70834 Federal Register / Vol. 76, No. 220 / Tuesday, November 15, 2011 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 63 

[EPA–HQ–OAR–2004–0305; FRL–9491–2] 

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 stack emission limits for 

lead, work practice standards to 

minimize fugitive dust emissions, and 

the modification and addition of testing 

and monitoring and related notification, 

recordkeeping, and reporting 

requirements. 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 

November 15, 2011. 

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 http://www.regulations.gov Web 

site. 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 

http://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. 

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 Contact 1 OAQPS Contact 2

Primary Lead Processing ................................... Maria Malave, (202) 564–7027, 

malave.maria@epa.gov.

Nathan Topham, (919) 541–0483, 

topham.nathan@epa.gov. 

1EPA’s Office of Enforcement and Compliance Assurance. 

2EPA’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-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 

I. National Technology Transfer and 

Advancement Act 

J. Executive Order 12898: Federal Actions 

To Address Environmental Justice in 

Minority Populations and Low-Income 

Populations 


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Federal Register / Vol. 76, No. 220 / Tuesday, November 15, 2011 / Rules and Regulations 70835 

1USEPA. Documentation for Developing the 

Initial Source Category List—Final Report, USEPA/ 

OAQPS, EPA–450/3–91–030, July, 1992. 

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 MACT 2 code 

Primary Lead Processing ............................................................................................................................ 331419 0204 

1 North American Industry Classification System. 

2 Maximum Achievable Control Technology. 

Table 2 is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by the final action for the 

source 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 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 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 January 17, 2012. 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 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 

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 bestperforming 12 percent of existing 

sources in the category or subcategory 

(or the best-performing five sources for 

categories or subcategories with fewer 


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2EPA 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. 

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 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 technology-based 

standards and to revise the standards, if 

necessary, to provide an ample margin 

of safety to protect public health or to 

prevent, taking into consideration costs, 

energy, safety, and other relevant 

factors, an 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 (DC 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 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. 

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 emissions 

of lead and other pollutants 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. 

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 are 

requiring 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

• Work practice standards to 

minimize fugitive dust emissions. 

To satisfy section 112(d)(6) of the 

CAA, we are 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 


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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-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 emissions reductions in lead 

and other hazardous air pollutants 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 112 regulations 

governing the emissions of HAP during 

periods of startup, shutdown, and 

malfunction (SSM). Sierra Club v. EPA, 

551 F.3d 1019 (DC 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 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 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 (DC 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 conduct the 

perfect study.’’). See also, Weyerhaeuser 

v. Costle, 590 F.2d 1011, 1058 (DC 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 


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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 CFR 63.2 (definition of 

malfunction). 

Finally, the EPA recognizes that even 

equipment that is properly designed and 

maintained can sometimes fail and that 

such failure can sometimes cause an 

exceedance of the relevant emission 

standard. (See, e.g., State 

Implementation Plans: Policy Regarding 

Excessive Emissions During 

Malfunctions, Startup, and Shutdown 

(Sept. 20, 1999); Policy on Excess 

Emissions During Startup, Shutdown, 

Maintenance, and Malfunctions (Feb. 

15, 1983)). The EPA is therefore adding 

to the final rule an affirmative defense 

to civil penalties for exceedances of 

emission limits that are caused by 

malfunctions. See 40 CFR 63.1542 

Primary Lead Processing (defining 

‘‘affirmative defense’’ to mean, in the 

context of an enforcement proceeding, a 

response or defense put forward by a 

defendant, regarding which the 

defendant has the burden of proof, and 

the merits of which are independently 

and objectively evaluated in a judicial 

or administrative proceeding.). We also 

have added other regulatory provisions 

to specify the elements that are 

necessary to establish 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 CFR 22.24). The criteria ensure that 

the affirmative defense is available only 

where the event that causes an 

exceedance of the emission limit meets 

the narrow definition of malfunction in 

40 CFR 63.2 (sudden, infrequent, not 

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(d), 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 CFR 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 

(DC 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 (DC Cir. 1973), the DC 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 (DC 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 (DC 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 November 15, 2011. For the 

MACT standards being addressed in this 

action, the compliance date for the 

revised SSM requirements is the 

effective date of the standards, 

November 15, 2011. The compliance 

date for the revised emission standard 

in section 16.1543(a) is January 17, 

2012. The compliance date for the 

revised requirements in section 16.1544 

is February 13, 2012. The compliance 

date for the new refining and furnace 

area stack emission limit is 2 years from 

the effective date of the standard, 

November 15, 2013. 

