9410 Federal Register / Vol. 76, No. 33 / Thursday, February 17, 2011 / Proposed Rules 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 63 

[EPA–HQ–OAR–2004–0305; FRL–9263–2] 

RIN 2060–AQ43 

National Emission Standards for 

Hazardous Air Pollutants: Primary 

Lead Smelting 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing 

amendments to the national emission 

standards for hazardous air pollutants 

(NESHAP) for Primary Lead Smelting to 

address the results of the residual risk 

and technology reviews conducted as 

required under sections 112(d)(6) and 

(f)(2) of the Clean Air Act (CAA). These 

proposed amendments include revisions 

to the emission limits for lead, the 

addition of a lead concentration in air 

standard, and the modification and 

addition of testing and monitoring and 

related notification, recordkeeping, and 

reporting requirements. We are also 

proposing to revise provisions 

addressing periods of startup, 

shutdown, and malfunction to ensure 

that they are consistent with a recent 

court decision. Finally, we are 

proposing revisions to the rule’s 

applicability provision to make it 

consistent with the definition of the 

source category and proposing other 

minor technical changes to the standard. 

We are also responding to a petition for 

rulemaking filed on the standard with 

regard to lead as a surrogate and 

regulation of volatile organic 

compounds (VOC) and acid gases. 

DATES: Comments must be received on 

or before April 4, 2011. Under the 

Paperwork Reduction Act, comments on 

the information collection provisions 

are best assured of having full effect if 

the Office of Management and Budget 

(OMB) receives a copy of your 

comments on or before March 21, 2011. 

Public Hearing. If anyone contacts 

EPA requesting to speak at a public 

hearing by February 28, 2011, a public 

hearing will be held on March 4, 2011. 

ADDRESSES: Submit your comments, 

identified by Docket ID Number EPA– 

HQ–OAR–2004–0305, by one of the 

following methods: 

• http://www.regulations.gov: Follow 

the on-line instructions for submitting 

comments. 

• E-mail: a-and-r-docket@epa.gov, 

Attention Docket ID Number EPA–HQ– 

OAR–2004–0305. 

• Fax: (202) 566–9744, Attention 

Docket ID Number EPA–HQ–OAR– 

2004–0305. 

• Mail: U.S. Postal Service, send 

comments to: EPA Docket Center, EPA 

West (Air Docket), Attention Docket ID 

Number EPA–HQ–OAR–2004–0305, 

U.S. Environmental Protection Agency, 

Mailcode: 2822T, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460. 

Please include a total of two copies. In 

addition, please mail a copy of your 

comments on the information collection 

provisions to the Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB), Attn: 

Desk Officer for EPA, 725 17th Street, 

NW., Washington, DC 20503. 

• Hand Delivery: U.S. Environmental 

Protection Agency, EPA West (Air 

Docket), Room 3334, 1301 Constitution 

Ave., NW., Washington, DC 20004, 

Attention Docket ID Number EPA–HQ– 

OAR–2004–0305. Such deliveries are 

only accepted during the Docket’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions. Direct your comments to 

Docket ID Number EPA–HQ–OAR– 

2004–0305. EPA’s policy is that all 

comments received will be included in 

the public docket without change and 

may be made available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be confidential business 

information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through http:// 

www.regulations.gov or e-mail. The 

http://www.regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through http:// 

www.regulations.gov, your e-mail 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. For additional information 

about EPA’s public docket, visit the EPA 

Docket Center homepage at http:// 

www.epa.gov/epahome/dockets.htm. 

Docket. The EPA has established a 

docket for this rulemaking under Docket 

ID Number EPA–HQ–OAR–2004–0305. 

All documents in the docket are listed 

in the http://www.regulations.gov index. 

Although listed in the index, some 

information is not publicly available, 

e.g., 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. Publicly 

available docket materials are available 

either electronically in http:// 

www.regulations.gov or in hard copy at 

the EPA Docket Center, EPA West, 

Room 3334, 1301 Constitution Ave., 

NW., Washington, DC. The Public 

Reading Room is open from 8:30 a.m. to 

4:30 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the EPA Docket Center is 

(202) 566–1742. 

Public Hearing. If a public hearing is 

held, it will begin at 10 a.m. on March 

4, 2011 and will be held at EPA’s 

campus in Research Triangle Park, 

North Carolina, or at an alternate facility 

nearby. Persons interested in presenting 

oral testimony or inquiring as to 

whether a public hearing is to be held 

should contact Ms. Virginia Hunt, Office 

of Air Quality Planning and Standards, 

Sector Policies and Programs Division, 

Metals and Minerals Group (D243–02), 

U.S. Environmental Protection Agency, 

Research Triangle Park, North Carolina 

27711; telephone number: (919) 541– 

0832. 

FOR FURTHER INFORMATION CONTACT: For 

questions about this proposed action, 

contact Ms. Sharon Nizich, Sector 

Policies and Programs Division (D243– 

02), Office of Air Quality Planning and 

Standards, U.S. Environmental 

Protection Agency, Research Triangle 

Park, North Carolina 27711, telephone 

(919) 541–2825; fax number: (919) 541– 

5450; and e-mail address: 

nizich.sharon@epa.gov. For specific 

information regarding the risk modeling 

methodology, contact Ms. Elaine 

Manning, Health and Environmental 

Impacts Division (C539–02), Office of 

Air Quality Planning and Standards, 

U.S. Environmental Protection Agency, 

Research Triangle Park, North Carolina 

27711; telephone number: (919) 541– 

5499; fax number: (919) 541–0840; and 

e-mail address: 

manning.elaine@epa.gov. For 

information about the applicability of 


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the NESHAP to a particular entity, contact the appropriate person listed in 

Table 1 to this preamble. 

SUPPLEMENTARY INFORMATION: 

TABLE 1—LIST OF EPA CONTACTS FOR THE NESHAP ADDRESSED IN THIS PROPOSED ACTION

NESHAP for: OECA contact 1 OAQPS contact 2

Primary Lead Smelting ... Maria Malave, (202) 564–7027, malave.maria@epa.gov .. Sharon Nizich, (919) 541–2825, nizich.sharon@epa.gov. 

1EPA’s Office of Enforcement and Compliance Assurance. 

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

I. Preamble Acronyms and 

Abbreviations 

Several acronyms and terms used to 

describe industrial processes, data 

inventories, and risk modeling are 

included in this preamble. While this 

may not be an exhaustive list, to ease 

the reading of this preamble and for 

reference purposes, the following terms 

and acronyms are defined here: 

ADAF Age-dependent Adjustment Factors 

AERMOD Air dispersion model used by the 

HEM–3 model 

AEGL Acute Exposure Guideline Levels 

ANPRM Advance Notice of Proposed 

Rulemaking 

BACT Best Available Control Technology 

CAA Clean Air Act 

CBI Confidential Business Information 

CEEL Community Emergency Exposure 

Levels 

CEMS Continuous Emissions Monitoring 

System 

CERMS Continuous Emission Rate 

Monitoring System 

CFR Code of Federal Regulations 

EJ Environmental Justice 

EPA Environmental Protection Agency 

ERPG Emergency Response Planning 

Guidelines 

HAP Hazardous Air Pollutants 

HI Hazard Index 

HEM–3 Human Exposure Model version 3 

HON Hazardous Organic National 

Emissions Standards for Hazardous Air 

Pollutants 

HQ Hazard Quotient 

IRIS Integrated Risk Information System 

Km Kilometer 

LAER Lowest Achievable Emission Rate 

LOAEL Lowest Observed Adverse Effect 

Level 

MACT Maximum Achievable Control 

Technology 

MACT Code Code within the NEI used to 

identify processes included in a source 

category 

MIR Maximum Individual Risk 

NAAQS National Ambient Air Quality 

Standard 

NAC/AEGL Committee National Advisory 

Committee for Acute Exposure Guideline 

Levels for Hazardous Substances 

NAICS North American Industry 

Classification System 

NAS National Academy of Sciences 

NATA National Air Toxics Assessment 

NESHAP National Emissions Standards for 

Hazardous Air Pollutants 

NEI National Emissions Inventory 

NOAEL No Observed Adverse Effects Level 

NRC National Research Council 

NTTAA National Technology Transfer and 

Advancement Act 

OAQPS EPA’s Office of Air Quality 

Planning and Standards 

OECA EPA’s Office of Enforcement and 

Compliance Assurance 

OMB Office of Management and Budget 

PB-HAP Hazardous air pollutants known to 

be persistent and bio-accumulative in the 

environment 

POM Polycyclic Organic Matter 

RACT Reasonably Available Control 

Technology 

RBLC RACT/BACT/LAER Clearinghouse 

RFA Regulatory Flexibility Act 

RfC Reference Concentration 

RfD Reference Dose 

RTR Residual Risk and Technology Review 

SAB Science Advisory Board 

SBA Small Business Administration 

SCC Source Classification Codes 

SF3 2000 Census of Population and 

Housing Summary File 3 

SIP State Implementation Plan 

SOP Standard Operating Procedures 

SSM Startup, Shutdown, and Malfunction 

TOSHI Target Organ-Specific Hazard Index 

TPY Tons Per Year 

TRIM Total Risk Integrated Modeling 

System 

TTN Technology Transfer Network 

UF Uncertainty Factor 

UMRA Unfunded Mandates Reform Act 

URE Unit Risk Estimate 

VOC Volatile Organic Compounds 

VOHAP Volatile Organic Hazardous Air 

Pollutants 

WWW Worldwide Web 

Organization of this Document. The 

following outline is provided to aid in 

the location of information in this 

preamble. 

I. Preamble Acronyms and Abbreviations 

II. General Information 

A. Does this action apply to me? 

B. Where can I get a copy of this document 

and other related information? 

C. What should I consider as I prepare my 

comments for EPA? 

III. Background 

A. What is the statutory authority for this 

action? 

B. How did we consider the risk results in 

making decisions for this proposal? 

C. What other actions are we addressing in 

this proposal? 

IV. Analyses Performed and Background for 

the Source Category and MACT Standard 

A. How did we estimate risks posed by the 

source category? 

B. How did we perform the technology 

review? 

C. Overview of the source category and 

MACT standards 

V. Analyses Results and Proposed Decisions 

A. What data were used in our risk 

analyses? 

B. What are the results of the risk 

assessments and analyses? 

C. What are our proposed decisions on risk 

acceptability and ample margin of 

safety? 

D. What are the results and proposed 

decisions from the technology review? 

E. Variability 

F. What other actions are we proposing? 

VI. Proposed Action 

A. What actions are we proposing as a 

result of the residual risk reviews? 

B. What actions are we proposing as a 

result of the technology reviews? 

C. What other actions are we proposing? 

D. Compliance Dates 

VII. Request for Comments 

VIII.Submitting Data Corrections 

IX. Statutory and Executive Order Reviews 

A. Executive Order 12866: Regulatory 

Planning and 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 

II. General Information 

A. Does this action apply to me? 

The regulated industrial source 

category that is the subject of this 

proposal is listed in Table 2 to this 

preamble. Table 2 is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this proposed action for the 

source categories listed. This standard, 

and any changes considered in this 

rulemaking, would be directly 


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1USEPA. Documentation for Developing the 

Initial Source Category List—Final Report, USEPA/ 

OAQPS, EPA–450/3–91–030, July, 1992. 

applicable to sources as a Federal 

program. Thus, Federal, State, local, and 

tribal government entities are not 

affected by this proposed action. As 

defined in the source category listing 

report published by 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 As 

discussed in section III. (C)(3), to be 

consistent with the 1992 listing, EPA is 

proposing to change the applicability of 

the Primary Lead Smelting NESHAP to 

apply to any facility that produces lead 

metal from lead ore concentrates. 

Although the source category name in 

the 1992 listing will remain Primary 

Lead Smelting (as in 1992 listing) we are 

proposing to change the title of the rule 

to refer to Primary Lead Processing. For 

clarification purposes, all references to 

lead emissions in this preamble means 

‘‘lead compounds’’ (which is a HAP) and 

all reference to lead production means 

elemental lead (which is not a HAP) as 

provided under CAA 112(b)(7)). 

TABLE 2—NESHAP AND INDUSTRIAL SOURCE CATEGORIES AFFECTED BY THIS PROPOSED ACTION

Source category NESHAP NAICS code 1 MACT code 2

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

1 North American Industry Classification System. 

2 Maximum Achievable Control Technology. 

B. Where can I get a copy of this 

document and other related 

information? 

In addition to being available in the 

docket, an electronic copy of this 

proposal will also be available on the 

World Wide Web (WWW) through the 

Technology Transfer Network (TTN). 

Following signature by the EPA 

Administrator, a copy of this proposed 

action will be posted on the TTN’s 

policy and guidance page for newly 

proposed or promulgated rules at the 

following address: http://www.epa.gov/

ttn/atw/rrisk/rtrpg.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. What should I consider as I prepare 

my comments for EPA? 

Submitting CBI. Do not submit 

information containing CBI to EPA 

through http://www.regulations.gov or 

e-mail. Clearly mark the part or all of 

the information that you claim to be 

CBI. For CBI information on a disk or 

CD ROM that you mail to EPA, mark the 

outside of the disk or CD ROM as CBI 

and then identify electronically within 

the disk or CD ROM the specific 

information that is claimed as CBI. In 

addition to one complete version of the 

comment that includes information 

claimed as CBI, a copy of the comment 

that does not contain the information 

claimed as CBI must be submitted for 

inclusion in the public docket. If you 

submit a CD ROM or disk that does not 

contain CBI, mark the outside of the 

disk or CD ROM clearly that it does not 

contain CBI. Information not marked as 

CBI will be included in the public 

docket and EPA’s electronic public 

docket without prior notice. Information 

marked as CBI will not be disclosed 

except in accordance with procedures 

set forth in 40 CFR part 2. Send or 

deliver information identified as CBI 

only to the following address: Roberto 

Morales, OAQPS Document Control 

Officer (C404–02), Office of Air Quality 

Planning and Standards, U.S. 

Environmental Protection Agency, 

Research Triangle Park, North Carolina 

27711, Attention Docket ID Number 

EPA–HQ–OAR–2004–0305. 

III. Background 

A. What is the statutory authority for 

this action? 

Section 112 of the Clean Air Act 

(CAA) establishes a two-stage regulatory 

process to address emissions of 

hazardous air pollutants (HAP) from 

stationary sources. In the first stage, 

after EPA has identified categories of 

sources emitting one or more of the HAP 

listed in section 112(b) of the CAA, 

section 112(d) of the CAA calls for us 

to promulgate NESHAP for those 

sources. ‘‘Major sources’’ are those that 

emit or have the potential to emit 10 

tons per year (TPY) or more of a single 

HAP 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. 

MACT standards must require the 

maximum degree of emission reduction 

through the application of measures, 

processes, methods, systems, or 

techniques, including, but not limited 

to, measures which (A) Reduce the 

volume of or eliminate pollutants 

through process changes, substitution of 

materials or other modifications; 

(B) enclose systems or processes to 

eliminate emissions; (C) capture or treat 

pollutants when released from a 

process, stack, storage, or fugitive 

emissions point; (D) are design, 

equipment, work practice, or 

operational standards (including 

requirements for operator training or 

certification); or (E) are a combination of 

the above. CAA section 112(d)(2)(A)– 

(E). The MACT standards may take the 

form of design, equipment, work 

practice, or operational standards where 

EPA first determines either that, (A) a 

pollutant cannot be emitted through a 

conveyance designed and constructed to 

emit or capture the pollutants, or that 

any requirement for, or use of, such a 

conveyance would be inconsistent with 

law; or (B) the application of 

measurement methodology to a 

particular class of sources is not 

practicable due to technological and 

economic limitations. CAA sections 

112(h)(1)–(2). 

The MACT ‘‘floor’’ is the minimum 

control level allowed for MACT 

standards promulgated under CAA 

section 112(d)(3) and may not be based 

on cost considerations. For new sources, 

the MACT floor cannot be less stringent 

than the emission control that is 

achieved in practice by the bestVerDate Mar<15>2010 16:48 Feb 16, 2011 Jkt 223001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 E:\FR\FM\17FEP2.SGM 17FEP2

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2 ‘‘Adverse environmental effect’’ is defined in 

CAA section 112(a)(7) as any significant and 

widespread adverse effect, which may be 

reasonably anticipated to wildlife, aquatic life, or 

natural resources, including adverse impacts on 

populations of endangered or threatened species or 

significant degradation of environmental qualities 

over broad areas. 

controlled similar source. The MACT 

floors for existing sources can be less 

stringent than floors for new sources, 

but they cannot be less stringent than 

the average emissions limitation 

achieved by the best-performing 12 

percent of existing sources in the 

category or subcategory (or the bestperforming 5 sources for categories or 

subcategories with fewer than 30 

sources). In developing MACT 

standards, we must also consider 

control options that are more stringent 

than the floor. 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. 

The EPA is then required 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, under 

CAA section 112(d)(6). In conducting 

this review, EPA is not obliged to 

completely recalculate the prior MACT 

determination. NRDC v. EPA, 529 F.3d 

1077, 1084 (D.C. Cir., 2008). 

The second stage in standard-setting 

focuses on reducing any remaining 

‘‘residual’’ risk according to CAA section 

112(f). This provision requires, first, that 

EPA prepare a Report to Congress 

discussing (among other things) 

methods of calculating the risks posed 

(or potentially posed) by sources after 

implementation of the MACT standards, 

the public health significance of those 

risks, and the recommendations 

regarding legislation of such remaining 

risk. EPA prepared and submitted this 

report (Residual Risk Report to 

Congress, EPA–453/R–99–001) in March 

1999. Congress did not act in response 

to the report, thereby triggering EPA’s 

obligation under CAA section 112(f)(2) 

to analyze and address residual risk. 

Section 112(f)(2) of the CAA requires 

us to determine for source categories 

subject to certain MACT standards, 

whether the emissions standards 

provide an ample margin of safety to 

protect public health. If the MACT 

standards that apply to a source 

category emitting a HAP that is 

‘‘classified as a known, probable, or 

possible human carcinogen do not 

reduce lifetime excess cancer risks to 

the individual most exposed to 

emissions from a source in the category 

or subcategory to less than one-in-one 

million,’’ EPA must promulgate residual 

risk standards for the source category (or 

subcategory) as necessary to provide an 

ample margin of safety to protect public 

health. CAA section 112(f)(2)(A). In 

doing so, EPA may adopt standards 

equal to existing MACT standards if 

EPA determines that the existing 

standards are sufficiently protective. As 

stated in NRDC v. EPA, 529 F.3d 1077, 

1083 (D.C. Dir. 2008), ‘‘If EPA 

determines that the existing technologybased standards provide an ‘ample 

margin of safety,’ then the Agency is 

free to readopt those standards during 

the residual risk rulemaking.’’ Section 

112(f)(2) of the Clean Air Act further 

states that EPA must also adopt more 

stringent standards, if necessary, to 

‘‘prevent taking into consideration costs, 

energy, safety, and other relevant 

factors, an adverse environmental 

effect.’’ 2

When Section 112(f)(2) of the CAA 

was enacted in 1990, it expressly 

preserved our use of the two-step 

process for developing standards to 

address any residual risk and our 

interpretation of ‘‘ample margin of 

safety’’ developed in the National 

Emission Standards for Hazardous Air 

Pollutants: Benzene Emissions from 

Maleic Anhydride Plants, Ethylbenzene/ 

Styrene Plants, Benzene Storage Vessels, 

Benzene Equipment Leaks, and Coke 

By-Product Recovery Plants (Benzene 

NESHAP) (54 FR 38044, September 14, 

1989). The first step in this process is 

the determination of acceptable risk. 

The second step provides for an ample 

margin of safety to protect public health, 

which is the level at which the 

standards are set (unless a more 

stringent standard is required to 

prevent, taking into consideration costs, 

energy, safety, and other relevant 

factors, an adverse environmental 

effect). 

The terms ‘‘individual most exposed,’’ 

‘‘acceptable level,’’ and ‘‘ample margin of 

safety’’ are not specifically defined in 

the CAA. However, CAA section 

112(f)(2)(B) preserves the interpretation 

set out in the Benzene NESHAP, and the 

Court in NRDC v. EPA, concluded that 

EPA’s interpretation of subsection 

112(f)(2) is a reasonable one. See NRDC 

v. EPA, 529 F.3d at 1083 (D.C. Cir. 

2008), which says ‘‘[S]ubsection 

112(f)(2)(B) expressly incorporates 

EPA’s interpretation of the Clean Air 

Act from the Benzene standard, 

complete with a citation to the Federal 

Register.’’ See also, A Legislative History 

of the Clean Air Act Amendments of 

1990, volume 1, p. 877 (Senate debate 

on Conference Report). We notified 

Congress in the Residual Risk Report to 

Congress that we intended to use the 

Benzene NESHAP approach in making 

CAA section 112(f) residual risk 

determinations (EPA–453/R–99–001, p. 

ES–11). 

In the Benzene NESHAP, we stated as 

an overall objective: 

* * * in protecting public health with an 

ample margin of safety, we strive to provide 

maximum feasible protection against risks to 

health from hazardous air pollutants by (1) 

protecting the greatest number of persons 

possible to an individual lifetime risk level 

no higher than approximately 1-in-1 million; 

and (2) limiting to no higher than 

approximately 1-in-10 thousand [i.e., 100-in1 million] the estimated risk that a person 

living near a facility would have if he or she 

were exposed to the maximum pollutant 

concentrations for 70 years. 

The Agency also stated that, ‘‘The EPA 

also considers incidence (the number of 

persons estimated to suffer cancer or 

other serious health effects as a result of 

exposure to a pollutant) to be an 

important measure of the health risk to 

the exposed population. Incidence 

measures the extent of health risks to 

the exposed population as a whole, by 

providing an estimate of the occurrence 

of cancer or other serious health effects 

in the exposed population.’’ The Agency 

went on to conclude that ‘‘estimated 

incidence would be weighed along with 

other health risk information in judging 

acceptability.’’ As explained more fully 

in our Residual Risk Report to Congress, 

EPA does not define ‘‘rigid line[s] of 

acceptability,’’ but considers rather 

broad objectives to be weighed with a 

series of other health measures and 

factors (EPA–453/R–99–001, p. ES–11). 

The determination of what represents an 

‘‘acceptable’’ risk is based on a judgment 

of ‘‘what risks are acceptable in the 

world in which we live’’ (Residual Risk 

Report to Congress, p. 178, quoting the 

Vinyl Chloride decision at 824 F.2d 

1165) recognizing that our world is not 

risk-free. 

In the Benzene NESHAP, we stated 

that ‘‘EPA will generally presume that if 

the risk to [the maximum exposed] 

individual is no higher than 

approximately 1-in-10 thousand, that 

risk level is considered acceptable.’’ 54 

FR 38045. We discussed the maximum 

individual lifetime cancer risk as being 

‘‘the estimated risk that a person living 

near a plant would have if he or she 

were exposed to the maximum pollutant 

concentrations for 70 years.’’ Id. We 

explained that this measure of risk ‘‘is 

an estimate of the upper bound of risk 

based on conservative assumptions, 

such as continuous exposure for 24 

hours per day for 70 years.’’ Id. We 


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3Although defined as ‘‘maximum individual 

risk,’’ MIR refers only to cancer risk. MIR, one 

metric for assessing cancer risk, is the estimated 

risk were an individual exposed to the maximum 

level of a pollutant for a lifetime. 

4EPA previously provided estimates of total 

facility risk in a residual risk proposal for coke oven 

batteries (69 FR 48338, August 9, 2004). 

acknowledge that maximum individual 

lifetime cancer risk ‘‘does not 

necessarily reflect the true risk, but 

displays a conservative risk level which 

is an upper-bound that is unlikely to be 

exceeded.’’ Id. 

Understanding that there are both 

benefits and limitations to using 

maximum individual lifetime cancer 

risk as a metric for determining 

acceptability, we acknowledged in the 

1989 Benzene NESHAP that 

‘‘consideration of maximum individual 

risk * * * must take into account the 

strengths and weaknesses of this 

measure of risk.’’ Id. Consequently, the 

presumptive risk level of 100-in-1 

million (1-in-10 thousand) provides a 

benchmark for judging the acceptability 

of maximum individual lifetime cancer 

risk, but does not constitute a rigid line 

for making that determination. 

The Agency also explained in the 

1989 Benzene NESHAP the following: 

‘‘In establishing a presumption for MIR 

[maximum individual cancer risk], 

rather than a rigid line for acceptability, 

the Agency intends to weigh it with a 

series of other health measures and 

factors. These include the overall 

incidence of cancer or other serious 

health effects within the exposed 

population, the numbers of persons 

exposed within each individual lifetime 

risk range and associated incidence 

within, typically, a 50-kilometer (km) 

exposure radius around facilities, the 

science policy assumptions and 

estimation uncertainties associated with 

the risk measures, weight of the 

scientific evidence for human health 

effects, other quantified or unquantified 

health effects, effects due to co-location 

of facilities, and co-emission of 

pollutants.’’ Id. 

In some cases, these health measures 

and factors taken together may provide 

a more realistic description of the 

magnitude of risk in the exposed 

population than that provided by 

maximum individual lifetime cancer 

risk alone. As explained in the Benzene 

NESHAP, ‘‘[e]ven though the risks 

judged ‘‘acceptable’’ by EPA in the first 

step of the Vinyl Chloride inquiry are 

already low, the second step of the 

inquiry, determining an ‘‘ample margin 

of safety,’’ again includes consideration 

of all of the health factors, and whether 

to reduce the risks even further.’’ In the 

ample margin of safety decision process, 

the Agency again considers all of the 

health risks and other health 

information considered in the first step. 

