, and reporting requirements associated 

with the assertion of the affirmative defense might entail. The EPA’s 

estimate for the required notification, reports, and records, 

including the root cause analysis, totals $3,141, and is based on the 

time and effort required of a source to review relevant data, 

interview plant employees, and document the events surrounding a 

malfunction that has caused an exceedance of an emission limit. The 

estimate also includes time to produce and retain the record and 

reports for submission to the EPA. The EPA provides this illustrative 

estimate of this burden, because these costs are only incurred if 

there has been a violation, and a source chooses to take advantage of 

the affirmative defense.

Given the variety of circumstances under which malfunctions 

could occur, as well as differences among sources' operation and 

maintenance practices, we cannot reliably predict the severity and 

frequency of malfunction-related excess emissions events for a

particular source. It is important to note that the EPA has no basis 

currently for estimating the number of malfunctions that would 
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qualify for an affirmative defense. Current historical records would 

be an inappropriate basis, as source owners or operators previously 

operated their facilities in recognition that they were exempt from 

the requirement to comply with emissions standards during 

malfunctions. Of the number of excess emission events reported by 

source operators, only a small number would be expected to result 

from a malfunction (based on the definition above), and only a subset 

of excess emissions caused by malfunctions would result in the source 

choosing to assert the affirmative defense. Thus, we believe the 

number of instances in which source operators might be expected to 

avail themselves of the affirmative defense will be extremely small.

For this reason, we estimate no more than 2 or 3 such occurrences for 

all sources subject to 40 CFR part 63, subpart TTT over the 3-year 

period covered by this ICR. We expect to gather information on such 

events in the future, and will revise this estimate as better 

information becomes available.

For the Primary Lead Processing MACT standard, the ICR document 

prepared by the EPA, which has been revised to include the amendments 

to the standards, has been assigned the EPA ICR number 1856.08.

Burden changes associated with these amendments result from the 

reporting and recordkeeping requirements of the affirmative defense 

provisions and the lead concentration in air limit added to the rule.

The change in respondents’ annual reporting and recordkeeping burden 
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associated with these amendments for this collection (averaged over 

the first 3 years after the effective date of the standards) is 

estimated to be 30 labor hours at a cost of $3,141 per year for the 

affirmative defense reporting and recordkeeping provisions and 1,313

labor hours at a cost of $461,640 per year for the lead concentration 

in air limit reporting and recordkeeping provisions. There will be no 

capital costs associated with the information collection requirements 

of the final rule. There is no estimated change in annual burden to 

the Federal government for these amendments. Burden is defined at 5 

CFR 1320.3(b)

An agency may not conduct or sponsor, and a person is not 

required to respond to, a collection of information unless it 

displays a currently valid OMB control number. The OMB control 

numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. 

In addition, EPA is amending the table in 40 CFR part 9 of currently 

approved OMB control numbers for various regulations to list the 

regulatory citations for the information requirements contained in 

this final rule.

C. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) generally requires an 

agency to prepare a regulatory flexibility analysis of any rule 

subject to notice and comment rulemaking requirements under the 

Administrative Procedure Act, or any other statute, unless the agency
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certifies that the rule will not have a significant economic impact 

on a substantial number of small entities. Small entities include 

small businesses, small organizations, and small governmental 

jurisdictions.

For purposes of assessing the impact of these final rules on 

small entities, small entity is defined as: (1) a small business as 

defined by the Small Business Administration’s regulations at 13 CFR 

121.201; (2) a small governmental jurisdiction that is a government 

of a city, county, town, school district, or special district with a 

population of less than 50,000; and (3) a small organization that is 

any not-for-profit enterprise which is independently owned and 

operated and is not dominant in its field.

After considering the economic impacts of these final rules on 

small entities, I certify that this action will not have a 

significant economic impact on a substantial number of small 

entities. This final action will not impose any requirements on small 

entities. The costs associated with the new requirements in these 

final rules are not expected to present an undue burden to this 

industry as discussed above. 

D. Unfunded Mandates Reform Act 

This action contains no Federal mandates under the provisions of 

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 

1531-1538 for State, local, or tribal governments or the private 
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sector. The action imposes no enforceable duty on any State, local 

or tribal governments or the private sector. Therefore, this action 

is not subject to the requirements of sections 202 or 205 of the 

UMRA.

These rules are also not subject to the regulatory requirements 

that might significantly or uniquely affect small governments. They 

contain no requirements that apply to such governments or impose 

obligations upon them.

E. Executive Order 13132: Federalism

This action does not have federalism implications. It will not 

have substantial direct effects on the States, on the relationship 

between the national government and the States, or on the 

distribution of power and responsibilities among the various levels 

of government, as specified in Executive Order 13132. These final 

rules primarily affect private industry, and do not impose 

significant economic costs on State or local governments. Thus, 

Executive Order 13132 does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian 

Tribal Governments

This action does not have tribal implications, as specified in 

Executive Order 13175 (65 FR 67249, November 9, 2000). It will not 

have substantial direct effect on tribal governments, on the 

relationship between the Federal government and Indian tribes, or on 
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the distribution of power and responsibilities between the Federal 

government and Indian tribes, as specified in Executive Order 13175.

Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental 

Health Risks and Safety Risks

This action is not subject to Executive Order 13045 (62 FR

19885, April 23, 1997), because it is not economically significant as 

defined in Executive Order 12866. However, the agency does believe 

there is a disproportionate risk to children. Modeled ambient air 

lead concentrations from the one facility in this source category are 

in excess of the NAAQS for lead, which was set to “provide increased 

protection for children and other at-risk populations against an 

array of adverse health effects, most notably including neurological 

effects in children, including neurocognitive and neurobehavioral 

effects.” 73 FR 67007. However, the control measures promulgated in 

this notice will result in lead concentration levels that are in 

compliance with the lead NAAQS, thereby mitigating the risk of 

adverse health effects to children.

H. Executive Order 13211: Actions Concerning Regulations That 

Significantly Affect Energy Supply, Distribution, or Use

This action is not a “significant energy action” as defined in

Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not 

likely to have a significant adverse energy effect on the supply, 
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distribution, or use of energy. This action will not create any new 

requirements for sources in the energy supply, distribution, or use 

sectors. Further, we have concluded that these final rules are not 

likely to have any adverse energy effects.

