### E.O. 12866 Review 2060-AQ-42 email 012411 w4 att.txt From: Nizich.Sharon@epamail.epa.gov Sent: Monday, January 24, 2011 11:58 AM To: cortney_higgins@omb.eop.gov Cc: Fruh.Steve@epamail.epa.gov; Guinnup.Dave@epamail.epa.gov; Stewart.Michael@epamail.epa.gov; Talcott.Fred@epamail.epa.gov; tierney.jan@epamail.epa.gov; Hanzel, Veronica; Laney, Michael N.; French.Chuck@epamail.epa.gov; Westlin.Peter@epamail.epa.gov; Boswell.Colin@epamail.epa.gov Subject: Part of E.O. 12866 Review: EPA Staff Response t OMB comments pertaining to Primary Lead RTR, RIN 2060-AQ42 Attachments: E.O. 12866 Primary Lead Smelting 2060-AQ42 Proposal 12172010_revised 012411_OMBResponseCLN_v2.doc; E.O. 12866 Primary Lead Smelting 2060- AQ42 Proposal 12172010_revised 012411_OMBResponseRDLN_v2.doc; DRAFT_Redline_PrimLead_RTR_Tech_Sup_Doc_revised_012411.doc; DRAFT_Clean_PrimLead_RTR_Tech_Sup_Doc_revised_012411.docHello CortneyPlease find below the redline and clean copies for the rule package and the Technical Support Document. Note that the clean version (of course much easier to read) still includes your comments with highlights showing how we responded to your comments. THANKS. (See attached file: E.O. 12866 Primary Lead Smelting 2060-AQ42 Proposal 12172010_revised 012411_OMBResponseCLN_v2.doc)(See attached file: E.O. 12866 Primary Lead Smelting 2060-AQ42 Proposal 12172010_revised 012411_OMBResponseRDLN_v2.doc) (See attached file: DRAFT_Redline_PrimLead_RTR_Tech_Sup_Doc_revised_012411.doc)(See attached file: DRAFT_Clean_PrimLead_RTR_Tech_Sup_Doc_revised_012411.doc)

Sharon V. Nizich Metals and Minerals Group Sector Policies and Programs Division OAQPS - US EPA RTP NC 27711 919/541-2825

Page 1*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** **E.O. 12866 Primary Lead Smelting 2060-AQ42 Proposal**

6560-50-P

**ENVIRONMENTAL PROTECTION AGENCY**

**40 CFR Part 63 [EPA-HQ-OAR-2004-0305; FRL- ]**  **RIN 2060–AQ42 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 an 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 2 of 187 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 **[INSERT DATE 45 DAYS FROM DATE OF PUBLICATION IN THE FEDERAL REGISTER].**  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 **[INSERT DATE 30 DAYS FROM DATE OF PUBLICATION IN THE FEDERAL REGISTER].**  Public Hearing . If anyone contacts EPA requesting to speak at a public hearing by **[INSERT DATE 10 DAYS FROM DATE OF PUBLICATION IN THE FEDERAL REGISTER]**  , a public hearing will be

held on **[INSERT DATE 15 DAYS FROM DATE OF PUBLICATION IN THE FEDERAL REGISTER]** 

. **ADDRESSES:** Submit your comments, identified by Docket ID Number EPA-HQ-OAR-2004-0305, by one of the following methods:

 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 3 of 187

 Fax: (202) 566-9744, Attention Docket ID Number EPA-HQOAR-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 17 th 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-HQOAR-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 www.regulations.gov ,*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 4 of 187 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 www.regulations.gov or e-mail. The www.regulations.gov website 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 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 contactinformation in the body of your comment and with any disk or CDROM 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

.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 5 of 187 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 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 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 10:00 a.m. on **[INSERT DATE 15 DAYS FROM DATE OF PUBLICATION IN THE FEDERAL REGISTER]**  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,*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 6 of 187 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 the NESHAP to a particular entity, contact the appropriate person listed in Table 1 to this preamble.

**TABLE 1--LIST OF EPA CONTACTS FOR THE NESHAP ADDRESSED IN THIS 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 1 EPA’s Office of Enforcement and Compliance Assurance. 2 EPA’s Office of Air Quality Planning and Standards.

**SUPPLEMENTARY INFORMATION** : **I. Preamble Acronyms and Abbreviations***** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 7 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 8 of 187 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?*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 9 of 187 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? 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?*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 10 of 187 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 the proposed action for the source categories listed. This standard, and any changes considered in this rulemaking, would be directly 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

1 USEPA. Documentation for Developing the Initial Source Category List – Final Report , USEPA/OAQPS, EPA-450/3-91-030, July, 1992. Comment [vah1]: OMB comment A1 – Unclear what this means. RESPONSE: It means other government entities are not impacted. See next sentence that follows this sentence.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 11 of 187 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 12 of 187 C. What should I consider as I prepare my comments for EPA? Submitting CBI . Do not submit information containing CBI to EPA through 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-OAR2004-0305. **III. Background***** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 13 of 187 A. What is the statutory authority for this action?Section 112 of the Clean Air Act (CAA) establishes a twostage 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 14 of 187 (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 best-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 best-performing 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 15 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 16 of 187 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 emissionsfrom a source in the category or subcategory to less than onein-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 technology-based 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

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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 17 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 18 of 187 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-in-1 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 19 of 187 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 acknowledge that maximum individual lifetime cancer risk “does not necessarily reflect the true*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 20 of 187risk, but displays a conservative risk level which is an upperbound 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 21 of 187 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?*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 22 of 187

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

3 Although 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 23 of 187 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 HAP-related 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.

4 EPA previously provided estimates of total facility risk in a residual risk proposal for coke oven batteries (69 FR 48338, August 9, 2004).*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 24 of 187 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 non-cancer 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 25 of 187 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 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-*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 26 of 187 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 27 of 187 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

5 EPA’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/4AB3966E263D943A8525771F006 68381/$File/EPA-SAB-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

.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 28 of 187 significantly greater associated uncertainties than for the source category or facility-wide estimates, 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 29 of 187 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 section 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 Comment [vah2]: OMB comment A3 – I t will until the changes are finalized, right, so includes is more accurate. Response - accepted*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 30 of 187 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 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 31 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 32 of 187 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-by-case 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 as 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 33 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 34 of 187 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 Comment [vah3]: OMB Comment A4 – We need to discuss this requirement, including the following aspects:

- The Agency’s response to comments received on other proposed rules this year that included it

- Whether the Agency is duplicating efforts that are provided through other EPA programs (e.g. CERCLA or EPCRA notifications)

- Response: EPA has included this same language in several other 112 packages and until there is a final agency decision to change some aspect of it, we don't think it is wise to have the language vary among different proposals*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 35 of 187 failure of air pollution control and monitoring equipment, process equipment, or a process to operate in a normal or usual manner....” The criteria also are designed to ensure that steps are taken to correct the malfunction, to minimize emissions in accordance with Section 63.1543(i) and 63.1544(e) and to prevent future malfunctions. For example, the source must prove by a preponderance of the evidence that “[r]epairs were made as expeditiously as possible when the applicable emission limitations were being exceeded...” and that “[a]ll possible steps were taken to minimize the impact of the excess emissions on ambient air quality, the environment and human health....” In any judicial or administrative proceeding, the Administrator may challenge the assertion of the affirmative defense and, if the respondent has not met its burden of proving all of the requirements in the affirmative defense, appropriate penalties may be assessed in accordance with Section 113 of the Clean Air Act (see also 40 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.

 Added replacement language that eliminates the reference to SSM exemptions applicable to performance tests in 63.1546.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 36 of 187

 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 37 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 38 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 39 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 40 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 41 of 187 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 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) Because there is only one primary lead processing facility Comment [vah4]: OMB comment A6 – Is EPA asking for comment on this issue? If not, suggest including a request for comment here. If so, where is that request for comment? Response: Comment is requested on all aspects of this action as stated in Section VII.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 42 of 187 in the US, 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 Section 63.1544 **,** those limits would also continue toapply to the facility. We also are proposing that the plantwide 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 Comment [vah5]: OMB comment A7 - This should be 63.1544, right? Response: Correct Comment [vah6]: OMB Comment A8 – General Comment: The boundary standard isn’t needed to control fugitive emissions from this source, and this section can be deleted. The existence of the NAAQS, with requirements to monitor sites of maximum ambient concentration, makes the boundary standard unnecessary. Response: lead concentration in air limit will not be specifically required at property boundary so as to allow compliance flexibility for the facility. Furthermore, is this within EPA’s statutory authority for setting standards under 112? Please point to what part of 112(d)(2)(A)-(E) authorizes an ambient monitoring program? Response: There is no provision that prohibits EPA from setting a concentration in air limit and related monitoring requirements that would be applicable to the facility.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 43 of 187 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. Comment [vah7]: OMB comment A9 – Suggested change for better readability. R esponse - a ccepted*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 44 of 187

 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 notice 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, Comment [vah8]: OMB comment A10 – I s this change happening throughout all EPA program offices? R esponse: Yes. This effort correlates with recent law signed to use “plain language”.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 45 of 187 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, non-point, and mobile sources in the 50 States, the District of Columbia, Puerto Rico, and the Virgin Islands. The EPA collects*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 46 of 187 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. 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 beemitted by the MACT standards is referred to as the “MACTallowable” emissions level. This represents the highest Comment [vah9]: OMB comment A11 – Was this an ICR that went through OMB approval under the PRA? Directed at one facility only? May be helpful to clarify. RESPONSE: This did not go through OMB review since it was less than 10 facilities.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 47 of 187 emissions level that could be emitted by the facility without violating the MACT standards.

We discussed the use of both MACT-allowable 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 MACT-allowable 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 MACT-allowable level, we developed a ratio of MACT-allowable to actual emissions for each source type*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 48 of 187 (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 a 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 MACTallowable emissions. The estimate of MACT-allowable 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

.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 49 of 187 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 estimatethe concentrations of HAP in ambient air, (2) estimating longterm 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 theUnited States and Puerto Rico. However, in this instance, sitespecific meteorological data for the one facility in this source category were supplied by the state of Missouri and used for the

6 U.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).*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 50 of 187 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

7 A census block is generally the smallest geographic area for which census statistics are tabulated.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 51 of 187 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 dose response values have been developed in a manner consistent with EPA guidelines and have undergone a peer review process similar to that used by 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 52 of 187 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,

8 These 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/214C6E915BB04E14852570CA007 A682C/$File/ecadv02001.pdf.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 53 of 187 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, short-term 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 dose-response values available. As discussed Comment [vah10]: OMB comment A12 – Suggested change to be more accurate. R esponse - a ccepted*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 54 of 187 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 heavily-industrialized 4-county area (Harris,*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 55 of 187 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 99 th 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 site-specific 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

9 See http://www.tceq.state.tx.us/compliance/field_ops/eer/index.html or docket to access the source of these data. Comment [vah11]: OMB comment A13 – Is it appropriate to mention this given the data you have from this facility? Suggest deleting. Response: Since we always use the factor of 10 first for screening, this is appropriate.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 56 of 187 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 bio-accumulative 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, hexachlorocyclohexane, lead compounds, mercury compounds, methoxychlor, polychlorinated biphenyls, POM, toxaphene, and trifluralin. Emissions of two PB Comment [vah12]: OMB comment A14 – Unclear what is meant by the multiplier approach? Do you mean you used the 10x factor? R esponse: See changes*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 57 of 187 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 noninhalation 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 5 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 Comment [vah13]: OMB comment A15 – Suggested change for clarity. Response: accepted*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 58 of 187 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, and since there are no quantitative dose-response metrics in EPA’s IRIS for lead and its compounds, 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 of0.15 μg/m 3 based on a rolling 3-month period with a not-to-be-exceeded form, and which will require attainment by 2016. 73 FR 66964. We consider values below the level of the primary NAAQS to have a low potential for significant multi-pathway risks because the primary NAAQS is set as to protect public health with an adequate margin of safety. However, ambient air lead concentrations above the NAAQS, regardless of whether these concentrations occur at a populated census block, are considered to pose the potential for increased risk to public health because the primary NAAQS for lead 1) is a standard that applies anywhere in the ambient air; 2) was established to account for the air-related multi-pathway impacts of lead sources, which due Comment [vah14]: OMB comment A16 – Would be helpful to have some discussion about why an approach comparing to NAAQS is better than a scenario using the RfD. We note that the RfD has not been withdrawn and such values have been used for other multipathway exposure analyses. What is missing or different here that made EPA unable to run a comparison with this value? Response: No RfD for lead. Inserted text in uncertainties section addressing this.