Beyond that information, additional 

factors relating to the appropriate level 

of control will also be considered, 

including costs and economic impacts 

of controls, technological feasibility, 

uncertainties, and any other relevant 

factors. Considering all of these factors, 

the Agency will establish the standard 

at a level that provides an ample margin 

of safety to protect the public health, as 

required by CAA section 112(f). 54 FR 

38046. 

B. How did we consider the risk results 

in making decisions for this proposal? 

As discussed in section III.A of this 

preamble, we apply a two-step process 

for developing standards to address 

residual risk. In the first step, EPA 

determines if risks are acceptable. This 

determination ‘‘considers all health 

information, including risk estimation 

uncertainty, and includes a presumptive 

limit on maximum individual lifetime 

[cancer] risk (MIR) 3 of approximately 1- 

in-10 thousand [i.e., 100-in-1 million].’’ 

54 FR 38045. In the second step of the 

process, EPA sets the standard at a level 

that provides an ample margin of safety 

‘‘in consideration of all health 

information, including the number of 

persons at risk levels higher than 

approximately 1-in-1 million, as well as 

other relevant factors, including costs 

and economic impacts, technological 

feasibility, and other factors relevant to 

each particular decision.’’ Id. 

In past residual risk actions, EPA has 

presented and considered a number of 

human health risk metrics associated 

with emissions from the category under 

review, including: the MIR; the numbers 

of persons in various risk ranges; cancer 

incidence; the maximum non-cancer 

hazard index (HI); and the maximum 

acute non-cancer hazard (72 FR 25138, 

May 3, 2007; 71 FR 42724, July 27, 

2006). In our most recent proposals (75 

FR 65068, October 21, 2010 and 75 FR 

80220, December 21, 2010), EPA also 

presented and considered additional 

measures of health information, 

including: estimates of ‘‘facility-wide’’ 

risks (risks from all HAP emissions from 

the facility at which the source category 

is located); 4 demographic analyses 

(analyses of the distributions of HAPrelated risks across different social, 

demographic, and economic groups 

living near the facilities); and estimates 

of the risks associated with the 

maximum level of emissions which 

might be allowed by the current MACT 

standards (see, e.g., 75 FR 65068, 

October 21, 2010 and 75 FR 80220, 

December 21, 2010). EPA also discussed 

and considered risk estimation 

uncertainties. EPA is providing this 

same type of information in support of 

the proposed actions described in this 

Federal Register notice. 

The Agency is considering all 

available health information to inform 

our determinations of risk acceptability 

and ample margin of safety under CAA 

section 112(f). Specifically, as explained 

in the Benzene NESHAP, ‘‘the first step 

judgment on acceptability cannot be 

reduced to any single factor’’ and thus 

‘‘[t]he Administrator believes that the 

acceptability of risk under section 112 is 

best judged on the basis of a broad set 

of health risk measures and 

information.’’ 54 FR at 38046. Similarly, 

with regard to making the ample margin 

of safety determination, as stated in the 

Benzene NESHAP ‘‘[I]n the ample 

margin decision, the Agency again 

considers all of the health risk and other 

health information considered in the 

first step. Beyond that information, 

additional factors relating to the 

appropriate level of control will also be 

considered, including cost and 

economic impacts of controls, 

technological feasibility, uncertainties, 

and any other relevant factors.’’ Id. 

The Agency acknowledges that 

flexibility is provided by the Benzene 

NESHAP regarding what factors EPA 

might consider in making 

determinations and how they might be 

weighed for each source category. In 

responding to comment on our policy 

under the Benzene NESHAP, EPA 

explained that: ‘‘The policy chosen by 

the Administrator permits consideration 

of multiple measures of health risk. Not 

only can the MIR figure be considered, 

but also incidence, the presence of noncancer health effects, and the 

uncertainties of the risk estimates. In 

this way, the effect on the most exposed 

individuals can be reviewed as well as 

the impact on the general public. These 

factors can then be weighed in each 

individual case. This approach complies 

with the Vinyl Chloride mandate that 

the Administrator ascertain an 

acceptable level of risk to the public by 

employing [her] expertise to assess 

available data. It also complies with the 

Congressional intent behind the CAA, 

which did not exclude the use of any 

particular measure of public health risk 

from the EPA’s consideration with 

respect to CAA section 112 regulations, 

and, thereby, implicitly permits 

consideration of any and all measures of 

health risk which the Administrator, in 

[her] judgment, believes are appropriate 

to determining what will ‘protect the 

public health.’ ’’ 54 FR at 38057. 

For example, the level of the MIR is 

only one factor to be weighed in 


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5EPA’s responses to this and all other key 

recommendations of the SAB’s advisory on RTR 

risk assessment methodologies (which is available 

at: http://yosemite.epa.gov/sab/sabproduct.nsf/

4AB3966E263D943A8525771F00668381/$File/EPASAB-10-007-unsigned.pdf) are outlined in a memo 

to this rulemaking docket from David Guinnup 

entitled, EPA’s Actions in Response to the Key 

Recommendations of the SAB Review of RTR Risk 

Assessment Methodologies. 

determining acceptability of risks. It is 

explained in the Benzene NESHAP that 

‘‘an MIR of approximately 1-in-10 

thousand should ordinarily be the upper 

end of the range of acceptability. As 

risks increase above this benchmark, 

they become presumptively less 

acceptable under CAA section 112, and 

would be weighed with the other health 

risk measures and information in 

making an overall judgment on 

acceptability. Or, the Agency may find, 

in a particular case, that a risk that 

includes MIR less than the 

presumptively acceptable level is 

unacceptable in the light of other health 

risk factors.’’ Id. at 38045. Similarly, 

with regard to the ample margin of 

safety analysis, EPA stated in the 

Benzene NESHAP that: ‘‘* * * EPA 

believes the relative weight of the many 

factors that can be considered in 

selecting an ample margin of safety can 

only be determined for each specific 

source category. This occurs mainly 

because technological and economic 

factors (along with the health-related 

factors) vary from source category to 

source category.’’ Id. at 38061. 

EPA wishes to point out that certain 

health information has not been 

considered to date in making residual 

risk determinations. In assessing risks to 

populations in the vicinity of the 

facilities in each category, we present 

estimates of risk associated with HAP 

emissions from the source category 

alone (source category risk estimates) 

and HAP emissions from the entire 

facility at which the covered source 

category is located (facility-wide risk 

estimates). We do not attempt to 

characterize the risks associated with all 

HAP emissions impacting the 

populations living near the sources in 

these categories. That is, at this time, we 

do not attempt to quantify those HAP 

risks that may be associated with mobile 

source emissions, natural source 

emissions, persistent environmental 

pollution, or atmospheric 

transformation in the vicinity of the 

sources in these categories. 

The Agency understands the potential 

importance of considering an 

individual’s total exposure to HAP in 

addition to considering exposure to 

HAP emissions from the source category 

and facility. This is particularly 

important when assessing non-cancer 

risks, where pollutant-specific exposure 

levels (e.g., Reference Concentration 

(RfC)) are based on the assumption that 

thresholds exist for adverse health 

effects. For example, the Agency 

recognizes that, although exposures 

attributable to emissions from a source 

category or facility alone may not 

indicate the potential for increased risk 

of adverse non-cancer health effects in 

a population, the exposures resulting 

from emissions from the facility in 

combination with emissions from all of 

the other sources (e.g., other facilities) to 

which an individual is exposed may be 

sufficient to result in increased risk of 

adverse non-cancer health effects. In 

May 2010, the Science Advisory Board 

(SAB) advised us ‘‘* * * that RTR 

assessments will be most useful to 

decision makers and communities if 

results are presented in the broader 

context of aggregate and cumulative 

risks, including background 

concentrations and contributions from 

other sources in the area.’’ 5

While we are interested in placing 

source category and facility-wide HAP 

risks in the context of total HAP risks 

from all sources combined in the 

vicinity of each source, we are 

concerned about the uncertainties of 

doing so. At this point, we believe that 

such estimates of total HAP risks will 

have significantly greater associated 

uncertainties than for the source 

category or facility-wide estimates, and 

hence compounding the uncertainty in 

any such comparison. This is because 

we have not conducted a detailed 

technical review of HAP emissions data 

for source categories and facilities that 

have not previously undergone an RTR 

review or are not currently undergoing 

such review. We are requesting 

comment on whether and how best to 

estimate and evaluate total HAP 

exposure in our assessments, and, in 

particular, on whether and how it might 

be appropriate to use information from 

EPA’s National Air Toxics Assessment 

(NATA) to support such estimates. We 

are also seeking comment on how best 

to consider various types and scales of 

risk estimates when making our 

acceptability and ample margin of safety 

determinations under CAA section 

112(f). Additionally, we are seeking 

comments and recommendations for 

any other comparative measures that 

may be useful in the assessment of the 

distribution of HAP risks across 

potentially affected demographic 

groups. 

C. What other actions are we addressing 

in this proposal? 

1. Startup, Shutdown and Malfunction 

This proposed action would amend 

the provisions of the existing NESHAP 

that apply to periods of startup, 

shutdown, and malfunction (SSM). The 

proposed revisions of these provisions 

result from a Court decision that vacated 

portions of two provisions in EPA’s 

‘‘General Provisions’’ regulation under 

CAA section 112, governing the 

emissions of HAP during periods of 

SSM. The current Primary Lead 

Smelting MACT includes references to 

the vacated provisions in the General 

Provisions rule. 

We are proposing to revise the 

Primary Lead Smelting MACT standard 

to require affected sources to comply 

with the emission limitations at all 

times and during periods of SSM. 

Specifically, we are proposing several 

revisions to subpart TTT including 

revising Table 1 to indicate that the 

requirements of the General Provisions 

pertaining to SSM do not apply and to 

revise language in § 63.1547 (g)(1) and 

(2) to remove the exemption for bag leak 

detection alarm time attributable to SSM 

from total allowed alarm time. For 

reasons discussed below, we are also 

proposing to promulgate an affirmative 

defense to civil penalties for 

exceedances of emission standards 

caused by malfunctions, as well as 

criteria for establishing the affirmative 

defense. These changes would go into 

effect upon the effective date of 

promulgation of the final rule. 

The United States Court of Appeals 

for the District of Columbia Circuit 

vacated portions of two provisions in 

EPA’s CAA Section 112 regulations 

governing the emissions of HAP during 

periods of SSM. Sierra Club v. EPA, 551 

F.3d 1019 (D.C. Cir. 2008), cert. denied, 

130 S. Ct. 1735 (U.S. 2010). Specifically, 

the Court vacated the SSM exemptions 

contained in 40 CFR 63.6(f)(1) and 40 

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

regulation commonly known as the 

‘‘General Provisions Rule,’’ that EPA had 

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 are proposing the elimination of 

the SSM exemption in this rule. 

Consistent with Sierra Club v. EPA, EPA 

is proposing standards in this rule that 

apply at all times. We are also proposing 

several revisions to Table 1 (the General 

Provisions Applicability table). For 


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example, we are proposing to eliminate 

the incorporation of the General 

Provisions’ requirement that the source 

develop an SSM plan. We also are 

proposing to eliminate or revise certain 

recordkeeping and reporting that relate 

to the SSM exemption. EPA has 

attempted to ensure that we have not 

included in the proposed regulatory 

language any provisions that are 

inappropriate, unnecessary, or 

redundant in the absence of the SSM 

exemption. We are specifically seeking 

comment on whether there are any such 

provisions that we have inadvertently 

incorporated or overlooked. 

In proposing standards in this rule, 

EPA has taken into account startup and 

shutdown periods and, for the reasons 

explained below, has not proposed 

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 an SSM 

event. Also, compliance with the 

standard already requires averaging of 

emissions over a three month period, 

which accounts for the variability of 

emissions that may result during 

periods of startup and shutdown. 

Therefore, separate standards for 

periods of startup and shutdown are not 

being proposed. 

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 useful 

manner * * *’’ (40 CFR 63.2). EPA has 

determined that malfunctions should 

not be viewed as a distinct operating 

mode and, therefore, any emissions that 

occur at such times do not need to be 

factored into development of CAA 

section 112(d) standards, which, once 

promulgated, apply at all times. In 

Mossville Environmental Action Now v. 

EPA, 370 F.3d 1232, 1242 (D.C. Cir. 

2004), the court upheld as reasonable 

standards that had factored in 

variability of emissions under all 

operating conditions. However, nothing 

in section 112(d) or in case law requires 

that EPA anticipate and account for the 

innumerable types of potential 

malfunction events in setting emission 

standards. See, Weyerhaeuser v. Costle, 

590 F.2d 1011, 1058 (D.C. Cir. 1978)(‘‘In 

the nature of things, no general limit, 

individual permit, or even any upset 

provision can anticipate all upset 

situations. After a certain point, the 

transgression of regulatory limits caused 

by ‘uncontrollable acts of third parties,’ 

such as strikes, sabotage, operator 

intoxication or insanity, and a variety of 

other eventualities, must be a matter for 

the administrative exercise of case-bycase enforcement discretion, not for 

specification in advance by 

regulation.’’). 

Further, it is reasonable to interpret 

section 112(d) as not requiring EPA to 

account for malfunctions in setting 

emission standards. For example, we 

note that CAA section 112 uses the 

concept of ‘‘best performing’’ sources in 

defining MACT, the level of stringency 

that major source standards must meet. 

Applying the concept of ‘‘best 

performing’’ to a source that is 

malfunctioning presents significant 

difficulties. The goal of best performing 

sources is to operate in such a way as 

to avoid malfunctions of their units. 

Moreover, even if malfunctions were 

considered a distinct operating mode, 

we believe it would be impracticable to 

take malfunctions into account in 

setting CAA section 112(d) standards for 

Primary Lead Smelting. As noted above, 

by definition, malfunctions are sudden 

and unexpected events and it would be 

difficult to set a standard that takes into 

account the myriad different types of 

malfunctions that can occur across all 

sources in the category. Moreover, 

malfunctions can vary in frequency, 

degree, and duration, further 

complicating standard setting. 

In the unlikely event that a source 

fails to comply with the applicable CAA 

section 112(d) standards as a result of a 

malfunction event, EPA would 

determine an appropriate response 

based on, among other things, the good 

faith efforts of the source to minimize 

emissions during malfunction periods, 

including preventative and corrective 

actions, as well as root cause analyses 

to ascertain and rectify excess 

emissions. 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, EPA recognizes that even 

equipment that is properly designed and 

maintained can sometimes fail and that 

such failure can sometimes cause or 

contribute to 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).) EPA is therefore proposing to 

add 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 (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 are proposing 

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. (See 40 

CFR 22.24.) The criteria ensure that the 

affirmative defense is available only 

where the event that causes an 

exceedance of the emission limit meets 

the narrow definition of malfunction in 

40 CFR 63.2 (sudden, infrequent, not 

reasonably preventable and not caused 

by poor maintenance and/or careless 

operation). For example, to successfully 

assert the affirmative defense, the source 

must prove by a preponderance of the 

evidence that excess emissions ‘‘[w]ere 

caused by a sudden, short, 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 §§ 63.1543(i) and 

63.1544(e) and to prevent future 

malfunctions. For example, the source 

must prove by a preponderance of the 

evidence that ‘‘[r]epairs were made as 

expeditiously as possible when the 

applicable emission limitations were 

being exceeded * * *’’ and that ‘‘[a]ll 

possible steps were taken to minimize 

the impact of the excess emissions on 

ambient air quality, the environment 

and human health * * *.’’ In any 

judicial or administrative proceeding, 

the Administrator may challenge the 

assertion of the affirmative defense and, 

if the respondent has not met its burden 

of proving all of the requirements in the 

affirmative defense, appropriate 

penalties may be assessed in accordance 

with section 113 of the Clean Air Act 

(see also 40 CFR part 22.77). 

Specifically, we are proposing the 

following changes to the rule. 

• Added general duty requirements in 

§§ 63.1543 and 63.1544 to replace 

General Provision requirements that 

reference vacated SSM provisions. 


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• Added replacement language that 

eliminates the reference to SSM 

exemptions applicable to performance 

tests in § 63.1546. 

• Added paragraphs in § 63.1549(e) 

requiring the reporting of malfunctions 

as part of the affirmative defense 

provisions. 

• Added paragraphs in § 63.1549(b) 

requiring the keeping of certain records 

during malfunctions as part of the 

affirmative defense provisions. 

• Revised Table 1 to reflect changes 

in the applicability of the General 

Provisions to this subpart resulting from 

a court vacatur of certain SSM 

requirements in the General Provisions. 

2. Lead as a Surrogate and Regulation of 

Volatile Organic Compounds (VOC) and 

Acid Gas Emissions 

In a January 14, 2009, petition for 

rulemaking filed by the Natural 

Resources Defense Council and Sierra 

Club, the petitioners claim that for the 

Primary Lead Smelting MACT, EPA 

relied on lead as a surrogate for all HAP 

and they claim that it was inappropriate 

for EPA to do so in absence of a showing 

that lead is an appropriate surrogate for 

all other HAP (such as mercury, acid 

gases, and volatile organic compounds 

(VOC)). The petitioners asserted that 

EPA should set standards for other HAP 

absent a showing that lead is an 

appropriate surrogate for these HAP. 

They also assert that EPA’s PM standard 

does not reflect the emission level 

achieved by the best performing sources 

and that EPA must re-open the rule to 

set floors for PM in accordance with 

CAA section 112(d)(3). A copy of the 

petition is included in the docket. 

As part of this rulemaking, EPA is 

responding to the claims made by the 

petitioners regarding the Primary Lead 

Smelting MACT. 

As an initial matter, the petitioners 

are incorrect in their claim that EPA 

considers lead as a surrogate for all 

HAP. Rather, EPA used lead as a 

surrogate only for other metal HAP 

compounds in establishing the 

emissions limit in the current MACT 

standard for this source category (63 FR 

19206 and 64 FR 30195). EPA 

determined in the 1999 rule that lead, 

a nonvolatile metal HAP, is an 

appropriate surrogate for other 

nonvolatile metal HAP including 

antimony, arsenic, chromium, nickel, 

manganese, and cadmium. In the 

proposed rule for the Primary Lead 

Smelting MACT (63 FR 19206), EPA 

discussed the use of lead as a surrogate 

for metal HAP emissions and explained 

that strong correlations exist between 

emissions of lead and other metal HAP 

and that the technologies identified for 

the control of metal HAP are the same 

as those used to control lead emissions. 

Therefore, EPA expected that the 

standards requiring control of lead 

would achieve similar control of the 

other metal HAP emitted from primary 

lead smelters. No adverse comments 

were received regarding EPA’s proposed 

rationale for relying on lead as a 

surrogate for other metal HAP emitted 

by these sources and EPA adopted that 

rationale in the final rule promulgating 

the Primary Lead Smelting MACT. The 

petitioners do not have any substantive 

basis as to why EPA’s rationale is not 

supported. Nor do they claim that there 

is any new information that would 

support re-opening this issue. Thus they 

fail to present a basis for re-opening this 

issue. 

The petitioners also insist that EPA 

should have set standards for VOC and 

acid gases that are HAP because lead 

would not be a surrogate for these 

pollutants. EPA noted in the original 

proposal that due to small amounts of 

coke fed to the blast furnace, organic 

HAP (VOC) was emitted at a rate so low 

as to be infeasible to reduce. Again, no 

adverse comments were received on 

EPA’s proposed conclusions, which 

were adopted in the final rule, and the 

petitioners do not now provide 

substantive support for their claim. Nor 

do they explain why any such claim 

could not have been raised during the 

initial rulemaking. Thus, they fail to 

present a basis for re-opening the rule 

on this issue. 

Finally, petitioners claim that the ‘‘PM 

standard does not reflect the emission 

level achieved by the best performing 

sources.’’ This claim is unclear as there 

is no PM standard in the Primary Lead 

Smelting MACT. The monitoring 

provisions provide that PM should be 

measured in relation to a predetermined 

PM level as one test for indicating 

baghouse performance. However, the 

PM levels are not enforceable emission 

limits, but merely an indication that the 

baghouse may not be operating 

properly. Again, these provisions were 

clearly explained in the proposed and 

final Primary Lead Smelting MACT 

rulemakings. Any claims concerning the 

appropriateness of these monitoring 

requirements should have been raised 

during the initial rulemaking process. 

Petitioners do not claim any new 

grounds for raising this issue now. 

Thus, the petition fails to provide a 

basis for re-opening the MACT. 

3. Modification of the Applicability 

Provision 

EPA is proposing to amend the 

applicability section to apply to any 

facility processing lead ore concentrate 

to produce lead metal. Under the 

current applicability provisions, the 

affected sources include any sinter 

machine, blast furnace, dross furnace, 

process fugitive source, and fugitive 

dust source located at a primary lead 

smelter and excludes secondary lead 

smelters, lead refiners, or lead remelters. 

Combined with the current definition 

for ‘‘primary lead smelter,’’ the current 

rule effectively only applies to facilities 

that produce lead metal from lead 

sulfide ore concentrates using 

pyrometallurgical techniques. While the 

only processes available for the 

production of lead from lead ore 

concentrate at the time the MACT rule 

was developed were pyrometallurgical 

techniques, that applicability language 

is narrower than the primary lead 

smelting source category description 

EPA identified in its source category 

listing issued pursuant to CAA section 

112(c)(1), Documentation for 

Developing the Initial Source Category 

List (EPA–450/3–91–030, July 1992). In 

the source category listing, EPA defined 

the primary lead smelting source 

category as follows: ‘‘The Primary Lead 

Smelting source category includes 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, and 

refining operations. The sintering 

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 definition is clear 

that the primary intent was to cover 

sources that produce lead metal from 

ore concentrates, which would 

‘‘include’’ the use of a pyrometallurgical 

process, but would not be limited to 

such. As noted previously, at the time 

we promulgated the MACT standard, 

the only method of producing lead 

metal from ore concentrates was 

through use of pyrometallurgical 

techniques and we adopted an 

applicability provision that focused on 

that process. 

However, information provided by the 

sole operating primary lead smelting 

facility indicates that lead production is 

likely to continue at the current Doe 

Run facility, although using a process 

other than a pyrometallurgical 

technique. The new lead facility would 

continue to process lead ore concentrate 


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in order to produce lead metal. Based on 

the current applicability section and 

definitions, it could be interpreted that 

the future lead producing process, using 

techniques other than 

pyrometallurgical, would not be subject 

to the NESHAP for primary lead 

smelters. Such a limited interpretation 

is not consistent with EPA’s intent as 

evidenced by the broader definition in 

the source category list. Therefore, EPA 

is proposing to amend the applicability 

section to specify that the MACT 

applies to any lead processing facility 

that produces lead metal from lead ore 

concentrate. Consistent with the 

proposed revision to the applicability 

section, we are proposing to remove the 

definition of ‘‘primary lead smelter’’ and 

add a definition of ‘‘primary lead 

processor’’ which means any facility 

engaged in the production of lead metal 

from lead sulfide ore concentrates 

through the use of pyrometallurgical or 

other techniques. In addition, we are 

proposing to replace ‘‘primary lead 

smelter’’ with ‘‘primary lead processor’’ 

throughout 40 CFR subpart TTT. 

(§ 63.1541 through § 63.1545, § 63.1547 

through § 63.1549). We are specifically 

asking for comment on this proposed 

change in the definition. 

Because there is only one primary 

lead processing facility in the U.S., there 

will be no impact of this change on the 

number of existing facilities covered by 

the MACT. 

We note, however, that although we 

are changing the applicability section to 

clarify that the MACT applies to all 

processes for producing lead metal from 

ore concentrates, we are not today 

proposing a specific MACT standard 

that would apply to the as-yet 

undemonstrated hydrometallurgical 

process which Doe Run has indicated 

that it plans to build at the current Doe 

Run facility. If and when that process 

begins operation, we will consider 

whether to revise the MACT standard to 

specifically address that process or any 

other new processes. However, the 

limits applicable to specific emission 

sources currently in operation as 

specified in the MACT and as revised 

under CAA sections 112(d)(6) and (f)(2) 

in this rulemaking would continue to 

apply to any emission source at the 

facility that continues in operation, such 

as the refinery. In addition, to the extent 

that we establish a final air lead 

concentration limit as proposed in 

§ 63.1544, those limits would also 

continue to apply to the facility. We also 

are proposing that the plant-wide 

emission limit we are proposing today 

should continue to apply to any facility 

that meets the revised applicability 

definition, but we are specifically 

soliciting comment on whether it 

should apply. 

We are also taking this opportunity to 

clarify the reference to ‘‘lead refiners’’ in 

the second sentence of the applicability 

section, which provides that the MACT 

standard does not apply to ‘‘secondary 

lead smelters, lead refiners, or lead 

remelters.’’ The intent of this provision 

was to make clear that secondary lead 

smelters would not be subject to the rule 

because secondary lead smelters were 

listed as a separate source category and 

addressed in a separate MACT standard. 

With regard to lead refiners and lead 

remelters, the intent was to provide that 

these activities, to the extent that they 

are not located at facilities that produce 

lead from lead ore concentrate, would 

not be subject to the Primary Lead 

Smelting MACT. However, it was not 

the intention of the rule to exempt kettle 

refining operations included as part of 

a primary lead processing facility. 