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 


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3For 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. 

4EPA 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. 

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 and furnace area stacks 

can likely result in exceedences of the 

NAAQS for lead beyond the fenceline of 

the facility.3 These results also indicate 

that fugitive dust emissions could result 

in exposures approximately equal to the 

level of the NAAQS at the location of 

maximum impact. The 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) Offsite impact 3

Main stack 1 ............................................................................................................................................. 68.3 0.9 times the NAAQS. 

Refining stacks 2 ...................................................................................................................................... 9.1 8 times the NAAQS. 

Furnace area stack: (Controlled blast and drossing fugitives) ................................................................ 2.5 2 times the NAAQS. 

Fugitive dust ............................................................................................................................................ 1.0 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 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, 

the EPA is promulgating a combined 

lead emission limit for the furnace area 

and refining operations stacks at 1.2 

tons per year.4 In addition, the risk 

assessment projected ambient lead 

concentrations from fugitive dust 

emissions to be very close to the 

NAAQS for lead at the location of 

maximum impact; thus with respect to 

fugitive dust emissions, since only 

minimal (if any) reductions beyond 

those already in place are needed to 

ensure lead levels in the air do not 

exceed the NAAQS, the EPA believes 

that the work practice standards being 

promulgated in this rule, which are 

more stringent than currently required 

by the 1999 NESHAP, will ensure an 

acceptable level of risk. 

Moreover, since this NESHAP 

includes work practice standards to 

minimize fugitive dust emissions, and 

since ambient monitoring for lead is 

already conducted very close to this 

facility and in the local community to 

demonstrate whether the area is 

attaining the lead NAAQS, we have 

decided that fenceline monitoring to 

specifically demonstrate that the source 

has adopted sufficient work practice 

standards to ensure fugitive emissions 

do not cause exceedances of the NAAQS 

is not necessary. 

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 


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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 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 exposure 

levels, we can only say that worst case 

modeling suggests there could be 

potential risks. However, due to the 

highly conservative nature of this 

screening assessment and the 

uncertainties related to the results, we 

have concluded that, after 

implementation of the controls required 

by this rule, 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 costeffective 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 

standards we are promulgating today 

provide 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 dust 

emissions, including cleaning plant 

roadways, stabilization of material 

during storage and handling, and 

ensuring that doorways to process areas 

remain closed. In summary, we 

conclude that these standards being 

promulgated today will ensure risks are 

acceptable and public health is 

protected with an ample margin of 

safety and that there will not be 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 indicated 

the source had significantly lower 

emissions than the emission limit of 1 

pound of lead per ton of lead produced 

(lb/ton) required in the 1999 MACT 

standard. However, in comments 

received on the proposed rule, The Doe 

Run Company indicated that the 

proposed emission limit of 0.22 lb/ton 

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 emissions 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 promulgating 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 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). 

As mentioned earlier, we are not 

finalizing a requirement for fenceline 

monitoring to ensure that fugitive dust 

emissions do not cause an exceedance 

of the NAAQS offsite. The revised 

modeling showed substantially lower 

ambient concentrations due to fugitive 

dust emissions relative to the modeling 

performed for the proposed rule. We 

estimate current fugitive dust emissions 

result in maximum lead levels offsite 

that are approximately equal to the 

NAAQS. We are promulgating work 

practice standards beyond what is 

required by the 1999 rule that must be 

implemented by the source in order to 

ensure that fugitive emissions will not 

result in an exceedance of the NAAQS 

and thus result in an unacceptable risk. 

We expect that after implementation of 

this revised NESHAP, fugitive dust 

emissions from primary lead processing 


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facilities will not result in exposures 

levels above the NAAQS. Since the risk 

levels are much lower than we had 

estimated at proposal, and since we are 

promulgating specific work practice 

requirements to minimize fugitive dust 

emissions, we have determined that the 

proposed fenceline monitoring 

requirement is not necessary to show 

compliance with this NESHAP. 

Furthermore, there are already several 

monitors nearby that measure ambient 

lead levels and that should provide 

sufficient indication of whether fugitive 

lead emissions have been sufficiently 

reduced. 

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.’’ The 

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.’’ The EPA is also 

revising the language of 63.1551(a)(9) to 

clarify that the purpose of the root cause 

analysis is to determine, correct, and 

eliminate the primary cause of the 

malfunction. The root cause analysis 

itself does not necessarily require that 

the cause be determined, corrected or 

eliminated. However, in most cases, the 

EPA believes that a properly conducted 

root cause analysis will have such 

results. In addition, the EPA is revising 

63.1551(b) to state that a written report 

must be submitted within 45 days of the 

initial occurrence of the malfunction 

and that the source may seek an 

extension of up to an additional 30 

days. 