I. National Technology Transfer and Advancement Act

Section 12(d) of the National Technology Transfer and 

Advancement Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 

U.S.C. 272 note) directs the EPA to use voluntary consensus standards 

(VCS) in its regulatory activities, unless to do so would be 

inconsistent with applicable law or otherwise impractical. VCS are 

technical standards (e.g., materials specifications, test methods, 

sampling procedures, and business practices) that are developed or 

adopted by VCS bodies. NTTAA directs the EPA to provide Congress, 

through OMB, explanations when the agency decides not to use 

available and applicable VCS. 

This action does not involve technical standards. Therefore, the 

EPA did not consider the use of any VCS.

J. Executive Order 12898: Federal Actions To Address Environmental 

Justice in Minority Populations and Low-Income Populations

Executive Order 12898 (59 FR 7629, February 16, 1994) 

establishes Federal executive policy on environmental justice. Its 

main provision directs Federal agencies, to the greatest extent 

practicable and permitted by law, to make environmental justice part 
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of their mission by identifying and addressing, as appropriate, 

disproportionately high and adverse human health or environmental 

effects of their programs, policies, and activities on minority 

populations and low-income populations in the United States.

The EPA has determined that this final rule will not have 

disproportionately high and adverse human health or environmental 

effects on minority or low-income populations, because it does not 

decrease the level of protection provided to human health or the 

environment, but in fact decreases emissions of lead. To examine the 

potential for any environmental justice issues that might be 

associated with this rule, we evaluated the distributions of HAPrelated cancer and non-cancer risks across different social, 

demographic, and economic groups within the populations living near 

the one facility that is currently operating in this source category.

Our analyses also show that, although there is potential for an 

adverse environmental and human health effects from emission of lead, 

it does not indicate any significant potential for disparate impacts 

to the specific demographic groups analyzed.

The rule would require additional control measures to address 

the identified environmental and health risks and would therefore, 

decrease risks to any populations exposed to these sources.

K. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801, et seq., as added by 
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the Small Business Regulatory Enforcement Fairness Act of 1996, 

generally provides that, before a rule may take effect, the agency 

promulgating the rule must submit a rule report, which includes a 

copy of the rule, to each House of the Congress and to the 

Comptroller General of the United States. The EPA will submit a 

report containing this final rule and other required information to 

the United States Senate, the United States House of Representatives, 

and the Comptroller General of the United States prior to publication 

of the final rule in the Federal Register. A major rule cannot take 

effect until 60 days after it is published in the Federal Register.

This action is not a “major rule” as defined by 5 U.S.C. 804(2). The 

final rules will be effective on [INSERT DATE OF PUBLICATION].
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List of Subjects for 40 CFR Part 63

Environmental protection, Administrative practice and 

procedures, Air pollution control, Hazardous substances, 

Intergovernmental relations, Reporting and recordkeeping 

requirements.

______________

Dated: XXXXX XX, 2011.

________________________

Lisa P. Jackson,

Administrator.
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For the reasons stated in the preamble, the Environmental 

Protection Agency proposes to amend title 40, chapter I, of the 

Code of Federal Regulations as follows:

PART 63-–[AMENDED]

1. The authority citation for part 63 continues to read 

as follows:

Authority: 42 U.S.C. 7401, et seq.

Subpart TTT—[AMENDED]

§63.1541 Applicability.

(a) The provisions of this subpart apply to any facility 

engaged in producing lead metal from ore concentrates. The 

category includes, but is not limited to, the following smelting 

processes: sintering, reduction, preliminary treatment, refining 

and casting operations, process fugitive sources, and fugitive 

dust sources. The sinter process includes an updraft or 

downdraft sintering machine. The reduction process includes the 

blast furnace, electric smelting furnace with a converter or 

reverberatory furnace, and slag fuming furnace process units.

The preliminary treatment process includes the drossing kettles 

and dross reverberatory furnace process units. The refining 

process includes the refinery process unit. The provisions of 

this subpart do not apply to secondary lead smelters, lead 

refiners, or lead remelters.
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(b) Table 1 of this subpart specifies the provisions of 

subpart A of this part that apply and those that do not apply to 

owners and operators of primary lead processors.

3. Section 63.1542 is amended by adding a definition for 

“Affirmative defense,” “Lead refiner,” “Lead remelter,” “Primary 

lead processor,” and “Secondary lead smelter;” deleting the 

definition of “Primary lead smelter;” and revising the 

definitions of ”Fugitive dust source,” “Furnace area,” 

“Malfunction,” “Materials storage and handling area,” “Plant 

roadway,” “Process fugitive source,” “Refining and casting 

area,” “Sinter machine area,” and “Tapping location” to read as 

follows:

§63.1542 Definitions.

* * * * *

 Affirmative defense means, in the context of an enforcement 

proceeding, a response or defense put forward by a defendant, 

regarding which the defendant has the burden of proof, and the 

merits of which are independently and objectively evaluated in a 

judicial or administrative proceeding.

* * * * *

 Fugitive dust source means a stationary source of hazardous 

air pollutant emissions at a primary lead processor resulting 

from the handling, storage, transfer, or other management of 

lead-bearing materials where the source is not part of a 
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specific process, process vent, or stack. Fugitive dust sources 

include roadways, storage piles, materials handling transfer 

points, and materials transport areas.

 Furnace area means any area of a primary lead processor in 

which a blast furnace or dross furnace is located.

 Lead refiner means any facility that refines lead metal that 

is not located at a primary lead processor.

 Lead remelter means any facility that remelts lead metal 

that is not located at a primary lead processor. 

 Malfunction means any sudden, infrequent, and not reasonably 

preventable failure of air pollution control and monitoring 

equipment, process equipment, or a process to operate in a 

normal or usual manner which causes, or has the potential to 

cause, the emission limitations in an applicable standard to be 

exceeded. Failures that are caused in part by poor maintenance 

or careless operation are not malfunctions.