Therefore, EPA is proposing to add 

definitions for secondary lead smelters, 

lead refiners, and lead remelters in the 

definitions section of this NESHAP in 

order to further clarify the exemption in 

the applicability provisions with regard 

to these types of facilities. As this 

change only clarifies an existing 

provision in the rule, there will be no 

impact to the number of facilities 

covered by the rule. 

4. Other Changes 

The following lists additional minor 

changes we are proposing. This list 

includes rule changes that address 

editorial errors and plain language 

revisions. 

• As part of EPA’s effort to 

incorporate plain language into its 

regulations, replaced the word ‘‘shall’’ 

with ‘‘must.’’ (§ 63.1543 through 

§ 63.1550) 

• Correction to the original rule 

(‘‘thru’’ replaced with ‘‘through’’ in the 

definition of ‘‘tapping location’’). 

(§ 63.1542) 

• Minor wording change to definition 

of ‘‘fugitive dust source’’ to clarify 

meaning. (§ 63.1542) 

IV. Analyses Performed and 

Background of the Source Category and 

MACT Standard 

As discussed above, in this proposed 

rule we are proposing action to address 

the RTR requirements of CAA sections 

112(d)(6) and (f)(2) for the Primary Lead 

Smelting MACT standard. In this 

section, we describe the analyses 

performed to support the proposed 

decisions for the RTR for this source 

category and we also include 

background information on the source 

category and the MACT standard. 

A. How did we estimate risks posed by 

the source category? 

The EPA conducted a risk assessment 

that provided estimates of the MIR 

posed by the HAP emissions from the 

one source in the source category, the 

distribution of cancer risks within the 

exposed populations, cancer incidence, 

HI for chronic exposures to HAP with 

the potential to cause non-cancer health 

effects, hazard quotients (HQ) for acute 

exposures to HAP with the potential to 

cause non-cancer health effects, and an 

evaluation of the potential for adverse 

environmental effects. The risk 

assessments consisted of seven primary 

steps, as discussed below. 

The docket for this rulemaking 

contains the following document which 

provides more information on the risk 

assessment inputs and models: Draft 

Residual Risk Assessment for the 

Primary Lead Smelting Source Category. 

1. Establishing the Nature and 

Magnitude of Actual Emissions and 

Identifying the Emissions Release 

Characteristics 

For the Primary Lead Smelting source 

category, we compiled a preliminary 

dataset using readily available 

information, reviewed the data, and 

made changes where necessary. The 

preliminary dataset was based on data 

in the 2002 National Emissions 

Inventory (NEI) Final Inventory, Version 

1 (made publicly available on February 

26, 2006). The NEI is a database that 

contains information about sources that 

emit criteria air pollutants, their 

precursors, and HAP. The NEI database 

includes estimates of annual air 

pollutant emissions from point, nonpoint, and mobile sources in the 50 

States, the District of Columbia, Puerto 

Rico, and the Virgin Islands. The EPA 

collects this information and releases an 

updated version of the NEI database 

every 3 years. 

On December 4, 2009, a CAA Section 

114 Information Collection Request 

(ICR) was issued requesting information 

from the one facility in this source 

category. An updated dataset was 

created through incorporation of 

changes to the dataset from the ICR data 

review process and additional 

information gathered by EPA. The 

updated dataset contains information 

for the one facility in the source 

category and was used to conduct the 

risk assessment and other analyses that 

form the basis for the proposed risk and 

technology reviews. A copy of the 

dataset used and documentation of the 

risk assessment can be found in the 

docket. 


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6U.S. EPA. Revision to the Guideline on Air 

Quality Models: Adoption of a Preferred General 

Purpose (Flat and Complex Terrain) Dispersion 

Model and Other Revisions (70 FR 68218, 

November 9, 2005). 

7A census block is generally the smallest 

geographic area for which census statistics are 

tabulated. 

2. Establishing the Relationship 

Between Actual Emissions and MACT– 

Allowable Emissions Levels 

The available emissions data in the 

NEI and from other sources typically 

represent the estimates of mass of 

emissions actually emitted during the 

specified annual time period. These 

‘‘actual’’ emission levels are often lower 

than the emission levels that a facility 

might be allowed to emit and still 

comply with the MACT standards. The 

emissions level allowed to be emitted by 

the MACT standards is referred to as the 

‘‘MACT-allowable’’ emissions level. This 

represents the highest emissions level 

that could be emitted by the facility 

without violating the MACT standards. 

We discussed the use of both MACTallowable and actual emissions in the 

final Coke Oven Batteries residual risk 

rule (70 FR 19998–19999, April 15, 

2005) and in the proposed and final 

Hazardous Organic NESHAP (HON) 

residual risk rules (71 FR 34428, June 

14, 2006, and 71 FR 76609, December 

21, 2006, respectively). In those 

previous actions, we noted that 

assessing the risks at the MACTallowable level is inherently reasonable 

since these risks reflect the maximum 

level sources could emit and still 

comply with national emission 

standards. But we also explained that it 

is reasonable to consider actual 

emissions, where such data are 

available, in both steps of the risk 

analysis, in accordance with the 

Benzene NESHAP. (54 FR 38044, 

September 14, 1989.) It is reasonable to 

consider actual emissions because 

sources typically seek to perform better 

than required by emission standards to 

provide an operational cushion to 

accommodate the variability in 

manufacturing processes and control 

device performance. 

As described above, the actual 

emissions data were compiled based on 

the NEI, information gathered from the 

facility and State, and information 

received in response to the ICR. To 

estimate emissions at the MACTallowable level, we developed a ratio of 

MACT-allowable to actual emissions for 

each source type (i.e., the individual 

stacks and the aggregate fugitive 

emissions) for the one facility in the 

source category. This ratio is based on 

the level of control required by the 

MACT standards compared to the level 

of reported actual emissions and 

available information on the level of 

control achieved by the emissions 

controls in use. For example, if there 

was information to suggest that an 

emission point type was being 

controlled by 98 percent while the 

MACT standards required only 92 

percent control, we would estimate that 

MACT-allowable emissions from that 

emission point type could be as much 

as 4 times higher (8 percent allowable 

emissions compared with 2 percent 

actually emitted), and the ratio of 

MACT-allowable to actual would be 4:1 

for this emission point type. After 

developing these ratios for each 

emission point type at the one facility 

in this source category, we next applied 

these ratios to the maximum chronic 

risk estimates from the inhalation risk 

assessment to obtain maximum risk 

estimates based on MACT-allowable 

emissions. The estimate of MACTallowable emissions for the Primary 

Lead Smelting source category is 

described in section V of this preamble. 

3. Conducting Dispersion Modeling, 

Determining Inhalation Exposures, and 

Estimating Individual and Population 

Inhalation Risks 

Both long-term and short-term 

inhalation exposure concentrations and 

health risks from the source category 

addressed in this proposal were 

estimated using the Human Exposure 

Model (Community and Sector HEM–3 

version 1.1.0). The HEM–3 performs 

three of the primary risk assessment 

activities listed above: (1) Conducting 

dispersion modeling to estimate the 

concentrations of HAP in ambient air, 

(2) estimating long-term and short-term 

inhalation exposures to individuals 

residing within 50 km of the modeled 

sources, and (3) estimating individual 

and population-level inhalation risks 

using the exposure estimates and 

quantitative dose-response information. 

The dispersion model used by HEM– 

3 is AERMOD, which is one of EPA’s 

preferred models for assessing pollutant 

concentrations from industrial 

facilities.6 To perform the dispersion 

modeling and to develop the 

preliminary risk estimates, HEM–3 

draws on three data libraries. The first 

is a library of meteorological data, 

which is used for dispersion 

calculations. This library includes 1 

year of hourly surface and upper air 

observations for 130 meteorological 

stations, selected to provide coverage of 

the United States and Puerto Rico. 

However, in this instance, site-specific 

meteorological data for the one facility 

in this source category were supplied by 

the state of Missouri and used for the 

modeling. The data provided by the 

state of Missouri were for eight quarters 

(i.e., eight three-month periods) from 

April 1997 through June 1999. To obtain 

one year of meteorological data, we used 

the middle portion of these data, the 

year 1998, in our modeling. A second 

library of United States Census Bureau 

census block 7 internal point locations 

and populations provides the basis of 

human exposure calculations (Census, 

2000). In addition, for each census 

block, the census library includes the 

elevation and controlling hill height, 

which are also used in dispersion 

calculations. A third library of pollutant 

unit risk factors and other health 

benchmarks is used to estimate health 

risks. These risk factors and health 

benchmarks are the latest values 

recommended by EPA for HAP and 

other toxic air pollutants. These values 

are available at http://www.epa.gov/ttn/ 

atw/toxsource/summary.html and are 

discussed in more detail later in this 

section. 

In developing the risk assessment for 

chronic exposures, we used the 

estimated annual average ambient air 

concentration of each of the HAP 

emitted by each source for which we 

have emissions data in the source 

category. The air concentrations at each 

nearby census block centroid were used 

as a surrogate for the chronic inhalation 

exposure concentration for all the 

people who reside in that census block. 

We calculated the MIR for the one 

facility as the cancer risk associated 

with a lifetime (70-year period) of 

exposure to the maximum concentration 

at the centroid of an inhabited census 

block. Individual cancer risks were 

calculated by multiplying the estimated 

lifetime exposure to the ambient 

concentration of each of the HAP (in 

micrograms per cubic meter) by its Unit 

Risk Estimate (URE), which is an upper 

bound estimate of an individual’s 

probability of contracting cancer over a 

lifetime of exposure to a concentration 

of 1 microgram of the pollutant per 

cubic meter of air. In general, for 

residual risk assessments, we use URE 

values from EPA’s Integrated Risk 

Information System (IRIS). For 

carcinogenic pollutants without EPA 

IRIS values, we look to other reputable 

sources of cancer dose-response values, 

often using California Environmental 

Protection Agency (CalEPA) URE 

values, where available. In cases where 

new, scientifically credible doseresponse values have been developed in 

a manner consistent with EPA 

guidelines and have undergone a peer 

review process similar to that used by 


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8These classifications also coincide with the 

terms ‘‘known carcinogen, probable carcinogen, and 

possible carcinogen,’’ respectively, which are the 

terms advocated in the EPA’s previous Guidelines 

for Carcinogen Risk Assessment, published in 1986 

(51 FR 33992, September 24, 1986). Summing the 

risks of these individual compounds to obtain the 

cumulative cancer risks is an approach that was 

recommended by the EPA’s SAB in their 2002 peer 

review of EPA’s NATA entitled, NATA—Evaluating 

the National-scale Air Toxics Assessment 1996 

Data—an SAB Advisory, available at: http://

yosemite.epa.gov/sab/sabproduct.nsf/214C6E915BB

04E14852570CA007A682C/$File/ecadv02001.pdf. 

9See http://www.tceq.state.tx.us/compliance/

field_ops/eer/index.html or docket to access the 

source of these data. 

EPA, we may use such dose response 

values in place of, or in addition to, 

other values, if appropriate. In this 

review, IRIS values were available for 

both carcinogenic pollutants (cadmium 

and arsenic) emitted by the facility in 

this source category, and therefore IRIS 

values were used in the assessment. 

Incremental individual lifetime 

cancer risks associated with emissions 

from the one source in the source 

category were estimated as the sum of 

the risks for each of the carcinogenic 

HAP (including those classified as 

carcinogenic to humans, likely to be 

carcinogenic to humans, and suggestive 

evidence of carcinogenic potential 8) 

emitted by the modeled source. Cancer 

incidence and the distribution of 

individual cancer risks for the 

population within 50 km of the source 

were also estimated for the source 

category as part of these assessments by 

summing individual risks. A distance of 

50 km is consistent with both the 

analysis supporting the 1989 Benzene 

NESHAP (54 FR 38044) and the 

limitations of Gaussian dispersion 

models, including AERMOD. 

To assess risk of non-cancer health 

effects from chronic exposures, we 

summed the HQ for each of the HAP 

that affects a common target organ 

system to obtain the HI for that target 

organ system (or target organ-specific 

HI, TOSHI). The HQ is the estimated 

exposure divided by the chronic 

reference value, which is either the EPA 

RfC, defined as ‘‘an estimate (with 

uncertainty spanning perhaps an order 

of magnitude) of a continuous 

inhalation exposure to the human 

population (including sensitive 

subgroups) that is likely to be without 

an appreciable risk of deleterious effects 

during a lifetime,’’ or, in cases where an 

RfC is not available, the Agency for 

Toxic Substances and Disease Registry 

(ATSDR) chronic Minimal Risk Level 

(MRL) or the CalEPA Chronic Reference 

Exposure Level (REL). The REL is 

defined as ‘‘the concentration level at or 

below which no adverse health effects 

are anticipated for a specified exposure 

duration.’’ 

Screening estimates of acute 

exposures and risks were also evaluated 

for each of the HAP at the point of 

highest off-site exposure for each facility 

(i.e., not just the census block centroids) 

assuming that a person was located at 

this spot at a time when both the peak 

(hourly) emission rate and hourly 

dispersion conditions occurred. In 

general, acute HQ values were 

calculated using best available, shortterm dose-response value. These acute 

dose-response values include REL, 

Acute Exposure Guideline Levels 

(AEGL), and Emergency Response 

Planning Guidelines (ERPG) for 1-hour 

exposure durations. Notably, for HAP 

emitted from this source category, REL 

values were the only such doseresponse values available. As discussed 

below, we used conservative 

assumptions for emission rates, 

meteorology, and exposure location for 

our acute analysis. 

As described in the CalEPA’s Air 

Toxics Hot Spots Program Risk 

Assessment Guidelines, Part I, The 

Determination of Acute Reference 

Exposure Levels for Airborne Toxicants, 

an acute REL value (http:// 

www.oehha.ca.gov/air/pdf/acuterel.pdf) 

is defined as ‘‘the concentration level at 

or below which no adverse health 

effects are anticipated for a specified 

exposure duration is termed the REL. 

REL values are based on the most 

sensitive, relevant, adverse health effect 

reported in the medical and 

toxicological literature. REL values are 

designed to protect the most sensitive 

individuals in the population by the 

inclusion of margins of safety. Since 

margins of safety are incorporated to 

address data gaps and uncertainties, 

exceeding the REL does not 

automatically indicate an adverse health 

impact. 

To develop screening estimates of 

acute exposures, we first developed 

estimates of maximum hourly emission 

rates by multiplying the average actual 

annual hourly emission rates by a factor 

to cover routinely variable emissions. 

We chose the factor to use based on 

process knowledge and engineering 

judgment and with awareness of a Texas 

study of short-term emissions 

variability, which showed that most 

peak emission events, in a heavilyindustrialized 4-county area (Harris, 

Galveston, Chambers, and Brazoria 

Counties, Texas) were less than twice 

the annual average hourly emission rate. 

The highest peak emission event was 74 

times the annual average hourly 

emission rate, and the 99th percentile 

ratio of peak hourly emission rate to the 

annual average hourly emission rate was 

9.9 This analysis is provided in 

Appendix 4 of the Draft Residual Risk 

Assessment for Primary Lead Smelting 

which is available in the docket for this 

action. Considering this analysis, unless 

specific process knowledge or data are 

available to provide an alternate value, 

to account for more than 99 percent of 

the peak hourly emissions, we apply a 

conservative screening multiplication 

factor of 10 to the average annual hourly 

emission rate in these acute exposure 

screening assessments. For the Primary 

Lead Smelting source category, this 

factor of 10 was applied. 

In cases where all acute HQ values 

from the screening step were less than 

or equal to 1, acute impacts were 

deemed negligible and no further 

analysis was performed. In the cases 

where an acute HQ from the screening 

step was greater than 1, additional sitespecific data were considered to 

develop a more refined estimate of the 

potential for acute impacts of concern. 

Ideally, we would prefer to have 

continuous measurements over time to 

see how the emissions vary by each 

hour over an entire year. Having a 

frequency distribution of hourly 

emission rates over a year would allow 

us to perform a probabilistic analysis to 

estimate potential threshold 

exceedances and their frequency of 

occurrence. Such an evaluation could 

include a more complete statistical 

treatment of the key parameters and 

elements adopted in this screening 

analysis. However, we recognize that 

having this level of data is rare, hence 

our use of the multiplier (i.e., factor of 

10) approach in our screening analysis. 

4. Conducting Multipathway Exposure 

and Risk Modeling 

The potential for significant human 

health risks due to exposures via routes 

other than inhalation (i.e., 

multipathway exposures) and the 

potential for adverse environmental 

impacts were evaluated in a three-step 

process. In the first step, we determined 

whether any facilities emitted any HAP 

known to be persistent and bioaccumulative in the environment (PB– 

HAP). There are 14 PB–HAP 

compounds or compound classes 

identified for this screening in EPA’s Air 

Toxics Risk Assessment Library 

(available at http://www.epa.gov/ttn/

fera/risk_atra_vol1.html). They are 

cadmium compounds, chlordane, 

chlorinated dibenzodioxins and furans, 

dichlorodiphenyldichloroethylene, 

heptachlor, hexachlorobenzene, 


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hexachlorocyclohexane, lead 

compounds, mercury compounds, 

methoxychlor, polychlorinated 

biphenyls, POM, toxaphene, and 

trifluralin. Emissions of two PB HAP 

were identified in the emissions 

inventory for the Primary Lead Smelting 

source category: Lead compounds and 

cadmium compounds. 

Cadmium emissions were evaluated 

for potential non-inhalation risks and 

adverse environmental impacts using 

our recently developed screening 

scenario that was developed for use 

with the TRIM.FaTE model. This 

screening scenario uses environmental 

media outputs from the peer-reviewed 

TRIM.FaTE to estimate the maximum 

potential ingestion risks for any 

specified emission scenario by using a 

generic farming/fishing exposure 

scenario that simulates a subsistence 

environment. The screening scenario 

retains many of the ingestion and 

scenario inputs developed for EPA’s 

Human Health Risk Assessment 

Protocols (HHRAP) for hazardous waste 

combustion facilities. In the 

development of the screening scenario a 

sensitivity analysis was conducted to 

ensure that its key design parameters 

were established such that 

environmental media concentrations 

were not underestimated, and to also 

minimize the occurrence of false 

positives for human health endpoints. 

See Appendix 3 of the risk assessment 

document for a complete discussion of 

the development and testing of the 

screening scenario, as well as for the 

values of facility-level de minimis 

emission rates developed for screening 

potentially significant multi-pathway 

impacts. For the purpose of developing 

de minimis emission rates for our 

cadmium multi-pathway screening, we 

derived emission levels for cadmium at 

which the maximum human health risk 

would be 1-in-1 million for lifetime 

cancer risk. 

In evaluating the potential air-related 

multi-pathway risks from the emissions 

of lead compounds from the one facility 

in this source category, rather than 

developing a de minimis emission rate, 

we compared its maximum modeled 3- 

month average atmospheric lead 

concentration at any off-site location 

with the current primary National 

Ambient Air Quality Standard (NAAQS) 

for lead (promulgated in 2008), which is 

set to a level of 0.15 micro-grams per 

cubic meter (μg/m3) based on a rolling 

3-month period with a not-to-beexceeded form, and which will require 

attainment by 2016. 73 FR 66964. 

Notably, in making these comparisons, 

we estimated maximum rolling 3-month 

ambient lead concentrations taking into 

account all of the elements of the 

NAAQS for lead. That is, our estimated 

3-month lead concentrations are 

calculated in a manner that is consistent 

with the indicator, averaging time, and 

form of the NAAQS for lead, and those 

estimates are compared to the actual 

level of the lead NAAQS (0.15 μg/m3). 

The NAAQS value, a public health 

policy judgment, incorporated the 

Agency’s most recent health evaluation 

of air effects of lead exposure for the 

purposes of setting a national standard. 

In setting this value, the Administrator 

promulgated a standard that was 

requisite to protect public health with 

an adequate margin of safety. We 

consider values below the level of the 

primary NAAQS to protect against 

multi-pathway risks because, as 

mentioned above, the primary NAAQS 

is set as to protect public health with an 

adequate margin of safety. However, 

ambient air lead concentrations above 

the NAAQS are considered to pose the 

potential for increased risk to public 

health. We consider this NAAQS 

assessment to be a refined analysis 

given the numerous health studies, 

detailed risk and exposure analyses, and 

level of external peer and public review 

that went into the development of the 

primary NAAQS for lead, combined 

with the site-specific dispersion 

modeling analysis performed to develop 

the ambient concentration estimates due 

to emissions from the one Primary Lead 

Processing facility being addressed in 

this RTR. It should be noted, however, 

that this comparison does not account 

for possible population exposures to 

lead from sources other than the one 

being modeled; for example, via 

consumption of water from untreated 

local sources or ingestion of locally 

grown food. Nevertheless, the 

Administrator judged that such a 

standard, would protect, with an 

adequate margin of safety, 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. The 

Administrator, in setting the standard, 

also recognized that no evidence-or risk 

based bright line indicated a single 

appropriate level. Instead a collection of 

scientific evidence and other 

information was used to select the 

standard from a range of reasonable 

values. 73 FR 67006. 

We further note that comparing 

ambient lead concentrations to the 

NAAQS for lead, considering the level, 

averaging time, form and indicator, also 

informs whether there is the potential 

for adverse environmental effects. This 

is because the secondary lead NAAQS, 

which has the same averaging time, 

form, and level as the primary standard, 

was set to protect the public welfare 

which includes among other things 

soils, water, crops, vegetation and 

wildlife. CAA section 302(h). Thus, 

ambient lead concentrations above the 

NAAQS for lead also indicate the 

potential for adverse environmental 

effects. 

For additional information on the 

multi-pathway analysis approach, see 

the residual risk documentation as 

referenced in section IV.A of this 

preamble. The EPA solicits comment 

generally on the modeling approach 

used herein to assess air-related lead 

risks, and specifically on the use of the 

lead NAAQS in this analytical 

construct. 

5. Assessing Risks Considering 

Emissions Control Options 

In addition to assessing baseline 

inhalation risks and screening for 

potential multi-pathway risks, we also 

estimated risks considering the potential 

emission reductions that would be 

achieved by the particular control 

options under consideration. The 

expected emissions reductions were 

applied to the specific HAP and 

emissions points in the source category 

dataset to develop corresponding 

estimates of risk reductions. 

6. Conducting Other Risk-Related 

Analyses, Including Facility-Wide 

Assessments and Demographic Analyses 

a. Facility-Wide Risk 

To put the source category risks in 

context, for our residual risk review, we 

also examine the risks from the entire 

‘‘facility,’’ where the facility includes all 

HAP-emitting operations within a 

contiguous area and under common 

control. In other words, we examine the 

HAP emissions not only from the source 

category of interest, but also emissions 

of HAP from all other emission sources 

at the facility. In this rulemaking, for the 

sole facility in the Primary Lead 

Smelting source category, there are no 

other significant HAP emission sources 

present. With the exception of organic 

HAP sources determined to present 

insignificant risk, all HAP sources have 

been included in the risk analysis. 

Therefore, the facility-wide risks are the 

same as the source category risk and no 

separate facility-wide analysis was 

necessary. 

b. Demographic Analysis 

To examine the potential for any 

environmental justice issues that might 

be associated with HAP emissions with 

this source category, we evaluated the 


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10Risk and Technology Review—Analysis of 

Socio-Economic Factors for Populations Living Near 

Primary Lead Smelting Operations. 

distributions of HAP-related cancer and 

non-cancer risks across different social, 

demographic, and economic groups 

within the populations living near the 

one facility in this source category. The 

development of demographic analyses 

to inform the consideration of 

environmental justice issues in EPA 

rulemakings is evolving. EPA offers the 

demographic analyses in this 

rulemaking to inform the consideration 

of potential environmental justice 

issues, and invites public comment on 

the approaches used and the 

interpretations made from the results, 

with the hope that this will support the 

refinement and improve the utility of 

such analyses for future rulemakings. 

For the demographic analyses, we 

focus on the populations within 50 km 

of any facility with emission sources 

subject to the MACT standard (identical 

to the risk assessment). Based on the 

emissions for the source category or the 

facility, we then identified the 

populations that are estimated to have 

exposures to HAP which result in: (1) 

Cancer risks of 1-in-1 million or greater, 

(2) non-cancer HI of 1 or greater, and/ 

or (3) ambient lead concentrations above 

the level of the NAAQS for lead. We 

compare the percentages of particular 

demographic groups within the focused 

populations to the total percentages of 

those demographic groups nationwide. 

The results, including other risk 

metrics, such as average risks for the 

exposed populations, are documented 

in a technical report in the docket for 

the source category covered in this 

proposal.10

The basis for the risk values used in 

the demographic analyses for the one 

facility subject to the Primary Lead 

Smelting MACT was the modeling 

results based on actual emissions levels 

obtained from the HEM–3 model 

described above. The risk values for 

each census block were linked to a 

database of information from the 2000 

decennial census that includes data on 

race and ethnicity, age distributions, 

poverty status, household incomes, and 

education level. The Census Department 

Landview® database was the source of 

the data on race and ethnicity, and the 

data on age distributions, poverty status, 

household incomes, and education level 

were obtained from the 2000 Census of 

Population and Housing Summary File 

3 (SF3) Long Form. While race and 

ethnicity census data are available at the 

census block level, the age and income 

census data are only available at the 

census block group level (which 

includes an average of 26 blocks or an 

average of 1,350 people). Where census 

data are available at the block group 

level but not the block level, we 

assumed that all census blocks within 

the block group have the same 

distribution of ages and incomes as the 

block group. 