V. Summary of Significant Comments 

and Responses 

In the proposed action, we requested 

public comments on all aspects of the 

proposal, including our residual risk 

reviews and resulting proposed 

standards, our technology reviews and 

resulting proposed standard, and our 

proposed amendments to delete the 

startup and shutdown exemptions and 

the malfunction exemption and to 

establish an affirmative defense for 

malfunctions. 

We received written comments from 

16 commenters. Our responses to some 

of the significant public comments are 

provided below. Responses to the 

comments that are not in the preamble 

have been placed in the docket. See 

Summary of Public Comments and 

Responses for Primary Lead Processing 

NESHAP (October 2011), for summaries 

of other comments and our responses to 

them. 

A. Timeline for Compliance 

Comment: Two commenters opposed 

the compliance timing and supported 

extending the compliance date beyond 

two years for several reasons. One 

commenter stated that according to the 

time line in the proposed rule, the 

facility will operate in its current form 

for only a few months after the 

compliance date of the rule. This creates 

a dilemma for the State and facility in 

terms of implementation, planning, 

resources and compliance. The 

commenter suggested that the 

implementation and attainment 

schedules for this MACT rule should 

correspond to those of the 2008 

NAAQS. 

One commenter identified three 

provisions they suggest could be used to 

allow more than 2 years for compliance: 

(1) 112(i)(3)(A) establishes 3 years for 

compliance for section 112 standards, 

(2) 112(i)(5) allows exemption for up to 

6 years for facilities demonstrating 90 

percent reduction in HAP prior to first 

proposal of a section 112(d) standard, 

and (3) 112(h)(3) allows an alternative 

means of compliance in some 

circumstances. The commenter stated 

that 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 twoyear 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 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 twoyear 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 twoyear 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 two-year 

compliance timeframe relies, in part, on 

the various steps that must be 

undertaken to implement a plan to 

monitor lead concentration in air. But 

this reliance is also misplaced because 

it requires Doe Run to comply with the 

new Lead NAAQS in 2013, or more than 

two years before the Lead NAAQS itself 

requires compliance. No statutory 

authority supports such accelerated 

compliance for the lead NAAQS or 

preemption of the SIP process. In short, 


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the two-year timeframe rests on faulty 

grounds: Factually, it is inconsistent 

with the Consent Decree requirements, 

and legally, it unlawfully attempts to 

speed up the previously-established 

compliance timeframe for the lead 

NAAQS. 

Response: Section 112(i)(3) 

establishes the compliance timeframe 

for any standard issued under section 

112 for existing sources and provides 

that the compliance date shall be as 

expeditiously as practicable but no later 

than 3 years following the effective date 

of the standard. Section 112(f)(4), 

however, expressly provides more 

specific requirements for standards 

issued under section 112(f) and thus for 

section 112(f) standards those more 

prescriptive requirements govern in 

place of the compliance requirements in 

section 112(i)(3). Specifically, section 

112(f)(4) provides that a source cannot 

emit an air pollutant in violation of a 

standard issued under subsection (f) 

except that the standard will not apply 

until 90 days after its effective date. It 

also provides that the Administrator 

may grant a waiver for a period of up 

to 2 years from the effective date if 

necessary for the installation of controls 

and if measures will be taken in the 

interim to ensure public health is 

protected from imminent endangerment. 

Thus, for standards applicable to the 

furnace and refinery area emissions and 

the work practice standards to address 

fugitive emissions, which were issued 

under section 112(f), the compliance 

period may not exceed two years from 

the effective date of the standard. We 

are providing 90 days for compliance 

with the work practice standards and 

two years for compliance with the 

standards applicable to the furnace and 

refinery area stacks. 

The main stack emission limit, 

proposed under 112(d)(6), is subject to 

the section 112(i)(3) compliance 

provisions. We are establishing an 

emission standard of 0.97 lb Pb/ton of 

lead produced that would replace the 

existing standard of 1 lb Pb/ton of lead 

produced. This standard is based on the 

level of emissions that the source is 

already achieving in practice and thus 

no additional controls would be needed 

to meet that emission limit for the main 

stack. For that reason, we are requiring 

compliance with the new limit for the 

main stack within 60 days of the 

effective date of this final rule as this 

timeframe constitutes compliance ‘‘as 

expeditiously as practicable.’’ 