 Materials storage and handling area means any area of a 

primary lead processor in which lead-bearing materials 

(including ore concentrate, sinter, granulated lead, dross, 

slag, and flue dust) are stored or handled between process 

steps, including areas in which materials are stored in piles, 

bins, or tubs, and areas in which material is prepared for 

charging to a sinter machine or smelting furnace or other lead

processing operation.
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* * * * *

 Plant roadway means any area of a primary lead processor 

that is subject to vehicle traffic, including traffic by 

forklifts, front-end loaders, or vehicles carrying ore 

concentrates or cast lead ingots. Excluded from this definition 

are employee and visitor parking areas, provided they are not 

subject to traffic by vehicles carrying lead-bearing materials. 

 Primary lead processor means any facility engaged in the 

production of lead metal from lead sulfide ore concentrates 

through the use of pyrometallurgical or other techniques.

 Process fugitive source means a source of hazardous air 

pollutant emissions at a primary lead processor that is 

associated with lead smelting, processing or refining but is not 

the primary exhaust stream and is not a fugitive dust source. 

Process fugitive sources include sinter machine charging 

locations, sinter machine discharge locations, sinter crushing 

and sizing equipment, furnace charging locations, furnace taps, 

and drossing kettle and refining kettle charging or tapping 

locations.

 Refining and casting area means any area of a primary lead 

processor in which drossing or refining operations occur, or 

casting operations occur.

 Secondary lead smelter means any facility at which leadbearing scrap material, primarily, but not limited to, lead-acid 
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batteries, is recycled into elemental lead or lead alloys by 

smelting.

* * * * *

 Sinter machine area means any area of a primary lead 

processor where a sinter machine, or sinter crushing and sizing 

equipment is located.

* * * * *

 Tapping location means the opening through which lead and 

slag are removed from the furnace.

4. Section 63.1543 is revised to read as follows:

§63.1543 Standards for process and process fugitive sources.

(a) No owner or operator of any existing, new, or 

reconstructed primary lead processor shall discharge or cause to 

be discharged into the atmosphere lead compounds in excess of 

0.97 pounds per ton of lead metal produced from the aggregation 

of emissions discharged from air pollution control devices used 

to control emissions from the sources listed in paragraphs 

(a)(1) through (a)(9) of this section.

(1) Sinter machine;

(2) Blast furnace;

(3) Dross furnace;

(4) Dross furnace charging location;

(5) Blast furnace and dross furnace tapping location;
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(6) Sinter machine charging location;

(7) Sinter machine discharge end;

(8) Sinter crushing and sizing equipment; and

(9) Sinter machine area.

(b) No owner or operator of any existing, new, or 

reconstructed primary lead processor shall discharge or cause to 

be discharged into the atmosphere lead compounds in excess of 

1.2 tons per year from the aggregation of the air pollution 

control devices used to control emissions from furnace area and 

refining and casting operations.

(c) The process fugitive sources listed in paragraphs 

(a)(4) through (a)(8) of this section must be equipped with a 

hood and must be ventilated to a baghouse or equivalent control 

device. The hood design and ventilation rate must be consistent 

with American Conference of Governmental Industrial Hygienists 

recommended practices.

(d) The sinter machine area must be enclosed in a building 

that is ventilated to a baghouse or equivalent control device at 

a rate that maintains a positive in-draft through any doorway 

opening.

(e) Except as provided in paragraph (f) of this section, 

following the initial tests to demonstrate compliance with 

paragraphs (a) and (b) of this section, the owner or operator of 

a primary lead processor must conduct compliance tests for lead 
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compounds on an quarterly basis (no later than 100 days 

following any previous compliance test).

(f) If the 12 most recent compliance tests demonstrate 

compliance with the emission limit specified in paragraphs (a) 

and (b) of this section, the owner or operator of a primary lead 

processor shall be allowed up to 12 calendar months from the 

last compliance test to conduct the next compliance test for 

lead compounds.

(g) The owner or operator of a primary lead processor must 

maintain and operate each baghouse used to control emissions 

from the sources listed in paragraphs (a)(1) through (a)(9) and 

(b) of this section such that the alarm on a bag leak detection 

system required under §63.1547(c)(8) does not sound for more 

than five percent of the total operating time in a 6-month 

reporting period.

(h) The owner or operator of a primary lead processor must 

record the date and time of a bag leak detection system alarm 

and initiate procedures to determine the cause of the alarm 

according to the corrective action plan required under 

§63.1547(f) within 1 hour of the alarm. The cause of the alarm 

must be corrected as soon as practicable.

(i) At all times, the owner or operator must operate and 

maintain any affected source, including associated air pollution 
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control equipment and monitoring equipment, in a manner 

consistent with safety and good air pollution control practices 

for minimizing emissions. Determination of whether such 

operation and maintenance procedures are being used will be 

based on information available to the Administrator which may 

include, but is not limited to, monitoring results, review of 

operation and maintenance procedures, review of operation and 

maintenance records, and inspection of the source.

5. Section 63.1544 is revised to read as follows:

§63.1544 Standards for fugitive dust sources.

(a) Each owner or operator of any existing, new or 

reconstructed primary lead processor must adopt and implement 

work practice standards or other measures to reduce fugitive 

dust emissions sufficient to ensure that lead levels in the air 

at the fenceline do not exceed 0.15 μg/m3 on a 3-month rolling 

average.

(b) Consistent with the requirements in section 

63.1547(k), each owner or operator of any existing, new or 

reconstructed primary lead processor must establish a monitoring 

network at locations approved by the Administrator to ensure 

compliance with the requirements of paragraph (a). 

(c) At all times, the owner or operator must operate and 

maintain any affected source, including associated air pollution 
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control equipment and monitoring equipment, in a manner 

consistent with safety and good air pollution control practices 

for minimizing emissions. Determination of whether such 

operation and maintenance procedures are being used will be 

based on information available to the Administrator which may 

include, but is not limited to, monitoring results, review of 

operation and maintenance procedures, review of operation and 

maintenance records, and inspection of the source.

6. Section 63.1545 is revised to read as follows:

§63.1545 Compliance dates.