We focused the analysis on those 

census blocks where source category 

risk results show either estimated 

lifetime inhalation cancer risks above 1- 

in-1 million or chronic non-cancer 

indices above 1. In addition, in this case 

we also focused on those census blocks 

where estimated ambient lead 

concentrations were above the level of 

the lead NAAQS. For each of these 

cases, we determined the relative 

percentage of different racial and ethnic 

groups, different age groups, adults with 

and without a high school diploma, 

people living in households below the 

national median income, and for people 

living below the poverty line within 

those census blocks. The specific census 

population categories included: 

• Total population; 

• White; 

• African American (or Black); 

• Native Americans; 

• Other races and multiracial; 

• Hispanic or Latino; 

• People living below the poverty 

line; 

• Children 18 years of age and under; 

• Adults 19 to 64 years of age; 

• Adults 65 years of age and over; 

• Adults without a high school 

diploma. 

It should be noted that these 

categories overlap in some instances, 

resulting in some populations being 

counted in more than one category (e.g., 

other races and multiracial and 

Hispanic). In addition, while not a 

specific census population category, we 

also examined risks to ‘‘Minorities,’’ a 

classification which is defined for these 

purposes as all race population 

categories except white. 

The methodology and the results of 

the demographic analyses for this 

source category are included in the 

technical report available in the docket 

for this action. (Risk and Technology 

Review—Analysis of Socio-Economic 

Factors for Populations Living Near 

Primary Lead Smelting Operations). 

7. Considering Uncertainties in Risk 

Assessment 

Uncertainty and the potential for bias 

are inherent in all risk assessments, 

including that performed for the source 

category addressed in this proposal. 

Although uncertainty exists, we believe 

the approach that we took, which used 

conservative tools and assumptions, 

ensures that our decisions are healthprotective. A brief discussion of the 

uncertainties in the emissions dataset, 

dispersion modeling, inhalation 

exposure estimates, and dose-response 

relationships follows below. A more 

thorough discussion of these 

uncertainties is included in the risk 

assessment documentation (Draft 

Residual Risk Assessment for Primary 

Lead Smelting) available in the docket 

for this action. 

a. Uncertainties in the Emissions 

Dataset 

Although the development of the RTR 

dataset involved quality assurance/ 

quality control processes, the accuracy 

of emissions values will vary depending 

on the source of the data, the degree to 

which data are incomplete or missing, 

the degree to which assumptions made 

to complete the datasets are accurate, 

whether and to what extent errors were 

made in estimating emissions values, 

and other factors. The emission 

estimates considered in this analysis are 

annual totals provided by the facility 

that do not reflect short-term 

fluctuations during the course of a year 

or variations from year to year. In 

contrast, the estimates of peak hourly 

emission rates for the acute effects 

screening assessment were based on 

multiplication factors applied to the 

average annual hourly emission rates 

(the default factor of 10 was used for 

Primary Lead Smelting), which is 

intended to account for emission 

fluctuations due to normal facility 

operations. 

b. Uncertainties in Dispersion Modeling 

While the analysis employed EPA’s 

recommended regulatory dispersion 

model, AERMOD, we recognize that 

there is uncertainty in ambient 

concentration estimates associated with 

any model, including AERMOD. In 

circumstances where we had to choose 

between various model options, where 

possible, we selected model options 

(e.g., rural/urban, plume depletion, 

chemistry) that provided an 

overestimate of ambient concentrations 

of the HAP rather than an 

underestimate. However, because of 

practicality and data limitation reasons, 

some factors (e.g., building downwash) 

have the potential in some situations to 

overestimate or underestimate ambient 

impacts. Despite these uncertainties, we 

believe that at off-site locations and 

census block centroids, the approach 

considered in the dispersion modeling 

analysis should generally yield 

overestimates of ambient HAP 

concentrations. 


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11Short-term mobility is movement from one 

microenvironment to another over the course of 

hours or days. Long-term mobility is movement 

from one residence to another over the course of a 

lifetime. 

12U.S. EPA. National-Scale Air Toxics 

Assessment for 1996. (EPA 453/R–01–003; January 

2001; page 85.) 

13 IRIS glossary (http://www.epa.gov/NCEA/iris/ 

help_gloss.htm). 

14An exception to this is the URE for benzene, 

which is considered to cover a range of values, each 

end of which is considered to be equally plausible, 

and which is based on maximum likelihood 

estimates. 

15According to the NRC report, Science and 

Judgment in Risk Assessment (NRC, 1994) ‘‘[Default] 

options are generic approaches, based on general 

scientific knowledge and policy judgment, that are 

applied to various elements of the risk assessment 

process when the correct scientific model is 

unknown or uncertain.’’ The 1983 NRC report, Risk 

Assessment in the Federal Government: Managing 

the Process, defined default option as ‘‘the option 

chosen on the basis of risk assessment policy that 

Continued 

c. Uncertainties in Inhalation Exposure 

The effects of human mobility on 

exposures were not included in the 

assessment. Specifically, short-term 

mobility and long-term mobility 

between census blocks in the modeling 

domain were not considered.11 As a 

result, this simplification will likely 

bias the assessment toward 

overestimating the highest exposures. In 

addition, the assessment predicted the 

chronic exposures at the centroid of 

each populated census block as 

surrogates for the exposure 

concentrations for all people living in 

that block. Using the census block 

centroid to predict chronic exposures 

tends to over-predict exposures for 

people in the census block who live 

farther from the facility, and underpredict exposures for people in the 

census block who live closer to the 

facility. Thus, using the census block 

centroid to predict chronic exposures 

may lead to a potential understatement 

or overstatement of the true maximum 

impact for any one individual, but is an 

unbiased estimate of average risk and 

incidence. 

The assessments evaluate the 

projected cancer inhalation risks 

associated with pollutant exposures 

over a 70-year period, which is the 

assumed lifetime of an individual. In 

reality, both the length of time that 

modeled emissions sources at facilities 

actually operate (i.e., more or less than 

70 years), and the domestic growth or 

decline of the modeled industry (i.e., the 

increase or decrease in the number or 

size of United States facilities), will 

influence the future risks posed by a 

given source or source category. 

Depending on the characteristics of the 

industry, these factors will, in most 

cases, result in an overestimate both in 

individual risk levels and in the total 

estimated number of cancer cases. 

However, in rare cases, where a facility 

maintains or increases its emission 

levels beyond 70 years, residents live 

beyond 70 years at the same location, 

and the residents spend most of their 

days at that location, then the risks 

could potentially be underestimated. 

Annual cancer incidence estimates from 

exposures to emissions from these 

sources would not be affected by 

uncertainty in the length of time 

emissions sources operate. For the 

specific source in this source category 

we anticipate significant reduction in 

activities and emissions in the relatively 

near future. If this happens, chronic 

risks based on the continuation of 

current emission levels will be over 

estimated. 

The exposure estimates used in these 

analyses assume chronic exposures to 

ambient levels of pollutants. Because 

most people spend the majority of their 

time indoors, actual exposures may not 

be as high, depending on the 

characteristics of the pollutants 

modeled. For many of the HAP, indoor 

levels are roughly equivalent to ambient 

levels, but for very reactive pollutants or 

larger particles, these levels are 

typically lower. This factor has the 

potential to result in an overstatement of 

25 to 30 percent of exposures.12

In addition to the uncertainties 

highlighted above, there are several 

factors specific to the acute exposure 

assessment that should be highlighted. 

The accuracy of an acute inhalation 

exposure assessment depends on the 

simultaneous occurrence of 

independent factors that may vary 

greatly, such as hourly emissions rates, 

meteorology, and human activity 

patterns. In this assessment, we assume 

that individuals remain for 1 hour at the 

point of maximum ambient 

concentration as determined by the cooccurrence of peak emissions and worstcase meteorological conditions. These 

assumptions would tend to overestimate 

actual exposures since it is unlikely that 

a person would be located at the point 

of maximum exposure during the time 

of worst-case impact. 

d. Uncertainties in Dose-Response 

Relationships 

There are uncertainties inherent in 

the development of the dose-response 

values used in our risk assessments for 

cancer effects from chronic exposures 

and non-cancer effects from both 

chronic and acute exposures. Some 

uncertainties may be considered 

quantitatively, and others generally are 

expressed in qualitative terms. We note 

as a preface to this discussion a point on 

dose-response uncertainty that is 

brought out in EPA’s 2005 Cancer 

Guidelines; namely, that ‘‘the primary 

goal of EPA actions is protection of 

human health; accordingly, as an 

Agency policy, risk assessment 

procedures, including default options 

that are used in the absence of scientific 

data to the contrary, should be health 

protective.’’ (EPA 2005 Cancer 

Guidelines, pages 1–7.) This is the 

approach followed here as summarized 

in the next several paragraphs. A 

complete detailed discussion of 

uncertainties and variabilities in doseresponse relationships is given in the 

residual risk documentation which is 

available in the docket for this action. 

Cancer URE values used in our risk 

assessments are those that have been 

developed to generally provide an upper 

bound estimate of risk. That is, they 

represent a ‘‘plausible upper limit to the 

true value of a quantity’’ (although this 

is usually not a true statistical 

confidence limit).13 In some 

circumstances, the true risk could be as 

low as zero; however, in other 

circumstances the risk could be 

greater.14 When developing an upper 

bound estimate of risk and to provide 

risk values that do not underestimate 

risk, health-protective default 

approaches are generally used. To err on 

the side of ensuring adequate healthprotection, EPA typically uses the upper 

bound estimates rather than lower 

bound or central tendency estimates in 

our risk assessments, an approach that 

may have limitations for other uses (e.g., 

priority-setting or expected benefits 

analysis). 

Chronic non-cancer reference (RfC 

and RfD) values represent chronic 

exposure levels that are intended to be 

health-protective levels. Specifically, 

these values provide an estimate (with 

uncertainty spanning perhaps an order 

of magnitude) of a continuous 

inhalation exposure (RfC) or a daily oral 

exposure (RfD) to the human population 

(including sensitive subgroups) that is 

likely to be without an appreciable risk 

of deleterious effects during a lifetime. 

To derive values that are intended to be 

‘‘without appreciable risk,’’ the 

methodology relies upon an uncertainty 

factor (UF) approach (U.S. EPA, 1993, 

1994) which includes consideration of 

both uncertainty and variability. When 

there are gaps in the available 

information, UF are applied to derive 

reference values that are intended to 

protect against appreciable risk of 

deleterious effects. The UF are 

commonly default values,15 e.g., factors 


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appears to be the best choice in the absence of data 

to the contrary’’ (NRC, 1983a, p. 63). Therefore, 

default options are not rules that bind the Agency; 

rather, the Agency may depart from them in 

evaluating the risks posed by a specific substance 

when it believes this to be appropriate. In keeping 

with EPA’s goal of protecting public health and the 

environment, default assumptions are used to 

ensure that risk to chemicals is not underestimated 

(although defaults are not intended to overtly 

overestimate risk). See EPA, 2004, An Examination 

of EPA Risk Assessment Principles and Practices, 

EPA/100/B–04/001 available at: http:// 

www.epa.gov/osa/pdfs/ratf-final.pdf. 

of 10 or 3, used in the absence of 

compound-specific data; where data are 

available, UF may also be developed 

using compound-specific information. 

When data are limited, more 

assumptions are needed and more UF 

are used. Thus, there may be a greater 

tendency to overestimate risk in the 

sense that further study might support 

development of reference values that are 

higher (i.e., less potent) because fewer 

default assumptions are needed. 

However, for some pollutants, it is 

possible that risks may be 

underestimated. 

While collectively termed ‘‘UF,’’ these 

factors account for a number of different 

quantitative considerations when using 

observed animal (usually rodent) or 

human toxicity data in the development 

of the RfC. The UF are intended to 

account for: (1) Variation in 

susceptibility among the members of the 

human population (i.e., inter-individual 

variability); (2) uncertainty in 

extrapolating from experimental animal 

data to humans (i.e., interspecies 

differences); (3) uncertainty in 

extrapolating from data obtained in a 

study with less-than-lifetime exposure 

(i.e., extrapolating from sub-chronic to 

chronic exposure); (4) uncertainty in 

extrapolating the observed data to 

obtain an estimate of the exposure 

associated with no adverse effects; and 

(5) uncertainty when the database is 

incomplete or there are problems with 

the applicability of available studies. 

Many of the UF used to account for 

variability and uncertainty in the 

development of acute reference values 

are quite similar to those developed for 

chronic durations, but they more often 

use individual UF values that may be 

less than 10. UF are applied based on 

chemical-specific or health effectspecific information (e.g., simple 

irritation effects do not vary appreciably 

between human individuals, hence a 

value of 3 is typically used), or based on 

the purpose for the reference value (see 

the following paragraph). The UF 

applied in acute reference value 

derivation include: (1) Heterogeneity 

among humans; (2) uncertainty in 

extrapolating from animals to humans; 

(3) uncertainty in lowest observed 

adverse effect (exposure) level to no 

observed adverse effect (exposure) level 

adjustments; and (4) uncertainty in 

accounting for an incomplete database 

on toxic effects of potential concern. 

Additional adjustments are often 

applied to account for uncertainty in 

extrapolation from observations at one 

exposure duration (e.g., 4 hours) to 

derive an acute reference value at 

another exposure duration (e.g., 1 hour). 

As further discussed below, there is 

no RfD or other comparable chronic 

health benchmark value for lead 

compounds. Thus, to address 

multipathway human health and 

environmental risks associated with 

emissions of lead from this facility, 

ambient lead concentrations were 

compared to the NAAQS for lead. In 

developing the NAAQS for lead, EPA 

considered human health evidence 

reporting adverse health effects 

associated with lead exposure, as well 

as an EPA conducted multipathway risk 

assessment that applied models to 

estimate human exposures to air-related 

lead and the associated risk (73 FR 

66979). EPA also explicitly considered 

the uncertainties associated with both 

the human health evidence and the 

exposure and risk analyses when 

developing the NAAQS for lead. For 

example, EPA considered uncertainties 

in the relationship between ambient air 

lead and blood lead levels (73 FR 

66974), as well as uncertainties between 

blood lead levels and loss of IQ points 

in children (73 FR 66981). 

In considering the evidence and risk 

analyses and their associated 

uncertainties, the EPA Administrator 

noted his view that there is no evidenceor risk-based bright line that indicates a 

single appropriate level. Instead, he 

noted, there is a collection of scientific 

evidence and judgments and other 

information, including information 

about the uncertainties inherent in 

many relevant factors, which needs to 

be considered together in making this 

public health policy judgment and in 

selecting a standard level from a range 

of reasonable values (73 FR 66998). In 

so doing, the Administrator decided 

that, a level for the primary lead 

standard of 0.15 μg/m3, in combination 

with the specified choice of indicator, 

averaging time, and form, is requisite to 

protect public health, including the 

health of sensitive groups, with an 

adequate margin of safety (73 FR 67006). 

A thorough discussion of the health 

evidence, risk and exposure analyses, 

and their associated uncertainties can be 

found in EPA’s final rule revising the 

lead NAAQS (73 FR 66970–66981, 

November 12, 2008). 

We also note the uncertainties 

associated with the health-based (i.e., 

primary) NAAQS are likely less than the 

uncertainties associated with doseresponse values developed for many of 

the other HAP, particularly those HAP 

for which no human health data exist. 

In 1988, 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.’’ EPA’s IRIS 

assessment for Lead and compounds 

(inorganic) (CASRN 7439–92–1), http:// 

www.epa.gov/iris/subst/0277.htm. 

We also note that because of the 

multi-pathway, multi-media impacts of 

lead, the risk assessment supporting the 

NAAQS considered direct inhalation 

exposures and indirect air-related multipathway 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). In revising the NAAQS for lead, 

we note that the Administrator placed 

more weight on the evidence-based 

framework and less weight on the 

results from the risk assessment, 

although he did find the risk estimates 

to be roughly consistent with and 

generally supportive of the evidencebased framework applied in the NAAQS 

determination. 73 FR 67004. Thus, 

when revising the NAAQS for lead to 

protect public health with an adequate 

margin of safety, EPA considered both 


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the health evidence and the risk 

assessment, albeit to different extents. 

In addition to the uncertainties 

discussed above with respect to chronic, 

cancer, and the lead NAAQS reference 

values, there are also uncertainties 

associated with acute reference values. 

Not all acute reference values are 

developed for the same purpose, and 

care must be taken when interpreting 

the results of an acute assessment of 

human health effects relative to the 

reference value or values being 

exceeded. Where relevant to the 

estimated exposures, the lack of shortterm dose-response values at different 

levels of severity should be factored into 

the risk characterization as potential 

uncertainties. 

Although every effort is made to 

identify peer-reviewed reference values 

for cancer and non-cancer effects for all 

pollutants emitted by the sources 

included in this assessment, some 

hazardous air pollutants continue to 

have no peer-reviewed reference values 

for cancer or chronic non-cancer or 

acute effects. Since exposures to these 

pollutants cannot be included in a 

quantitative risk estimate, an 

understatement of risk for these 

pollutants at environmental exposure 

levels is possible. 

Additionally, chronic reference values 

for several of the compounds included 

in this assessment are currently under 

EPA IRIS review (e.g., cadmium and 

nickel), and revised assessments may 

determine that these pollutants are more 

or less potent than the current value. We 

may re-evaluate residual risks for the 

final rulemaking if, as a result of these 

reviews, a dose-response metric changes 

enough to indicate that the risk 

assessment supporting this notice may 

significantly understate human health 

risk. 

e. Uncertainties in the Multipathway 

and Environmental Effects Assessment 

We generally assume that when 

exposure levels are not anticipated to 

adversely affect human health, they also 

are not anticipated to adversely affect 

the environment. For each source 

category, we generally rely on the sitespecific levels of PB–HAP emissions to 

determine whether a full assessment of 

the multi-pathway and environmental 

effects is necessary. For PB–HAPS other 

than lead (i.e., cadmium), site-specific 

PB–HAP emission levels were far below 

levels which would trigger a refined 

assessment of multi-pathway impacts, 

thus we are confident that these types 

of impacts are insignificant for the one 

facility in this source category. 

f. Uncertainties in the Facility-Wide 

Risk Assessment 

We did not conduct a separate 

facility-wide risk assessment for this 

proposal because all of the HAP 

emission sources at the one facility 

subject to the MACT are covered by the 

MACT standard under review. Thus, the 

level of the facility-wide HAP emissions 

is the same as the level of emissions 

from the emissions sources subject to 

the MACT standard under review. 

g. Uncertainties in the Demographic 

Analysis 

Our analysis of the distribution of 

risks across various demographic groups 

is subject to the typical uncertainties 

associated with census data (e.g., errors 

in filling out and transcribing census 

forms), as well as the additional 

uncertainties associated with the 

extrapolation of census-block group data 

(e.g., income level and education level) 

down to the census block level. 

B. How did we perform the technology 

review? 

Our technology review is focused on 

the identification and evaluation of 

developments in practices, processes, 

and control technologies. If a review of 

available information identifies such 

developments, then we conduct an 

analysis of the technical feasibility of 

these developments, along with the 

impacts (costs, emission reductions, risk 

reductions, etc.). We then make a 

decision on whether it is necessary to 

amend the regulation to require any 

identified developments. 

Based on specific knowledge of the 

primary lead smelting source category, 

we began by identifying known 

developments in practices, processes, 

and control technologies. For the 

purpose of this exercise, we considered 

any of the following to be a 

‘‘development’’: 

• Any add-on control technology or 

other equipment that was not identified 

and considered during MACT 

development; 

• Any improvements in add-on 

control technology or other equipment 

(that was identified and considered 

during MACT development) that could 

result in significant additional emission 

reduction; 

• Any work practice or operational 

procedure that was not identified and 

considered during MACT development; 

and 

• Any process change or pollution 

prevention alternative that could be 

broadly applied that was not identified 

and considered during MACT 

development. 

In addition to looking back at 

practices, processes, or control 

technologies reviewed at the time we 

developed the MACT standards, we 

reviewed a variety of sources of data to 

aid in our evaluation of whether there 

were additional practices, processes, or 

controls to consider. One of these 

sources of data was subsequent air 

toxics rules. Since the promulgation of 

the MACT standard for the primary lead 

smelting source category addressed in 

this proposal, EPA has developed air 

toxics regulations for a number of 

additional source categories. We 

reviewed the regulatory requirements 

and/or technical analyses associated 

with these subsequent regulatory 

actions to identify any practices, 

processes, and control technologies 

considered in these efforts that could 

possibly be applied to emission sources 

in the primary lead smelting source 

category. 

We also consulted EPA’s RACT/ 

BACT/LAER Clearinghouse (RBLC). The 

terms ‘‘RACT,’’ ‘‘BACT,’’ and ‘‘LAER’’ are 

acronyms for different program 

requirements under the CAA provisions 

addressing the national ambient air 

quality standards. Control technologies, 

classified as RACT (Reasonably 

Available Control Technology), BACT 

(Best Available Control Technology), or 

LAER (Lowest Achievable Emission 

Rate) apply to stationary sources 

depending on whether the sources are 

existing or new, and on the size, age, 

and location of the facility. BACT and 

LAER (and sometimes RACT) are 

determined on a case-by-case basis, 

usually by state or local permitting 

agencies. EPA established the RBLC to 

provide a central database of air 

pollution technology information 

(including technologies required in 

source-specific permits) to promote the 

sharing of information among 

permitting agencies and to aid in 

identifying future possible control 

technology options that might apply 

broadly to numerous sources within a 

category or apply only on a source-bysource basis. The RBLC contains over 

5,000 air pollution control permit 

determinations that can help identify 

appropriate technologies to mitigate 

many air pollutant emission streams. 

We searched this database to determine 

whether any practices, processes, or 

control technologies are included for the 

types of processes covered by the 

primary lead smelting MACT. 

We also requested information from 

the facility regarding developments in 

practices, processes, or control 

technology. Finally, we reviewed other 

information sources, such as state or 


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16As provided above in section III(C)(3), we are 

proposing to change the standard to apply to 

Primary Lead Processors. 

local permitting agency databases and 

industry-supported databases. 

C. Overview of the Source Category and 

MACT Standards 

1. Source Category and MACT Standard 

The National Emission Standard for 

Primary Lead Smelting (or MACT rule) 

was promulgated on June 4, 1999 (64 FR 

30194) and codified at 40 CFR part 63, 

subpart TTT. As promulgated in 1999, 

the MACT standard applies to affected 

sources of HAP at primary lead 

smelters.16 The MACT defines ‘‘Primary 

lead smelters’’ as ‘‘any facility engaged 

in the production of lead metal from 

lead sulfide ore concentrates through 

the use of pyrometallurgical 

techniques.’’ 40 CFR 63.1542. The 

MACT standard for the Primary Lead 

Smelting source category does not apply 

to secondary lead smelters, lead 

remelters, or lead refiners (§ 63.1541). 

Today there is one facility (The Doe Run 

Company in Herculaneum, Missouri) 

operating that is subject to the MACT 

standards (See Section V.A. below). 

At the time of promulgation of the 

Primary Lead Smelting MACT rule, 

there were three operating lead smelters. 

Due to economic pressures (decreased 

market demand for lead) and regulatory 

pressures, two of the lead smelting 

facilities subject to the MACT standard 

have since been permanently closed, 

leaving one primary lead smelter 

currently operating in the United States. 

No new primary lead smelters have 

been built in the last 20 years, and no 

new primary lead processing facilities 

using pyrometallurgical techniques are 

anticipated in the foreseeable future. 

The one operating lead smelter is not 

collocated with other sources of HAP 

emissions. 

Lead is used to make various 

construction and consumer products 

such as batteries, paint, glass, piping, 

and filler. Lead sulfide (PbS) ore 

concentrates are the main feed material 

to primary lead smelters. The primary 

lead smelting process consists of lead 

sulfide concentrate storage and 

handling, sintering of ore concentrates, 

sinter crushing and handling, smelting 

of sinter to lead metal, drossing (i.e., 

removing the solid oxide deposits), 

refining and alloying of lead metal, and 

smelting of the drosses. 

HAP are emitted from primary lead 

smelting as process emissions (stack), 

process fugitive emissions, and fugitive 

dust emissions. Process emissions are 

associated with the exhaust gases from 

sinter machines and blast and dross 

furnaces. HAP expected in process 

emissions are metals (mostly lead 

compounds, but also some arsenic, 

cadmium, and other metals) and also 

may include small amounts of organic 

compounds that result from incomplete 

combustion of coke, which is charged 

along with sinter to the blast furnace. 

Process fugitive emissions occur at 

various points during the smelting 

process (such as during charging and 

tapping of furnaces) and the only HAP 

emitted are metal HAP. Fugitive dust 

emissions result from the entrainment of 

dust due to material handling, vehicle 

traffic, and wind erosion from storage 

piles and the only HAP emitted are 

metal HAP. 