Concerning section 112(i)(5), the 

provision only applies to standards 

promulgated pursuant to section 112(d) 

(and not 112(f)) and also only where a 

source achieves a 90% reduction (95% 

in the case of HAPs that are particulate 

matter) prior to the proposal of the 

section 112(d) standard. Thus, this 

provision does not apply to the 

standards established under 112(f) in 

this final rule. With regard to the 

emission standard proposed for the 

main stack, stack test data indicate that 

the main stack emissions are 

substantially higher than the 14 tons per 

year value cited by the commenter. 

Based on performance test data, the 

facility has not achieved the reductions 

in emissions required to apply the 

alternative compliance dates in section 

112(i)(5). 

Section 112(h)(3) allows the 

Administrator through notice and 

comment rulemaking to accept an 

alternative means of emission limit in 

place of a work practice standard 

established under 112(h)(1) if the owner 

or operator of a source establishes that 

such alternative means will achieve 

reductions at least equivalent to those 

that would be achieved by the work 

practice standard. It is unclear precisely 

what the commenter is suggesting with 

regard to this provision. However, it 

seems they may be suggesting that the 

new hydrometallurgical process that 

they plan to install after they close the 

pyrometallurgical processes should be 

considered an alternative means of 

compliance with the work practice 

standard. It is unclear how this process 

would address the emissions covered by 

the work practice standards we are 

establishing which are intended to 

address current fugitive dust 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 dust emissions 

addressed through the work practice 

standards, it would not be an 

appropriate substitute in the absence of 

being able to achieve the necessary 

reductions within the compliance 

period. We note that our determination 

here does not preclude Doe Run from 

submitting additional information that 

may further support a demonstration 

under section 112(h)(3) and for which 

we could take further action in a 

separate rulemaking. 

As to the concerns the commenter 

raises about this situation being unique, 

we do not disagree. However, the statute 

is clear that the maximum compliance 

period for standards issued pursuant to 

section 112(f) is two years. The 

commenter submits no facts or 

information that supports a legal basis 

for providing a longer period for 

compliance for the refining and furnace 

area stack limits and for the work 

practice standards to minimize fugitive 

dust 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 industrial 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 contemplates 

but requires, if practicable, for areas to 

attain the 2008 lead NAAQS earlier than 

December 31, 2015. 

Additionally, we are not requiring 

fenceline monitoring as part of the final 

NESHAP amendments. Therefore, the 

commenter’s concerns related to 

potential conflict between monitoring 

for the NAAQS and this NESHAP are no 

longer relevant. 

Comment: One commenter stated that 

the proposed emission standards and 

ambient standard had negative 

implications for determining 

compliance under the proposed twoyear 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 mg/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 


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example, Doe Run achieves an aggregate 

emission of 0.22 lb/ton on a facility 

wide basis but exceeds 0.91 tpy for its 

furnace and refining and casting 

operations, would it be in compliance? 

Of the three numerical standards, the 

commenter stated that only the 0.91 tpy 

limit can arguably be linked to Section 

112(f), and even that is unclear. The 

0.91 tpy standard is derived from the 

Lead NAAQS risk analysis. Despite this 

starting point, this standard is 

subsumed in the proposed 0.22 lb/ton 

plant-wide limit which arose under the 

section 112(d)(6) technology review, 

adjusted for ‘‘variability in the 

operations and emissions.’’ While an 

effort is made to differentiate the 

components of the 0.22 lb/ton standard 

as to which portion fits under what 

statutory authority, this single plantwide 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. Additionally, 

we have eliminated the fenceline 

monitoring requirement from the final 

rule. These changes 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 plantwide limit is not needed under either of 

those statutory requirements. 

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 

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. 

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. 

Although, the source category name 

in the 1999 NESHAP was ‘‘primary lead 

smelting’’ rather than ‘‘primary lead 

processing,’’ it was given that title 

because, at that time smelting was the 

only technology used to process lead ore 

into lead metal. However, the threeword title should not be read as limiting 

the broader language in the description 

of the source category, which provides 

the full evidence of EPA’s intent of what 

should be included in the source 

category. 

Recently, during the development of 

this RTR rulemaking, we became aware 

of a new primary lead processing and 

production technology (i.e., 

hydrometallurgical process). It is our 

understanding that even after this new 

technology is in place, the facility plans 

to continue operating some of the same 

thermal processes in use now and 

subject to the NESHAP (such as refining 

and casting) which continue to have the 

potential to emit significant amounts of 

lead. We also note that this facility will 

continue to have the potential for 

fugitive emissions. For these reasons, 

we conclude that it is appropriate and 

necessary to update the title for the 

MACT standard and the applicability 

section of the standard, consistent with 

the description of the listed source 

category, to ensure these emissions 

points continue to be subject to 

emissions standards. However, it is also 

important to note that the rule being 

promulgated today has no requirements 

that apply to the hydrometallurgical 

processes themselves, since this process 

currently does not exist at this facility. 