Comment [vah15]: OMB comment A17 - Please revise. This implies that any NAAQS exceedance ‘imposes significant health risk’. Just as this is not true for an RfD, this is not correct for the NAAQS. Please find other pre-existing language to use here and throughout the risk assessment to describe what an NAAQS exceedance may imply. Response: see changes*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 59 of 187 to the multi-media transport of lead after it is deposited from the atmosphere, may be experienced by individuals in areas distal to the original site of the deposition; and 3) 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 also consider this type of 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. We further note that comparing ambient lead concentrations to the NAAQS for lead 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 Comment [vah16]: OMB comment A18 – There are no studies linking air lead levels above 0.15 to IQ. Response: See changes.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 60 of 187 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. 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 61 of 187 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 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 62 of 187 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 ®

10 Risk and Technology Review – Analysis of Socio-Economic Factors for Populations Living Near Primary Lead Smelting Operations

. Comment [vah17]: OMB comment A20 - So a HI analysis was done using a NAAQS value? Unclear if this is appropriate considering what the NAAQS represents. Response: See changes

Comment [vah18]: OMB comment A21 – Suggestions made for clarity Response: See changes*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 63 of 187 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; Comment [vah19]: OMB comment A22 - This text is from the previous RTR proposed rule (shipbuilding, wood furniture mfg, etc). Why the change for this rule? Response: changes accepted*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 64 of 187 • 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.

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 Comment [vah20]: OMB comment A23 - Given the developmental effects of lead exposure, what do we know about this demographic group? Response: See discussion in Section V.B.4 below.

Comment [vah21]: OMB comment A24 - Please include clear discussion of major uncertainties associate with the NAAQS evaluation— please use language verbatim from the NAAQS. It is very important to be transparent about uncertainties and assumptions associated w/ the NAAQS derivation. R esponse: See below*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 65 of 187 exists, we believe the approach that we took, which used conservative tools and assumptions, ensures that our decisions are health-protective. 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 (referenced earlier) 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 66 of 187 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. 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 67 of 187 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 under-predict 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

11 Short-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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 68 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 69 of 187 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 co-occurrence of peak emissions and worst-case 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

12 U.S. EPA. National-Scale Air Toxics Assessment for 1996. (EPA 453/R–01–003; January 2001; page 85.)*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 70 of 187 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 dose-response 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

13 IRIS glossary (http://www.epa.gov/NCEA/iris/help_gloss.htm ). 14 An 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 71 of 187 adequate health-protection, 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 representchronic exposure levels that are intended to be healthprotective 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 of 10 or 3, used in

15 According 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 72 of 187 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)

default option as “the option chosen on the basis of risk assessment policy that 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 73 of 187 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 effect-specific 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 for lead compounds. Thus, to address multipathway human health and*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 74 of 187 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 (73FR66979). 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 (73FR66974), as well as uncertainties between blood lead levels and loss of IQ points in children (73FR66981). In considering the evidence and risk analyses and their associated uncertainties, the EPA Administrator noted his view that there is no evidence- or 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 (73FR66998). In so doing, the Administrator decided that, a*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 75 of 187 level for the primary lead standard of 0.15 μ g/m 3 , 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 (73FR67006). 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 healthbased (i.e., primary) NAAQS are likely less than the uncertainties associated with dose-response values developed for many of the other HAP. While the dose-response values for many HAP rely solely on extrapolation of data from animal toxicological studies, the development of the lead NAAQS considered results from numerous human epidemiological studies. Although epidemiologic studies have their associated uncertainties (e.g., the extent to which factors other than ambient lead concentrations could be influencing blood lead concentrations), we believe that it is likely that the magnitude of these uncertainties is relatively less than extrapolating response values from animals to humans. 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 Comment [vah22]: OMB comment A26 - Please bring language forward here and include discussion of uncertainty of using a NAAQS value here instead of an RfC/RfD—which are clearly derived for what some could say is a more relevant purpose than the NAAQS. Response: See discussion above.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 76 of 187 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 multi-pathway exposures from industrial sources like primary and secondary lead smelting operations. It also considered background lead exposures from other sources (like contaminated Comment [vah23]: OMB comment A 29 - What was policy relevant exposures for the NAAQS may be quite different from what is policy relevant here. This aspect of the NAAQS derivation, and appropriateness here should be discussed in detail Response: See changes*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 77 of 187 drinking water and exposure to lead-based paints). In revising the NAAQS for lead, we note that the Administrator placed more weight on the health evidence 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 health evidence (73FR67004). Thus, when revising the NAAQS for lead to protect public health with an adequate margin of safety, EPA considered both the health evidence and the risk assessment, albeit to different extents. 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 short-term 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. Comment [vah24]: OMB comment A30 – This seems out of place. Likely belongs earlier in the text. Response: See changes*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 78 of 187 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 thefinal rulemaking if, as a result of these reviews, a doseresponse 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 site-specific 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

. Comment [vah25]: OMB comment 31 – Perhaps uncertainties w/ the NAAQS value should be discussed here. Response: See discussion above.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 79 of 187 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 80 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 81 of 187 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-by-source basis. The RBLC contains over 5,000 air pollution control permit*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 82 of 187 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 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

16 As provided above in section III (C)(3), we are proposing to change the standard to apply to a Primary Lead Processors Comment [vah26]: OMB comment A 33 - This Section A does not seem to belong in a section titled “Analyses Results and Proposed Decisions.” Suggest moving these to the previous section, “Analyses Performed” to a section C. titled “Overview of the source category and MACT standards.” Response: See response to comment A32 a b o ve*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 83 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 84 of 187 emissions, 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 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, Comment [vah27]: OMB comment A34 – Clarifying lead compounds are HAP. Response - accepted*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 85 of 187 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 perton of lead produced (1 lb/ton). 40 CFR 63.1542(a). A plantwide 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 86 of 187 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 plant-wide 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,*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 87 of 187 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 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 Comment [vah28]: OMB comment A35 – How do we know this? Response: 2005 NEI dataset included VOC HAP from boiler combustion which were found to be negligible. The revised technology review memo discusses consideration of these emissions under the technology review Further, we performed a worst-case risk screening of these emissions and determined that they posed less than 0.0002in a million cancer risk. The technical support document in the docket discusses these emissions and their removal from the risk analysis dataset.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 88 of 187 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 μ g/m 3 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 μ g/m 3 to 0.15

μ g/m 3 . 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

17 EPA 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. Comment [vah29]: OMB comment A36 – Do we know when/if this will be approved? RESPONSE: FR for final approval is progressing toward publication, Region 7 is reviewing it currently; it has already been reviewed and approved by R7 Counsel.

Comment [vah30]: OMB comment A37 – Please make changes if this addition is not correct. Response: accepted*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 89 of 187 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

18 EPA 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. Comment [vah31]: OMB comment A38 - Seems like these steps seem to negate the need to take action under residual risk. Response: Note that these steps were implemented and are reflected in 2008 data, however, the risk analysis indicates remaining risk.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 90 of 187 installation of pleated filters and lowering the air-to-cloth 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 Comment [vah32]: OMB comment A39 – Has Doe Run made these changes? Response: Yes these changes are reflected in the reported 2008 emission levels.

Comment [vah33]: OMB commentA40 - Need a section on the monitoring requirements through the NAAQS program. How many monitors in the direct vicinity of the smelter are in place, and how many are required? Mention that the design value which will determine attainment status is based on the highest reading monitor, and that monitors that read within x% of the NAAQS cannot be discontinued. Etc. Response: We should discuss. These monitoring requirements are for the State and not the facility. This section describes SIP requirements for the facility.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 91 of 187 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. The state also requires an annual emissions inventory based on thestack tests for the point discharges and AP-42 or facilityspecific emission factors for fugitive emissions. As a result of the implementation of the emission control requirements in the currently approved 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 92 of 187 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 US 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 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 Comment [vah34]: OMB comment A41 - Might be useful to have discussion about why these actions are not sufficient and further action under the MACT is required. Response: This section only presents other requirements affecting Doe Run. Our discussion of how those are considered under this action are discussed below in Section V.C.1.

Comment [vah35]: OMB comment A42 – What does this mean? SVN r e sponse: This is a negotiated health-based level which has not been set yet: I believe thru the consent decree, negotiation will occur after remediation is completed. Also I believe this remediation covers more than just Clean Air Act Violations. See pages 94-95 of the consent decree. Comment [vah36]: OMB commen t A43 and A44 – Under the consent decree, is lead monitoring required during the site remediation period? R esponse: The consent decree indicates that this is a remediation similar to a RCRA corrective action which typically requires air monitoring during remediation activity. What level of monitoring will be stipulated in the remedial action plan TBD. See pages 94-95 of the consent decree. When will it be finalized? Response; We don’t know, per Region 7: It's very possible it could be held up for a while, as a private party has filed a motion to intervene with the court. Depending on whether (and to what extent) the court allows discovery on the CD, it could take some time. We are currently awaiting the judge's decision on the private party's motion and our responses.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 93 of 187 sulfide ore, potentially on the same property as the current smelter. 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 Comment [vah37]: OMB comment A 32 - See next comment regarding placement of section A. We also suggest moving section B to the previous section, or renaming this section to appropriately characterize what is included in the section. Response: We moved the section. Note the opening paragraph does not include mention that this section (currently) includes the modeling input data descriptions. Response: addressed, see changes.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 94 of 187 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. 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 95 of 187 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 recently-promulgated 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 Comment [vah38]: OMB comment A45 - Suggest that this section include a robust discussion of the modeling results compared to the measured concentration data at nearby monitors. Response: See below.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 96 of 187 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 Offsite refinedAcute Noncancer HQ 3 Actual Emissions

Level Allowable Emissions

Level Actual Emissions

Level Allowable Emissions

Level 30 30 4,900 0.0008 1 1 0.6 1 Estimated 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. 3 The maximum estimated acute exposure concentration was divided by available short-term dose-response values to develop an array of HQ values. HQ values shown use the lowest available acute dose-response value, which is the REL. See section IV.A of this preamble for explanation of acute dose-response values.

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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 97 of 187 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-in-1 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 themeteorological conditions associated with the worst-case shortterm 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. Comment [vah39]: OMB comment A 46 - Seems odd to even have discussion of 10x as the starting point if there are actual data associated with the facility. Response: We always us the 10X factor first, so it is appropriate.

Comment [vah40]: OMB comment A47 – change made for clarity. Response: accepted.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 98 of 187 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 multi-pathway 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 year. 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 section 63.1544. Since then, pursuant to requirements that the 2002 State SIP adopted for purposes of meeting the lead NAAQS, Doe Run enclosed the refining and Comment [vah41]: OMB comment A48 – So this means there was no risk?? Can we say this more clearly? Response: Note changes

Comment [vah42]: OMB comment A49 – Which one? Please clarify the year of the SIP that required this. Response – 2002 SIP, see changes*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 99 of 187 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 Comment [vah43]: OMB comment A50 – Can we specify which stack, or clarify that this is the “refinery stack” if that’s the case. Response: See changes.

Comment [vah44]: OMB comment A 51 – Can you provide this information in parentheses? Response: See changes. Is this the information you mean?

Comment [vah45]: OMB comment A 52 – Is this an appropriate metric? Response: note change*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 100 of 187 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. **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) MaximumImpactActual Emissions Allowable Emissions 1 (TPY) Maximum ImpactAllowable 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

1 Allowable 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. Comment [vah46]: OMB comment A53 – How were these emissions input into the air model? Response: this was discussed on the conference call 1/19. Please note if further explanation is requested. Comment [vah47]: OMB comment A54 – What is the location of this maximum concentration? Response: see note*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 101 of 187 3 Fugitive 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 south east boundary of the facility (see Figure 3.1-1 of the risk assessment document). 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 102 of 187 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 4.6- and 3-fold respectively. With respect to the South Cross and Church Street monitors, AERMOD overestimates 3-month maximum lead concentrations by approximately 2.8- and 4.2-fold, respectively. Moreover, results also indicate that the maximum 3-month average lead concentration calculated from any of these monitors is approximately equal to the maximum 3-month average lead concentration estimated by AERMOD at any 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 μgs/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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 103 of 187 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 (μgs/m 3 ) Maximum Monitored 3-

Month Lead Concentration 19 (μgs/m 3 ) Model to Monitor Ratio 20

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

19 Maximum 3-month monitored concentrations were calculated for the year 2008 based on data submitted to EPA’s Air Quality System (AQS). 20 Negative sign denotes an underestimation of AERMOD modeled ambient lead concentrations, relative to monitored concentrations. AERMOD estimated concentrations were based on 2008 emissions estimates. Comment [vah48]: OMB comment A55 – Could you please use the Table format from the most recent RTR proposal (shipbuilding, Wood Furniture MFG, etc)? It was easier to follow. I’ve pasted in the empty table. Response: see changes*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 104 of 187 **Race by percent** White 75 96 96 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, which is well below the national percentage. 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 105 of 187 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 a significant potential for any environmental justice issues. 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 Comment [vah49]: OMB comment A56 – What are EPA”s criteria for “significant potential for environmental justice”? Response: There are no bright line criteria – we could ask for comment on this interpretation, but it’s really not necessary since everything in this proposal is subject to comment.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 106 of 187 Primary Lead Smelting source category, the risk analysis indicates that the cancer risks to the individual most exposedcould be as high as 30-in-1 million due to actual or MACTallowable emissions. These risks are considerably less than 100-in-1 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 Comment [vah50]: OMB comment A57 - What is meant by significant?? This is not clear. Is over 1000 people the significance threshold? Response: see changes*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 107 of 187 estimated that modeled off-site 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 (73FR67007)”, 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 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. 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 Comment [vah51]: OMB comment A58 - It might be helpful to understand (with this explanation provided earlier) how the fugitive emissions were translated/modeled into an ambient concentration. Response: This was explained in conference call 1/19; however, is it necessary to explain that process here? Response: See changes

Comment [vah52]: OMB comment A60 - Is this a quote from the Lead NAAQS? Perhaps it would be better to use a quote.