The MACT standard (40 CFR part 63, 

subpart TTT) applies to process 

emissions (stack) from sinter machines, 

blast furnaces, and dross furnaces; 

process fugitive emissions from sinter, 

blast furnace, drossing and refining 

processes, concentrate handling, and 

locations around such processes; and 

fugitive dust emission sources, such as 

roadways, storage piles and the plant 

yard. Process emissions of lead 

compounds from sinter machines, blast 

furnaces, and dross furnaces, and 

process fugitive emissions from the blast 

furnace and dross furnace charging, 

blast furnace and dross furnace tapping, 

and the sinter machine (charging, 

discharging, crushing, and sizing) are 

limited to 500 grams (g) of lead 

emissions per mega gram (Mg) of lead 

produced (500 g/Mg), which is equal to 

1.0 pound (lb) of lead emissions per ton 

of lead produced (1 lb/ton). 40 CFR 

63.1542(a). A plant-wide limit format 

was used for MACT because it was 

consistent with SIPs, the commingling 

of exhaust gases from processes to a 

single stack made it impossible to set 

limits for individual sources, it gave the 

facilities more flexibility in complying 

with the standard, and it promoted 

pollution prevention by giving each 

facility the ability to meet the emission 

limit through any combination of source 

reduction and control technology 

options. (63 FR 19208). 

In addition to being subject to the 

plant-wide emission limit of the 

standard, process fugitive emissions 

must be captured by a hood and 

ventilated to a baghouse or equivalent 

control device and the hood design and 

ventilation rate must be consistent with 

American Conference of Governmental 

Industrial Hygienists recommended 

practices. 40 CFR 63.1543(b). In 

addition, the sinter machine area 

fugitives must be enclosed in a building 

that is ventilated to a baghouse at a rate 

that maintains a positive in-draft 

through any doorway opening. 40 CFR 

63.1543(c). The MACT standard also 

requires the use of bag leak detection 

systems for continuous monitoring of 

baghouses. 40 CFR 63.1547(c)(9). For 

fugitive dust sources, as defined in 40 

CFR 63.1544, the MACT standard 

requires that the owner or operator 

prepare and operate at all times 

according to a standard operating 

procedures (SOP) manual. The SOP 

manual must describe in detail the 

measures used to control fugitive dust 

emissions from plant roadways, material 

storage and handling areas, sinter 

machine areas, blast and dross furnace 

areas, and refining and casting 

operations areas. Existing work practice 

manual(s) that describe the measures in 

place to control fugitive dust sources 

required as part of a state 

implementation plan for lead satisfy this 

requirement. 

2. MACT as it Applies to Doe Run 

Company Primary Lead Smelter, 

Herculaneum, Missouri 

As stated above, the Doe Run Smelter 

in Herculaneum, Missouri, is the sole 

remaining lead processing facility in the 

United States subject to the MACT. The 

1999 MACT rule established a plantwide lead emission limit of 1 lb of lead 

per ton of lead produced that applies to 

the aggregation of emissions from 

specific sources that discharge from air 

pollution control devices. Compliance 

with the plant-wide emission limit is 

demonstrated by annual stack testing. 

The rule lists nine sources as subject to 

the plant-wide limit including: (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. At the Doe Run 

plant, lead emissions from these sources 

are controlled by baghouses that exhaust 

through two stacks. The sources in the 

sinter operation, the blast furnace, and 

the dross furnace are controlled by three 

baghouses all of which discharge 

through one emission point, which is 

designated as the main stack. The 

building that houses the blast furnace 

and dross kettles is vented to a separate 

baghouse (#7) which discharges through 

a separate stack, designated as the 

furnace area stack. 

Under the 1999 MACT rule, all other 

sources of process fugitive and fugitive 

dust emissions are required to follow 

work practice standards detailed in the 

plant’s standard operating procedures 

(SOP) manual. 

The HAP emitted in the largest 

quantities from the Doe Run facility are 


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17EPA most recently approved the Missouri SIP 

for Herculaneum in 2002 (67 FR 18497, April 16, 

2002). Missouri Department of Natural Resources 

(MDNR) substantially revised the requirements for 

the smelter in 2007. EPA has proposed approval of 

this revision, but has not yet taken final action. 

18EPA most recently approved the Missouri SIP 

for Herculaneum in 2002 (67 FR 18497, April 16, 

2002). MDNR substantially revised the 

requirements for the smelter in 2007. EPA has 

proposed approval of this revision, but has not yet 

taken final action. 

19 Doe Run Company submits annual emissions 

inventories to MDNR that report speciated metals 

using speciation factors for each metal/source 

derived in the late 1990s through emissions testing. 

lead compounds, which account for 

over 99 percent of the total HAP 

emissions by mass. The remaining HAP 

emissions are arsenic, antimony, 

cadmium, cobalt, nickel and trace 

organic HAP. Negligible levels of 

organic HAP are also emitted from 

natural gas-fired space heating at the 

facility and the incomplete combustion 

of coke in the blast furnace. Further 

discussions of the emission profile for 

this facility is included in the Technical 

Support Document in the docket. 

3. Missouri SIP and the Lead NAAQS as 

They Apply to Doe Run Company, 

Herculaneum, Missouri 

In addition to the MACT standard, the 

Doe Run Company’s primary lead 

smelter in Herculaneum, Missouri is 

subject to a SIP for the purpose of 

attaining and maintaining the lead 

NAAQS.17 The current SIP, which was 

approved in 2002, addresses the former 

lead ambient air concentration limit of 

1.5 μg/m3 NAAQS. In addition, the 2007 

SIP submittal from the State includes 

requirements addressing lead emissions 

from the Doe Run facility and can be 

found at http://www.dnr.mo.gov/env/ 

apcp/docs/2009drh-leadsip.pdf. 

In 2008, EPA revised the lead NAAQS 

from 1.5 μg/m3 to 0.15 μg/m3. In 

November 2010, EPA identified or 

‘‘designated’’ several areas as not 

meeting the lead NAAQS. These 

‘‘nonattainment’’ designations include 

portions of Jefferson County, Missouri 

surrounding the Doe Run facility. 

Missouri is required by the Act to take 

steps to further control pollution in this 

area, and to detail these steps in a 

revision to the SIP. The revised SIP is 

due to EPA within eighteen months 

after the effective date of the 

designation, or by June 2012, and 

attainment of the NAAQS should be 

achieved by 2016. 

The SIP and the pending 2007 SIP 

submittal contain specific measures to 

be implemented by the Doe Run plant 

to reduce lead emissions. The State of 

Missouri revised the control 

requirements for the Doe Run facility in 

2001 and 2007, requiring numerous 

emissions-reducing measures and 

improvements to add-on control 

devices, processes, and work 

practices.18 These included 

improvements to existing emission 

control technology, adding or upgrading 

enclosures, process changes and 

limitations, and work practices. These 

requirements are summarized below. 

Point Source Requirements—As 

required under the SIP, lead emissions 

from the refining kettles and refining 

building emissions must be captured 

and vented to baghouses. Doe Run 

implemented these controls and vents 

the emissions to baghouses #8 and #9 

and the exhaust from the baghouse #9 

is combined with baghouse #7 exhaust 

and vented to a common stack. 

Although the MACT standard does not 

require Doe Run to do so, it has 

included emissions from refining 

Baghouses #8 and #9 in their 

demonstrations of compliance with the 

MACT plant-wide lead emission limit. 

Under the 2007 SIP submittal, Doe 

Run was required to make 

improvements to existing baghouse 

controls including the installation of 

pleated filters and lowering the air-tocloth ratio for baghouses, increased 

ventilation and improved ventilation 

hoods at the blast furnace, and using 

reverse flow technology for baghouse 

cleaning. The 2007 SIP submittal also 

required the installation of enclosures 

and/or partial enclosures for unloading 

ore concentrate, sinter storage, and the 

sides of the sinter machine (which will 

be evacuated to a baghouse). 

Process Requirements—Process 

changes to reduce emissions required by 

the SIP included a process control 

system for the injection of air through 

the blast furnace tuyeres located at the 

bottom of the blast furnace, limitations 

on individual process and overall plant 

throughputs, and limiting specific 

operations to only certain times of the 

day when the impact on ambient air 

concentrations is less. The SIP also 

stipulates that emissions from 

malfunctions will be reduced by alarms 

that sound when the baghouse fan 

malfunctions, an interlock system to 

restrict air flow into the blast furnace 

when the baghouse is not operating 

properly, and cameras for the dross and 

refinery kettles to detect kettle failure 

(i.e., when a plume of smoke is detected 

from the stack, the kettle burner can be 

immediately shut off and the problem 

corrected). 

Fugitive Dust Requirements—Under 

both the current SIP and the 2007 SIP 

submittal, work practices are required to 

reduce fugitive dust emissions. 

Requirements include road watering 

and automatic sprinklers, using new 

regenerative sweepers to remove dust 

from paved surfaces to reduce emissions 

from traffic, maintaining a minimum 

water content percentage for ore 

concentrate and for baghouse dust that 

is loaded into railcars, and inspecting 

the siding that encloses buildings 

(followed by prompt repairs if needed). 

Missouri requires Doe Run to report 

all metal HAP emissions annually based 

on a speciation analysis that was 

performed.19 The state also requires an 

annual emissions inventory based on 

the stack tests for the point discharges 

and AP–42 or facility-specific emission 

factors for fugitive emissions. 

As a result of the implementation of 

the emission control requirements in the 

currently approved 2002 SIP, and the 

additional requirements adopted by the 

state, as discussed above, the Doe Run 

facility has achieved a significant 

reduction of lead and metal HAP 

emissions since 2000 through a 

combination of reduced production 

levels and improved emissions controls. 

Based on emissions inventory data 

submitted to the Missouri Department of 

Natural Resources (DNR), total HAP 

emissions have been reduced from an 

estimated 140 tons in 2000 to 20 tons in 

2008, and the majority of the 20 tons are 

lead compound emissions. The 2008 

reported emissions reflect 

implementation of all emission controls 

stipulated in the 2002 SIP and the 2007 

SIP revision. 

4. Other Federal and State Actions 

Affecting Doe Run Company 

More recently, the 2008 revision to 

the lead NAAQS has resulted in Doe 

Run Company deciding that it is not 

feasible for the facility to reduce 

emissions further to the level necessary 

to meet the newly revised NAAQS 

without closure of the current smelting 

operations. As a result of past and 

ongoing regulatory compliance issues at 

the facility, the facility has entered into 

a consent decree with U.S. EPA Region 

VII and the State of Missouri. Under the 

consent decree, the facility will, among 

other things, close the existing smelter 

operation and remediate the site to an 

agreed-upon level. The consent decree 

requires that all support operations for 

the smelter cease by December 31, 2013 

and that the blast furnace cease 

operations by April 1, 2014. 

Remediation of the site is required to 

commence following approval of a plan 

to be submitted to EPA in January 2013. 

Under the consent decree, the existing 

refining, casting and alloying operations 


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will be allowed to continue operation. 

Notice of the consent decree was 

published for public comment on 

October 15, 2010, (75 FR 63506). Once 

finalized, the consent decree is federally 

enforceable among the parties. 

Prior to closure of the current smelter, 

the Doe Run Company may build and 

bring to full operation a new 

hydrometallurgical process that will 

produce lead from lead sulfide ore, 

potentially adjacent to the current 

smelter. The hydrometallurgical process 

uses chemical reactions involving 

fluboric acid which allows recovery of 

lead metal through leaching, 

electrowinning, and co-product 

treatment processes. Some of the lead 

from the new process is likely to 

undergo further processing at the 

existing refinery, primarily for 

remelting/casting purposes. Based on 

limited data from a demonstration 

project, Doe Run expects that lead 

emissions from the hydrometallurgical 

process will be minimal. 

V. Analyses Results and Proposed 

Decisions 

This section of the preamble provides 

a description of the dataset used in the 

RTR analysis, the results of our RTR for 

the source category, and our proposed 

decisions concerning changes to the 

Primary Lead Smelting MACT standard. 

As noted previously, all references to 

lead emissions in this proposal means 

‘‘lead compounds,’’ which is the 

regulated HAP under CAA section 112. 

All reference to lead production means 

the production of element lead. 

A. What data were used in our risk 

analyses? 

For the Primary Lead Smelting source 

category, we compiled a preliminary 

dataset using readily available 

information, reviewed the data, and 

made changes where necessary. The 

preliminary dataset was based on data 

in the 2002 National Emissions 

Inventory (NEI) Final Inventory, Version 

1 (made publicly available on February 

26, 2006), and the 2005 National 

Emissions Inventory (NEI), version 2.0 

(made publicly available in October 

2008). The 2005 NEI was updated to 

develop the 2005 National Air Toxics 

Assessment (NATA) Inventory. NATA 

inventory updates for the primary lead 

smelting category included SIP data 

provided by the state of MO to EPA. The 

2005 NATA inventory was used with 

updated 2008 data received in an 

Information Collection Request (ICR) 

response from the Doe Run facility. The 

NEI is a database that contains 

information about sources that emit 

criteria air pollutants, their precursors, 

and HAP. The NEI database includes 

estimates of annual air pollutant 

emissions from point and volume 

sources, emission release characteristic 

data such as emission release height, 

temperature, velocity, and location 

latitude/longitude coordinates. We 

reviewed the NEI datasets, checked 

geographic coordinates, and made 

changes based on available information. 

We also reviewed the emissions and 

other data to identify data anomalies 

that could affect risk estimates. 

The risk assessment was based on 

estimates of the actual emissions and 

allowable emissions. The estimates of 

actual emissions were for the year 2008 

and were based on data from the ICR 

along with data from our NEI dataset. 

These estimates included both stack and 

fugitive emission sources. Fugitive dust 

sources include material handling 

(concentrate, sinter, fume and dross), 

plantwide resuspension (roadways, 

storage piles and plant yard) and other 

miscellaneous sources (vents and heat 

stacks). The material handling sources 

contribute approximately 84 percent of 

the total fugitive dust emissions, while 

plantwide resuspension and 

miscellaneous sources contribute 

approximately 11 and 5 percent, 

respectively. The estimates of allowable 

emissions were calculated using 

production data from the ICR response 

combined with the current emissions 

limits in the MACT standard. 

Lead compounds account for about 99 

percent of the HAP emissions from the 

source category, or about 20 tons in 

2008. The facility also reported small 

emissions of five other metal HAP, and 

trace levels of 25 organic HAP. 

The emissions data, calculations and 

risk assessment inputs for the Primary 

Lead Smelting source category are 

described further in the Technical 

Support Document for this action which 

is available in the docket for this 

proposed rulemaking. 

We used the 2008 production 

information as the basis for calculating 

the MACT allowable ratio (allowable to 

actual) because the 2008 emissions are 

the most recent reported emissions that 

also reflect implementation of the 

requirements of the 2007 SIP revision. 

For more information on the ratio of 

actual to MACT-allowable emissions, 

see the Technical Support Document in 

the docket for this action describing the 

emission data information and 

estimation of MACT-allowable emission 

levels and associated risks and impacts. 

B. What are the results of the risk 

assessments and analyses? 

For the Primary Lead Smelting source 

category, we conducted an inhalation 

risk assessment for all HAP emitted. We 

also conducted a multi-pathway 

analysis for cadmium and lead. With 

respect to lead, we used the recentlypromulgated lead NAAQS to evaluate 

the potential for multi-pathway and 

environmental effects. Furthermore, we 

conducted a demographic analysis of 

population risks. Details of the risk 

assessments and additional analyses can 

be found in the residual risk 

documentation referenced in section 

IV.A of this preamble, which is 

available in the docket for this action. 

1. Inhalation Risk Assessment Results 

Table 3 provides an overall summary 

of the results of the inhalation risk 

assessment. 

TABLE 3—PRIMARY LEAD SMELTING INHALATION RISK ASSESSMENT RESULTS

Maximum individual cancer risk 

(in 1 million) 1 Estimated 

population at risk 

≥ 1-in-1 million 

Estimated annual 

cancer incidence 

(cases per year) 

Maximum chronic non-cancer 

TOSHI 2 Maximum off-site 

refined acute 

Actual non-cancer HQ 3

emissions level 

Allowable 

emissions level 

Actual 

emissions level 

Allowable 

emissions level 

30 30 4,900 0.0008 1 1 0.6 

1Estimated maximum individual excess lifetime cancer risk. 

2 Maximum TOSHI. The target organ with the highest TOSHI for the Primary Lead Smelting source category is the kidney. 

3The maximum acute HQ value shown uses the only available acute dose-response value for arsenic, which is the REL. See section IV.A of 

this preamble for explanation of acute dose-response values. 


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The results of the chronic inhalation 

cancer risk assessment indicate that, 

based on estimates of actual emissions 

from the base year 2008, the maximum 

individual lifetime cancer risk could be 

as high as 30-in-1 million with fugitive 

dust emissions of cadmium dominating 

the risk. The total estimated cancer 

incidence from this source category 

based on actual emission levels is 

0.0008 excess cancer cases per year or 

one case in every 1,250 years. 

Approximately 200 people were 

estimated to have cancer risks above 

10-in-1 million and approximately 4,900 

people were estimated to have cancer 

risks above 1-in-1 million. When 

considering the maximum levels of 

emissions allowed under the current 

MACT standard, the MIR remains 30-in1 million. The MIR remains the same 

since the fugitive dust emissions are 

governed by work practices, which 

under § 63.1544 are defined as the 

measures that will be ‘‘put into place to 

control fugitive dust emissions.’’ Thus, 

the actual emissions, which reflect the 

measures that have been put in place, 

should be equivalent to the allowable 

emissions. 

The maximum chronic noncancer 

TOSHI value is 1, with fugitive 

emissions of cadmium dominating those 

impacts. When considering MACT 

allowable emissions, the maximum 

chronic noncancer TOSHI value 

remains 1 since, for the reasons 

provided above, MACT-allowable 

fugitive emissions are equal to actual 

fugitive emissions. 

Based on the acute REL value for 

arsenic, an off-site screening-level acute 

HQ value from this facility could be as 

high as 6. However, the emissions factor 

of 10 times the average hourly emissions 

rate is not appropriate in this instance, 

given that fugitive emissions are 

minimized during the meteorological 

conditions associated with the worstcase short-term impacts (i.e., during 

low-wind, stable atmospheric 

conditions). Thus, we refined the 

assessment and estimated a maximum 

off-site HQ value of 0.6. 

The results of a multipathway 

screening analysis for cadmium 

emissions from this facility were well 

below the de minimis emission rate that 

would indicate a non-negligible risk of 

adverse health effects from 

multipathway exposures. We estimate 

the specific multipathway de minimis 

emission rate for cadmium to be 0.65 

TPY and only 0.1 TPY is emitted from 

the one facility in this source category. 

Thus, there appears to be little, if any, 

multipathway risk associated with 

cadmium emissions from this facility. 

In evaluating the potential multipathway risks from emissions of lead 

compounds, we compared modeled 

maximum 3-month rolling average 

atmospheric concentrations with the 

NAAQS for lead. Table 4 presents the 

results of our lead impact analysis 

broken down by emission point 

considering actual 2008 emissions as 

well as the maximum emissions of lead 

that the MACT standard would have 

allowed based on production rates for 

calendar year 2008. For purposes of our 

analysis, we determined separately the 

risk from each of the types or processes/ 

emissions sources regulated by the 

current MACT, with one exception. 

Under the MACT, emissions from the 

refining and casting area were 

considered fugitive emissions subject to 

work practice standards under 

§ 63.1544. Since then, pursuant to 

requirements that the 2002 State SIP 

adopted for purposes of meeting the 

1.50 μg/m3 lead NAAQS, Doe Run 

enclosed the refining and casting area 

and vents those emissions to the 

refinery stacks. We considered these 

stack emissions separate from the 

fugitive dust emissions. Thus, the four 

emission process/sources we evaluated 

for risk were: (1) The main stack, (2) the 

furnace area stack, (3) the refinery stack, 

and (4) fugitive emissions. 

The analysis indicates that under both 

actual 2008 or MACT allowable 

emission scenarios, emissions from the 

main stack do not result in lead levels 

above the NAAQS within the 50 km 

radius that was modeled. This is likely 

due to the height of the stack (500 feet), 

which would result in broader and 

further dispersal of lead emissions. 

However, results of the analysis did 

indicate that modeled ambient air lead 

concentrations resulting from this 

facility’s fugitive dust emissions could 

exceed the NAAQS for lead by as much 

as 50-fold at the property boundary 

based on both actual and allowable 

emissions. Moreover, results indicate 

that modeled emissions from the 

furnace area stack could result in 

NAAQS exceedances under both actual 

2008 and MACT-allowable emissions 

scenarios. In addition, the actual 

estimated emissions from the refining 

stacks, which were put into place based 

on requirements adopted by the State 

for purposes of the SIP, could result in 

NAAQS exceedances. We were unable 

to calculate a ‘‘MACT allowable’’ 

emission level for the refinery 

emissions, which under the MACT are 

included as fugitive emissions. This 

analysis also indicates that within 

50 km of this facility, approximately 

1,900 people could be exposed to 

ambient air lead concentrations 

exceeding the level of the NAAQS for 

lead. 

As mentioned above, to evaluate the 

potential for adverse environmental 

effects, we also compared maximum 

3-month rolling average atmospheric 

concentrations with the current 

secondary NAAQS for lead, which is the 

same as the primary standard. Thus, the 

analyses presented in Table 4 also 

indicate the potential for adverse 

environmental effects from emissions of 

lead. Note that modeling performed for 

this analysis is based on different inputs 

than SIP modeling done for the one 

remaining primary lead facility, and 

thus results differ. 

TABLE 4—SUMMARY OF MODELED LEAD CONCENTRATIONS RELATIVE TO THE NAAQS BASED ON ESTIMATED ACTUAL

2008 AND MACT ALLOWABLE EMISSIONS

Emission point 

Actual 

2008 

emissions 

(TPY) 

Maximum impact— 

actual emissions 

Allowable 

emissions 1

(TPY) 

Maximum impact— 

allowable emissions 

Main stack 2 ............................................................................... 13.31 0.05 times the NAAQS .... 65.8 0.25 times the NAAQS. 

Refining stacks .......................................................................... 2.74 3 times the NAAQS ......... NA NA. 

Furnace area stack: (controlled blast and drossing fugitives) .. 1.81 2 times the NAAQS ......... 8.94 10 times the NAAQS. 

Fugitive dust 3 ............................................................................ 2.85 50 times the NAAQS ....... 2.85 50 times the NAAQS. 

1Allowable emissions for the main stack and furnace area emission points are based on 1 lb of Pb/ton production (MACT limit); Refinery emissions are included as fugitive emissions under MACT but are now vented to a stack because of SIP requirements; therefore, we were unable to 

calculate a ‘‘MACT allowable’’ emission level. 2 Main stack is the emission point for sinter machine, blast furnace and drossing operations. 


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20Maximum 3-month monitored concentrations 

were calculated for the year 2008 based on data 

submitted to EPA’s Air Quality System (AQS). 

21Negative sign denotes an underestimation of 

AERMOD modeled ambient lead concentrations, 

relative to monitored concentrations. AERMOD 

estimated concentrations were based on the 2008 

emissions estimates described in section V.A. 

3Fugitive dust emissions are covered by work practices under current MACT and were calculated via emission factors assuming compliance 

with the MACT. The site of maximum ambient air lead concentration resulting from fugitive dust emissions occurs in close proximity to the southeast boundary of the facility (see Figure 3.1–1 of the risk assessment document). Note that this maximum result and its location are based on 

modeling 2008 emissions using 1998 site-specific meteorology, and that these may differ from inputs used for other types of modeling (e.g., SIP 

modeling.) 

2. Facility-wide Risk Assessment 

Results 

Our screening analysis determined 

that the organic HAP emissions from 

facility represented negligible risk and 

were determined to be insignificant 

with regard to this risk analysis. As a 

result, all significant HAP emissions 

from the one facility in this category are 

reflected in the risk analyses presented 

above; therefore, facility-wide risks are 

equivalent to those of the source 

category. 

3. Model to Monitor Comparison 

In addition to the results presented 

above, we also compared maximum 

AERMOD estimates of ambient air lead 

concentrations with those measured at 4 

monitors in close proximity to the 

Herculaneum Primary Lead Smelting 

Facility for calendar year 2008. More 

specifically, we compared maximum 3- 

month rolling average lead 

concentrations (for calendar year 2008) 

calculated from data reported at the 

Main Street, Circle Street, South Cross, 

and Church Street monitors to the 

maximum 3-month rolling average lead 

concentrations at model receptor 

locations in close proximity to these 

monitoring sites. These monitor 

locations were chosen because they 

represented the closest offsite monitors 

to the Herculaneum primary lead 

smelter. Thus, lead measurements at 

these monitoring sites would likely be 

dominated by emissions from this 

facility which is important given that 

AERMOD estimates of ambient air lead 

concentrations only considered lead 

emissions from this facility (i.e., only 

lead emissions from the Herculaneum 

primary lead smelter were used as 

inputs into AERMOD). 

Results of this analysis are presented 

in Table 5 and indicate that with respect 

to the Main Street and Circle Street 

monitors, AERMOD underestimates 3- 

month maximum lead concentrations by 

approximately 2.8- and 4.2-fold, 

respectively. While these monitor to 

model comparisons are not in complete 

agreement on a point-by-point basis, we 

note that this would not be expected 

given the general uncertainties 

associated with using dispersion 

modeling to estimate ambient pollutant 

concentrations and considering that the 

meteorological data used to develop the 

model estimates were from a different 

year than the actual monitoring and 

emissions data (i.e., meteorological data 

used in the AERMOD simulation was 

from 1998 while the emissions estimates 

and the monitoring data were from 

2008). However, results do indicate that 

the maximum 3-month average lead 

concentration across the group of 

monitors nearest the facility is 

approximately equal to the maximum 3- 

month average lead concentration 

estimated by AERMOD across the group 

of these monitoring sites (i.e., both the 

Main Street monitor and the South 

Cross AERMOD estimate indicate the 

maximum 3-month average lead 

concentration to be approximately 2.1 

μg/m3). Taken together, these results 

indicate that AERMOD estimates of 

ambient air lead concentration provide 

a reasonable representation of the 

measured 3-month maximum lead 

concentrations present in the ambient 

air near this facility. 