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As noted in the response to comments, 

if a new process such as the 

hydrometallurgical process is developed 

and put into use in the future, then EPA 

would consider what standards to 

propose for such process after such 

process is operational. 

We believe section 112(d)(1) provides 

the authority for this revision to the 

standard. That provision requires EPA 

to ‘‘promulgate regulations establishing 

emission standards for each category or 

subcategory of major sources and area 

sources’’ of the hazardous air pollutants 

listed in section 112(b)(1). Because 

EPA’s initial promulgation of the MACT 

standard did not fully describe the 

source category, and thus did not 

regulate all potential sources within the 

source category, we believe it is now 

appropriate to revise the applicability 

provision to fully cover the sources as 

provided under the source category 

listing. 

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 lead production 

process cannot be treated as a major 

source category. 

Response: As explained in detail 

elsewhere, the EPA has the authority to 

impose additional requirements on 

emission points already subject to an 

emission standard and to impose 

requirements on previously unregulated 

emission points in performing a risk and 

technology review. The EPA has 

exercised that authority here by 

establishing emission limitations for 

activities previously only subject to 

work practice requirements. The 

commenter’s arguments to the contrary 

notwithstanding, the revised 

applicability definition will result in a 

source category containing a major 

source, the Doe Run facility. Doe Run is 

currently a major source of lead 

emissions and will be a major source of 

such emissions on the date by which it 

must initially comply with the newly 

established emission limits for refining 

activities. Thus, regardless of the level 

of its emissions following conversion to 

the hydrometallurgical process, Doe 

Run must meet the newly established 

emission limits by the specified date(s). 

As noted elsewhere, a new 

hydrometallurgical process is not 

subject to an emission limit under the 

existing MACT standard as it now exists 

or following the changes resulting from 

this rulemaking; 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 rulepromulgating 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 * * * 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 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 mg/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 CFR 


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5Harrison, 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., Prade`re, 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, 4. (2011). Water, Air, & Soil Pollution, 

Vol. 218, p. 157–163.; Sobanska, S., Ricq, N., 

Laboudigue, A., Guillermo, R., Bre ́mard, 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. 

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 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 dust 

emissions would need to be addressed 

by work practice standards (as is 

allowed under section 112(h)(1)). 

Finally, we proposed a fenceline 

monitoring requirement to ensure that 

the work practice standards adequately 

address fugitive dust emissions 

consistent with the requirements of 

section 112(f). However, we have 

eliminated the fenceline monitoring 

requirement in the final rule. Instead, 

we are specifying work practice 

standards to minimize fugitive dust 

emissions. Because we are not requiring 

fenceline monitoring in this final rule, 

the commenter’s concerns related to 

redundant monitoring requirements 

need not be addressed. 

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 dust 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 dust 

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. 

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 (DC 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 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 the 

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 the 

EPA was regulating particulate matter 

‘‘through the back door.’’ In the present 

situation, the 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 

uncontrolled subcategories of these sources. 

See Proposed Rule, 75 Fed. Reg. 65068, 

65115, 65106 (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 the 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 the 

EPA has discretion in determining how 

to address a purported flaw in a 

promulgated standard. The ‘‘as 

necessary’’ language cited by the 


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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 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) and (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 

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 the 

target organ specific hazard index 

(TOSHI) for chronic non-cancer effects 

evaluates the cumulative effects of HAP 

on a given target organ. Further, our 

assessment for Primary Lead Processing 

is cumulative in that it considers all 

emission points within the fenceline 

(since they are all covered by the 

MACT). Moreover, the level of the lead 

NAAQS, which we used as the metric 

for defining unacceptable risk, was set 

based on all air-related 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 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 

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 


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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 3-month lead concentrations. 

Alternately, the commenter stated that 

the EPA should either defer to 

appropriate air quality monitoring 

information or to the modeling run used 

for the 2007 SIP revision attainment 

demonstration as the basis for this RTR. 

Some commenters also suggested using 

AERMOD modeling followed by 

LEADPOST, rather than using HEM–3 to 

ultimately calculate 3-month rolling 

average lead concentrations. 