Comment [vah53]: OMB comment A61 - This would be the place to defer to the Lead NAAQS program, and point out that a regulatory program is in place to address this. Comment [vah54]: OMB deleted this section Comment [vah55]: OMB inserted “considered approaches to control” which we did not consider appropriate here and did not accept the change. Comment [vah56]: OMB comment A 62 – Which of these sources drive the exceedance of the NAAQS? Comment [vah57]: This change by OMB is consistent with removal of the property boundary ambient limit.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 108 of 187 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 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/m 3

. 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 Comment [vah58]: OMB comment A63 - The information supporting this statement should be in the docket for the public to review.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 109 of 187 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/m3. Thus, our evaluation of risks based on actual emissions already considered emissions with these controls largely in place. In order to substantially reduce fugitive dust emissions to a level that would ensure that the risk is not unacceptable, we believe that a complete remediation of the primary lead smelter site including roadways, storage piles and other exposed surfaces is necessary. Such measures are necessary to prevent suspension and re-suspension of lead dust that make up fugitive dust emissions. 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 lead concentration in air limit of 0.15 μg/m 3 to be measured at locations approved by the Administrator. Comment [vah59]: OMB comment A64 - So Doe Run is already in compliance with 2007 SIP requirements? Would be good to mention that earlier. Response: The control measure required by the 2007 SIP revisions have been implemented, which is stated here , however, it would not be appropriate to state full compliance with SIP because there are other requirements of the SIP that involve other aspects besides the emissions control measures. We have added reference to the implementation of these controls in section IV.C. Comment [vah60]: OMB comment A65 - Again, it would help to understand what is driving the exceedance caused by the fugitive emissions. Response: Road dust, slag piles and material handling cause a cumulative effect and there is no specific driver. Refer to Section IV.C. for a discussion of sources contributing fugitive dust emissions. Comment [vah61]: OMB comment A66 – This effort is required under the consent decree, right? If so, please mention that here. R esponse: See footnote for this paragraph. Comment [vah62]: OMB made changes here that change the meaning of the section. Their change makes the section read that Missouri DNR and EPA will need to develop a plan to attain the NAAQS standard that could involve complete remediation of the primary lead smelter site... This is not what the section is saying. It would be the facility’s responsibility to make emissions reductions to meet risk acceptability. Comment [vah63]: OMB made changes here changing that we are proposing the limit to that we will defer to the existing NAAQS program that has established a limit.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 110 of 187 This lead concentration in air limit would be established as the enforceable requirement to address fugitive emissions under the

MACT standard. 21 Because we are proposing an 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

21 Under 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. Comment [vah64]: O MB added a section here that “EPA has determined that implementation of the NAAQS through the development and execution of a SIP will provide the greatest protection from fugitive dust emissions at this source.” Comment [vah65]: OMB comment A67 - Since this is being proposed under 112(f)(2)(A), where has the Agency provided a discussion of cost, energy, safety, or other relevant factors? Response: This is being proposed under 112(f) with reference to acceptability of risk only. Under risk acceptability, we do not consider costs, etc. Comment [vah66]: OMB comment A68 - Need to expand on why this is a very unique circumstance in which reducing risk to acceptable levels for fugitive emissions will be achieved through the NAAQS. -the indicator (Pb in PM10 or TSP) is the preferred indicator under 112 as well as the NAAQS -fugitive dust that could lead to exceedances of a monitored level could come from onsite and offsite dust, and only the SIP will provide the regulatory authority to address both.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 111 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 112 of 187 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 113 of 187 In summary, our analysis indicates that in order to ensure that lead emissions from this source do not pose an unacceptable risk, emissions from 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 ug/m3 for any 3-month period at all of the modeled locations. Further, we conclude that in order to achieve the 0.15 ug/m3 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/m 3 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. Comment [vah67]: O MB made changes to this bullet to read “Furthermore, the attaining the existing ambient lead concentration limit of 0.15 μg/m 3 at the property boundary as required through implementation of the NAAQS will ensure that fugitive dust emission levels will not exceed safe levels.”*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 114 of 187 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 the 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 Comment [vah68]: OMB comment A69 – Please clarify this language; difficult to understand. Response: see changes

Comment [vah69]: O MB made changes to this section to basically say that the NAAQS requires a monitoring plan ....and that provisions to reduce monitoring is included in the NAAQS.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 115 of 187 monitoring below 50 percent of the air lead concentration limit is achieved. 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 the 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 though quarterly stack testing until Comment [vah70]: OMB comment A70 - This is redundant with the NAAQS requirements and can be moved to section 5.A.3*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 116 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 117 of 187 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 in 1-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 Comment [vah71]: OMB comment A71 – What is the cancer risk before these standards are in place?? Response: 30 in a million – see table 3, Section V. B.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 118 of 187 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 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 119 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 120 of 187 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. Emissionsdata from earlier years would not reflect all of the emissionreducing 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 121 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 122 of 187 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 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 technology-based emissions from the main stack in order to establish a plant-wide emission limit. Because the*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 123 of 187 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 arerequesting comment on the appropriateness of applying the plantwide 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 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 124 of 187 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. 22 In determining the contribution to a plant-wide emission

22 Run-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 at 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 themaintenance cycle in which a fabric filter is tested). Test-totest variability can be termed long-term variability. 72 FR at 54878.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 125 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 126 of 187 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 source’s past performance. This formula uses a pooled variance (in the s 2 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 short-term 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:*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 127 of 187 x  ̄ = 2008 annual emissions n = the number of test runs m = the number of test runs in the compliance average s 2 = 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) x TINV(2 x probability, n-1 degrees of freedom) X 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 128 of 187 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. **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 section 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 Comment [vah72]: OMB deleted this text.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 129 of 187 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 Comment [vah73]: OMB deleted this text*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 130 of 187 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 131 of 187 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 ofInitial Source Category List – Final Report”, USEPA/OAQPS, EPA450/3-91-030, July, 1992. In support of this applicability*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 132 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 133 of 187 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 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***** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 134 of 187 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 the 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 135 of 187 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 D**  **efinition** 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)*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 136 of 187 **Data Element D**  **efinition** 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 (ft 3 /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 (T P Y) REVISED SCC Code Enter revised SCC Code here*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 137 of 187 **Data Element D**  **efinition** 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) 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 138 of 187 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 2424.01.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 139 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 140 of 187 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 [Insert date of publication in the Federal Register.] , a comment to OMB is best assured of having its full effect if OMB receives it by [Insert date 30 days after publication in the Federal Register.] . The final rule will respond to any OMB or public comments on the information*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 141 of 187 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-for-profit enterprise which is independently owned and operated and is not dominant in its field. This proposed rule is currently applicable to one operating facility that does not meet the definition of a small entity. 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 142 of 187 entities. 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.

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,*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 143 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 144 of 187 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 protect public health with an adequate margin of safety from adverse health effects, most notably including the loss of IQ points in children. 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 145 of 187 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 Number 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 146 of 187 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 HAP-related 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 147 of 187 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 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, our analyses show that although there is the potential

for adverse environmental and human health effects from emissions of lead, there are no disparate impacts on environmental justice populations (see section V.B.1). Notably however, the proposed rule would require additional control*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 148 of 187 measures to address the identified environmental and health risks and would therefore, decrease risks to any populations exposed to these sources.

Comment [vah74]: OMB comment A72 - What exactly does this mean? Can specific numbers be provided? What would define an ‘appreciable disparity’? Note their copy does not have the most recent revisions for this section. Response: see changes*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** National Emission Standards for Hazardous Air Pollutant Emissions: Primary Lead Smelting Page 149 of 187

**List of Subjects in 40 CFR Part 63** Environmental protection, Air pollution control, Reporting and recordkeeping requirements, Lead.

____________________________ Dated:

____________________________ Lisa P. Jackson, Administrator.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 150 of 187 For reasons set out in the preamble, title 40, chapter I, of the Code of Federal Regulations is amended as

follows: **PART 63--[AMENDED]** 1. The authority citation for part 63 continues to read as

follows: Authority: 42 U.S.C. 7401 et seq . 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 151 of 187 (b) Table 1 of this subpart specifies the provisions of subpart A of this part that apply and those that do not apply to owners and operators of primary lead processors. 3. Section 63.1542 is amended by adding a definition for “Affirmative defense,” “Lead refiner,” “Lead remelter,” “Primary lead processor, and “Secondary lead smelter;” ”deleting the definition of “Primary lead smelter;” and revising the definitions of ”Fugitive dust source,” “Furnace area,” “Malfunction,” “Materials storage and handling area,” “Plant roadway,” “Process fugitive source,” “Refining and casting area,” Sinter machine area,” and “Tapping location” to read as

follows: § **63.1542 Definitions.**

* * * * *

Affirmative defense means, in the context of an enforcement proceeding, a response or defense put forward by a defendant, regarding which the defendant has the burden of proof, and the merits of which are independently and objectively evaluated in a judicial or administrative proceeding.

* * * * * Fugitive dust source means a stationary source of hazardous air pollutant emissions at a primary lead processor resulting from the handling, storage, transfer, or other management of*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 152 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 153 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 154 of 187 processor in which drossing or refining operations occur, or casting operations occur. Secondary lead smelter means any facility at which leadbearing scrap material, primarily, but not limited to, lead-acid 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 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 155 of 187 (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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 156 of 187 (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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 157 of 187 (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/m 3 on a 3-month*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 158 of 187 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 [INSERT DATE TWO YEARS FROM THE DATE OF PUBLICATION OF THESE AMENDMENTS IN THE FEDERAL REGISTER]. (b) Each owner or operator of a new primary lead processor must achieve compliance with the requirements of this subpart no later than [INSERT DATE 60 DAYS AFTER PUBLICATION OF THESE AMENDMENTS IN THE FERERAL REGISTER] or startup, whichever is

later.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 159 of 187

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 appendix A of part 60 of this chapter: (i) Method 1 must be used to select the sampling port location and the number of traverse points. (ii) Method 2, 2F, 2G must be used to measure volumetric

flow rate. (iii) Method 3, 3A, 3B must be used for gas analysis. (iv) Method 4 must be used to determine moisture content of the stack gas. (v) Method 12 or Method 29 must be used to determine lead emissions rate of the stack gas. (2) A performance test shall consist of at least three runs. For each test run with Method 12 or Method 29, the minimum sample time must be 60 minutes and the minimum volume must be 1 dry standard cubic meter (35 dry standard cubic feet).*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 160 of 187 (3) Performance tests shall be completed quarterly, once every 3 months, to determine compliance. (4) The lead emission rate in pounds per quarter is calculated by multiplying the quarterly lead emission rate in pounds per hour by the quarterly plant operating time, in hours as shown in Equation 1: (Eq. 1)

Where:

E Pb = quarterly lead emissions, pounds per quarter;

ER Pb = quarterly lead emissions rate, pounds per hour; and QPOT = quarterly plant operating time, hours per quarter. (5) The lead production rate, in units of tons per quarter, must be determined based on production data for the previous quarter according to the procedures detailed in paragraphs (a)(3)(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)(3)(i) through*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 161 of 187 (a)(3)(iii) of this section. (6) To determine compliance with the production-based leadcompound emission rate in §63.1543(a), the quarterly productionbased lead compound emission rate, in units of pounds of lead emissions per ton of lead produced, is calculated as shown in Equation 2 by dividing lead emissions by lead production.