TABLE 5—COMPARISON OF AERMOD MODELED TO AMBIENT AIR LEAD CONCENTRATIONS REPORTED BY FOUR

MONITORS SURROUNDING THE HERCULANEUM PRIMARY LEAD SMELTING FACILITY

Location 

Maximum AEMOD 

modeled 3-month 

lead concentration 

(μg/m3) 

Maximum monitored 

3-month lead concentration 20 (μg/m3) 

Model to 

monitor ratio 21

Main Street ............................................................................................................ 0.47 3.14 ¥4.6 

Circle Street ........................................................................................................... 0.38 1.14 ¥3.0 

South Cross ........................................................................................................... 2.13 0.75 2.8 

Church Street ......................................................................................................... 1.99 0.47 4.2 

4. Demographic Risk Analysis Results 

Demographic analyses were 

performed to investigate the population 

distribution of: (1) Cancer risks at or 

above 1-in-1 million and (2) risks from 

ambient air lead concentrations above 

the NAAQS for lead. Results are 

summarized in Table 5 and are based on 

modeling using estimated actual 

emissions levels for the population 

living within 50 km of this facility. 

TABLE 6—PRIMARY LEAD SMELTING DEMOGRAPHIC RISK ANALYSIS RESULTS

Nationwide 

Population with 

cancer risk 

greater than 

1 in a million 

Population with 

ambient air lead 

concentrations 

exceeding the 

NAAQS 

Total population ......................................................................................................... 285,000,000 4,900 1,900 

Race by percent 

White .......................................................................................................................... 75 96 96 


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TABLE 6—PRIMARY LEAD SMELTING DEMOGRAPHIC RISK ANALYSIS RESULTS—Continued 

Nationwide 

Population with 

cancer risk 

greater than 

1 in a million 

Population with 

ambient air lead 

concentrations 

exceeding the 

NAAQS 

All Other Races ......................................................................................................... 25 4 4 

Race by percent 

White .......................................................................................................................... 75 96 96 

African American ....................................................................................................... 12 4 3 

Native American ........................................................................................................ 0 .9 0 .2 0 

Other and Multiracial ................................................................................................. 12 1 0 .8 

Ethnicity by percent 

Hispanic ..................................................................................................................... 14 1 0 .3 

Non-Hispanic ............................................................................................................. 86 99 99 .7 

Income by percent 

Below poverty level .................................................................................................... 13 15 15

Above poverty level ................................................................................................... 87 85 85 

Results of the risk assessment indicate 

that there are approximately 4,900 

people exposed to a cancer risk greater 

than 1-in-1 million, and 1,900 people in 

areas with ambient air lead 

concentrations above the NAAQS for 

lead. In both instances, the 

demographics analysis estimates that 

about 4 percent of these populations can 

be classified as a minority (listed as ‘‘all 

Other Races’’ in the table), which is well 

below the national percentage of 25. 

Similarly, in the cancer and lead 

demographic analyses, the percentage of 

‘‘African American,’’ ‘‘Hispanic,’’ ‘‘Native 

American,’’ and ‘‘Other and Multiracial’’ 

population groups are well below the 

corresponding national percentages. 

With respect to the percentage of those 

‘‘Below the Poverty Level,’’ in both 

demographic analyses there is a small (2 

percent) increment above the 

corresponding national percentage. 

However, given that the total population 

affected is small (i.e., 4,900 individuals 

for cancer risk greater than 1-in-1 

million and 1,900 individuals in areas 

with lead concentrations above the 

NAAQS), we do not think this indicates 

any significant potential for disparate 

impacts to the specific demographic 

groups analyzed. 

Moreover, given the extent to which 

lead may impact children’s health, we 

further note that our demographic 

analysis doesn’t indicate the presence of 

a higher percentage of children than one 

would normally expect around this 

facility. That is, while the national 

percentage of children 18 years and 

younger is 27%, the percentage of 

children living near this facility who are 

estimated to be exposed to lead 

concentrations above the NAAQS is 

only slightly higher at 28% (see Risk 

and Technology Review—Analysis of 

Socio-Economic Factors for Populations 

Living Near Primary Lead Smelting 

Facilities in the docket for this proposed 

rulemaking), a difference which is likely 

not significant. 

C. What are our proposed decisions on 

risk acceptability and ample margin of 

safety? 

1. Risk Acceptability 

As noted in section III.B of this 

preamble, we weigh all health risk 

factors in our risk acceptability 

determination, including cancer risks to 

the individual most exposed, risk 

estimation uncertainty, and other health 

information. For the Primary Lead 

Smelting source category, the risk 

analysis indicates that the cancer risks 

to the individual most exposed could be 

as high as 30-in-1 million due to actual 

or MACT-allowable emissions. These 

risks are considerably less than 100-in1 million, which is the upper bound of 

the presumptive range of acceptability. 

The incidence of cancer is very low— 

0.0008 excess cancer cases per year; or 

one case every 1,250 years. Similarly, 

the risks of chronic non-cancer health 

effects from HAP emissions other than 

lead were low, with a maximum HQ of 

1. Moreover, while an initial screening 

analysis suggested that fugitive 

emissions of arsenic had the potential to 

create a risk of acute health effects, a 

refined analysis based on our 

knowledge of this emission source 

indicated that the risk was low (HQ = 

0.6). In addition to these health 

analyses, a demographics analysis did 

not indicate the potential for 

significantly disproportionate heath 

impacts (see above, section V(3)(c)). 

Thus, risks associated with the non-lead 

emissions from the Primary Lead 

Smelting source category for cancer, 

acute and chronic non-cancer health 

effects and environmental effects are 

considered acceptable. 

However, since ambient air lead 

concentrations resulting from emissions 

from this facility were modeled to be in 

excess of the NAAQS for lead, the risks 

associated with lead emissions from this 

facility were judged to be significant. 

Our analysis estimated that modeled offsite ambient air lead concentrations 

(based on actual 2008 emissions) 

resulting from this facility could be as 

high as 50 times the NAAQS for lead 

based on fugitive dust emissions, and 

that approximately 1,900 individuals 

could be exposed to lead concentrations 

in excess of the NAAQS. Given that the 

NAAQS for lead 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)’’, 

we are proposing that risks associated 

with lead emissions from this source 

category are unacceptable. 

As noted above, our risk analysis for 

lead was based on modeled 3-month 

rolling average lead concentrations in 

ambient air in comparison to the 

primary lead NAAQS. We believe that 

in order to provide an acceptable level 

of risk, lead concentrations in the 

ambient air must be reduced to the level 

of the lead NAAQS. Thus, we 


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22Under the consent decree, of which we sought 

public comment last fall, fugitive dust sources will 

be addressed by site remediation; however, some 

fugitive dust emissions will remain during the 

remediation of the site, which will likely extend 

beyond April 2014. 

considered specific emission limits for 

the three emission sources/points that 

were modeled to result in lead 

concentrations in excess of the NAAQS 

(see Table 4); refinery stack, furnace 

area stack, and fugitive dust emissions, 

with the majority of fugitive dust 

impacts from material handling sources. 

Based on our analysis, we conclude that 

in order to meet the NAAQS for lead at 

all model receptors, fugitive dust 

emissions would have to be reduced by 

approximately 98 percent to 0.064 TPY, 

refinery stack emissions and furnace 

area stack emissions would have to be 

reduced by approximately 80 percent to 

a total of 0.91 TPY (the maximum 

impacts of refinery and furnace 

emission points occur at the same 

location.) Further, because the 

maximum ambient air impacts of the 

refinery/furnace emissions, the fugitive 

dust emissions, and the main stack do 

not significantly overlap each other, we 

estimate that lead emissions from all 

emission points other than the main 

stack would have to be limited to a total 

of approximately 0.97 TPY in order to 

ensure 3-month rolling average ambient 

air lead concentrations do not exceed 

the lead NAAQS level of 0.15 μg/m3. As 

noted above, emissions from the main 

stack (i.e., emission point for sinter 

machine, blast furnace and drossing 

operations) did not result in ambient air 

lead concentrations in excess of the lead 

NAAQS at modeled locations within 50 

km of the property boundary and thus 

we are not proposing any reductions at 

the main stack in order to ensure an 

acceptable level or risk. 

Once we determined the emissions 

reductions necessary to achieve an 

acceptable level of risk, we investigated 

available emissions control options and 

their ability to reduce emissions and 

health risks for fugitive dust and for 

stack emissions from both the refining 

and furnace area stacks. Control options 

considered for reducing fugitive dust 

emissions and associated risks include 

improved or additional work practices, 

site remediation, application of 

additional capture/control measures, 

and lead production limitations. With 

the exception of site remediation, all of 

these control measures have been 

implemented to varying degrees at the 

Doe Run facility in response to the 

Missouri SIP, as revised in 2002 and the 

2007 revisions submitted for approval to 

the SIP. As such, because the actual 

emissions for 2008 reflect the 

implementation of those control 

measures, requiring those controls 

under the MACT would be unlikely to 

yield the additional 98 percent 

reduction in fugitive emissions 

necessary to meet the primary lead 

NAAQS level of 0.15 μg/m 3. Thus, our 

evaluation of risks based on actual 

emissions already considered emissions 

with these controls largely in place. In 

order to ensure that site remediation 

efforts, or any other efforts the source 

may choose to undertake, will result in 

sufficient emission reductions to 

address the unacceptable level of risk, 

we are proposing to establish a lead 

concentration in air limit of 0.15 μg/m 3

to be measured at locations approved by 

the Administrator. This lead 

concentration in air limit would be 

established as the enforceable 

requirement to address fugitive 

emissions under the MACT standard.22

Because we are proposing a 

concentration limit to address fugitive 

dust emissions, we no longer believe it 

is necessary for the affected facility to 

provide a plan to the Administrator 

describing work practices that will be 

used to reduce fugitive emissions. 

Therefore, we are proposing to remove 

the requirement to develop and submit 

a work practice standard operating 

procedure (SOP) manual as required in 

§ 63.1544(a). 

As an alternative to proposing 

compliance monitoring requirements for 

demonstration of compliance with the 

lead concentration in air limit, we 

considered retaining the current fugitive 

dust emissions requirement to develop 

and submit to the Administrator or 

delegated authority a work practices 

SOP. Using this alternative approach, 

we believe it would be necessary to 

modify the current general requirements 

for an SOP by specifying the minimum 

work practice requirements that the 

plan must include. For example, under 

this alternative approach, we would 

require that the SOP must include, at a 

minimum, detailed descriptions of all 

measures that would be used to control 

fugitive dust emissions from plant 

roadways; material storage, transfer and 

handling areas; sinter machine areas; 

furnace areas; refining and casting areas; 

and other areas the Administrator may 

identify. Further, EPA would require 

that the SOP contain detailed 

descriptions of work practices including 

road watering and automatic sprinklers, 

methods to remove dust from paved 

surfaces to reduce emissions from 

traffic, maintenance of minimum water 

content for ore concentrate and for 

baghouse dust that will be handled or 

transferred, and procedures for the 

inspection of building siding or 

damages and openings. The SOP would 

be required to include procedures, 

including recordkeeping, to ensure that 

the work practices are being 

implemented at a frequency and in a 

manner that would ensure that fugitive 

dust emissions are being minimized. To 

determine whether the work practices 

described in the SOP are reducing 

emissions sufficient to comply with the 

lead concentration in air limit, the 

owner or operator would be required 

once a year to model the fugitive dust 

emissions using measurement data or 

emission factors according to an 

approved fugitive dust emissions 

modeling plan. At a minimum, EPA 

would require that this modeling plan 

include a detailed description of each 

fugitive dust emission source; a detailed 

description of the control practices or 

techniques used to limit fugitive dust 

emissions from each source; the 

emission factors, test data or other 

methods used to characterize and 

quantify lead emissions from each 

source; a description of the emissions 

modeling that will be used to estimate 

the concentrations of lead in air at or 

near the property boundary as 

contributed by each source as well as 

cumulatively contributed by all sources; 

a description of process or other 

conditions that would indicate the need 

to demonstrate compliance more often 

than annually; the calculations to be 

used to show compliance with the air 

lead concentration limit that consider 

the highest modeled air lead 

concentrations from the modeled 

fugitive dust sources and any 

contributions from background lead 

concentrations in air; and a description 

of the records that will be kept. We are 

seeking comments on the proposed 

requirements to monitor air lead 

concentrations versus the alternative 

approach described above, of requiring 

extensive work practices and a work 

practice SOP in conjunction with 

emissions modeling, to demonstrate 

compliance with the air lead 

concentration limit. 

Measures available for reducing lead 

emissions from the refining and furnace 

area stacks include upgrading existing 

baghouses by replacing the existing 

fabric bags with high efficiency 

membrane bag filters. Another option 

would be to add extra in-line baghouses 

after existing baghouses. Such measures 

would reduce lead emissions and 

associated risk to within acceptable 

levels. 

In summary, our analysis indicates 

that in order to ensure that lead 

emissions from this source do not pose 

an unacceptable risk, emissions from 


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this facility would need to be reduced 

to a level that would ensure that these 

emissions would not result in air lead 

levels greater than the 0.15 μg/m 3 for 

any 3-month period at all of the 

modeled locations. Further, we 

conclude that in order to achieve the 

0.15 μg/m 3 level (for any 3-month 

rolling average) at all modeled locations, 

fugitive dust emissions would need to 

be reduced by 98 percent and the 

emissions from the furnace area and 

refining operation stacks would need to 

be reduced by 80 percent. We have 

identified emission reduction and 

control options for achieving the 

required reductions, which include 

implementation of site remediation, 

work practices, and upgrade of existing 

baghouses with membrane bags and/or 

addition of an additional in-series 

baghouse. 

We are proposing the following 

requirements to ensure that risk is 

reduced to an acceptable level. 

• A stack lead emission cap of 0.91 

TPY that would apply to the furnace 

area stack and the refining operation 

stacks. 

• An air lead concentration limit of 

0.15 μg/m3 based on 3-month rolling 

average (to be measured at locations 

approved by the Administrator) to 

ensure that fugitive dust emission levels 

will not exceed the NAAQS. 

The proposed limits apply to both 

new and existing facilities. Any facility 

subject to the MACT would be required 

to meet these requirements for each 

emission unit it is operating that is 

subject to the limit. In order to address 

any fugitive dust emissions, the facility, 

regardless of whether it is operating all 

or just some of the emission sources 

covered by this action, would be 

required to meet the air lead 

concentration emission limit. 

For both new and existing facilities, 

compliance with the air lead 

concentration limit would be 

demonstrated using lead compliance 

monitoring devices and would be based 

on a rolling 3-month average 

concentration. The proposed rule 

requires development of a monitoring 

plan for approval by the Administrator 

that includes the minimum sampling 

and analysis methods and compliance 

demonstration criteria provided in the 

rule. A provision is included in this 

proposed rule that allows for reduced 

monitoring if the facility demonstrates 

an air lead concentration for three 

consecutive years at less than 50 percent 

of the air lead concentration limit. The 

monitoring can be reduced to once 

every six months unless one of the 6- 

month monitoring events exceeds 50 

percent of the air lead concentration 

limit, at which time monitoring will be 

required to resume based on the initial 

plan approved by the Administrator 

until another three years of consecutive 

monitoring below 50 percent of the air 

lead concentration limit is achieved. 

The compliance requirements discussed 

above were designed to allow for 

flexibility, prevention of redundant 

requirements, and also to provide 

consistency with current monitoring 

required at the site. We are soliciting 

comment on this approach. For existing 

facilities, compliance with the emission 

limit for the furnace area and refinery 

stacks would be demonstrated through 

stack testing conducted on a quarterly 

basis. All performance testing will be 

consistent with the existing MACT 

testing requirements, with the exception 

of frequency. As provided in § 63.153(e) 

of the current rule, the facility can 

reduce compliance testing frequency if 

the most recent three compliance tests 

demonstrated compliance. We are 

maintaining this provision, however, 

because this proposed rule increases the 

testing frequency to quarterly, the 

number of most recent tests necessary to 

comply with this provision will be 

increased from three to 12. New primary 

lead processing facilities would be 

required to demonstrate compliance 

using a lead continuous emission 

monitoring systems (CEMS). However, 

since the Agency has not finalized the 

performance specification for the use of 

these instruments, we are deferring the 

effective date of the requirement to 

install, correlate, maintain and operate 

lead CEMS until these actions can be 

completed. The lead CEMS installation 

deadline will be established through 

future rulemaking, along with other 

pertinent requirements. In the event 

operations commence at a new facility 

prior to promulgation of the 

performance specification, compliance 

would be demonstrated through 

quarterly stack testing until 

promulgation of the lead CEMS 

performance specification. 

2. Ample Margin of Safety 

Reducing lead emissions to meet the 

NAAQS would ensure that emissions of 

all HAP do not pose an unacceptable 

risk. Once we ensure that the risk is 

acceptable, we then look to determine 

whether further reductions are 

appropriate to ensure an ample margin 

of safety. In this part of our analysis, we 

again consider the health factors we 

considered to determine whether the 

risks are acceptable but we also consider 

the cost of controls. 

With regard to lead emissions, we are 

proposing to require most of the 

emission sources at the facility to 

implement all technically feasible 

controls in order to ensure that the 

ambient air meets the level of the lead 

NAAQS, which is the level that we have 

determined will ensure an acceptable 

level of risk. Because all feasible 

controls will need to be adopted in 

order to meet that proposed standard, 

there are no additional controls to 

consider for the three emission sources: 

Fugitive dust emissions, the furnace 

area stack, and the refinery stacks. We 

further note that the same controls we 

have proposed for the three emission 

points to reduce lead emissions are the 

same controls that would reduce risks 

from cadmium and all other metal HAP 

known to be emitted from this source 

category. Thus, we are proposing that 

the controls required to ensure that risk 

from lead emissions from those three 

emission points is acceptable also 

protect public health with an ample 

margin of safety with regard to 

emissions from all metal HAP from 

these three emission points. Notably, 

after these standards are in place, we 

estimate that the MIR cancer risk due to 

the non-lead HAP will be less than 1-in1 million. 

Our risk analysis indicates that the 

main stack emissions do not result in 

ambient air lead levels exceeding the 

NAAQS based on either actual or 

allowable emission levels. We 

determined, as discussed section V.D. 

below, that it is technologically feasible 

to reduce emissions from the main stack 

to a level well below the allowable level 

of the MACT, since those levels are 

currently being achieved, and thus we 

are proposing to require such controls 

under CAA section 112(d)(6). We 

evaluated whether there were additional 

controls to further reduce emissions 

from the main stack and determined 

that lead emissions from the main stack 

could be further reduced by replacing 

the standard cloth bags with membrane 

bags at a capital cost of approximately 

$2 million and an annual cost of $0.3 

million. Assuming a 50 percent 

reduction from 2008 main stack 

emissions, the cost of reducing lead 

emissions would be about $40,000 to 

$229,000 per ton of lead. (See the 

Technical Support Document included 

in the docket for a complete discussion 

of this analysis.) Because the highest 

ambient air lead concentration resulting 

from the emissions from the main stack 

already is more than 20 times below the 

level that is considered acceptable, it 

was determined that although 

additional controls such as membrane 

bags could result in additional emission 

reductions, the additional controls are 

not warranted since they would not 


jlentini on DSKJ8SOYB1PROD with PROPOSALS2
9434 Federal Register / Vol. 76, No. 33 / Thursday, February 17, 2011 / Proposed Rules 

appreciably reduce risk. We are 

proposing that the MACT standard, with 

the changes we are proposing under the 

section 112(d)(6) technology review as 

described in section V.D. below will 

provide an ample margin of safety with 

regard to emissions of lead and other 

HAP from the main stack. 

D. What are the results and proposed 

decisions from the technology review? 

We evaluated developments in 

practices, processes, and control 

technologies applicable to emission 

sources subject to the Primary Lead 

Smelting MACT. This included a search 

of the RBLC Clearinghouse, the 

California BACT Clearinghouse, the 

internet, and correspondence with state 

agencies and industry. We have 

determined that there have been 

advances in emission control measures 

since the Primary Lead Smelting MACT 

standard was originally promulgated in 

1999. 

The 1999 MACT limit was set using 

the lead emission limits from the lead 

SIPs for the three states in which 

primary lead smelting sources were 

operational at the time of the 

rulemaking. EPA took each of the three 

lead SIP limits, in lb/day, divided them 

by the corresponding lead production 

capacity, in tons/day, and calculated a 

lead emission rate in lb/ton. The results 

were as follows: 

ASARCO—Missouri 1.0 lb/ton 

ASARCO—Montana 1.0 lb/ton 

Doe Run—Missouri 0.84 lb/ton 

The values were ranked and the 

median value (1.0 lb/ton) was selected 

as representative of the MACT floor. 

Since the MACT standard was 

promulgated, the industry has 

undergone significant changes. Two of 

the three facilities have shut down. The 

only remaining primary lead smelting 

facility is the Doe Run smelter at 

Herculaneum, Missouri, which is 

subject to control requirements under 

the Missouri SIP for lead. The existing 

SIP, as well as a 2007 SIP revision 

submitted by the State and proposed for 

approval by EPA require numerous 

emissions-reducing measures and 

improvements to add-on control 

devices, processes, and work practices. 

We considered these developments in 

practices, processes, and control 

technologies in our technology review. 

Recent emissions tests (2000 through 

2008) at the Doe Run facility support 

that these improvements have resulted 

in significantly lower emissions and 

demonstrate that actual lead emissions 

from the facility are much lower than 

are allowed under the current MACT 

rule. To assess the impacts of 

developments in practices, processes 

and control technologies on lead 

emissions, emissions data from 2008 

were compared with emissions data 

from 2000. Data from 2008 were 

selected because they reflect the many 

improvements that have been 

implemented at the facility since 

promulgation of the MACT rule. 

Emissions data from earlier years would 

not reflect all of the emission-reducing 

changes that have been implemented at 

the Doe Run facility given that some of 

the improvements were not 

implemented until 2007 and 2008. As 

described above, technological 

improvements to baghouses and 

processes that have been implemented 

at the facility since the MACT rule was 

promulgated have resulted in 

substantially lower emissions from 

these sources at this facility. These 

improvements include upgrade of cloth 

bags and ventilation improvements. In 

2008, lead emissions from the main 

stack, which vents emissions from the 

sintering operation and the blast and 

dross furnace, were 13.31 TPY. In 

addition, emissions from the furnace 

area stack (i.e., the blast furnace and 

dross plant building which vent to 

baghouse 7) were 1.81 TPY, for a total 

of approximately 15.1 TPY. At the 2008 

lead production rate of 149,500 tons, the 

lead emission rate for these sources at 

Doe Run was about 0.2 lb/ton, or 80 

percent less than the current MACT 

limit of 1 lb/ton. Based on this 

demonstrated performance, EPA 

believes that under Section 112(d)(6), 

the MACT standard should be revised to 

reflect the reduction achieved in 

practice. 

Because we believe that the 2008 

emissions of 13.31 TPY from the main 

stack (or combined sintering/blast 

furnace/drossing operations) reflect the 

annual rate of emissions achievable as a 

result of the technological 

improvements that have been made 

since 1999, we are proposing an 

emission limit based on the actual 2008 

annual emissions that vent to the main 

stack (i.e., sintering, blast furnace and 

drossing operations). In order to account 

for variability in the operation and 

emissions, recent stack tests were used 

to calculate the 95 percent upper 

predictive limit (UPL). The 95 percent 

UPL for the main stack is 15 TPY. 

Variability in the operations and 

emission for this source are discussed in 

more detail in Section E below. 

Although we believe that there have 

been developments in processes, 

practices and control technologies with 

regard to the furnace area stack and with 

regard to refining and casting 

operations, as reflected by the more 

stringent requirements that have been 

implemented in accordance with the 

approved SIP and the 2007 SIP 

revisions; we are not proposing 

additional requirements for these stacks 

as part of our technology review because 

we have already proposed that these 

stacks implement all feasible controls, 

regardless of cost, in order to ensure that 

the risks due to these emission points 

are acceptable. Thus, there are no 

additional developments in practices, 

processes and control technologies 

beyond those which are reflected in the 

emission limits we have proposed to 

meet CAA section 112(f)(2), above. 

To be consistent with the existing 

MACT standard, EPA is proposing to 

retain the plant-wide pound per ton of 

production format that currently applies 

to the aggregate emissions from the 

main stack and the furnace area stack. 

Because there are also stacks for the 

refining and casting operations, we are 

proposing to include those emissions as 

part of the plant-wide emission limit. 