(a) Each owner or operator of an existing primary lead 

processor must achieve compliance with the requirements in 

§16.1543(a) no later than [INSERT DATE 60 DAYS FROM THE DATE OF 

PUBLICATION OF THESE AMENDMENTS IN THE FEDERAL REGISTER]. Each 

owner or operator of an existing primary lead processor must 

achieve compliance with the requirements in § 63.1543(b), §

63.1543(e), and § 63.1544 of this subpart no later than [INSERT 

DATE TWO YEARS FROM THE DATE OF PUBLICATION OF THESE AMENDMENTS 

IN THE FEDERAL REGISTER].

(b) Each owner or operator of a new primary lead processor

must achieve compliance with the requirements of this subpart no 

later than [INSERT DATE 60 DAYS AFTER PUBLICATION OF THESE 

AMENDMENTS IN THE FERERAL REGISTER] or startup, whichever is 

later.
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(c) Prior to the dates specified in §63.1545(a), each owner 

or operator of an existing primary lead processor must continue 

to comply with the requirements of §63.1543 and §63.1544 as 

promulgated in the June 4, 1999 NESHAP for Primary Lead 

Smelting.

(d) Each owner or operator of an existing primary lead 

processor must comply with the requirements of 63.1547(g)(1), 

63.1547(g)(2), 63.1551, and the revisions to Table 1 of Subpart 

TTT of Part 63 on [INSERT DATE OF PUBLICATION OF THESE 

AMENDMENTS IN THE FEDERAL REGISTER].

7. Section 63.1546 is revised to read as follows:

§63.1546 Performance testing.

(a) The following procedures must be used to determine 

quarterly compliance with the emissions standard for lead 

compounds under §63.1543(a) and (b) for existing sources:

(1) Each owner or operator of existing sources listed in 

§63.1543(a)(1) through (9) and (b) must determine the lead 

compound emissions rate, in units of pounds of lead per hour 

according to the following test methods in appendix A of part 60 

of this chapter:

(i) Method 1 must be used to select the sampling port 

location and the number of traverse points.

(ii) Method 2, 2F, 2G must be used to measure volumetric 

flow rate.
Page 103 of 130

(iii) Method 3, 3A, 3B must be used for gas analysis.

(iv) Method 4 must be used to determine moisture content of 

the stack gas.

(v) Method 12 or Method 29 must be used to determine lead 

emissions rate of the stack gas.

(2) A performance test shall consist of at least three 

runs. For each test run with Method 12 or Method 29, the minimum 

sample time must be 60 minutes and the minimum volume must be 1 

dry standard cubic meter (35 dry standard cubic feet).

(3) Performance tests shall be completed quarterly, once 

every 3 months, to determine compliance.

(4) The lead emission rate in pounds per quarter is 

calculated by multiplying the quarterly lead emission rate in 

pounds per hour by the quarterly plant operating time, in hours 

as shown in Equation 1:

(Eq. 1)

Where: 

EPb = quarterly lead emissions, pounds per quarter;

ERPb = quarterly lead emissions rate, pounds per hour; and

QPOT = quarterly plant operating time, hours per quarter.

(5) The lead production rate, in units of tons per 

quarter, must be determined based on production data for the 

previous quarter according to the procedures detailed in 

paragraphs (a)(5)(i) through (iv) of this section:
Page 104 of 130

(i) Total lead products production multiplied by the 

fractional lead content must be determined in units of tons.

(ii) Total copper matte production multiplied by the 

fractional lead content must be determined in units of tons.

(iii) Total copper speiss production multiplied by the 

fractional lead content must be determined in units of tons.

(iv) Total quarterly lead production must be determined by 

summing the values obtained in paragraphs (a)(5)(i) through 

(a)(5)(iii) of this section.

(6) To determine compliance with the production-based lead 

compound emission rate in §63.1543(a), the quarterly productionbased lead compound emission rate, in units of pounds of lead 

emissions per ton of lead produced, is calculated as shown in 

Equation 2 by dividing lead emissions by lead production.

(Eq. 2)

Where :

CEPb = quarterly production-based lead compound emission 

rate, in units of pounds of lead emissions per ton of lead 

produced;

EPb = quarterly lead emissions, pounds per quarter; and

PPb = quarterly lead production, tons per quarter.

(7) To determine quarterly compliance with the emissions 

standard for lead compounds under §63.1543(b), sum the lead 
Page 105 of 130

compound emission rates for the current and previous three 

quarters for the sources in §63.1543 (b), as determined in 

accordance with paragraphs (a)(1) through (a)(4) of this 

section.

(b) Owner and operators must perform an initial compliance 

test to demonstrate compliance with the sinter building in-draft 

requirements of §63.1543(d) at each doorway opening in 

accordance with paragraphs (b)(1) through (b)(4) of this 

section.

(1) Use a propeller anemometer or equivalent device.

(2) Determine doorway in-draft by placing the anemometer in 

the plane of the doorway opening near its center.

(3) Determine doorway in-draft for each doorway that is 

open during normal operation with all remaining doorways in 

their customary position during normal operation.

(4) Do not determine doorway in-draft when ambient wind 

speed exceeds 2 meters per second.

(c) Performance tests shall be conducted under such 

conditions as the Administrator specifies to the owner or 

operator based on representative performance of the affected 

source for the period being tested. Upon request, the owner or 

operator shall make available to the Administrator such records 

as may be necessary to determine the conditions of performance 

tests.
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8. Section 63.1547 is revised to read as follows:

§63.1547 Monitoring requirements.

(a) Owners and operators of primary lead processors must 

prepare, and at all times operate according to, a standard 

operating procedures manual that describes in detail the 

procedures for inspection, maintenance, and bag leak detection 

and corrective action for all baghouses that are used to control 

process, process fugitive, or fugitive dust emissions from any 

source subject to the lead emission standards in §§63.1543 and 

63.1544, including those used to control emissions from general 

ventilation systems.

(b) The standard operating procedures manual for baghouses 

required by paragraph (a) of this section must be submitted to 

the Administrator or delegated authority for review and 

approval.

(c) The procedures specified in the standard operating 

procedures manual for inspections and routine maintenance must, 

at a minimum, include the requirements of paragraphs (c)(1) 

through (c)(8) of this section.

(1) Weekly confirmation that dust is being removed from 

hoppers through visual inspection or equivalent means of 

ensuring the proper functioning of removal mechanisms.