(Eq. 2)

Where :

CE Pb = quarterly production-based lead compound emission rate, in units of pounds of lead emissions per ton of lead produced;

E Pb = quarterly lead emissions, pounds per quarter; and

P Pb = quarterly lead production, tons per quarter. (7) To determine 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 Sec. 63.1543(d) at each doorway opening in*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 162 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 163 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 164 of 187 and shaker-type baghouses to ensure that bags are not kinked (kneed or bent) or laying on their sides. Such checks are not required for shaker-type baghouses using self-tensioning (spring loaded) devices. (6) Quarterly confirmation of the physical integrity of the baghouse through visual inspection of the baghouse interior for

air leaks. (7) Quarterly inspection of fans for wear, material buildup, and corrosion through visual inspection, vibration detectors, or equivalent means. (8) Except as provided in paragraph (h) of this section, continuous operation of a bag leak detection system. (d) The procedures specified in the standard operating procedures manual for maintenance must, at a minimum, include a preventative maintenance schedule that is consistent with the baghouse manufacturer's instructions for routine and long-term

maintenance. (e) The bag leak detection system required by paragraph (c)(9) 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 165 of 187 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 166 of 187 (6) Following initial adjustment, the owner or operator must not adjust the sensitivity or range, averaging period, alarm set points, or alarm delay time, except as detailed in the approved SOP required under paragraph (a) of this section. In no event shall the sensitivity be increased by more than 100 percent or decreased more than 50 percent over a 365-day period unless a responsible official certifies that the baghouse has been inspected and found to be in good operating condition. (7) For negative pressure, induced air baghouses, and positive pressure baghouses that are discharged to the atmosphere through a stack, the bag leak detector must be installed downstream of the baghouse and upstream of any wet acid gas scrubber. (8) Where multiple detectors are required, the system's instrumentation and alarm may be shared among detectors. (f) The standard operating procedures manual required by paragraph (a) of this section must include a corrective action plan that specifies the procedures to be followed in the event of a bag leak detection system alarm. The corrective action plan must include at a minimum, procedures to be used to determine the cause of an alarm, as well as actions to be taken to minimize emissions, which may include, but are not limited to, the following.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 167 of 187 (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 Sec. 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 168 of 187 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 Sec. 63.1543 are exempt from the requirement in paragraph (c)(9) 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 169 of 187 (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 Sec. 63.1543(d) in accordance with either paragraph (i)(1), (i)(2), or (i)(3) of this section. (1) Owners and operators must check and record on a daily basis doorway in-draft at each doorway in accordance with the methodology specified in Sec. 63.1546(b). (2) Owners and operators must establish and maintainbaseline ventilation parameters which result in a positive indraft according to paragraphs (i)(2)(i) through (i)(2)(iv) of

this section. (i) Owners and operators must install, calibrate, maintain, and operate a monitoring device that continuously records the volumetric flow rate through each separately ducted hood; or install, calibrate, maintain, and operate a monitoring device that continuously records the volumetric flow rate at the 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 170 of 187 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 buildingin-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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 171 of 187

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. (2) If a CEMS used to measure lead emissions is applicable, the owner or operator must install a CERMS with a sensor in a location that provides representative measurement of the exhaust gas flow rate at the sampling location of the CEMS used to measure lead emissions, taking into account the manufacturer’s*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 172 of 187 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 173 of 187 (3) Each owner or operator must calculate the lead emissions rate in tons per year by summing all hours of CEMS data for a year to determine compliance with 63.1543 (b). (i) When the CERMS are unable to provide quality assured data the following applies: (A) When data are not available for periods of up to 48 hours, the highest recorded hourly emission rate from the previous 24 hours must be used. (B) When data are not available for 48 or more hours, the maximum daily emission rate based on the previous 30 days must

be used. (k) The owner or operator of each source subject to §63.1544(a) must operate a continuous monitoring system for the measurement of lead compound concentrations in air. (1) The owner or operator must operate compliance monitors sufficient in number, location, and frequency of sample collection to detect expected maximum concentrations of lead compounds in air due to emissions from the affected source(s) in accordance with a written plan as described in (k)(2) of this paragraph and approved by the Administrator. The plan must include descriptions of the sampling and analytical methods

used. (2) The owner or operator must submit a written plan*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 174 of 187 describing and explaining the basis for the design and adequacy of the compliance monitoring network, the sampling, analytical, and quality assurance procedures, and any 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 concentration of lead in air measured by the compliance monitoring system are less than [50 percent] of the lead concentration in air limit in §63.1544(a) for three consecutive years, the owner or operator may submit a revised plan to reduce the monitoring sampling and analysis frequency (e.g., from daily to weekly). For any subsequent period, if any rolling three-month average lead concentration in air measured at any monitor in the monitoring system exceeds [50 percent] of the concentration limit in §63.1544(a), the owner or operator must resume monitoring pursuant to paragraph (k)(1) at all monitors until another three consecutive years of lead concentration in air measurements less than [50 percent] of the lead concentration in*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 175 of 187

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 Sec. 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 Sec. 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 Sec. 63.1547(k)(2) to the Administrator or delegated authority along with a notification that the primary lead processor is*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 176 of 187 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 Sec. 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 177 of 187 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 Sec. 63.1547(a). (6) If an owner or operator chooses to demonstrate continuous compliance with the sinter building in-draft requirement under Sec. 63.1543(d) by employing the method allowed in Sec. 63.1547(i)(1), the records of the daily doorway in-draft checks, an identification of the periods when there was not a positive in-draft, and an explanation of the corrective

actions taken. (7) If an owner or operator chooses to demonstrate continuous compliance with the sinter building in-draft requirement under Sec. 63.1543(d) by employing the method allowed in Sec. 63.1547(i)(2), the records of the output from the continuous volumetric flow monitor(s), an identification of the periods when the 15-minute volumetric flow rate dropped below the minimum established during the most recent in-draft*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 178 of 187 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 Sec. 63.1543(d) by employing the method allowed in Sec. 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 179 of 187 comply with the reporting requirements of Sec. 63.10 of subpart A, General Provisions as specified in Table 1 of this subpart. (e) In addition to the information required under Sec. 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 Sec. 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 Sec. 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 180 of 187 requirement under §63.1543(d) by employing the method allowed in §63.1547(i)(2), the reports must contain an identification of the periods when the 15-minute volumetric flow rate(s) dropped below the minimum established during the most recent in-draft 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)*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 181 of 187

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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 182 of 187 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 183 of 187 applicable emission limitations were being exceeded. Off-shift and overtime labor were used, to the extent practicable to make these repairs; and (3) The frequency, amount and duration of the excess emissions (including any bypass) were minimized to the maximum extent practicable during periods of such emissions; and (4) If the excess emissions resulted from a bypass of control equipment or a process, then the bypass was unavoidable to prevent loss of life, 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 184 of 187 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 (d)(1) of this section. 12. Table 1 to Subpart TTT of Part 63 is revised to read as

follows: Table 1 of Subpart TTT – General Provisions Applicability to Subpart TTT

**Reference Applies**  **to s**  **ubpart Comment***** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 185 of 187

**T TT**  * * * * * * * 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) N o 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 N o opacity limits i n 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) N o 63.8(c)(2)-(d)(2) Yes 63.8(d)(3) Yes, except*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 186 of 187

f or 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) Y es 63.10(d)(5) No S ee 63.1549(e)(9) for reporting of malfunctions. 63.10(e)-((f) Yes * * * * * * **** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 187 of 187*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** **E.O. 12866 Primary Lead Smelting 2060-AQ42 Proposal**

6560-50-P

**ENVIRONMENTAL PROTECTION AGENCY**

**40 CFR Part 63 [EPA-HQ-OAR-2004-0305; FRL- ]**  **RIN 2060–AQ42 National Emission Standards for Hazardous Air Pollutant**  **s: Emissions:**  **Primary Lead Smelting**

**AGENCY:** Environmental Protection Agency (EPA).

**ACTION:** Proposed rule.

**SUMMARY:** This action proposes how EPA is proposing amendments to the national emission standards for hazardous air pollutants (NESHAP) for Primary Lead Smelting to will 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).

for the Primary Lead Smelting national emission standard s for hazardous air pollutants (NESHAP)

. These proposed amendments include revisions to the emission limits for lead, the addition of an 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 It also proposes to address provisions related to emissions during periods of startup, shutdown, and malfunction to ensure that they are*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 2 of 198 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 as they apply under that standard , to respond 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

. , and to revise the applicability portion of the standard to conform to the definition of the source category as established in 1992.

**DATES:** Comments must be received on or before **[INSERT DATE 45 DAYS FROM DATE OF PUBLICATION IN THE FEDERAL REGISTER].**  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 **[INSERT DATE 30 DAYS FROM DATE OF PUBLICATION IN THE FEDERAL REGISTER].**  Public Hearing . If anyone contacts EPA requesting to speak at a public hearing by **[INSERT DATE 10 DAYS FROM DATE OF PUBLICATION IN THE FEDERAL REGISTER]**  , a public hearing will be

held on **[INSERT DATE 15 DAYS FROM DATE OF PUBLICATION IN THE FEDERAL REGISTER]** 

. **ADDRESSES:** Submit your comments, identified by Docket ID Number EPA-HQ-OAR-2004-0305, by one of the following methods:*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 3 of 198

 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-HQOAR-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 17 th 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-HQOAR-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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 4 of 198 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 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 www.regulations.gov or e-mail. The www.regulations.gov website 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 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 contactinformation in the body of your comment and with any disk or CDROM 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 5 of 198 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 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 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 10:00 a.m. on **[INSERT DATE 15 DAYS FROM DATE OF PUBLICATION IN THE FEDERAL REGISTER]**  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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 6 of 198 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 the NESHAP to a particular entity, contact the appropriate person listed in Table 1 to this preamble.

**TABLE 1--LIST OF EPA CONTACTS FOR THE NESHAP ADDRESSED IN THIS 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 7 of 198 1 EPA’s Office of Enforcement and Compliance Assurance. 2 EPA’s Office of Air Quality Planning and Standards.

**SUPPLEMENTARY INFORMATION** : **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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 8 of 198 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 PPRTV Provisional Peer Rev iewed Toxicity Value 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 9 of 198 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? V. Analys es Results and Proposed Decisions C. Overview of the source category and MACT standards V. Analyses Results and Proposed Decisions

A. Overview of the s ource c ategory and MACT s tandards B A . What data were used in our risk analyses? C B . What are the results of the risk assessments and analyses? D C . What are our proposed decisions on risk acceptability and ample margin of safety? E D . What are the results and proposed decisions from the technology review? F E . Variability G 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? 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 Formatted: Indent: Before: 0", Hanging: 0.5"*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 10 of 198 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 the proposed action for the source categories listed. This standard, and any changes considered in this rulemaking, would be directly 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

1 USEPA. Documentation for Developing the Initial Source Category List – Final Report , USEPA/OAQPS, EPA-450/3-91-030, July, 1992. Comment [vah1]: OMB comment A1 – Unclear what this means. RESPONSE: It means other government entities are not impacted. See next sentence that follows this sentence.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 11 of 198 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 12 of 198 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 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 13 of 198 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-OAR2004-0305. **III. Background** A. What is the statutory authority for this action?Section 112 of the Clean Air Act (CAA) establishes a twostage 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 are to must require the maximum degree of emission reduction through the reflect application of measures, processes, methods, systems, or techniques, including, but not limited to, measures which (A) reduce the volume of or eliminate Formatted: Highlight Comment [vah2]: OMB comment A2 – Reads awkwardly Response: See changes

Formatted: Highlight Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 14 of 198 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 best-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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 15 of 198 12 percent of existing sources in the category or subcategory (or the best-performing 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)*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 16 of 198 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 emissionsfrom a source in the category or subcategory to less than onein-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 technology-based 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 17 of 198 factors, an adverse environmental effect .” , 2 but must consider cost, energy, safety, and other relevant factors in do ing so. CAA section 112(f)(2)A).

When Section 112(f)(2) (B) of the CAA was enacted in 1990,

it expressly preserve d s our use of the a 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

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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 18 of 198 interpretation set out in the Benzene NESHAP, and the Court in

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

. ” ). (D . C. Cir., 2 008). 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-in-1 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 19 of 198 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

risk s 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 20 of 198 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 acknowledge that maximum individual lifetime cancer risk “does not necessarily reflect the truerisk, but displays a conservative risk level which is an upperbound 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 21 of 198 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 22 of 198 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.

3 Although 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 23 of 198 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 more recent propos als (75 FR 65068, October 21, 2010 and 75 FR 80220, December 21, 2010), ed actions , 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 HAP-related 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.