Thus we are proposing a plant-wide 

lead emission limit of 0.22 pounds of 

lead per ton of lead produced based on 

the proposed reductions due to the 

section 112 (f)(2) risk review for the 

furnace area and refining operations 

stacks (discussed above in Section C) 

and the reduction in emissions from the 

main stack (sinter/blast furnace/ 

drossing operations) based on this 

Section 112(d)(6) technology review 

This proposed plant-wide lead emission 

limit was determined by summing the 

15 TPY for the main stack and the 0.91 

TPY for the furnace area and the 

refining operation, and dividing by the 

annual production from 2008 of 149,564 

tons. We note that variability was only 

applied in establishing technologybased emissions from the main stack in 

order to establish a plant-wide emission 

limit. Because the emission levels 

required from the refining operation and 

furnace area stacks are based on 

acceptable risk, we conclude it is not 

appropriate to consider variability in 

establishing limits for these emission 

points. 

We are proposing that the plant-wide 

lead emission limit apply to new and 

existing facilities that are subject to the 

MACT. By default this would include 

any new, controlled lead processing 

source not currently covered, including 

lead processing by other than the 

current techniques. We are requesting 

comment on the appropriateness of 

applying the plant-wide lead emission 

limit to any future new lead processing 

technique. 

For the existing facility, compliance 

with the plant-wide stack emission limit 

would be demonstrated in the same 


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23Run-to-run variability is essentially within-test 

variability, and encompasses variability in 

individual runs comprising the compliance test, 

and includes uncertainties in correlation of 

monitoring parameters and emissions, and 

imprecision of stack test methods and laboratory 

analysis. 72 FR 54877 (Sept. 27, 2007). Test-to-test 

variability results from variability in pollution 

device control efficiencies over time (depending on 

many factors, including for fabric filters the point 

in the maintenance cycle in which a fabric filter is 

tested). Test-to-test variability can be termed longterm variability. 72 FR 54878. 

manner as discussed above in section 

V.C.1 for the furnace area and refining 

stack limit (i.e., stack testing on a 

quarterly basis). We are proposing stack 

testing on a quarterly basis as opposed 

to testing on an annual basis since this 

allows the facility the opportunity to 

adjust their emissions throughout the 

year to be in compliance, rather than to 

find they are out of compliance at the 

end of the year, thereby risking 

violations. This schedule also coincides 

with other quarterly monitoring and 

reporting required of the facility. Also as 

discussed in section V.C.1, new primary 

lead processing facilities would be 

required to demonstrate compliance 

using lead continuous emission 

monitoring systems (CEMS). 

E. Variability 

In assessing sources’ performance, 

EPA may consider variability both in 

identifying which performers are ‘‘best’’ 

and in assessing their level of 

performance. Brick MACT, 479 F. 3d at 

881–82; see also Mossville Envt’l Action 

Now v. EPA, 370 F.3d 1232, 1241–42 

(D.C. Cir 2004) (EPA must exercise its 

judgment, based on an evaluation of the 

relevant factors and available data, to 

determine the level of emissions control 

that has been achieved by the best 

performing sources considering these 

sources’ operating variability). 

Variability in lead producers’ 

performance has a number of causes. 

For emissions of lead compounds that 

are controlled by baghouses, the 

variability is chiefly due to variations in 

performance of the control device for 

which both run-to-run and test-to-test 

variability must be accounted.23

In determining the contribution to a 

plant-wide emission limit of the main 

stack, we considered annual emissions 

discharged from the air pollution 

control devices that control lead 

emissions. For this rule, we used the 

2008 emissions reported by Doe Run to 

the State of Missouri. 

We assessed variability using a 

statistical formula designed to estimate 

an emissions level that is equivalent to 

the source’s performance based on 

future compliance tests. Specifically, 

the calculated limit is an upper 

prediction limit (UPL) calculated with 

the Student’s t-test using the TINV 

function in Microsoft Excel®. The 

Student’s t-test has also been used in 

other EPA rulemakings (e.g., NESHAP 

for Portland Cement Manufacturing [75 

FR 54970, September 9, 2010]; NSPS for 

Hospital/Medical/Infectious Waste 

Incinerators [74 FR 51368, October 6, 

2009]; NESHAP for Industrial, 

Commercial, and Institutional Boilers 

and Process Heaters-Proposed [75 FR 

32006, June 4, 2010]) in accounting for 

variability. A prediction interval for a 

future observation is an interval that 

will, with a specified degree of 

confidence, contain the next (or some 

other pre-specified) randomly selected 

observation from a population. In other 

words, the prediction interval estimates 

what the upper bound of future values 

will be, based upon present or past 

samples taken. The UPL consequently 

represents the value which we can 

expect the mean of future observations 

(3-run average for lead) to fall below 

within a specified level of confidence, 

based upon the results of an 

independent sample from the same 

population. In other words, if we were 

to randomly select a future test 

condition from any of these sources (i.e., 

average of 3 runs or 30-day average) we 

can be 95 percent confident that the 

reported level will fall at or below the 

UPL value. Use of the UPL is 

appropriate in this rulemaking because 

it sets a limit any single or future source 

can meet based on the sources past 

performance. 

This formula uses a pooled variance 

(in the s2 term) that encompasses all the 

data-point to data-point variability. 

Where variability was calculated using 

the UPL statistical approach, we used 

the sample standard deviation 

calculated from the emissions data 

distributions for lead. The standard 

deviation is the common measure of the 

dispersion of the data set around an 

average. We note here that the 

methodology accounts for both shortterm and long-term variability and 

encompasses run-to-run and test-to-test 

variability. 

We adopted a form of the UPL 

equation that has been used in more 

recent rulemakings. See 75 FR 54970 

(September 9, 2010), 75 FR 32020 (June 

4, 2010) and 75 FR 31905 (June 4, 2010). 

The UPL used in this proposed rule is 

calculated by: 

Where: 

x ̄ = 2008 annual emissions 

n = the number of test runs 

m = the number of test runs in the 

compliance average 

s2 = observed variance 

t = student t distribution statistic 

This calculation was performed using 

the following Excel functions: 95 

percent UPL = 2008 annual emissions + 

[STDEV (Test Runs) × TINV (2 × 

probability, n-1 degrees of freedom) × 

SQRT ((1/n) + (1/m))], for a one-tailed 

t-value, probability of 0.05, and sample 

size of n. 

F. What other actions are we proposing? 

As discussed in Section III.C. above, 

EPA is proposing to remove provisions 

in the existing standard that would have 

exempted sources from complying with 

the standard during periods of startup, 

shutdown and malfunction. Specifically 

we are proposing revisions to subpart 

TTT Table 1 and rule provisions to 

remove applicability of the General 

Provisions with regard to SSM and 

remove the exemption for bag leak 

detection alarm time attributable to SSM 

events from determining compliance 

with the total alarm time limit. In 

addition, we are proposing to 

promulgate an affirmative defense to 

civil penalties for exceedances of 

emission limits caused by malfunctions, 

as well as criteria for establishing the 

affirmative defense. 

EPA has attempted to ensure that we 

have not included in the proposed 

regulatory language any provisions that 

are inappropriate, unnecessary, or 

redundant in the absence of the SSM 

exemption. We are specifically seeking 

comment on whether there are any such 

provisions that we have inadvertently 

incorporated or overlooked. 


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VI. Proposed Action 

A. What actions are we proposing as a 

result of the residual risk reviews? 

Consistent with CAA section 112 

(f)(2), we are proposing to amend the 

MACT standard for primary lead 

processing to include a lead 

concentration in air limit of 0.15 μg/m3 

(based on 3-month rolling averages)to be 

measured at locations approved by the 

Administrator to address the risks from 

all fugitive dust emissions addressed in 

40 CFR 63.1544. We are also proposing 

to remove refining and casting 

operations from § 63.1544 and to require 

that emissions from these operations be 

vented to one or more stacks. Finally, 

we are proposing to establish an 

emission cap of 0.91 TPY for the furnace 

area stack and the refining operation 

stacks. These limits were established 

based on the level of reductions in lead 

emissions from the three sources that 

are necessary to show that the lead 

NAAQS will not be exceeded within the 

50 km modeled domain. We believe the 

NAAQS level represents an acceptable 

level of risk and that the proposed limits 

are necessary to ensure that risks from 

these sources are acceptable. We are 

proposing that the risk posed by lead 

emissions from the main stack and by 

emissions of all other HAP is 

acceptable. 

We are proposing that compliance 

with the emission limits applicable to 

the furnace area and refinery stacks 

would be demonstrated based on stack 

testing for existing facilities and, for 

new facilities, using CEMS after 

promulgation of performance 

specifications for a CEMS capable of 

measuring lead emissions. 

We are proposing that compliance 

with the lead concentration in air limit 

would be demonstrated using a 

compliance monitoring system 

approved by the Administrator. 

We are also proposing that the 

Primary Lead Smelting standard, as we 

have proposed to revise it to ensure an 

acceptable level of risk, will also protect 

public health with an ample margin of 

safety. With regard to lead emissions 

from fugitive dust sources and from the 

furnace and refining area stacks, we 

have not identified any feasible controls 

beyond those needed to meet the 

proposed emission limits that will 

provide an acceptable level of risk . The 

standards we are proposing to ensure an 

acceptable level of risk for lead 

emissions will also reduce the risk from 

cadmium and will also reduce 

emissions of all other metal HAP known 

to be emitted from this source category 

because the controls that will reduce 

lead emissions are the same controls 

that will reduce emissions of these other 

metal HAP. The cancer risk from 

cadmium emissions will be reduced 

from 30-in-1 million to less than 1-in-1 

million. Therefore, we are proposing 

that the existing MACT, as it would be 

modified based on our proposed 

requirements for lead emissions, would 

provide an ample margin of safety with 

respect to emissions from all metal 

HAP. 

With regard to lead emissions from 

the main stack, we have identified 

developments in practices, processes 

and control technologies since 

promulgation of the MACT standard in 

1999, and are proposing a reduced 

emission limit for the main stack based 

on these improvements. Since the main 

stack does not pose an unacceptable risk 

at its current emissions level, we are not 

proposing reductions for this emission 

point under 112(f)(2). However, we are 

proposing a reduced emission limit 

under 112(d)(6) due to the 

improvements we identified. 

B. What actions are we proposing as a 

result of the technology reviews? 

For the Primary Lead Smelting source 

category, we have determined that there 

have been developments in practices, 

processes, or control technologies since 

the promulgation of the MACT 

standards that are feasible for the one 

facility in this source category to 

implement at the main stack. The 

proposed limit is consistent with the 

current demonstrated performance of 

the facility based on obligations adopted 

by the State and reflected in the 2002 

SIP and 2007 SIP revision for Doe Run. 

We are proposing that a performance 

of 15.11 TPY has been demonstrated for 

emissions from the main stack, taking 

into consideration variability of 

emissions from that stack. The existing 

MACT lead emissions standard that is 

applicable to emissions from the main 

stack is a plant-wide emission limit that 

also applies to emissions from the 

furnace-area stack. We are proposing to 

revise the plant-wide limit to reflect the 

15.11 TPY limit for the main stack as 

well as the emissions limits we are 

proposing for the furnace-area and 

refinery stacks under CAA section 

112(f)(2). Thus, we are proposing to 

revise the plant-wide emissions limit 

from 1 pound of lead per ton of lead 

produced, to 0.22 pound of lead per ton 

of lead produced and the new limit 

would include emissions from the 

refinery stack as well as emissions from 

the main stack and the furnace area 

stack. Compliance with this limit would 

be demonstrated quarterly with stack 

testing. For new facilities, compliance 

would be demonstrated using lead 

CEMS. 

C. What other actions are we proposing? 

As described above, we are proposing 

to amend the applicability section for 

the MACT rule to tailor it to the 

definition of the source category we 

established under CAA section 

112(c)(1). See ‘‘Documentation for 

Development of Initial Source Category 

List—Final Report’’, USEPA/OAQPS, 

EPA–450/3–91–030, July, 1992. In 

support of this applicability provision 

clarification, we are also proposing to 

replace the definition of ‘‘primary lead 

smelter’’ with a definition of ‘‘primary 

lead processor’’. The ‘‘primary lead 

processor’’ definition would include any 

facility that produces lead from 

processing of lead sulfide ore by 

pyrometallurgical (smelting) or any 

other technique. We are also proposing 

to add definitions of ‘‘secondary lead 

smelters’’, ‘‘lead refiners’’, and ‘‘lead 

remelters’’ to clarify the meaning of 

those terms in the second sentence of 

the applicability provision. 

We propose to amend the Primary 

Lead Smelting MACT standards to 

remove the language that exempts bag 

leak detection system alarm time 

incurred during periods of SSM from 

inclusion in the allowable alarm time. 

This change is being made to ensure the 

rule is consistent with the court’s ruling 

in Sierra Club v. EPA, 551 F.3d 1019 

(D.C. Cir. 2008). We are also proposing 

minor modifications throughout the rule 

to incorporate plain language and to 

make editorial and clarifying revisions. 

In addition, we are proposing changes to 

Table 1 of the rule to reflect revisions 

to SSM requirements. 

D. Compliance Dates 

We are proposing that the 

requirements under CAA section 

112(f)(2) for the one existing source, if 

finalized, must be implemented no later 

than two years after the effective date of 

this rule. Consistent with CAA section 

112(f)(4)(B), we are proposing that a 

two-year compliance period is necessary 

so the facility has adequate time to 

install additional controls and 

demonstrate compliance, including the 

time necessary to purchase, install and 

test replacement bags, or if the facility 

decides to add a new baghouse in series 

with an existing baghouse, seek bids, 

select a vendor, install and test the new 

equipment; prepare and submit the 

required monitoring plan to monitor 

lead concentrations in air; purchase, 

install and conduct quality assurance 

and quality control measures on 

compliance monitoring equipment and; 

conduct site remediation necessary to 


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reduce fugitive emissions. A two-year 

compliance period is also consistent 

with the schedule of required actions 

contained in the Consent Decree. 

In addition, we are proposing that the 

plant-wide limit that would reflect 

reductions required for the main stack 

pursuant to CAA section 112(d)(6) and 

for the furnace area and refinery stacks 

pursuant to CAA section 112(f)(2) must 

be met no later than two years after the 

effective date of this rule. Because these 

limits reflect the reductions from the 

furnace area and refinery stacks 

required under section 112(f)(2), we 

believe a two-year compliance 

timeframe is needed for the same 

reasons provided above. 

VII. Request for Comments 

We are soliciting comments on all 

aspects of this proposed action. All 

comments received during the comment 

period will be considered. In addition to 

general comments on this proposed 

actions, we are also interested in any 

additional data that may help to reduce 

the uncertainties inherent in the risk 

assessments. We are specifically 

interested in receiving corrections to the 

dataset used for risk modeling. Such 

data should include supporting 

documentation in sufficient detail to 

allow characterization of the quality and 

representativeness of the data or 

information. Please see the following 

section for more information on 

submitting data. 

VIII. Submitting Data Corrections 

The facility-specific data used in the 

source category risk analyses and 

demographic analyses are available for 

download on the RTR Web Page at 

http://www.epa.gov/ttn/atw/rrisk/ 

rtrpg.html. The data files include 

detailed information for each HAP 

emissions release point for the facility 

included in the source category. 

If you believe the data are not 

representative or are inaccurate, please 

identify the data in question, provide 

your reason for concern, and provide 

any ‘‘improved’’ data that you have, if 

available. When you submit data, we 

request that you provide documentation 

of the basis for the revised values to 

support your suggested changes. To 

submit comments on the data 

downloaded from the RTR Web page, 

complete the following steps: 

(1) Within this downloaded file, enter 

suggested revisions to the data fields 

appropriate for that information. The 

data fields that may be revised include 

the following: 

Data element Definition 

Control Measure ........................................................................ Are control measures in place? (yes or no). 

Control Measure Comment ....................................................... Select control measure from list provided, and briefly describe the control measure. 

Delete ........................................................................................ Indicate here if the facility or record should be deleted. 

Delete Comment ....................................................................... Describes the reason for deletion. 

Emission Calculation Method Code For Revised Emissions ... Code description of the method used to derive emissions. For example, CEM, 

material balance, stack test, etc. 

Emission Process Group .......................................................... Enter the general type of emission process associated with the specified emission point. 

Fugitive Angle ........................................................................... Enter release angle (clockwise from true North); orientation of the y-dimension 

relative to true North, measured positive for clockwise starting at 0 degrees 

(maximum 89 degrees). 

Fugitive Length .......................................................................... Enter dimension of the source in the east-west (x-) direction, commonly referred 

to as length (ft). 

Fugitive Width ........................................................................... Enter dimension of the source in the north-south (y-) direction, commonly referred to as width (ft). 

Malfunction Emissions .............................................................. Enter total annual emissions due to malfunctions (TPY). 

Malfunction Emissions Max Hourly ........................................... Enter maximum hourly malfunction emissions here (lb/hr). 

North American Datum ............................................................. Enter datum for latitude/longitude coordinates (NAD27 or NAD83); if left blank, 

NAD83 is assumed. 

Process Comment ..................................................................... Enter general comments about process sources of emissions. 

REVISED Address .................................................................... Enter revised physical street address for MACT facility here. 

REVISED City ........................................................................... Enter revised city name here. 

REVISED County Name ........................................................... Enter revised county name here. 

REVISED Emission Release Point Type .................................. Enter revised Emission Release Point Type here. 

REVISED End Date .................................................................. Enter revised End Date here. 

REVISED Exit Gas Flow Rate .................................................. Enter revised Exit Gas Flowrate here (ft3/sec). 

REVISED Exit Gas Temperature .............................................. Enter revised Exit Gas Temperature here (F). 

REVISED Exit Gas Velocity ...................................................... Enter revised Exit Gas Velocity here (ft/sec). 

REVISED Facility Category Code ............................................. Enter revised Facility Category Code here, which indicates whether facility is a 

major or area source. 

REVISED Facility Name ........................................................... Enter revised Facility Name here. 

REVISED Facility Registry Identifier ......................................... Enter revised Facility Registry Identifier here, which is an ID assigned by the 

EPA Facility Registry System. 

REVISED HAP Emissions Performance Level Code ............... Enter revised HAP Emissions Performance Level here. 

REVISED Latitude ..................................................................... Enter revised Latitude here (decimal degrees). 

REVISED Longitude .................................................................. Enter revised Longitude here (decimal degrees). 

REVISED MACT Code ............................................................. Enter revised MACT Code here. 

REVISED Pollutant Code .......................................................... Enter revised Pollutant Code here. 

REVISED Routine Emissions ................................................... Enter revised routine emissions value here (TPY). 

REVISED SCC Code ................................................................ Enter revised SCC Code here. 

REVISED Stack Diameter ......................................................... Enter revised Stack Diameter here (ft). 

REVISED Stack Height ............................................................. Enter revised Stack Height here (Ft). 

REVISED Start Date ................................................................. Enter revised Start Date here. 

REVISED State ......................................................................... Enter revised State here. 

REVISED Tribal Code ............................................................... Enter revised Tribal Code here. 

REVISED Zip Code ................................................................... Enter revised Zip Code here. 

Shutdown Emissions ................................................................. Enter total annual emissions due to shutdown events (TPY). 

Shutdown Emissions Max Hourly ............................................. Enter maximum hourly shutdown emissions here (lb/hr).


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Data element Definition 

Stack Comment ......................................................................... Enter general comments about emission release points. 

Startup Emissions ..................................................................... Enter total annual emissions due to startup events (TPY). 

Startup Emissions Max Hourly .................................................. Enter maximum hourly startup emissions here (lb/hr). 

Year Closed .............................................................................. Enter date facility stopped operations. 

2. Fill in the commenter information 

fields for each suggested revision (i.e., 

commenter name, commenter 

organization, commenter e-mail address, 

commenter phone number, and revision 

comments). 

3. Gather documentation for any 

suggested emissions revisions (e.g., 

performance test reports, material 

balance calculations, etc.). 

4. Send the entire downloaded file 

with suggested revisions in Microsoft®

Access format and all accompanying 

documentation to Docket ID Number 

EPA–HQ–OAR–2004–0305 (through one 

of the methods described in the 

ADDRESSES section of this preamble). To 

expedite review of the revisions, it 

would also be helpful if you submitted 

a copy of your revisions to the EPA 

directly at RTR@epa.gov in addition to 

submitting them to the docket. 

5. If you are providing comments on 

a facility, you need only submit one file 

for that facility, which should contain 

all suggested changes for all sources at 

that facility. We request that all data 

revision comments be submitted in the 

form of updated Microsoft® Access files, 

which are provided on the http:// 

www.epa.gov/ttn/atw/rrisk/rtrpg.html 

Web page. 

IX. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review 

Under Executive Order 12866 (58 FR 

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

significant regulatory action because it 

raises novel legal and policy issues. 

Accordingly, EPA submitted this action 

to the Office of Management and Budget 

(OMB) for review under Executive 

Order 12866 and any changes made in 

response to OMB recommendations 

have been documented in the docket for 

this action. 

B. Paperwork Reduction Act 

The information collection 

requirements in this rule have been 

submitted for approval to the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act, 44 U.S.C. 

3501 et seq. The Information Collection 

Request (ICR) document prepared by 

EPA has been assigned EPA ICR number 

1856.07. 

We are proposing new paperwork 

requirements to the Primary Lead 

Smelting source category in the form of 

monitoring for lead concentrations in air 

and increased frequency for stack 

testing as described in 40 CFR 

63.1547(k) (compliance monitoring) and 

40 CFR 63.1546 (stack testing). These 

requirements are described in section 

VI.A and B. Although these are 

additional requirements under today’s 

proposed rule, they are consistent with 

existing monitoring and testing 

currently conducted by the facility to 

meet MACT and SIP requirements. 

Therefore, we do not believe that the 

additional paperwork required by these 

proposed changes would constitute an 

undue burden to the facility. 

We estimate one regulated entity is 

currently subject to subpart TTT and 

will be subject to all proposed 

standards. This facility will have no 

capital costs associated with the 

information collection requirements in 

the proposed rule. 

The estimated recordkeeping and 

reporting burden after the effective date 

of the proposed rule is estimated to be 

1,323 labor hours at a cost of $465,503. 

This estimate includes the cost of 

reporting, including reading 

instructions, and information gathering. 

Recordkeeping cost estimates include 

reading instructions, planning activities, 

monitoring plan development, 

conducting compliance monitoring, 

sampling and analysis and maintenance 

of rolling 3-month average data. The 

average hours and cost per regulated 

entity would be 1,323 hours and 

$465,503 based on one facility response 

per year. 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. 

To comment on the Agency’s need for 

this information, the accuracy of the 

provided burden estimates, and any 

suggested methods for minimizing 

respondent burden, EPA has established 

a public docket for this rule, which 

includes this ICR, under Docket ID 

number EPA–HQ–OAR–2004–0305. 

Submit any comments related to the ICR 

to EPA and OMB. See ADDRESSES

section at the beginning of this notice 

for where to submit comments to EPA. 

Send comments to OMB at the Office of 

Information and Regulatory Affairs, 

Office of Management and Budget, 725 

17th Street, NW., Washington, DC 

20503, Attention: Desk Office for EPA. 

Since OMB is required to make a 

decision concerning the ICR between 30 

and 60 days after February 17, 2011, a 

comment to OMB is best assured of 

having its full effect if OMB receives it 

by March 21, 2011. The final rule will 

respond to any OMB or public 

comments on the information collection 

requirements contained in this proposal. 

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 impacts of today’s proposed rule on 

small entities, small entity is defined as: 

(1) A small business that is a small 

industrial entity as defined by the Small 

Business Administration’s (SBA) 

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 today’s proposed rule on 

small entities, I certify that this action 

will not have a significant economic 

impact on a substantial number of small 

entities. This proposed rule will not 

impose any requirements on small 

entities. This proposed rule is currently 

applicable to one operating facility that 

does not meet the definition of a small 

entity. 

We continue to be interested in the 

potential impacts of the proposed rule 

on small entities and welcome 

comments on issues related to such 

impacts. 


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D. Unfunded Mandates Reform Act 

This proposed rule does not contain 

a federal mandate 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 

proposed rule would not result in 

expenditures of $100 million or more 

for State, local, and tribal governments, 

in aggregate, or the private sector in any 

1 year. The proposed rule imposes no 

enforceable duties on any State, local or 

tribal governments or the private sector. 

Thus, this proposed rule is not subject 

to the requirements of sections 202 or 

205 of the UMRA. 

This proposed rule is also not subject 

to the requirements of section 203 of 

UMRA because it contains no regulatory 

requirements that might significantly or 

uniquely affect small governments 

because it contains no requirements that 

apply to such governments nor does it 

impose obligations upon them. 

E. Executive Order 13132: Federalism 

This proposed rule 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. None of the 

facilities subject to this action are 

owned or operated by State 

governments, and, because no new 

requirements are being promulgated, 

nothing in this proposal will supersede 

State regulations. Thus, Executive Order 

13132 does not apply to this proposed 

rule. 

In the spirit of Executive Order 13132, 

and consistent with EPA policy to 

promote communications between EPA 

and State and local governments, EPA 

specifically solicits comment on this 

proposed rule from State and local 

officials. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

Subject to the Executive Order 13175 

(65 FR 67249, November 9, 2000) EPA 

may not issue a regulation that has tribal 

implications, that imposes substantial 

direct compliance costs, and that is not 

required by statute, unless the Federal 

government provides the funds 

necessary to pay the direct compliance 

costs incurred by tribal governments, or 

EPA consults with tribal officials early 

in the process of developing the 

proposed regulation and develops a 

tribal summary impact statement. EPA 

has concluded that this proposed rule 

will not have tribal implications, as 

specified in Executive Order 13175. 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. 