Two commenters identified specific 

issues with regard to the modeling 

approach and input data including: 

• The ratio of modeled results to 

monitored data should not exceed a 

factor of two. The commenter provided 

specific corrections and analysis of data. 

• The NAAQS attainment 

demonstration model developed by the 

State of Missouri and the RTR modeling, 

although conducted for different 

purposes, are both based on compliance 

with the same standard for the same 

geographic location. Therefore, the 

output of both dispersion models, 

whether for residual risk assessment or 

SIP development, should reflect the 

maximum ambient air lead 

concentration. The commenter stated 

that any data limitations should be 

addressed with input from the 

commenter. 

• Improvements from the 2007 SIP for 

the fugitive emissions from 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 threemonth average ambient air 

concentration of 1.12 mg/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 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 a matter of policy’’ 

and that ‘‘the task at hand is to provide 

a quantitative risk assessment of the 

maximum non-adverse facility-level 

emissions rate for all ages, which cannot 

be done on the basis of a risk assessment 

that studied children only. 

Response: The lead NAAQS was a 

public 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 mg/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 change of 1.0 mg/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 mg/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 


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6This 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. 

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 air-related multi-pathway 

exposures from industrial sources like 

primary and secondary lead smelting 

operations. We conclude that the level 

of the NAAQS presents an acceptable 

level of risk from lead in ambient air. 

Moreover, we are promulgating 

emissions limits (for the furnace area 

and refining operation stacks) to reduce 

emissions and promulgating specific 

work practice standards to minimize 

fugitive emissions to ensure that 

emissions do not result in exceedances 

of the NAAQS. As part of our ‘‘ample 

margin of safety’’ analysis, we examined 

whether there were additional cost 

effective controls available to further 

reduce emissions and risks. As 

explained elsewhere in this notice and 

in other supporting documents available 

in the docket, we have not identified 

any additional cost effective controls to 

reduce emissions further and 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 mg/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-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 

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. We did not identify any 

additional cost-effective controls 

beyond those that would need to be 

implemented to ensure an acceptable 

level of risk. Thus, with regard to the 

two stack emissions points (the furnace 

area stack and the refinery stacks) for 

which we are requiring action to ensure 

an acceptable level of risk, and for 

fugitive dust emissions, for which we 

are specifying work practice standards, 

we have concluded that there are no 

additional cost-effective controls and 

that an ample margin of safety will be 

provided by the same controls that 

ensure an acceptable level of risk. 

Moreover, there are no additional cost 

effective controls to further reduce 

emissions from the main stack beyond 

those controls that are already applied. 

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 

accounted for or prevented 

environmental risks from lead or nonlead 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 FR 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 


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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 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’’ (U.S. 

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 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 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-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 multi-pathway, multimedia impacts of lead, the risk 

assessment supporting the NAAQS 

considered direct inhalation exposures 

and indirect air-related multi-pathway 

exposures from industrial sources like 

primary and secondary lead smelting 

operations. It 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 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 


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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 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 

of the proposed rule 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. Moreover, although the 

requirements that we are promulgating 

in today’s action are somewhat different 

than the proposed requirements, we 

believe that the requirements that we 

are promulgating will also ensure that 

the facility’s contribution to ambient 

concentrations of lead will not present 

an unacceptable level of risk. In 

addition, as discussed previously, we 

have not identified any additional costeffective controls and we therefore 

conclude that the same level of controls 

to achieve acceptable risks will 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 as much 

as 10 tons per year of lead from the 

furnace area and refining operations 

stacks. We also expect reductions will 

be achieved with the additional work 

practices, but we have not been able to 

quantify those reductions. These 

controls and work practices will also 

reduce emissions of other HAP emitted 

from the facility. The costs of these 

controls and work practices were not 

directly considered in the decision 

because these controls and practices are 

necessary to ensure that risks are 

acceptable. 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. 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, we 

concluded that there were no additional 

cost effective developments in practices, 

processes or control technologies for 

any sources other than the main stack. 

VII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review, and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

Under Executive Order 12866 (58 FR 

51735, October 4, 1993), this action is a 

‘‘significant regulatory action.’’ This 

action is a significant regulatory action 

because it raises novel legal and policy 

issues. Accordingly, the EPA submitted 

this action to the Office of Management 

and Budget (OMB) for review under 

Executive Order 12866 and Executive 

Order 13563 (76 FR 3821, January 21, 

2011), and any changes made in 

response to OMB recommendations 

have been documented in the docket for 

this action. 