4 EPA previously provided estimates of total facility risk in a residual risk proposal for coke oven batteries (69 FR 48338, August 9, 2004). Formatted: Superscript

Formatted: Not Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 24 of 198 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 25 of 198 also incidence, the presence of non-cancer 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 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 26 of 198 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 becausetechnological and economic factors (along with the healthrelated 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 27 of 198 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 28 of 198 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, 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

5 EPA’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/4AB3966E263D943A8525771F006 68381/$File/EPA-SAB-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

.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 29 of 198 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 include s d 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 and work practice standards 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 section 63.1547 Formatted: Underline

Formatted: Indent: First line: 0.5"

Formatted: Highlight

Comment [vah3]: OMB comment A3 – I t will until the changes are finalized, right, so includes is more accurate. Response - accepted*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 30 of 198 (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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 31 of 198 proposing several revisions to Table 1 (the General Provisions Applicability table). For 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 32 of 198 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 33 of 198 strikes, sabotage, operator intoxication or insanity, and a variety of other eventualities, must be a matter for the administrative exercise of case-by-case enforcement discretion, not for specification in advance by regulation.”) 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 as 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 34 of 198 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 Formatted: Indent: Before: 0", First line: 0.5"*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 35 of 198 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 Section 63.1543( j 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 Comment [vah4]: OMB Comment A4 – We need to discuss this requirement, including the following aspects:

- The Agency’s response to comments received on other proposed rules this year that included it

- Whether the Agency is duplicating efforts that are provided through other EPA programs (e.g. CERCLA or EPCRA notifications)

- Response: EPA has included this same language in several other 112 packages and until there is a final agency decision to change some aspect of it, we don't think it is wise to have the language vary among different proposals*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 36 of 198 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.

 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. Formatted: Indent: First line: 0.5", No bullets or numbering*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 37 of 198

 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. Formatted: Underline

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Comment [vah5]: OMB Comment A5 – Will this be provided in the docket? If so, please indicate that. Response: We will include a copy in the docket.

Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 38 of 198 Rather, EPA has provided for the use of 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 theyclaim that there is any new information that would support reopening this issue. Thus they fail to present a basis for reopening this issue.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 39 of 198 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 40 of 198 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 Formatted: Underline*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 41 of 198 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 in order to produce lead metal. Based on the current applicability*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 42 of 198 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) Because there is only one primary lead processing facility in the US, 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 Comment [vah6]: OMB comment A6 – Is EPA asking for comment on this issue? If not, suggest including a request for comment here. If so, where is that request for comment? Response: Comment is requested on all aspects of this action as stated in Section VII.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 43 of 198 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 property boundary maximum lead

concentration in air limit as proposed in Section 63.154 4 3 **,** 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 Formatted: Highlight Formatted: Highlight

Formatted: Highlight Comment [vah7]: OMB comment A7 - This should be 63.1544, right? Response: Correct

Formatted: Highlight Formatted: Highlight Comment [vah8]: OMB Comment A8 – General Comment: The boundary standard isn’t needed to control fugitive emissions from this source, and this section can be deleted. The existence of the NAAQS, with requirements to monitor sites of maximum ambient concentration, makes the boundary standard unnecessary. Response: lead concentration in air limit will not be specifically required at property boundary so as to allow compliance flexibility for the facility. Furthermore, is this within EPA’s statutory authority for setting standards under 112? Please point to what part of 112(d)(2)(A)-(E) authorizes an ambient monitoring program? Response: There is no provision that prohibits EPA from setting a concentration in air limit and related monitoring requirements that would be applicable to the facility.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 44 of 198 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

. to the extent that they are not located at facilities that produce lead from

lead ore concentrate

. 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 to the NESHAP rule 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.

4. Ot Ot her Changes

The following lists additional minor changes the specific

items we are proposing as changes to the MACT . This list includes rule changes that address editorial errors and , plain language revisions , and changes due to statutory and legal Comment [vah9]: OMB comment A9 – Suggested change for better readability. Response - accepted

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Page 45 of 198 requirements

. We are taking this opportunity to make changes in the rule to include plain language text and to address minor editorial

errors. Specifically, the following changes were made i n the

rule.

 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) Addition of general duty requirements in § 63.1543 and § 63.1544 as a result of changes made affecting the applicability of the General Provision req uirements to this subpart

. 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 pro visions. Added paragraphs in 63.1549(b) requiring the keeping of certain records during malfunctions as part of the affirmative defense provisions. Formatted: Font color: Auto, Complex Script Font: Times New Roman

Comment [vah10]: OMB comment A10 – Is this change happening throughout all EPA program offices? R esponse: Yes. This effort correlates with recent law signed to use “plain language”.

Formatted: Indent: Before: 0.25", No bullets or numbering*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 46 of 198 Revisions throughout Table 1 to reflect changes in the applicability of the General Provisions to this subpa rt resulting from a court vacatur of certain SSM requirements in

the General Provisions.

**IV. Analyses Performed and Background of the Source Category and** 

**MACT Standard** As discussed above, in this notice 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 Formatted: Indent: Before: 0", Hanging: 0.5", Tab stops: 0.38", Left + 0.44", Left + Not at 0" + 0.5" Formatted: Highlight

Formatted: Highlight

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Page 47 of 198 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, non-point, 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 48 of 198 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. 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 beemitted by the MACT standards is referred to as the “MACTallowable” 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 MACT-allowable and actual

emissions in the final Coke Oven Batteries residual risk rule (70 FR 19998–19999, April 15, 2005) and in the proposed and Comment [vah11]: OMB comment A11 – Was this an ICR that went through OMB approval under the PRA? Directed at one facility only? May be helpful to clarify. RESPONSE: This did not go through OMB review since it was less than 10 facilities.

Formatted: Indent: Before: 0", First line: 0.5"*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 49 of 198 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 MACT-allowable 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 MACT-allowable 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 50 of 198 emissions controls in use. For example, if there was information to suggest that a 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 MACTallowable emissions. The estimate of MACT-allowable 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 Formatted: Indent: Before: 0", First line: 0.5"

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Page 51 of 198the concentrations of HAP in ambient air, (2) estimating longterm 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 theUnited States and Puerto Rico. However, in this instance, sitespecific 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

6 U.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).*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 52 of 198 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

7 A census block is generally the smallest geographic area for which census statistics are tabulated.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 53 of 198 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 dose response values have been developed in a manner consistent with EPA guidelines and have undergone a peer review process similar to that used by 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 54 of 198 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,

8 These 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/214C6E915BB04E14852570CA007 A682C/$File/ecadv02001.pdf.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 55 of 198 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, short-term 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 dose-response 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 Formatted: Highlight

Comment [vah12]: OMB comment A12 – Suggested change to be more accurate. Response - accepted*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 56 of 198 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 heavily-industrialized 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 99 th percentile ratio of peak hourly Comment [vah13]: OMB comment A13 – Is it appropriate to mention this given the data you have from this facility? Suggest deleting. Response: Since we always use the factor of 10 first for screening, this is appropriate.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 57 of 198 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 site-specific 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

9 See http://www.tceq.state.tx.us/compliance/field_ops/eer/index.html or docket to access the source of these data.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 58 of 198 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 bio-accumulative 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, hexachlorocyclohexane, lead compounds, mercury compounds, methoxychlor, polychlorinated biphenyls, POM, toxaphene, and trifluralin. Emissions of two , different PB HAP were identified in the emissions inventory for the Primary Lead Smelting source category: lead compounds and

cadmium compounds

. Formatted: Highlight Comment [vah14]: OMB comment A14 – Unclear what is meant by the multiplier approach? Do you mean you used the 10x factor? R esponse: See changes

Formatted: Highlight

Formatted: Highlight Comment [vah15]: OMB comment A15 – Suggested change for clarity. Response: accepted*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 59 of 198Cadmium emissions were evaluated for potential noninhalation 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 5 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 60 of 198 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, and since there are no quantitative dose-response metrics in EPA’s IRIS for lead and its compounds, 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 of0.15 μg/m 3 based on a rolling 3-month period with a not-to-be-exceeded form , and which will require attainment by 2016 . 73 FR 66964. We consider values below the level of the primary NAAQS to have a low potential for significant multi-pathway risks because the primary NAAQS is set as to protect public health with an adequate margin of safety. However, ambient air lead concentrations above the NAAQS, regardless of whether these concentrations occur at a populated census block, are considered to pose the potential for increased risk to public a significant

health risk because the primary NAAQS for lead 1) the primary NAAQS for lead is a standard that applies anywhere in the ambient air; 2) the primary NAAQS was established to account for the air-related multi-pathway impacts of lead sources, which due to the multi-media transport of lead after it is deposited from the atmosphere, may be experienced by individuals in areas Formatted: Highlight

Comment [vah16]: OMB comment A16 – Would be helpful to have some discussion about why an approach comparing to NAAQS is better than a scenario using the RfD. We note that the RfD has not been withdrawn and such values have been used for other multipathway exposure analyses. What is missing or different here that made EPA unable to run a comparison with this value? Response: No RfD for lead. Inserted text in uncertainties section addressing this. Formatted: Highlight Formatted: Highlight

Formatted: Highlight

Comment [vah17]: OMB comment A17 - Please revise. This implies that any NAAQS exceedance ‘imposes significant health risk’. Just as this is not true for an RfD, this is not correct for the NAAQS. Please find other pre-existing language to use here and throughout the risk assessment to describe what an NAAQS exceedance may imply. Response: see changes Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 61 of 198 distal to the original site of the deposition; and 3) 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. lead levels above the primary NAAQS have been associated with significant neurological effects, including loss of intelligent quotient (IQ) points in children. We also consider this type of 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. We further note that comparing ambient lead concentrations to the NAAQS for lead 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 Formatted: Highlight

Formatted: Highlight

Comment [vah18]: OMB comment A18 – There are no studies linking air lead levels above 0.15 to IQ. Response: See changes.

Comment [vah19]: OMB comment A19 – Is this a quote from the NAAQS? Can we provide a quote? Response: See Changes*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 62 of 198 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. 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 Formatted: Indent: First line: 0.5"

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Page 63 of 198 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 . W

-

- ith 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 risk s was 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 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. Formatted: Indent: Before: 0.5"*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 64 of 198 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). and which 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) or non-cancer HI of 1 or greater , and/or 3) ( based on the emissions of the source category or the facility, respectively) . In the case of Primary Lead Processing, we also focused on the population estimated to be exposed to 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

10 Risk and Technology Review – Analysis of Socio-Economic Factors for Populations Living Near Primary Lead Smelting Operations

. Formatted: Highlight

Formatted: Highlight Formatted: Highlight

Comment [vah20]: OMB comment A20 - So a HI analysis was done using a NAAQS value? Unclear if this is appropriate considering what the NAAQS represents. Response: See changes Formatted: Highlight

Comment [vah21]: OMB comment A21 – Suggestions made for clarity Response: See chan g es*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 65 of 198 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 Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 66 of 198 line within those census blocks. and 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 Hispanic or Latino ;

• People living below the poverty line

. 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. Comment [vah22]: OMB comment A22 - This text is from the previous RTR proposed rule (shipbuilding, wood furniture mfg, etc). Why the change for this rule? Response: changes accepted Formatted: Highlight Formatted: Highlight

Formatted: Highlight

Comment [vah23]: OMB comment A23 - Given the developmental effects of lead exposure, what do we know about this demographic group? Response: See discussion in Section V.B.4 below.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 67 of 198 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.

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 health-protective. 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 (referenced earlier) 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 Comment [vah24]: OMB comment A24 - Please include clear discussion of major uncertainties associate with the NAAQS evaluation— please use language verbatim from the NAAQS. It is very important to be transparent about uncertainties and assumptions associated w/ the NAAQS derivation. R esponse: See below

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Page 68 of 198 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. Formatted: Indent: Before: 0.5"*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 69 of 198 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 under-predict 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

11 Short-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. Formatted: Indent: Before: 0.5"*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 70 of 198 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 71 of 198 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 co-occurrence of peak emissions and worst-case 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

12 U.S. EPA. National-Scale Air Toxics Assessment for 1996. (EPA 453/R–01–003; January 2001; page 85.) Formatted: Indent: Before: 0.5"*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 72 of 198 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 dose-response 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

13 IRIS glossary (http://www.epa.gov/NCEA/iris/help_gloss.htm ). 14 An 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 73 of 198 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 health-protection, 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 representchronic exposure levels that are intended to be healthprotective 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 74 of 198 are commonly default values, 15 e.g. , factors 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

15 According 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 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 75 of 198 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 effect-specific 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 76 of 198 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 for lead compounds. Thus, t T o 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 (73FR66979). 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 (73FR66974), as well as uncertainties between blood lead levels and loss of IQ points in children (73FR66981). In considering the evidence and risk analyses and their associated uncertainties, the EPA Administrator noted his view that there is no evidence- or 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 Formatted: Highlight Formatted: Highlight Formatted: Highlight

Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 77 of 198 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 (73FR66998). In so doing, the Administrator decided that, a level for the primary lead standard of 0.15 μ g/m 3 , 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 (73FR67006). uncertainties associated with the health evidence and risk and exposure analyses were explicitly considered during

the standard

- settin g process. More specifically, these uncertainties were carefully considered when selecting the appropriate indicator, averaging time, form, and level of the NAAQS for lead. A thorough discussion description of the health evidence, risk and exposure analyses, and their associated

uncertainties and how they were considered in setting the primary and secondary NAAQS can be found in EPA’s final rule revising establishing the lead NAAQS (73 FR 66970-66981, November 12, 2008). In addition, w W e also note that the uncertainties

associated with the establishment of the health-based (i.e., primary) NAAQS are small relative to those for likely less than

the uncertainties associated with dose-response values developed for many of the other HAP s . While the dose-response values for Comment [vah25]: OMB comment A25 - While they were considered, they did not disappear and still need to be robustly discussed here. Response: See changes Formatted: Highlight