(2) Daily check of compressed air supply for pulse-jet 

baghouses.
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(3) An appropriate methodology for monitoring cleaning 

cycles to ensure proper operation.

(4) Monthly check of bag cleaning mechanisms for proper 

functioning through visual inspection or equivalent means.

(5) Quarterly visual check of bag tension on reverse air 

and shaker-type baghouses to ensure that bags are not kinked 

(kneed or bent) or laying on their sides. Such checks are not 

required for shaker-type baghouses using self-tensioning (spring 

loaded) devices.

(6) Quarterly confirmation of the physical integrity of the

baghouse through visual inspection of the baghouse interior for 

air leaks.

(7) Quarterly inspection of fans for wear, material 

buildup, and corrosion through visual inspection, vibration 

detectors, or equivalent means.

(8) Except as provided in paragraph (h) of this section, 

continuous operation of a bag leak detection system.

(d) The procedures specified in the standard operating 

procedures manual for maintenance must, at a minimum, include a 

preventative maintenance schedule that is consistent with the 

baghouse manufacturer's instructions for routine and long-term 

maintenance.
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(e) The bag leak detection system required by paragraph 

(c)(8) of this section must meet the specifications and 

requirements of (e)(1) through (e)(8) of this section.

(1) The bag leak detection system must be certified by the 

manufacturer to be capable of detecting particulate matter 

emissions at concentrations of 10 milligram per actual cubic 

meter (0.0044 grains per actual cubic foot) or less.

(2) The bag leak detection system sensor must provide 

output of relative particulate matter loadings, and the owner or 

operator must continuously record the output from the bag leak 

detection system.

(3) The bag leak detection system must be equipped with an 

alarm system that will sound when an increase in relative 

particulate loading is detected over a preset level, and the 

alarm must be located such that it can be heard or otherwise 

determined by the appropriate plant personnel.

(4) Each bag leak detection system that works based on the 

triboelectric effect must be installed, calibrated, and 

maintained in a manner consistent with guidance provided in the 

U.S. Environmental Protection Agency guidance document ”Fabric 

Filter Bag Leak Detection Guidance” (EPA-454/R-98-015). Other 

bag leak detection systems must be installed, calibrated, and 

maintained in a manner consistent with the manufacturer's 

written specifications and recommendations.
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(5) The initial adjustment of the system must, at a 

minimum, consist of establishing the baseline output by 

adjusting the sensitivity (range) and the averaging period of 

the device, and establishing the alarm set points and the alarm 

delay time.

(6) Following initial adjustment, the owner or operator 

must not adjust the sensitivity or range, averaging period, 

alarm set points, or alarm delay time, except as detailed in the 

approved SOP required under paragraph (a) of this section. In no 

event shall the sensitivity be increased by more than 100 

percent or decreased more than 50 percent over a 365-day period 

unless a responsible official certifies that the baghouse has 

been inspected and found to be in good operating condition.

(7) For negative pressure, induced air baghouses, and 

positive pressure baghouses that are discharged to the 

atmosphere through a stack, the bag leak detector must be 

installed downstream of the baghouse and upstream of any wet 

acid gas scrubber.

(8) Where multiple detectors are required, the system's 

instrumentation and alarm may be shared among detectors.

(f) The standard operating procedures manual required by 

paragraph (a) of this section must include a corrective action 

plan that specifies the procedures to be followed in the event 

of a bag leak detection system alarm. The corrective action plan 
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must include at a minimum, procedures to be used to determine 

the cause of an alarm, as well as actions to be taken to 

minimize emissions, which may include, but are not limited to, 

the following.

(1) Inspecting the baghouse for air leaks, torn or broken 

bags or filter media, or any other condition that may cause an 

increase in emissions.

(2) Sealing off defective bags or filter media.

(3) Replacing defective bags or filter media, or otherwise 

repairing the control device.

(4) Sealing off a defective baghouse compartment.

(5) Cleaning the bag leak detection system probe, or 

otherwise repairing or maintaining the bag leak detection 

system.

(6) Shutting down the process producing the particulate 

emissions.

(g) The percentage of total operating time the alarm on the 

bag leak detection system sounds in a 6-month reporting period 

must be calculated in order to determine compliance with the 

five percent operating limit in §63.1543(h). The percentage of 

time the alarm on the bag leak detection system sounds must be 

determined according to paragraphs (g)(1) through (g)(3) of this 

section.
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(1) For each alarm where the owner or operator initiates 

procedures to determine the cause of an alarm within 1 hour of 

the alarm, 1 hour of alarm time must be counted.

(2) For each alarm where the owner or operator does not 

initiate procedures to determine the cause of the alarm within 1 

hour of the alarm, alarm time will be counted as the actual 

amount of time taken by the owner or operator to initiate 

procedures to determine the cause of the alarm.

(3) The percentage of time the alarm on the bag leak 

detection system sounds must be calculated as the ratio of the 

sum of alarm times to the total operating time multiplied by 

100.

(h) Baghouses equipped with HEPA filters as a secondary 

filter used to control process or process fugitive sources 

subject to the lead emission standards in §63.1543 are exempt 

from the requirement in paragraph (c)(8) of this section to be 

equipped with a bag leak detector. The owner or operator of an 

affected source that uses a HEPA filter must monitor and record 

the pressure drop across the HEPA filter system daily. If the 

pressure drop is outside the limit(s) specified by the filter 

manufacturer, the owner or operator must take appropriate 

corrective measures, which may include, but not be limited to, 

the following:
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(1) Inspecting the filter and filter housing for air leaks 

and torn or broken filters.

(2) Replacing defective filter media, or otherwise 

repairing the control device.

(3) Sealing off a defective control device by routing air 

to other comparable control devices.

(4) Shutting down the process producing the particulate 

emissions.

(i) Owners and operators must monitor sinter machine 

building in-draft to demonstrate continued compliance with the 

operating standard specified in §63.1543(d) in accordance with 

either paragraph (i)(1), (i)(2), or (i)(3) of this section.

(1) Owners and operators must check and record on a daily 

basis doorway in-draft at each doorway in accordance with the 

methodology specified in §63.1546(b).