B. Paperwork Reduction Act 

The Office of Management and Budget 

(OMB) has approved the information 

collection requirements contained in 

this rule under the provisions of the 

Paperwork Reduction Act, 44 U.S.C. 

3501 et seq. and has assigned OMB 

control number 2060–0414. 

The information requirements are 

based on notification, recordkeeping, 

and reporting requirements in the 

NESHAP General Provisions (40 CFR 

part 63, subpart A), which are 

mandatory for all operators subject to 

national emission standards. These 

recordkeeping and reporting 

requirements are specifically authorized 

by section 114 of the CAA (42 U.S.C. 

7414). All information submitted to the 

EPA pursuant to the recordkeeping and 

reporting requirements for which a 

claim of confidentiality is made is 

safeguarded according to agency 

policies set forth in 40 CFR part 2, 

subpart B. 

This final rule includes new 

paperwork requirements for increased 

frequency for stack testing as described 

in 40 CFR 63.1546. 

When a malfunction occurs, sources 

must report the event 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 reasonably 

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. 

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 


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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 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 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. 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 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-forprofit 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 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 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 


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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, 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 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 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 

HAP-related 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 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 

November 15, 2011. 

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: November 4, 2011. 

Lisa P. Jackson, 

Administrator. 

For the reasons stated in the 

preamble, the Environmental Protection 

Agency amends 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] 

■ 2. Section 63.1541 is revised to read 

as follows: 

§ 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. 

(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;’’ 

removing 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 


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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 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. 

* * * * * 

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 lead-bearing scrap 

material, primarily, but not limited to, 

lead-acid 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 (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; 

(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 (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 compounds on a 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 (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 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: 


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§ 63.1544 Standards for fugitive dust 

sources. 

(a) Each owner or operator of a 

primary lead processor must prepare, 

and at all times operate according to, a 

standard operating procedures manual 

that describes in detail the measures 

that will be put in place to control 

fugitive dust emissions from the sources 

listed in paragraphs (a)(1) through (a)(5) 

of this section that incorporates each of 

the specific work practices listed in 

paragraphs (a)(1) through (a)(5) of this 

section: 

(1) Plant roadways. (i) Paved plant 

roadways must be cleaned using a wet 

sweeper unless the temperature falls 

below 39 degrees Fahrenheit or when 

the application of water results in the 

formation of ice. During periods when 

the temperature is below 39 degrees 

Fahrenheit, paved plant roadways must 

be cleaned using a high efficiency dry 

sweeper. 

(ii) Continuously operate a sprinkler 

system to wet plant roadways to prevent 

fugitive dust entrainment. This 

sprinkler system must be operated 

except during periods when the 

temperature is less than 39 degrees 

Fahrenheit or when the application of 

water results in formation of ice. 

(2) Material storage and handling 

area(s). (i) Chemically stabilize inactive 

concentrate storage piles a minimum of 

once every month to reduce particulate 

from wind born re-suspension. 

(ii) Finished sinter must be 

sufficiently wetted to ensure fugitive 

dust emissions are minimized prior to 

loading to railcars. 

(3) Sinter machine area(s). (i) 

Personnel doors must be kept closed 

during operations except when entering 

or exiting the furnace building by the 

aid of door weights or similar device for 

automatic closure. 

(ii) Large equipment doors must 

remain closed except when entering or 

existing the building using an automatic 

closure system or equivalent lock-andkey method. 

(iii) It may be necessary to open doors 

subject to the requirements in 

§ 63.1544(a)(3)(i) and (ii) to prevent heat 

stress or exhaustion of workers inside 

the sinter plant building. Records of 

such periods must be included in the 

report required under § 63.1549(e)(8). 

(4) Furnace area(s). (i) Personnel 

doors must be kept closed during 

operations except when entering or 

exiting the furnace building by the aid 

of door weights or similar device for 

automatic closure. 

(ii) Large equipment doors must 

remain closed except when entering or 

existing the building using an automatic 

closure system or equivalent lock-andkey method. 

(iii) It may be necessary to open doors 

subject to the requirements in 

§ 63.1544(a)(4)(i) and (ii) to prevent heat 

stress or exhaustion of workers inside 

the blast furnace building. Records of 

such periods must be included in the 

report required under § 63.1549(e)(8). 

(5) Refining and casting area(s). (i) 

Personnel doors must be kept closed 

during operations except when entering 

or exiting the furnace building by the 

aid of door weights or similar device for 

automatic closure. 

(ii) Large equipment doors must 

remain closed except when entering or 

existing the building using an automatic 

closure system or equivalent lock-andkey method. 