EPA specifically solicits additional 

comment on this proposed action from 

tribal officials. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

This proposed rule is not subject to 

Executive Order 13045 (62 FR 19885, 

April 23, 1997) because it is not 

economically significant as defined in 

Executive Order 12866. However, the 

Agency does believe there is a 

disproportionate risk to children. 

Modeled ambient air lead 

concentrations from the one facility in 

this source category are in excess of the 

NAAQS for lead, which was set to 

‘‘provide increased protection for 

children and other at-risk populations 

against an array of adverse health 

effects, most notably including 

neurological effects in children, 

including neurocognitive and 

neurobehavioral effects.’’ 73 FR 67007. 

However, the control measures 

proposed 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 under Executive 

Order 13211, ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001), because it is 

not likely to have significant adverse 

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. 

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 EPA to use voluntary consensus 

standards in its regulatory activities 

unless to do so would be inconsistent 

with applicable law or otherwise 

impractical. Voluntary consensus 

standards are technical standards (e.g., 

materials specifications, test methods, 

sampling procedures, and business 

practices) that are developed or adopted 

by voluntary consensus standards 

bodies. The NTTAA directs EPA to 

provide Congress, through OMB, 

explanations when the Agency decides 

not to use available and applicable 

voluntary consensus standards. 

This proposed rulemaking does not 

involve technical standards. Therefore, 

EPA is not considering the use of any 

voluntary consensus standards. 

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. 

To examine the potential for any 

environmental justice issues that might 

be associated with each source category, 

we evaluated the distributions of HAPrelated cancer and non-cancer risks 

across different social, demographic, 

and economic groups within the 

populations living near the facilities 

where these source categories are 

located. The methods used to conduct 

demographic analyses for this rule are 

described in section IV.A of the 

preamble for this rule. The development 

of demographic analyses to inform the 

consideration of environmental justice 

issues in EPA rulemakings is an 

evolving science. The EPA offers the 

demographic analyses in today’s 

rulemaking as examples of how such 

analyses might be developed to inform 

such consideration, and invites public 

comment on the approaches used and 

the interpretations made from the 

results, with the hope that this will 

support the refinement and improve 

utility of such analyses for future 

rulemakings. 

In the case of Primary Lead 

Processing, we focused on populations 

within 50 km of the one facility in this 

source category with emission sources 

subject to the MACT standard. More 

specifically, for these populations we 


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evaluated exposures to HAP which 

could result in cancer risks of 1-in-1 

million or greater, or population 

exposures to ambient air lead 

concentrations above the level of the 

NAAQS for lead. We compared the 

percentages of particular demographic 

groups within the focused populations 

to the total percentages of those 

demographic groups nationwide. The 

results of this analysis are documented 

in section V.B.1 (see Table 6), as well as 

in a technical report located in the 

docket for this rulemaking. In brief, 

although our analyses show that there is 

the potential for adverse environmental 

and human health effects from 

emissions of lead, it does not indicate 

any significant potential for disparate 

impacts to the specific demographic 

groups analyzed (see section V.B.1). 

Notably however, the proposed 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. 

List of Subjects in 40 CFR Part 63 

Environmental protection, Air 

pollution control, Reporting and 

recordkeeping requirements, Lead. 

Dated: January 31, 2011. 

Lisa P. Jackson, 

Administrator. 

For reasons set out in the preamble, 

title 40, chapter I, of the Code of Federal 

Regulations is proposed to be amended: 

PART 63—[AMENDED] 

1. The authority citation for part 63 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

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: 

a. Adding in alphabetical order 

definitions for ‘‘Affirmative defense,’’ 

‘‘Lead refiner,’’ ‘‘Lead remelter,’’ 

‘‘Primary lead processor,’’ and 

‘‘Secondary lead smelter’’. 

b. Removing the definition for 

‘‘Primary lead smelter’’. 

c. Revising the definitions for 

‘‘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’’. 

§ 63.1542 Definitions. 

* * * * * 

Affirmative defense means, in the 

context of an enforcement proceeding, a 

response or defense put forward by a 

defendant, regarding which the 

defendant has the burden of proof, and 

the merits of which are independently 

and objectively evaluated in a judicial 

or administrative proceeding. 

* * * * * 

Fugitive dust source means a 

stationary source of hazardous air 

pollutant emissions at a primary lead 

processor resulting from the handling, 

storage, transfer, or other management 

of lead-bearing materials where the 

source is not part of a 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 0.22 


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pounds per ton of lead metal produced 

from the aggregation of emissions 

discharged from air pollution control 

devices used to control emissions at 

primary lead processing facilities, 

including the sources listed in 

paragraphs (a)(1) through (a)(10) 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; 

(9) Sinter machine area; and 

(10) Refining and casting, and furnace 

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 0.91 tons 

per year from the air pollution control 

devices used to control emissions from 

furnace area and refining and casting 

operations. 

(c) The process fugitive sources listed 

in paragraphs (a)(4) through (a)(8) of this 

section must be equipped with a hood 

and must be ventilated to a baghouse or 

equivalent control device. The hood 

design and ventilation rate must be 

consistent with American Conference of 

Governmental Industrial Hygienists 

recommended practices. 

(d) The sinter machine area must be 

enclosed in a building that is ventilated 

to a baghouse or equivalent control 

device at a rate that maintains a positive 

in-draft through any doorway opening. 

(e) Except as provided in paragraph (f) 

of this section, following the initial tests 

to demonstrate compliance with 

paragraphs (a)and (b) of this section, the 

owner or operator of a primary lead 

processor must conduct compliance 

tests for lead compounds on an 

quarterly basis (no later than 100 days 

following any previous compliance 

test). 

(f) If the 12 most recent compliance 

tests demonstrate compliance with the 

emission limit specified in paragraphs 

(a) and (b) of this section, the owner or 

operator of a primary lead processor 

shall be allowed up to 12 calendar 

months from the last compliance test to 

conduct the next compliance test for 

lead compounds. 

(g) The owner or operator of a primary 

lead processor must maintain and 

operate each baghouse used to control 

emissions from the sources listed in 

paragraphs (a)(1) through (a)(10) 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: 

§ 63.1544 Standards for fugitive dust 

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 that cause the 

concentration of lead in air to exceed 

0.15 μg/m3 on a 3-month rolling average 

measured at locations approved by the 

Administrator. 

(b) 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 of this subpart no later 

than [DATE TWO YEARS FROM 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER]. 

(b) Each owner or operator of a new 

primary lead processor must achieve 

compliance with the requirements of 

this subpart no later than [DATE 60 

DAYS AFTER PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER] or startup, whichever is 

later. 

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 

(10) must determine the lead compound 

emissions rate, in units of pounds of 

lead per hour according to the following 

test methods in appendices of part 60 of 

this chapter: 

(i) Method 1 to appendix A–1 of 40 

CFR part 60 must be used to select the 

sampling port location and the number 

of traverse points. 

(ii) Methods 2 and 2F of appendix 

A–1 and Method 2G of appendix A–2 of 

40 CFR part 60 must be used to measure 

volumetric flow rate. 

(iii) Methods 3, 3A, 3B of appendix 

A–2 of 40 CFR part 60 must be used for 

gas analysis. 

(iv) Method 4 of appendix A–3 of 40 

CFR part 60 must be used to determine 

moisture content of the stack gas. 

(v) Method 12 of appendix A–5 or 

Method 29 of appendix A–8 of 40 CFR 

part 60 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 of appendix A–5 or 

Method 29 of appendix A–8 of 40 CFR 

part 60, the minimum sample time must 

be 60 minutes and the minimum 

volume must be 1 dry standard cubic 

meter (35 dry standard cubic feet). 

(3) Performance tests shall be 

completed quarterly, once every 3 

months, to determine compliance. 

(4) The lead emission rate in pounds 

per quarter is calculated by multiplying 

the quarterly lead emission rate in 

pounds per hour by the quarterly plant 

operating time, in hours as shown in 

Equation 1: 

Where: 

EPb = quarterly lead emissions, pounds per 

quarter; 


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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 (a)(5)(iii) of this section. 

(6) To determine compliance with the 

production-based lead compound 

emission rate in § 63.1543(a), the 

quarterly production-based lead 

compound emission rate, in 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 

(a)(10) to determine compliance with 

§ 63.1543(b), as determined in 

accordance with paragraphs (a)(1) 

through (a)(4) of this section. 

(b) Owner and operators must perform 

an initial compliance test to 

demonstrate compliance with the sinter 

building in-draft requirements of 

§ 63.1543(d) at each doorway opening in 

accordance with paragraphs (b)(1) 

through (b)(4) of this section. 

(1) Use a propeller anemometer or 

equivalent device. 

(2) Determine doorway in-draft by 

placing the anemometer in the plane of 

the doorway opening near its center. 

(3) Determine doorway in-draft for 

each doorway that is open during 

normal operation with all remaining 

doorways in their customary position 

during normal operation. 

(4) Do not determine doorway in-draft 

when ambient wind speed exceeds 2 

meters per second. 

(c) Performance tests shall be 

conducted under such conditions as the 

Administrator specifies to the owner or 

operator based on representative 

performance of the affected source for 

the period being tested. Upon request, 

the owner or operator shall make 

available to the Administrator such 

records as may be necessary to 

determine the conditions of 

performance tests. 

8. Section 63.1547 is revised to read 

as follows: 

§ 63.1547 Monitoring requirements. 

(a) Owners and operators of primary 

lead processors must prepare, and at all 

times operate according to, a standard 

operating procedures manual that 

describes in detail the procedures for 

inspection, maintenance, and bag leak 

detection and corrective action for all 

baghouses that are used to control 

process, process fugitive, or fugitive 

dust emissions from any source subject 

to the lead emission standards in 

§§ 63.1543 and 63.1544, including those 

used to control emissions from general 

ventilation systems. 

(b) The standard operating procedures 

manual for baghouses required by 

paragraph (a) of this section must be 

submitted to the Administrator or 

delegated authority for review and 

approval. 

(c) The procedures specified in the 

standard operating procedures manual 

for inspections and routine maintenance 

must, at a minimum, include the 

requirements of paragraphs (c)(1) 

through (c)(8) of this section. 

(1) Weekly confirmation that dust is 

being removed from hoppers through 

visual inspection or equivalent means of 

ensuring the proper functioning of 

removal mechanisms. 

(2) Daily check of compressed air 

supply for pulse-jet baghouses. 

(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 (e)(8) of 

this section. 

(1) The bag leak detection system 

must be certified by the manufacturer to 

be capable of detecting particulate 

matter emissions at concentrations of 10 

milligram per actual cubic meter (0.0044 

grains per actual cubic foot) or less. 

(2) The bag leak detection system 

sensor must provide output of relative 

particulate matter loadings, and the 

owner or operator must continuously 

record the output from the bag leak 

detection system. 

(3) The bag leak detection system 

must be equipped with an alarm system 

that will sound when an increase in 

relative particulate loading is detected 

over a preset level, and the alarm must 

be located such that it can be heard or 

otherwise determined by the 

appropriate plant personnel. 

(4) Each bag leak detection system 

that works based on the triboelectric 

effect must be installed, calibrated, and 

maintained in a manner consistent with 

guidance provided in the U.S. 

Environmental Protection Agency 

guidance document ’’Fabric Filter Bag 

Leak Detection Guidance’’ (EPA–454/R– 

98–015). Other bag leak detection 

systems must be installed, calibrated, 

and maintained in a manner consistent 

with the manufacturer’s written 

specifications and recommendations. 

(5) The initial adjustment of the 

system must, at a minimum, consist of 

establishing the baseline output by 

adjusting the sensitivity (range) and the 

averaging period of the device, and 

establishing the alarm set points and the 

alarm delay time. 

(6) Following initial adjustment, the 

owner or operator must not adjust the 

sensitivity or range, averaging period, 

alarm set points, or alarm delay time, 

except as detailed in the approved SOP 

required under paragraph (a) of this 


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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(h). 

The percentage of time the alarm on the 

bag leak detection system sounds must 

be determined according to paragraphs 

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

(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), (i)(2), or (i)(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 (i)(2)(iv) of this section. 

(i) Owners and operators must install, 

calibrate, maintain, and operate a 

monitoring device that continuously 

records the volumetric flow rate through 

each separately ducted hood; or install, 

calibrate, maintain, and operate a 

monitoring device that continuously 

records the volumetric flow rate at the 

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 (a)(10) must install, 

calibrate, maintain, and operate a 

continuous emission monitoring system 

(CEMS) for measuring lead emissions 

and a continuous emission rate 

monitoring system (CERMS) subject to 

Performance Specification 6 of 

Appendix B to part 60. 

(1) Each owner or operator of a source 

subject to the emissions limits for lead 

compounds under § 63.1543(a) and (b) 

must install a CEMS for measuring lead 

emissions within 180 days of 

promulgation of performance 

specifications for lead CEMS. 

(i) Prior to promulgation of 

performance specifications for CEMS 

used to measure lead concentrations, an 

owner or operator must use the 

procedure described in § 63.1546(a)(1) 

through (a)(7) of this section to 

determine compliance. 

(ii) [Reserved] 

(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 


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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 (b)(2)(i) of this section. 

(iii) Each owner or operator must 

perform an initial relative accuracy test 

of the CERMS in accordance with the 

applicable Performance Specification in 

Appendix B to part 60 of the chapter. 

(iv) Each owner or operator must 

operate the CERMS and record data 

during all periods of operation of the 

affected facility including periods of 

startup, shutdown, and malfunction, 

except for periods of monitoring system 

malfunctions, repairs associated with 

monitoring system malfunctions, and 

required monitoring system quality 

assurance or quality control activities 

(including, as applicable, calibration 

checks and required zero and span 

adjustments. 

(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. 

(ii) [Reserved] 

(k) The owner or operator of each 

source subject to § 63.1544(a) must 

operate a continuous monitoring system 

for the measurement of lead compound 

concentrations in air. 

(1) The owner or operator must 

operate compliance monitors sufficient 

in number, location, and frequency of 

sample collection to detect expected 

maximum concentrations of lead 

compounds in air due to emissions from 

the affected source(s) in accordance 

with a written plan as described in 

(k)(2) of this paragraph and approved by 

the Administrator. The plan must 

include descriptions of the sampling 

and analytical methods used. The plan 

may take into consideration existing 

monitoring being conducted under a 

state monitoring plan in accordance 

with part 58 of this chapter. 

(2) The owner or operator must 

submit a written plan describing and 

explaining the basis for the design and 

adequacy of the compliance monitoring 

network, the sampling, analytical, and 

quality assurance procedures, and any 

other related procedures, and the 

justification for any seasonal, 

background, or other data adjustments 

within 45 days after the effective date of 

this subpart. 

(3) The Administrator at any time may 

require changes in, or expansion of, the 

monitoring program, including 

additional sampling and analytical 

protocols and network design. 

(l) If all rolling three-month average 

concentrations of lead in air measured 

by the compliance monitoring system 

are less than 50 percent of the lead 

concentration in air limit in § 63.1544(a) 

for three consecutive years, the owner or 

operator may submit a revised plan to 

reduce the monitoring sampling and 

analysis frequency (e.g., from daily to 

weekly). For any subsequent period, if 

any rolling three-month average lead 

concentration in air measured at any 

monitor in the monitoring system 

exceeds 50 percent of the concentration 

limit in § 63.1544(a), the owner or 

operator must resume monitoring 

pursuant to paragraph (k)(1) of this 

section at all monitors until another 

three consecutive years of lead 

concentration in air measurements less 

than 50 percent of the lead 

concentration in air limit is 

demonstrated. 

9. Section 63.1548 is revised to read 

as follows: 

§ 63.1548 Notification requirements. 

(a) The owner or operator of a primary 

lead processor must comply with the 

notification requirements of § 63.9 of 

subpart A, General Provisions as 

specified in Table 1 of this subpart. 

(b) The owner or operator of a primary 

lead processor must submit the standard 

operating procedures manual for 

baghouses required under § 63.1547(a) 

to the Administrator or delegated 

authority along with a notification that 

the primary lead processor is seeking 

review and approval of the manual and 

procedures. Owners or operators of 

existing primary lead processors must 

submit this notification no later than 

November 6, 2000. The owner or 

operator of a primary lead processor that 

commences construction or 

reconstruction after April 17, 1998, 

must submit this notification no later 

than 180 days before startup of the 

constructed or reconstructed primary 

lead processor, but no sooner than 

September 2, 1999. 

(c) The owner or operator of a primary 

lead processor must submit the 

compliance monitoring network plan 

required under § 63.1547(k)(2) to the 

Administrator or delegated authority 

along with a notification that the 

primary lead processor is seeking 

review and approval of the plan. 

Owners or operators of existing primary 

lead processors must submit this 

notification no later than 45 days after 

promulgation of this subpart. The owner 

or operator of a new, reconstructed, or 

modified primary lead processor must 

submit this notification no later than 

180 days before startup of the 

constructed or reconstructed primary 

lead processor. 

10. Section 63.1549 is revised to read 

as follows: 

§ 63.1549 Recordkeeping and reporting 

requirements. 

(a) The owner or operator of a primary 

lead processor must comply with the 

recordkeeping requirements of § 63.10 

of subpart A, General Provisions as 

specified in Table 1 of this subpart. 

(b) In addition to the general records 

required by paragraph (a) of this section, 

each owner or operator of a primary 

lead processor must maintain for a 

period of 5 years, records of the 

information listed in paragraphs (b)(1) 

through (b)(10) of this section. 

(1) Production records of the weight 

and lead content of lead products, 

copper matte, and copper speiss. 

(2) Records of the bag leak detection 

system output. 

(3) An identification of the date and 

time of all bag leak detection system 

alarms, the time that procedures to 

determine the cause of the alarm were 

initiated, the cause of the alarm, an 

explanation of the actions taken, and the 

date and time the cause of the alarm was 

corrected. 

(4) Any recordkeeping required as 

part of the requirements described in 

the compliance monitoring system plan 

required under § 63.1547(k)(2). 

(5) Any recordkeeping required as 

part of the practices described in the 

standard operating procedures manual 

for baghouses required under 

§ 63.1547(a). 

(6) If an owner or operator chooses to 

demonstrate continuous compliance 

with the sinter building in-draft 

requirement under § 63.1543(d) by 

employing the method allowed in 

§ 63.1547(i)(1), the records of the daily 

doorway in-draft checks, an 


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Federal Register / Vol. 76, No. 33 / Thursday, February 17, 2011 / Proposed Rules 9445 

identification of the periods when there 

was not a positive in-draft, and an 

explanation of the corrective actions 

taken. 

(7) If an owner or operator chooses to 

demonstrate continuous compliance 

with the sinter building in-draft 

requirement under § 63.1543(d) by 

employing the method allowed in 

§ 63.1547(i)(2), the records of the output 

from the continuous volumetric flow 

monitor(s), an identification of the 

periods when the 15-minute volumetric 

flow rate dropped below the minimum 

established during the most recent indraft determination, and an explanation 

of the corrective actions taken. 

(8) If an owner or operator chooses to 

demonstrate continuous compliance 

with the sinter building in-draft 

requirement under § 63.1543(d) by 

employing the method allowed in 

§ 63.1547(i)(2), and volumetric flow rate 

is monitored at the baghouse inlet, 

records of the daily checks of damper 

positions, an identification of the days 

that the damper positions were not in 

the positions established during the 

most recent in-draft determination, and 

an explanation of the corrective actions 

taken. 

(9) Records of the occurrence and 

duration of each malfunction of 

operation (i.e., process equipment) or 

the air pollution control equipment and 

monitoring equipment. 

(10) Records of actions taken during 

periods of malfunction to minimize 

emissions in accordance with 

§§ 63.1543(i) and 63.1544(e), including 

corrective actions to restore 

malfunctioning process and air 

pollution control and monitoring 

equipment to its normal or usual 

manner of operation. 

(c) Records for the most recent 2 years 

of operation must be maintained on site. 

Records for the previous 3 years may be 

maintained off site. 

(d) The owner or operator of a 

primary lead processor must comply 

with the reporting requirements of 

§ 63.10 of subpart A, General Provisions 

as specified in Table 1 of this subpart. 

(e) In addition to the information 

required under § 63.10 of the General 

Provisions, the owner or operator must 

provide semi-annual reports containing 

the information specified in paragraphs 

(e)(1) through (e)(9) of this section to the 

Administrator or designated authority. 

(1) The reports must include records 

of all alarms from the bag leak detection 

system specified in § 63.1547(e). 

(2) The reports must include a 

description of the actions taken 

following each bag leak detection 

system alarm pursuant to § 63.1547(f). 

(3) The reports must include a 

calculation of the percentage of time the 

alarm on the bag leak detection system 

sounded during the reporting period 

pursuant to § 63.1547(g). 

(4) If an owner or operator chooses to 

demonstrate continuous compliance 

with the sinter building in-draft 

requirement under § 63.1543(d) by 

employing the method allowed in 

§ 63.1547(i)(1), the reports must contain 

an identification of the periods when 

there was not a positive in-draft, and an 

explanation of the corrective actions 

taken. 

(5) If an owner or operator chooses to 

demonstrate continuous compliance 

with the sinter building in-draft 

requirement under § 63.1543(d) by 

employing the method allowed in 

§ 63.1547(i)(2), the reports must contain 

an identification of the periods when 

the 15-minute volumetric flow rate(s) 

dropped below the minimum 

established during the most recent 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 must contain a 

summary of the compliance monitoring 

results for the required reporting period, 

including an explanation of any periods 

when the procedures outlined in the 

compliance monitoring system plan 

required by § 63.1547(k)(2) were not 

followed and the corrective actions 

taken. 

(9) If there was a malfunction during 

the reporting period, the report shall 

also include the number, duration, and 

a brief description for each type of 

malfunction which occurred during the 

reporting period and which caused or 

may have caused any applicable 

emission limitation to be exceeded. The 

report must also include a description of 

actions taken by an owner or operator 

during a malfunction of an affected 

source to minimize emissions in 

accordance with §§ 63.1543(i) and 

63.1544(b), including actions taken to 

correct a malfunction. 

11. Section 63.1550 is revised to read 

as follows: 

§ 63.1550 Delegation of authority. 

(a) In delegating implementation and 

enforcement authority to a State under 

section 112(1) 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 in 40 CFR 63.2. 

Appropriate penalties may be assessed, 

however, if you fail to meet your burden 

of proving all the requirements in the 

affirmative defense. The affirmative 

defense shall not be available for claims 

for injunctive relief. 

(a) To establish the affirmative 

defense in any action to enforce such a 

limit, you must timely meet the 

notification requirements in paragraph 

(b) of this section, and must prove by a 

preponderance of evidence that: 

(1) The excess emissions: 

(i) Were caused by a sudden, short, 

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 


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(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, 

severe 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; 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 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 30 days of the initial occurrence 

of the exceedance of the standard in this 

subpart to demonstrate, with all 

necessary supporting documentation, 

that it has met the requirements set forth 

in paragraph (a) of this section. 

12. Table 1 to Subpart TTT of Part 63 

is revised to read as follows: 

TABLE 1 TO SUBPART TTT OF PART 63—GENERAL PROVISIONS APPLICABILITY TO SUBPART TTT 

Reference Applies to subpart 

TTT Explanation 

§ 63.1 ................................................................................................................................. Yes. 

§ 63.2 ................................................................................................................................. Yes. 

§ 63.3 ................................................................................................................................. Yes. 

§ 63.4 ................................................................................................................................. Yes. 

§ 63.5 ................................................................................................................................. Yes. 

§ 63.6(a), (b), (c) ................................................................................................................ Yes. 

§ 63.6 (d) ........................................................................................................................... No .......................... Section reserved. 

§ 63.6(e)(1)(i) ..................................................................................................................... No .......................... See § 63.1543(i) and 

§ 63.1544(b) for general duty 

requirement. 

§ 63.6(e)(1)(ii) .................................................................................................................... No. 

§ 63.6(e)(1)(iii) ................................................................................................................... Yes. 

§ 63.6(e)(2) ........................................................................................................................ No .......................... Section reserved. 

§ 63.6(e)(3) ........................................................................................................................ No. 

§ 63.6(f)(1) ......................................................................................................................... No. 

§ 63.6(g) ............................................................................................................................. Yes. 

§ 63.6(h) ............................................................................................................................. No .......................... No opacity limits in rule. 

§ 63.6(i) .............................................................................................................................. Yes. 

§ 63.6(j) .............................................................................................................................. Yes. 

§ 63.7(a)–(d) ...................................................................................................................... Yes. 

§ 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. 


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Federal Register / Vol. 76, No. 33 / Thursday, February 17, 2011 / Proposed Rules 9447 

TABLE 1 TO SUBPART TTT OF PART 63—GENERAL PROVISIONS APPLICABILITY TO SUBPART TTT—Continued 

Reference Applies to subpart 

TTT Explanation 

§ 63.10(d)(5) ...................................................................................................................... No .......................... See § 63.1549(e)(9) for reporting 

of malfunctions. 

§ 63.10(e)–((f) .................................................................................................................... Yes. 

§ 63.11 ............................................................................................................................... No .......................... Flares will not be used to comply 

with the emission limits. 

§ 63.12 through 63.15 ....................................................................................................... Yes.

[FR Doc. 2011–2866 Filed 2–16–11; 8:45 am] 

BILLING CODE 6560–50–P 


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