(2) Owners and operators must establish and maintain 

baseline ventilation parameters which result in a positive indraft according to paragraphs (i)(2)(i) through (i)(2)(iv) of 

this section.

(i) Owners and operators must install, calibrate, maintain, 

and operate a monitoring device that continuously records the 

volumetric flow rate through each separately ducted hood; or 

install, calibrate, maintain, and operate a monitoring device 

that continuously records the volumetric flow rate at the 
Page 113 of 130

control device inlet of each exhaust system ventilating the 

building. The flow rate monitoring device(s) can be installed in 

any location in the exhaust duct such that reproducible flow 

rate measurements will result. The flow rate monitoring 

device(s) must have an accuracy of plus or minus 10 percent over 

the normal process operating range and must be calibrated 

according to manufacturer's instructions.

(ii) During the initial demonstration of sinter building 

in-draft, and at any time the owner or operator wishes to reestablish the baseline ventilation parameters, the owner or 

operator must continuously record the volumetric flow rate 

through each separately ducted hood, or continuously record the 

volumetric flow rate at the control device inlet of each exhaust 

system ventilating the building and record exhaust system damper 

positions. The owner or operator must determine the average 

volumetric flow rate(s) corresponding to the period of time the 

in-draft compliance determinations are being conducted.

(iii) The owner or operator must maintain the volumetric 

flow rate(s) at or above the value(s) established during the 

most recent in-draft determination at all times the sinter 

machine is in operation. Volumetric flow rate(s) must be 

calculated as a 15-minute average.

(iv) If the volumetric flow rate is monitored at the 

control device inlet, the owner or operator must check and 
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record damper positions daily to ensure they are in the 

positions they were in during the most recent in-draft 

determination.

(3) An owner or operator may request an alternative 

monitoring method by following the procedures and requirements 

in §63.8(f) of the General Provisions.

(j) Each owner or operator of new or modified sources 

listed under §63.1543 (a)(1) through (a)(9) and (b) must 

install, calibrate, maintain, and operate a continuous emission 

monitoring system (CEMS) for measuring lead emissions and a 

continuous emission rate monitoring system (CERMS)subject to 

Performance Specification 6 of Appendix B to part 60.

(1) Each owner or operator of a source subject to the 

emissions limits for lead compounds under §63.1543(a)and (b) 

must install a CEMS for measuring lead emissions within 180 days 

of promulgation of performance specifications for lead CEMS.

(i) Prior to promulgation of performance specifications for 

CEMS used to measure lead concentrations, an owner or operator 

must use the procedure described in §63.1546 (a)(1) through 

(a)(7) of this section to determine compliance. 

(2) If a CEMS used to measure lead emissions is applicable, 

the owner or operator must install a CERMS with a sensor in a 

location that provides representative measurement of the exhaust 

gas flow rate at the sampling location of the CEMS used to 
Page 115 of 130

measure lead emissions, taking into account the manufacturer’s 

recommendations. The flow rate sensor is that portion of the 

system that senses the volumetric flow rate and generates an 

output proportional to that flow rate.

(i) The CERMS must be designed to measure the exhaust gas 

flow rate over a range that extends from a value of at least 20 

percent less than the lowest expected exhaust flow rate to a 

value of at least 20 percent greater than the highest expected 

exhaust gas flow rate. 

(ii) The CERMS must be equipped with a data acquisition and 

recording system that is capable of recording values over the 

entire range specified in paragraph (b)(2)(i) of this section. 

(iii) Each owner or operator must perform an initial 

relative accuracy test of the CERMS in accordance with the 

applicable Performance Specification in Appendix B to part 60 of 

the chapter. 

(iv) Each owner or operator must operate the CERMS and 

record data during all periods of operation of the affected 

facility including periods of startup, shutdown, and 

malfunction, except for periods of monitoring system 

malfunctions, repairs associated with monitoring system 

malfunctions, and required monitoring system quality assurance 

or quality control activities (including, as applicable, 

calibration checks and required zero and span adjustments.
Page 116 of 130

(3) Each owner or operator must calculate the lead 

emissions rate in tons per year by summing all hours of CEMS 

data for a year to determine compliance with 63.1543 (b).

(i) When the CERMS are unable to provide quality assured 

data the following applies:

(A) When data are not available for periods of up to 48 

hours, the highest recorded hourly emission rate from the 

previous 24 hours must be used.

(B) When data are not available for 48 or more hours, the 

maximum daily emission rate based on the previous 30 days must 

be used.

(k) The owner or operator of each source subject to 

§63.1544(a) must operate a continuous monitoring system for the 

measurement of lead compound concentrations in air.

(1) The owner or operator must operate compliance monitors 

sufficient in number, location, and frequency of sample 

collection to detect expected maximum concentrations of lead 

compounds in air due to emissions from the affected source(s) in 

accordance with a written plan as described in (k)(2) of this 

paragraph and approved by the Administrator. The plan must 

include descriptions of the sampling and analytical methods 

used. The plan may take into consideration existing monitoring 

being conducted under a state monitoring plan in accordance with 

Part 58.
Page 117 of 130

(2) The owner or operator must submit a written plan 

describing and explaining the basis for the design and adequacy 

of the compliance monitoring network, the sampling, analytical, 

and quality assurance procedures, and any other related 

procedures, and the justification for any seasonal, background, 

or other data adjustments within 45 days after the effective 

date of this subpart. 

(3) The Administrator at any time may require changes in, 

or expansion of, the monitoring program, including additional 

sampling and analytical protocols and network design.

(l) If all rolling three-month average concentrations of 

lead in air measured by the compliance monitoring system are 

less than [50 percent] of the lead concentration in air limit in 

§63.1544(a) for three consecutive years, the owner or operator 

may submit a revised plan to reduce the monitoring sampling and 

analysis frequency (e.g., from daily to weekly).

For any subsequent period, if any rolling three-month 

average lead concentration in air measured at any monitor in the 

monitoring system exceeds [50 percent] of the concentration 

limit in §63.1544(a), the owner or operator must resume 

monitoring pursuant to paragraph (k)(1) at all monitors until 

another three consecutive years of lead concentration in air 
Page 118 of 130

measurements less than [50 percent] of the lead concentration in 

air limit is demonstrated.