(iii) It may be necessary to open doors 

subject to the requirements in 

§ 63.1544(a)(5)(i) and (ii) to prevent heat 

stress or exhaustion of workers inside 

the refining and casting building. 

Records of such periods must be 

included in the report required under 

§ 63.1549(e)(8). 

(b) Notwithstanding paragraph (c) of 

this section, the standard operating 

procedures manual shall be submitted 

to the Administrator or delegated 

authority for review and approval. 

(c) Existing manuals that describe the 

measures in place to control fugitive 

dust sources required as part of a State 

implementation plan for lead shall 

satisfy the requirements of paragraph (a) 

of this section provided they include all 

the work practices as described in 

paragraphs (a)(1) through (5) of this 

section and provided they address all 

the sources listed in paragraphs (a)(1) 

through (5) of this section. 

(d) At all times, the owner or operator 

must operate and maintain any affected 

source, including associated air 

pollution 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 January 17, 2012. Each owner or 

operator of an existing primary lead 

processor must achieve compliance 

with the requirements of § 63.1544 no 

later than February 13, 2012. Each 

owner or operator of an existing primary 

lead processor must achieve compliance 

with the requirements in § 63.1543(b) 

and (e) of this subpart no later than 

November 15, 2013. 

(b) Each owner or operator of a new 

primary lead processor must achieve 

compliance with the requirements of 

this subpart no later than January 17, 

2012 or startup, whichever is later. 

(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) and (2), 63.1551, and 

Table 1 of Subpart TTT of Part 63 on 

November 15, 2011. 

■ 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. 

(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 


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the quarterly lead emission rate in 

pounds per hour by the quarterly plant 

operating time, in hours as shown in 

Equation 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: 

(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 (iii) of this section. 

(6) To determine compliance with the 

production-based lead compound 

emission rate in § 63.1543(a), the 

quarterly production-based lead 

compound emission rate, in 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. 

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 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 (4) of this 

section. 

(b) Owners 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 (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. 

■ 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 (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. 

(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 selftensioning (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. 

(e) The bag leak detection system 

required by paragraph (c)(8) of this 

section must meet the specifications and 

requirements of (e)(1) through (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. 

(5) The initial adjustment of the 

system must, at a minimum, consist of 

establishing the baseline output by 

adjusting the sensitivity (range) and the 


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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 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(g). 

The percentage of time the alarm on the 

bag leak detection system sounds must 

be determined according to paragraphs 

(g)(1) through (3) of this section. 

(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: 

(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), (2), or (3) of this 

section. 

(1) Owners and operators must check 

and record on a daily basis doorway indraft 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 in-draft according to paragraphs 

(i)(2)(i) through (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 

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 

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 (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) 


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through (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 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 (j)(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. 

(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. 

■ 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. 

■ 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 (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. 

(4) Any recordkeeping required as 

part of the practices described in the 

standard operating procedures manual 

for baghouses required under 

§ 63.1547(a). 

(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)(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. 

(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), 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 indraft determination, 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), 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. 

(8) Records of the occurrence and 

duration of each malfunction of 

operation (i.e., process equipment) or 

the air pollution control equipment and 

monitoring equipment. 

(9) Records of actions taken during 

periods of malfunction to minimize 

emissions in accordance with 

§§ 63.1543(i) and 63.1544(d), 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-annual reports containing 

the information specified in paragraphs 

(e)(1) through (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). 


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(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 indraft 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 shall contain a 

summary of the fugitive dust control 

measures performed during the required 

reporting period, including an 

explanation of any periods when the 

procedures outlined in the standard 

operating procedures manual required 

by § 63.1544(a) were not followed and 

the corrective actions taken. The reports 

shall not contain copies of the daily 

records required to demonstrate 

compliance with the requirements of the 

standard operating procedures manuals 

required under §§ 63.1544(a) and 

63.1547(a). 

(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 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(d), 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. 

(a) Affirmative defense. 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. Off-shift 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 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. 

(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. 

■ 13. Table 1 to Subpart TTT of Part 63 

is revised to read as follows: 


jlentini on DSK4TPTVN1PROD with RULES2
Federal Register / Vol. 76, No. 220 / Tuesday, November 15, 2011 / Rules and Regulations 70859 

TABLE 1 OF SUBPART TTT—GENERAL PROVISIONS APPLICABILITY TO SUBPART TTT 

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(d) 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. 

§ 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 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. 

* * * * * * * 

[FR Doc. 2011–29287 Filed 11–14–11; 8:45 am] 

BILLING CODE 6560–50–P 


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