Formatted: Highlight

Comment [vah26]: OMB comment A26 - Please bring language forward here and include discussion of uncertainty of using a NAAQS value here instead of an RfC/RfD—which are clearly derived for what some could say is a more relevant purpose than the NAAQS. Response: See discussion above. Formatted: Highlight Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 78 of 198 many HAP rely solely on extrapolation of data from animal toxicological studies, the This is because t he development of the lead NAAQS considered used the results from numerous human epidemiological studies

. rather than relying solely on the extrapolation of animal studies

. A lthough epidemiologic studies have their associated uncertainties (e.g., the extent to which

factors other than ambient lead concentrations could be influencing blood lead concentrations), we believe that it is likely that the magnitude of these uncertainties is relatively less than extrapolating response values from animals to humans. 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 Comment [vah27]: OMB comment A28 – Should discuss uncertainties in the epi data. Response: See changes Formatted: Highlight Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 79 of 198 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 In addition, because of the multi-pathway, multi-media impacts of lead, the risk assessment supporting the NAAQS the development of the NAAQS considered direct inhalation exposures and indirect air-related multi-pathway exposures from industrial sources like primary and secondary lead smelting operations . It also considered , as well as background lead exposures from all 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 health evidence 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 health evidence (73FR67004). Thus, when revising the NAAQS for lead to protect public health with an adequate margin of safety, EPA considered both the health evidence and the risk assessment,

albeit to different extents. when deriving an ambient Comment [vah28]: OMB comment A 29 - What was policy relevant exposures for the NAAQS may be quite different from what is policy relevant here. This aspect of the NAAQS derivation, and appropriateness here should be discussed in detail Response: See changes Formatted: Highlight Formatted: Highlight Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 80 of 198 concentration level which is considered to protect human health with an adequate margin of safety. 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 short-term 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 thefinal rulemaking if, as a result of these reviews, a doseresponse metric changes enough to indicate that the risk Comment [vah29]: OMB comment A30 – This seems out of place. Likely belongs earlier in the text. Response: See changes*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 81 of 198 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 site-specific 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

. Comment [vah30]: OMB comment 31 – Perhaps uncertainties w/ the NAAQS value should be discussed here. Response: See discussion above.

Formatted: Indent: Before: 0.5"*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 82 of 198 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;*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 83 of 198 • 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 84 of 198 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-by-source 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 85 of 198 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 local permitting agency databases and industry-supported

databases.

**V. Analyses Results and Proposed Decisions**  This section of the preamble provides bac kground information on the Primary Lead Smelting MACT standard and source category, 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

referenc es 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.

C A

. 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

16 As provided above in section III (C)(3), we are proposing to change the standard to apply to a Primary Lead Processors Formatted: Highlight Comment [vah31]: OMB comment A 32 - See next comment regarding placement of section A. We also suggest moving section B to the previous section, or renaming this section to appropriately characterize what is included in the section. Note the opening paragraph does not include mention that this section (currently) includes the modeling input data descriptions. R esponse: We moved these sections per your suggestion.

Formatted: Highlight Formatted: Highlight

Comment [vah32]: OMB comment A 33 - This Section A does not seem to belong in a section titled “Analyses Results and Proposed Decisions.” Suggest moving these to the previous section, “Analyses Performed” to a section C. titled “Overview of the source category and MACT standards.” Response: See response to comment A32 a b o ve Formatted: Underline*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 86 of 198 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 B . 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. The Doe Run Company in Herculaneum, Missouri, is the sole operating facility currently subject to the MACT

standard. 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 87 of 198 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, 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 from sinter machines, blast furnaces, and dross furnaces; process fugitive emissions from sinter, blast Formatted: Highlight Comment [vah33]: OMB comment A34 – Clarifying lead compounds are HAP. Response

- a ccepted*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 88 of 198 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 perton of lead produced (1 lb/ton). 40 CFR 63.1542(a). A plantwide 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-wi d s e 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 89 of 198 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 plant-wide lead emission limit of 1 lb of lead per ton of lead produced that applies to the aggregation of Formatted: Indent: Before: 0", First line: 0.5" Formatted: Underline*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 90 of 198 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 lead compounds, which account for over 99 percent of the total HAP emissions by mass. The remaining HAP emissions*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 91 of 198 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

discussion s of the emission profile for this facility is included in the Technical SupportTechnology Review Memo 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 μ g/m 3 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 μ g/m 3 to 0.15

μ g/m 3 . In November 2010, EPA identified or “designated” several areas as not meeting the lead NAAQS. These “nonattainment”

17 EPA 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. Comment [vah34]: OMB comment A35 – How do we know this? Response: 2005 NEI dataset included VOC HAP from boiler combustion which were found to be negligible. The revised technology review memo discusses consideration of these emissions under the technology review Further, we performed a worst-case risk screening of these emissions and determined that they posed less than 0.0002in a million cancer risk. The technical support document in the docket discusses these emissions and their removal from the risk analysis dataset. Formatted: Highlight Formatted: Highlight Formatted: Highlight Formatted: Highlight Formatted: Underline

Comment [vah35]: OMB comment A36 – Do we know when/if this will be approved? RESPONSE: FR for final approval is progressing toward publication, Region 7 is reviewing it currently; it has already been reviewed and approved by R7 Counsel.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 92 of 198 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 emission s to baghouses

18 EPA 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. Formatted: Highlight

Comment [vah36]: OMB comment A37 – Please make changes if this addition is not correct. Response: accepted

Comment [vah37]: OMB comment A38 - Seems like these steps seem to negate the need to take action under residual risk. Response: Note that these steps were implemented and are reflected in 2008 data, however, the risk analysis indicates remaining risk.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 93 of 198 #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-to-cloth 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 Comment [vah38]: OMB comment A39 – Has Doe Run made these changes? Response: Yes these changes are reflected in the reported 2008 emission levels.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 94 of 198 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. The state also requires an annual emissions inventory based on thestack tests for the point discharges and AP-42 or facilityspecific emission factors for fugitive emissions.

As a result of the implementation of the emission control requirements in the currently approved SIP, and the additional requirements adopted by the state, as discussed above, the Doe Run facility has achieved a significant reduction of lead and Comment [vah39]: OMB commentA40 - Need a section on the monitoring requirements through the NAAQS program. How many monitors in the direct vicinity of the smelter are in place, and how many are required? Mention that the design value which will determine attainment status is based on the highest reading monitor, and that monitors that read within x% of the NAAQS cannot be discontinued. Etc. Response: We should discuss. These monitoring requirements are for the State and not the facility. This section describes SIP requirements for the facility.

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Page 95 of 198 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 US 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. Formatted: Highlight

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Comment [vah40]: OMB comment A41 - Might be useful to have discussion about why these actions are not sufficient and further action under the MACT is required. Response: This section only presents other requirements affecting Doe Run. Our discussion of how those are considered under this action are discussed below in Section V.C.1.

Comment [vah41]: OMB comment A42 – What does this mean? SVN r e sponse: This is a negotiated health-based level which has not been set yet: I believe thru the consent decree, negotiation will occur after remediation is completed. Also I believe this remediation covers more than just Clean Air Act Violations. See pages 94-95 of the consent decree.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 96 of 198 Under the consent decree, the existing refining, casting and alloying operations 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 on the same property as the current smelter. 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. Comment [vah42]: O MB comment A43 and A44 – Under the consent decree, is lead monitoring required during the site remediation period? R esponse: The consent decree indicates that this is a remediation similar to a RCRA corrective action which typically requires air monitoring during remediation activity. What level of monitoring will be stipulated in the remedial action plan TBD. See pages 94-95 of the consent decree. When will it be finalized? Response; We don’t know, per Region 7: It's very possible it could be held up for a while, as a private party has filed a motion to intervene with the court. Depending on whether (and to what extent) the court allows discovery on the CD, it could take some time. We are currently awaiting the judge's decision on the private party's motion and our responses.

Formatted: Highlight Comment [vah43]: OMB comment A 32 - See next comment regarding placement of section A. We also suggest moving section B to the previous section, or renaming this section to appropriately characterize what is included in the section. Response: We moved the section. Note the opening paragraph does not include mention that this section (currently) includes the modeling input data descriptions. Response: addressed, see changes.

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Page 97 of 198 B 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 98 of 198 The risk assessment was based on estimates of the actual

2008 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. The estimates of allowable emissions were calculated using production data from the ICR response combined with the current emissions limits in

the MACT standard. to calculate the MACT allowable emissions

. Further information on this data set can be reviewed in the Residual Risk Assessment for the Primary Lead Smelting Source Category d ocument found in the docket. 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. For more detail, see the memo in the docket for this action describing th e risk assessment inputs and models for the Primary Lead Smelting source category.

We used the 2008 emission production information as the basis for calculating the MACT allowable ratio (allowable to actual) because the 2008 emissions these are the most recent*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 99 of 198 reported emissions that also reflect implementation of the requirements of the 2007 SIP emission reduction requirements revision . For more information on the ratio of actual to MACT-allowable emissions, see the Technical Support

Document memo in the docket for this action describing the

emission data information and estimation of MACT-allowable emission levels and associated risks and impacts.

C 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 recently-promulgated 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** Formatted: Underline Comment [vah44]: OMB comment A45 - Suggest that this section include a robust discussion of the modeling results compared to the measured concentration data at nearby monitors. Response: See below.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 100 of 198

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 T OSHI 2 Maximum Offsite refinedAcute Noncancer HQ 3 Actual Emissions

Level Allowable Emissions

Level Actual Emissions

Level Allowable Emissions

Level 30 30 4,900 0.0008 1 1 0.6 1 Estimated 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. 3 The maximum estimated acute exposure concentration was divided by available short-term dose-response values to develop an array of HQ values. HQ values shown use the lowest available acute dose-response value, which is the REL. See section IV.A of this preamble for explanation of acute dose-response values. 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-in-1 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 101 of 198 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, we refined the assessment and estimated a

maximum off

- site acute HQ value of 0.6. T t he refined assessment

took into consideration that an emissions factor of 10 times the average hourly emissions rate (see above, section 2.4) is not appropriate in this instance, given that fugitive emissions are minimized during the meteorological conditions associated with the worst-case 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 Formatted: Highlight

Comment [vah45]: OMB comment A 46 - Seems odd to even have discussion of 10x as the starting point if there are actual data associated with the facility. Response: We always us the 10X factor first, so it is appropriate.

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Comment [vah46]: OMB comment A47 – change made for clarity. Response: accepted.

Comment [vah47]: OMB comment A48 – So this means there was no risk?? Can we say this more clearly? Response: Note changes*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 102 of 198 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 multi-pathway 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 year. 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 section 63.1544. Since then, pursuant to requirements that the 2002 State SIP adopted for purposes of meeting the lead NAAQS, Doe Run enclosed the refining and casting area and vents those emissions to the refinery stacks. a stack . 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. Formatted: Highlight

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Comment [vah48]: OMB comment A49 – Which one? Please clarify the year of the SIP that required this. Response – 2002 SIP, see changes Formatted: Highlight Comment [vah49]: OMB comment A50 – Can we specify which stack, or clarify that this is the “refinery stack” if that’s the case. Response: See changes.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 103 of 198 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 3

- mon th rolling average lead concentrations that could exceed the lead 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. Comment [vah50]: OMB comment A 51 – Can you provide this information in parentheses? Response: See changes. Is this the information you mean? Formatted: Highlight

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Comment [vah51]: OMB comment A52 – Is this an appropriate metric? Formatted: Highlight Formatted: Highlight Comment [vah52]: OMB comment A 52 – Is this an appropriate metric? Response: note change Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 104 of 198 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. **Table 4. Summary of Modeled**  **Lead Concentrations Relative to the NAAQS**  **Based on Estimated Given**  **Actual 2008 and MACT Allowable Emissions** 

Emission Point Actual 2008 Emissions (TPY) MaximumImpactActual Emissions Allowable Emissions 1 (TPY) Maximum ImpactAllowable 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

1 Allowable 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. 3 Fugitive 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 south east boundary of the facility (see Figure 3.1-1 of the risk assessment document). 2. Facility-wide Risk Assessment Results

. Comment [vah53]: OMB comment A53 – How were these emissions input into the air model? Response: this was discussed on the conference call 1/19. Please note if further explanation is requested. Comment [vah54]: OMB comment A54 – What is the location of this maximum concentration? Response: see note

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Page 105 of 198 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 A ll 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 Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 106 of 198 (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 4.6- and 3-fold respectively. With respect to the South Cross and Church Street monitors, AERMOD overestimates 3-month maximum lead concentrations by approximately 2.8- and 4.2-fold, respectively. Moreover, results also indicate that the maximum 3-month average lead concentration calculated from any of these monitors is approximately equal to the maximum 3-month average lead concentration estimated by AERMOD at any 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 μgs/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.