9. Section 63.1548 is revised to read as follows:

§63.1548 Notification requirements.

(a) The owner or operator of a primary lead processor must 

comply with the notification requirements of §63.9 of subpart A, 

General Provisions as specified in Table 1 of this subpart.

(b) The owner or operator of a primary lead processor must 

submit the standard operating procedures manual for baghouses 

required under §63.1547(a) to the Administrator or delegated 

authority along with a notification that the primary lead 

processor is seeking review and approval of the manual and 

procedures. Owners or operators of existing primary lead 

processors must submit this notification no later than November 

6, 2000. The owner or operator of a primary lead processor that 

commences construction or reconstruction after April 17, 1998, 

must submit this notification no later than 180 days before 

startup of the constructed or reconstructed primary lead 

processor, but no sooner than September 2, 1999.

(c) The owner or operator of a primary lead processor must 

submit the compliance monitoring network plan required under 

§63.1547(k)(2) to the Administrator or delegated authority along 

with a notification that the primary lead processor is seeking 

review and approval of the plan. Owners or operators of existing 
Page 119 of 130

primary lead processors must submit this notification no later 

than 45 days after promulgation of this subpart. The owner or 

operator of a new, reconstructed, or modified primary lead 

processor must submit this notification no later than 180 days 

before startup of the constructed or reconstructed primary lead 

processor.

10. Section 63.1549 is revised to read as follows:

§63.1549 Recordkeeping and reporting requirements.

(a) The owner or operator of a primary lead processor must 

comply with the recordkeeping requirements of §63.10 of subpart 

A, General Provisions as specified in Table 1 of this subpart.

(b) In addition to the general records required by 

paragraph (a) of this section, each owner or operator of a 

primary lead processor must maintain for a period of 5 years, 

records of the information listed in paragraphs (b)(1) through 

(b)(10) of this section.

(1) Production records of the weight and lead content of 

lead products, copper matte, and copper speiss.

(2) Records of the bag leak detection system output.

(3) An identification of the date and time of all bag leak 

detection system alarms, the time that procedures to determine 

the cause of the alarm were initiated, the cause of the alarm, 

an explanation of the actions taken, and the date and time the 

cause of the alarm was corrected.
Page 120 of 130

(4) Any recordkeeping required as part of the requirements 

described in the compliance monitoring system plan required 

under §63.1547(k)(2).

(5) Any recordkeeping required as part of the practices 

described in the standard operating procedures manual for 

baghouses required under §63.1547(a).

(6) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(1), the records of the daily doorway in-draft 

checks, an identification of the periods when there was not a 

positive in-draft, and an explanation of the corrective actions 

taken.

(7) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(2), the records of the output from the continuous 

volumetric flow monitor(s), an identification of the periods 

when the 15-minute volumetric flow rate dropped below the 

minimum established during the most recent in-draft 

determination, and an explanation of the corrective actions 

taken.

(8) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 
Page 121 of 130

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(2), and volumetric flow rate is monitored at the 

baghouse inlet, records of the daily checks of damper positions, 

an identification of the days that the damper positions were not 

in the positions established during the most recent in-draft 

determination, and an explanation of the corrective actions 

taken.

(9) Records of the occurrence and duration of each 

malfunction of operation (i.e., process equipment) or the air 

pollution control equipment and monitoring equipment. 

(10) Records of actions taken during periods of malfunction 

to minimize emissions in accordance with §§63.1543(i) and 

63.1544(e), including corrective actions to restore 

malfunctioning process and air pollution control and monitoring 

equipment to its normal or usual manner of operation. 

(c) Records for the most recent 2 years of operation must 

be maintained on site. Records for the previous 3 years may be 

maintained off site.

(d) The owner or operator of a primary lead processor must 

comply with the reporting requirements of §63.10 of subpart A, 

General Provisions as specified in Table 1 of this subpart.

(e) In addition to the information required under §63.10 of 

the General Provisions, the owner or operator must provide semi-
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annual reports containing the information specified in 

paragraphs (e)(1) through (e)(9) of this section to the 

Administrator or designated authority.

(1) The reports must include records of all alarms from the 

bag leak detection system specified in §63.1547(e).

(2) The reports must include a description of the actions 

taken following each bag leak detection system alarm pursuant to 

§63.1547(f).

(3) The reports must include a calculation of the 

percentage of time the alarm on the bag leak detection system 

sounded during the reporting period pursuant to §63.1547(g).

(4) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(1), the reports must contain an identification of 

the periods when there was not a positive in-draft, and an 

explanation of the corrective actions taken.

(5) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(2), the reports must contain an identification of 

the periods when the 15-minute volumetric flow rate(s) dropped 

below the minimum established during the most recent in-draft 
Page 123 of 130

determination, and an explanation of the corrective actions 

taken.

(6) If an owner or operator chooses to demonstrate 

continuous compliance with the sinter building in-draft 

requirement under §63.1543(d) by employing the method allowed in 

§63.1547(i)(2), and volumetric flow rate is monitored at the 

baghouse inlet, the reports must contain an identification of 

the days that the damper positions were not in the positions 

established during the most recent in-draft determination, and 

an explanation of the corrective actions taken. 

(7) The reports must contain a summary of the records 

maintained as part of the practices described in the standard 

operating procedures manual for baghouses required under 

§63.1547(a), including an explanation of the periods when the 

procedures were not followed and the corrective actions taken.

(8) The reports must contain a summary of the compliance 

monitoring results for the required reporting period, including 

an explanation of any periods when the procedures outlined in 

the compliance monitoring system plan required by §63.1547(k)(2) 

were not followed and the corrective actions taken.

(9) If there was a malfunction during the reporting period, 

the report shall also include the number, duration, and a brief 

description for each type of malfunction which occurred during 

the reporting period and which caused or may have caused any 
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applicable emission limitation to be exceeded. The report must 

also include a description of actions taken by an owner or 

operator during a malfunction of an affected source to minimize 

emissions in accordance with §§63.1543(i) and 63.1544(b), 

including actions taken to correct a malfunction.

11. Section 63.1550 is revised to read as follows:

§63.1550 Delegation of authority.

(a) In delegating implementation and enforcement authority 

to a State under section 112(l) of the act, the authorities 

contained in paragraph (b) of this section must be retained by 

the Administrator and not transferred to a State.

(b) Authorities which will not be delegated to States: no

restrictions.

12. Section 63.1551 is added to read as follows:

§63.1551 Affirmative defense for exceedance of emission limit 

during malfunction.

In response to an action to enforce the standards set forth 

in this subpart you may assert an affirmative defense to a claim 

for civil penalties for exceedances of such standards that are 

caused by malfunction, as defined at 40 CFR 63.2. Appropriate 

penalties may be assessed, however, if you fail to meet your 

burden of proving all of the requirements in the affirmative 

defense. The affirmative defense shall not be available for 

claims for injunctive relief.
Page 125 of 130

(a) To establish the affirmative defense in any action to 

enforce such a limit, you must timely meet the notification 

requirements in paragraph (b) of this section, and must prove by 

a preponderance of evidence that:

(1) The excess emissions: 

(i) Were caused by a sudden, infrequent, and unavoidable 

failure of air pollution control and monitoring equipment, 

process equipment, or a process to operate in a normal or usual 

manner, and 

(ii) Could not have been prevented through careful 

planning, proper design or better operation and maintenance 

practices; and

 (iii) Did not stem from any activity or event that could 

have been foreseen and avoided, or planned for; and

(iv) Were not part of a recurring pattern indicative of 

inadequate design, operation, or maintenance; and

(2) Repairs were made as expeditiously as possible when 

the applicable emission limitations were being exceeded. Offshift and overtime labor were used, to the extent practicable to 

make these repairs; and

 (3) The frequency, amount and duration of the excess 

emissions (including any bypass) were minimized to the maximum 
Page 126 of 130

extent practicable during periods of such emissions; and

 (4) If the excess emissions resulted from a bypass of 

control equipment or a process, then the bypass was unavoidable 

to prevent loss of life, personal injury, or severe property 

damage; and

 (5) All possible steps were taken to minimize the impact of 

the excess emissions on ambient air quality, the environment and 

human health; and

 (6) All emissions monitoring and control systems were kept 

in operation if at all possible, consistent with safety and good 

air pollution control practices; and

 (7) All of the actions in response to the excess emissions 

were documented by properly signed, contemporaneous operating 

logs; and

(8) At all times, the facility was operated in a manner 

consistent with good practices for minimizing emissions; and

(9) A written root cause analysis has been prepared, the 

purpose of which is to determine, correct, and eliminate the 

primary causes of the malfunction and the excess emissions 

resulting from the malfunction event at issue. The analysis 

shall also specify, using best monitoring methods and 

engineering judgment, the amount of excess emissions that were 

the result of the malfunction. 
Page 127 of 130

(b) Notification. The owner or operator of the facility 

experiencing an exceedance of its emission limit(s) during a 

malfunction shall notify the Administrator by telephone or 

facsimile (FAX) transmission as soon as possible, but no later 

than two business days after the initial occurrence of the 

malfunction, if it wishes to avail itself of an affirmative 

defense to civil penalties for that malfunction. The owner or 

operator seeking to assert an affirmative defense shall also 

submit a written report to the Administrator within 45 days of 

the initial occurrence of the exceedance of the standards in 

this subpart to demonstrate, with all necessary supporting 

documentation, that it has met the requirements set forth in 

paragraph (a) of this section. The owner or operator may seek 

an extension of this deadline for up to 30 additional days by 

submitting a written request to the Administrator before the 

expiration of the 45 day period. Until a request for an 

extension has been approved by the Administrator, the owner or 

operator is subject to the requirement to submit such report 

within 45 days of the initial occurrence of the exceedance. 

12. Table 1 to Subpart TTT of Part 63 is revised to read as 

follows:

Table 1 of Subpart TTT – General Provisions Applicability to 

Subpart TTT
Page 128 of 130

Reference

Applies 

to 

subpart 

TTT Comment

* * * * * * *

63.6(a), (b), (c) Yes

63.6 (d) No Section reserved.

63.6(e)(1)(i) No See 63.1543(i) 

and 63.1544(b) 

for general duty 

requirement. 

63.6(e)(1)(ii) No

63.6(e)(1)(iii) Yes

63.6(e)(2) No Section reserved.

63.6(e)(3) No

63.6(f)(1) No

63.6(g) Yes

63.6(h) No No opacity limits 

in rule.

63.6(i) Yes

63.6(j) Yes

§63.7(a)-(d) Yes
Page 129 of 130

§63.7(e)(1) No See 63.1546(c). 

§63.7(e)(2)-(e)(4) Yes

63.7(f), (g), (h) Yes

63.8(a)-(b) Yes

63.8(c)(1)(i) No

63.8(c)(1)(ii) Yes

63.8(c)(1)(iii) No

63.8(c)(2)-(d)(2) Yes

63.8(d)(3) Yes, 

except 

for last 

sentence

63.8(e)-(g) Yes

63.9(a),(b),(c),(e),(g),(h)(1)through 

(3), (h)(5) and (6), (i) and (j)

Yes

63.9(f) No

63.9(h)(4) No Reserved

63.10(b)(2)(i) No

63.10(b)(2)(ii) No See 63.1549(b)(9) 

and (10) for 

recordkeeping of 

occurrence and 
Page 130 of 130

duration of 

malfunctions and 

recordkeeping of 

actions taken 

during 

malfunction. 

63.10(b)(2)(iii) Yes

63.10(b)(2)(iv)-(b)(2)(v) No

63.10(b)(2)(vi)-(b)(2)(xiv) Yes

63.(10)(b)(3) Yes

63.10(c)(1)-(9) Yes

63.10(c)(10)-(11) No See 63.1549(b)(9) 

and (10) for 

recordkeeping of 

malfunctions. 

63.10(c)(12)-(c)(14) Yes

63.10(c)(15) No

63.10(d)(1)-(4) Yes

63.10(d)(5) No See 63.1549(e)(9) 

for reporting of 

malfunctions.

63.10(e)-((f) Yes

* * * * * * *