Maximum AEMOD Maximum Model to Formatted: Line spacing: single*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 107 of 198

Location Modeled 3-Month Lead Concentration (μgs/m 3 ) Monitored 3- Month Lead Concentration 19 (μgs/m 3 ) Monitor Ratio 20

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 5**  **6 . Primary Lead Smelting Demographic Risk Analysis**  **Results**

Nationwide **Population with cancer risk**  **greater than 1 in a million**  **P opulation with**  **ambient air lead**

**concentrations exceeding the**  **NAAQS** Total population 285,000,000 4,900 1,900 **Race by percent** White 75 96 96 All Other Races 25 4 4 **Race by percent**

19 Maximum 3-month monitored concentrations were calculated for the year 2008 based on data submitted to EPA’s Air Quality System (AQS). 20 Negative sign denotes an underestimation of AERMOD modeled ambient lead concentrations, relative to monitored concentrations. AERMOD estimated concentrations were based on 2008 emissions estimates. Formatted: Line spacing: single

Comment [vah55]: OMB comment A55 – Could you please use the Table format from the most recent RTR proposal (shipbuilding, Wood Furniture MFG, etc)? It was easier to follow. I’ve pasted in the empty table. Response: see changes Formatted Table Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 108 of 198 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

Total All Minority (%) African American (%) Other and Multiracial (%) Hispanic or Latino (%) Native American (%) Below Poverty Level (%) Nationwide Demographic Breakdown 285,000,000 25 12 12 14 1 13

Population With Cancer Risk Greater Than 1 in 1 million Cancer risk 4,900 4 2 1 1 0.2 15 Population With Ambient Lead Concentrations Exceeding the NAAQS Lead risk 1,900 4 3 0.8 0.3 0 15 Total All Minority (%) African American (%) Other and Multiracial (%) Hispanic or Latino (%) Native American (%) Below Poverty Level (%) Nationwide Demographic Breakdown 285,000,000 25 12 12 14 1 13

Population With Cancer Risk Greater Than 1 in 1 million Cancer risk 4,900 4 2 1 1 0.2 15 Population With Ambient Lead Concentrations Exceeding the NAAQS Lead risk 1,900 4 3 0.8 0.3 0 15

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, which is well below the national percentage. Similarly, in the cancer and lead Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 109 of 198 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 a significant potential for any environmental justice issues. 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.

D C . What are our proposed decisions on risk acceptability and Comment [vah56]: OMB comment A56 – What are EPA”s criteria for “significant potential for environmental justice”? Response: There are no bright line criteria – we could ask for comment on this interpretation, but it’s really not necessary since everything in this proposal is subject to comment. Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 110 of 198 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 exposedcould be as high as 30-in-1 million due to actual or MACTallowable emissions. These risks are considerably less than 100-in-1 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 111 of 198 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 source categor y facility were judged to be significant. Our analysis estimated that modeled off-site 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 (73FR67007)” ambient lead concentrations in excess of the NAAQS are associated with significant neurological effects , including t he loss of IQ points in children and given the potential for adverse

environmental effects , 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 Formatted: Highlight

Comment [vah57]: OMB comment A57 - What is meant by significant?? This is not clear. Is over 1000 people the significance threshold? Response: see changes Formatted: Highlight Formatted: Highlight

Comment [vah58]: OMB comment A58 - It might be helpful to understand (with this explanation provided earlier) how the fugitive emissions were translated/modeled into an ambient concentration. Response: This was explained in conference call 1/19; however, is it necessary to explain that process here? Response: See changes Formatted: Highlight Formatted: Highlight

Comment [vah59]: OMB comment A59 - Again, I don’t believe there is direct evidence linking ambient air levels above the NAAQS to IQ decrements. Response: See changes Please use appropriate language. Exceeding a NAAQS does not imply that there will be significant neurological effects. As w/ RfD/RfC values there is conservatism in these derivations. Response See changes

Formatted: Highlight Formatted: Highlight Comment [vah60]: OMB comment A60 - Is this a quote from the Lead NAAQS? Perhaps it would be better to use a quote. Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 112 of 198 order to provide an acceptable level of risk, lead

concentrations in the ambient air must be reduced to meet the level of the lead NAAQS. Thus, we 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. Based on our analysis, In so doing , we found 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

would have to be reduce d by approximately 66 percent to 0.94

TPY , and furnace area stack emissions would have to be reduced by approximately 52 80 percent to a total of 0. 86 91 TPY (the maximum impacts of refinery and furnace emission points occur at the same location) . Further, because the maximum ambient air impacts of each of the separate refinery/furnace emission s points , 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 1.86 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/m 3

. As noted above, emissions from the main stack (i.e., emission point for sinter machine, blast furnace and drossing operations) Comment [vah61]: OMB comment A61 - This would be the place to defer to the Lead NAAQS program, and point out that a regulatory program is in place to address this. Formatted: Highlight

Comment [vah62]: OMB deleted this section

Formatted: Highlight Comment [vah63]: OMB inserted “considered approaches to control” which we did not consider appropriate here and did not accept the change.

Comment [vah64]: OMB comment A 62 – Which of these sources drive the exceedance of the NAAQS? Comment [vah65]: This change by OMB is consistent with removal of the property boundary ambient limit.

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Comment [vah66]: OMB comment A63 - The information supporting this statement should be in the docket for the public to review.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 113 of 198 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

each 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/m3. Thus, our evaluation of risks based on actual emissions already considered emissions with these Comment [vah67]: OMB comment A64 - So Doe Run is already in compliance with 2007 SIP requirements? Would be good to mention that earlier. Response: The control measure required by the 2007 SIP revisions have been implemented, which is stated here , however, it would not be appropriate to state full compliance with SIP because there are other requirements of the SIP that involve other aspects besides the emissions control measures. We have added reference to the implementation of these controls in section IV.C. Formatted: Highlight Comment [vah68]: OMB comment A65 - Again, it would help to understand what is driving the exceedance caused by the fugitive emissions. Response: Road dust, slag piles and material handling cause a cumulative effect and there is no specific driver. Refer to Section IV.C. for a discussion of sources contributing fugitive dust emissions.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 114 of 198 controls largely in place. In order to substantially reduce fugitive dust emissions to a level that would ensure that the risk is not unacceptable, we believe that a complete remediation of the primary lead smelter site including roadways, storage piles and other exposed surfaces is necessary. Such measures are necessary to prevent suspension and re-suspension of lead dust that make up fugitive dust emissions. 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 an ambient lead concentration in air limit of 0.15 μg/m 3 to be measured at locations approved by the

Administrator a t the prope rty boundary . This lead concentration

in air property boundary limit would be established as the enforceable requirement to address fugitive emissions under the

MACT standard. 21 Because we are proposing a n 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

21 Under 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 exten d t beyond April 2014. Formatted: Highlight Comment [vah69]: OMB comment A66 – This effort is required under the consent decree, right? If so, please mention that here. R esponse: See footnote for this paragraph. Comment [vah70]: OMB made changes here that change the meaning of the section. Their change makes the section read that Missouri DNR and EPA will need to develop a plan to attain the NAAQS standard that could involve complete remediation of the primary lead smelter site... This is not what the section is saying. It would be the facility’s responsibility to make emissions reductions to meet risk acceptability. Formatted: Highlight Formatted: Highlight Formatted: Highlight Comment [vah71]: OMB made changes here changing that we are proposing the limit to that we will defer to the existing NAAQS program that has established a limit. Formatted: Highlight Comment [vah72]: O MB added a section here that “EPA has determined that implementation of the NAAQS through the development and execution of a SIP will provide the greatest protection from fugitive dust emissions at this source.” Comment [vah73]: OMB comment A67 - Since this is being proposed under 112(f)(2)(A), where has the Agency provided a discussion of cost, energy, safety, or other relevant factors? Response: This is being proposed under 112(f) with reference to acceptability of risk only. Under risk acceptability, we do not consider costs, etc. Comment [vah74]: OMB comment A68 - Need to expand on why this is a very unique circumstance in which reducing risk to acceptable levels for fugitive emissions will be achieved through the NAAQS. -the indicator (Pb in PM10 or TSP) is the preferred indicator under 112 as well as the NAAQS -fugitive dust that could lead to exceedances of a monitored level could come from onsite and offsite dust, and only the SIP will provide the regulatory authority to address both.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 115 of 198 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 Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 116 of 198 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 in air limit that consider the highest modeled

air lead concentrations in air from the modeled fugitive dust sources and any contributions from background lead Formatted: Highlight

Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 117 of 198 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 in air 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 in air 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 this facility would need to be reduced to a

level that would ensure that these emissions would not result in

ambient air lead levels greater than the 0.15 ug/m3 for any 3- month period the NAAQS is being met at all of the modeled locations. Further, we found conclude that in order to

achieve meet the 0.15 ug/m3 level (for any 3-month rolling average) NAAQS at all modeled locations, fugitive dust emissions would need to be reduced by 98 percent and the emissions from Formatted: Highlight

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Formatted: Highlight Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 118 of 198 the furnace area and refining operation stacks would need to be reduced by 80 50 and 66 percent , respectively . 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. 86 91 TPY that would apply

to the furnace area stack and the refining operation

stacks

.

 A stack lead emission cap of 0.94 ton per year that would apply to the refining operation stacks.

 A n air n ambient lead concentration in air limit of 0.15 μg/m 3 based on 3-month rolling average (to be measured at locations approved by the Administrator) at the property boundary 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 Formatted: Highlight Formatted: Highlight Formatted: Highlight Formatted: Highlight

Comment [vah75]: O MB made changes to this bullet to read “Furthermore, the attaining the existing ambient lead concentration limit of 0.15 μg/m 3 at the property boundary as required through implementation of the NAAQS will ensure that fugitive dust emission levels will not exceed safe levels.”*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 119 of 198 fugitive dust emissions, the facility, regardless of whether it is operating all or just some of the subject emission sources covered by this action , would be required to meet the air

ambient lead concentration in air emission limit at the property boundary

. For both new and existing facilities, compliance with

the air property boundary maximum lead concentration in air limit would be demonstrated using lead ambient 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 the proposed rule that allows for reduced property boundary ambient monitoring if the facility demonstrates a n air n ambient lead concentratio n n in air at the property boundary for

two three consecutive years at less than 50 percent of the air

ambient lead concentration in air limit. The continuous monitoring can be reduced to once every six months unless one of the 6-month monitoring events exceeds 50 percent of the air

ambient lead concentration in air limit, at which time

continuous monitoring will be required to resume based on the initial plan approved by the Administrator until another two

three years of consecutive monitoring below 50 percent of the Formatted: Highlight Comment [vah76]: OMB comment A69 – Please clarify this language; difficult to understand. Response: see changes

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Comment [vah77]: OMB ma d e changes to this section to basically say that the NAAQS requires a monitoring plan ....and that provisions to reduce monitoring is included in the NAAQS.

Formatted: Highlight

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Page 120 of 198 air ambient lead concentration in air limit is achieved. For existing facilities, compliance with the emission limit s 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 the 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 though quarterly stack testing until Formatted: Highlight Formatted: Highlight Comment [vah78]: OMB comment A70 - This is redundant with the NAAQS requirements and can be moved to section 5.A.3*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 121 of 198 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 122 of 198 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 in 1-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 Comment [vah79]: OMB comment A71 – What is the cancer risk before these standards are in place?? Response: 30 in a million – see table 3, Section V. B.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 123 of 198 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 , , , s the additional controls are not warranted since they would not 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. Our risk analysis indicates that the main stack

emissions do not result in ambient lead levels exceeding the NAAQS based on either actual or allowable emission levels. We determined, as discussed section V.E. below, that it is technologically fea sible 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

. We evaluated

additional controls that would be feasible to further reduce

emission from the current level s. It was determined that

addition al controls such as membrane bags or add

- on baghouses

could result in addition al emission reductions, however, the cost for achieving those reductions would be prohibitive and

these additional controls would not appreciab ly reduc e the

associated risk

. ( A complete discussion of this analysis is*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 124 of 198 included in the docket.) As a result , w W e are proposing that to address the ample margin of safety for the main stack through a reduced MACT allowable emission rate under the sectio n 112(d)(6) technology review as described in section V.E. below will also provide an ample margin of safety with regard to emissions of

lead and other HAP from the main stack.

. E 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 Formatted: Indent: Before: 0", First line: 0", Tab stops: 0.19", Left + Not at 0.5"*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 125 of 198 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 126 of 198 the facility since promulgation of the MACT rule. Emissionsdata from earlier years would not reflect all of the emissionreducing 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 127 of 198 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 F 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 200 7 SIP revisions; we are not proposing additional requirements for these three two stacks stack 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 risk s due to from these emission points is 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 128 of 198 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 D ) 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 , the 0. 86 91 TPY for the furnace area , and the 0.94 TPY for the refining operation, and dividing by the annual production from 2008 of 149,564 tons. We note that variability was only applied in establishing technology-based 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 was not appropriate to consider variability in establishing limits for these emission points.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 129 of 198 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 arerequesting comment on the appropriateness of applying the plantwide 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 manner as discussed above in section V. C D .1 for the furnace area and refining stack s 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 D .1, new primary lead processing facilities would be required to demonstrate compliance using lead continuous emission monitoring systems (CEMS).

F E . Variability In assessing sources’ performance, EPA may consider*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 130 of 198 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. 22 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.

22 Run-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 at 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 themaintenance cycle in which a fabric filter is tested). Test-totest variability can be termed long-term variability. 72 FR at 54878.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 131 of 198 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]) (e.g., NESHAP for Portland Cement Manufacturing;

NSPS for Hospital/Medical/Infectious Waste Incinerators ; NESHAP

for Industri al, Commercial, and Institutional Boilers and

Process Heaters ) 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 Formatted: Not Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 132 of 198 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 source’s past performance. This formula uses a pooled variance (in the s 2 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 short-term 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 133 of 198 m = the number of test runs in the compliance average s 2 = 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) x TINV(2 x probability, n-1 degrees of freedom) X SQRT((1/n)+(1/m)) **]** , for a one-tailed t-value, probability of 0.05, and sample size of n

G 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 134 of 198 SSM exemption. We are specifically seeking comment on whether there are any such provisions that we have inadvertently incorporated or overlooked. **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 ambient concentration in air limit of 0.15 μg/m3 (based on 3-month rolling averages) to be measured at locations approved by

the Administrator the property boundary 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 section 63.1544 and to require that emissions from these operations be vented to one or more stacks

. with an emission cap

of 0.9 4 TPY. Finally, we are proposing to establish an emission cap of 0. 86 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 Formatted: Highlight

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Page 135 of 198 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 determined 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 for new facilities

. We are proposing that compliance with the ambient lead

concentration in air limit at the property boundary would be demonstrated using a ambient compliance monitoring system CEMS approved by the Administrator at four locations

. 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 Formatted: Highlight

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Page 136 of 198 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 137 of 198 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 138 of 198Initial Source Category List – Final Report”, USEPA/OAQPS, EPA450/3-91-030, 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 the 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 we are proposing under CAA section 112(f)(2) for the one existing source , if Formatted: Indent: First line: 0"

Formatted: Indent: Before: 0", First line: 0.5"*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 139 of 198 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 reduce fugitive emissions. A two-year compliance period is also consistent with the schedule of required actions contained in the Consent Decree.is necessary so the facility has adequate time to install additional controls and demonstrate compliance. In addition, we are proposing that the plant-wide limit that would reflect reductions required for the we are establishing to reflect the 15 TPY limit 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 Formatted: Highlight

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Page 140 of 198 area and refinery stacks required under section 112(f)(2), we believe a two-year compliance timeframe is need ed for the same reasons provided above.We recognize that the existing affected

source may need time to ensure that existing controls are working properly relative to new controls put in place to comply

with the proposed section 112(f)(2) requirements.

**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 the 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 Formatted: Indent: First line: 0"*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 141 of 198 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 D**  **efinition** 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 142 of 198 **Data Element D**  **efinition**

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 (ft 3 /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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 143 of 198 **Data Element D**  **efinition** 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) 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).*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 144 of 198 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 145 of 198 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 2424.01. We are proposing new paperwork requirements to the Primary Lead Smelting source category in the form of monitoring for

ambient air lead concentrations in air and increased frequency for stack testing as described in 40 CFR 63.1547(k) ( ambient compliance lead 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. Formatted: Highlight

Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 146 of 198 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 ambient 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 Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 147 of 198 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 [Insert date of publication in the Federal Register.] , a comment to OMB is best assured of having its full effect if OMB receives it by [Insert date 30 days after publication in the Federal Register.] . 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 148 of 198 population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. This proposed rule is currently applicable to one operating facility that does not meet the definition of a small entity. 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. 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.

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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 149 of 198 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 150 of 198 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 151 of 198 lead, which was set to protect public health with an adequate margin of safety from adverse health effects, most notably including the loss of IQ points in children. 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.

M odeled ambient lead c oncentrations from the one facility in this source category are in excess of the NAAQS for lead, which was set to protect public health with an adequate margin of safety from adverse health effects, and studies that indicate that lead levels above the NAAQ S can cause the loss of IQ points

in children. Importantly, modeling indicates that the control measures proposed in this notice will result in areas near this facility to meet the lead NAAQS , thereby mitigating the risk of adverse health effects to child ren. 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 Formatted: Font: (Default) Courier New, Complex Script Font: Courier New*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 152 of 198 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 Number 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 153 of 198 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 HAP-related 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 154 of 198 category with emission sources subject to the MACT standard. More specifically, for these populations we 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 I V. BC .1 (see Table 65 ), as well as in a technical report located in the docket for this rulemaking. In brief, our analyses show that although there is the potential

for adverse environmental and human health effects from emissions of lead, there are no disparate impacts on environmental justice populations (see section I V. BC .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. For this analysis, we analyzed risks due to the inhalation of HAP in two separate ways. In the first approach, we focus

the an alysis on the total populations residing within 5 km of each facility (source category and facility

- wide), regardless of their estimated risks, and examine the distributions of estimated risk across the various demographic groups within*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 155 of 198 those 5 km circles. In the other, we focus the analysis only on the populations within 5 km of any facility who are estimated to have HAP exposures which result in cancer risks of 1

- in

- 1 million or greater or non

- cancer hazard indices of 1 or greater (based on the emissions of the source category or the facility, respectively), once again examining the distributions of those risks across various demographic groups. The distance of 5 km was chosen for the first approach to allow comparison with previous demographic analyses performed at EPA, such as the one which was performed in support of the recent proposal for the boilers NESHAP. In each approach, we compare the percentages of particular demographic groups to their nationwide counterparts. In this preamble, we only pres ent the results of the second approach, since it focuses on the significant risks from either the source category or the facility

- wide emissions. The results of both approaches are documented in memos to the docket for this proposal. As described in the p reamble for the Primary Lead Smelting MACT standard source category, o ur analyses show s that there is potential for an adverse environmental effect or human health multipathway effect, however, acute and chronic non

- cancer health impacts are unlikely. Our analysis, however, determined

that although there is potential for health

- based risk, there is no appreciable disparity in risks between demographic groups. Comment [vah82]: OMB comment A72 - What exactly does this mean? Can specific numbers be provided? What would define an ‘appreciable disparity’? Note their copy does not have the most recent revisions for this section. Response: see changes*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 156 of 198 The proposed rule would require additional control measures to

address the identified risks and would therefore, decrease risks to any populations exposed to these sources

.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** National Emission Standards for Hazardous Air Pollutant Emissions: Primary Lead Smelting Page 157 of 198

**List of Subjects in 40 CFR Part 63** Environmental protection, Air pollution control, Reporting and recordkeeping requirements, Lead.

____________________________ Dated:

____________________________ Lisa P. Jackson, Administrator.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 158 of 198 For reasons set out in the preamble, title 40, chapter I, of the Code of Federal Regulations is amended as

follows: **PART 63--[AMENDED]** 1. The authority citation for part 63 continues to read as

follows: Authority: 42 U.S.C. 7401 et seq . 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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 159 of 198 (b) Table 1 of this subpart specifies the provisions of subpart A of this part that apply and those that do not apply to owners and operators of primary lead processors. 3. Section 63.1542 is amended by adding a definition for “Affirmative defense,” “Lead refiner,” “Lead remelter,” “Primary lead processor, and “Secondary lead smelter;” ”deleting the definition of “Primary lead smelter;” and revising the definitions of ”Fugitive dust source,” “Furnace area,” “Malfunction,” “Materials storage and handling area,” “Plant roadway,” “Process fugitive source,” “Refining and casting area,” and Sinter machine area,” and “Tapping location” to read

as follows: § **63.1542 Definitions.**

* * * * *

Affirmative defense means, in the context of an enforcement proceeding, a response or defense put forward by a defendant, regarding which the defendant has the burden of proof, and the merits of which are independently and objectively evaluated in a judicial or administrative proceeding.

* * * * * Fugitive dust source means a stationary source of hazardous air pollutant emissions at a primary lead processor resulting from the handling, storage, transfer, or other management of*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 160 of 198 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 Formatted: No underline*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 161 of 198 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 Formatted: No underline*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 162 of 198 processor in which drossing or refining operations occur, or casting operations occur. Secondary lead smelter means any facility at which leadbearing scrap material, primarily, but not limited to, lead-acid 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 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 Formatted: No underline*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 163 of 198 (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

0.9 1 4 tons per year from the air pollution control devices used

to control emissions from furnace area and refining and casting operations

. (c) 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. 86 tons per year fr om the air pollution control devices used

to control emissions from the building that contains the furnace

area .*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 164 of 198 ( d 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. ( e 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. ( f e ) Except as provided in paragraph ( g f ) of this section, following the initial tests to demonstrate compliance with paragraphs (a) and , (b) and (c) 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 3

calendar months 100 days following any previous compliance test). ( g f ) If the 12 most recent compliance tests demonstrate compliance with the emission limit specified in paragraphs (a) and , (b) and (c) 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. ( h g ) The owner or operator of a primary lead processor must*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 165 of 198 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. ( i 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. ( j 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:*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 166 of 198 **§63.1544 Standards for fugitive dust sources.** ( a) Each owner or operator of a primary lead process or must prepare, and at all times operate according to, a standard operating procedures manual that describes in detail the

measures that will be put in place to control fugitive dust emissions from the sources listed in paragraphs (a)(1) through (a)( 4 ) of this section: (1) Plant roadways; ( 2) Material s storage and handling area(s); (3) Sinter machine area(s); (4) Furnace area(s); and (b) Not withstanding paragraph (c) of this section, the standard operating procedures manual must be submitted to the

A dministrator or delegated authority for review and approval. (c) Existing manuals that describe the measures in place to control fugitive dust sources required as part of a State implementation plan for lead shall satisfy the requirements of paragraph (a) of this section provided they address the sources listed in paragraphs (a)(1) through (a)( 4 ) of this section. ( d 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

ambient concentration of lead in air to exceed 0.15 μg/m 3 on a 3- Formatted: Tab stops: Not at 0.64"

Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 167 of 198 month rolling average measured at locations approved by the

Administrator. the property boundary of the primary lead

processor . ( e 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 [INSERT DATE TWO YEARS FROM THE DATE OF PUBLICATION OF THESE AMENDMENTS IN THE FEDERAL REGISTER]. (b) Each owner or operator of a new primary lead processor must achieve compliance with the requirements of this subpart no later than [INSERT DATE 60 DAYS AFTER PUBLICATION OF THESE AMENDMENTS IN THE FERERAL REGISTER] or startup, whichever is Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 168 of 198

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) and (c) 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 appendix A of part 60 of this chapter: (i) Method 1 must be used to select the sampling port location and the number of traverse points. (ii) Method 2, 2F, 2G must be used to measure volumetric

flow rate. (iii) Method 3, 3A, 3B must be used for gas analysis. (iv) Method 4 must be used to determine moisture content of the stack gas. (v) Method 12 or Method 29 must be used to determine lead emissions rate of the stack gas. (2) A performance test shall consist of at least three runs. For each test run with Method 12 or Method 29, the*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 169 of 198 minimum sample time must be 60 minutes and the minimum volume must be 1 dry standard cubic meter (35 dry standard cubic feet). (3) Performance tests shall be completed quarterly, once every 3 months, to determine compliance. (4) The lead emission rate in pounds per quarter is calculated by multiplying the quarterly lead emission rate in pounds per hour by the quarterly plant operating time, in hours as shown in Equation 1: (Eq. 1)

Where:

E Pb = quarterly lead emissions, pounds per quarter;

ER Pb = quarterly lead emissions rate, pounds per hour; and QPOT = quarterly plant operating time, hours per quarter. (5) The lead production rate, in units of tons per quarter, must be determined based on production data for the previous quarter according to the procedures detailed in paragraphs (a)(3)(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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 170 of 198 (iv) Total quarterly lead production must be determined by summing the values obtained in paragraphs (a)(3)(i) through (a)(3)(iii) of this section. (6) To determine compliance with the production-based leadcompound emission rate in §63.1543(a), the quarterly productionbased lead compound emission rate, in units of pounds of lead emissions per ton of lead produced, is calculated as shown in Equation 2 by dividing lead emissions by lead production.

(Eq. 2)

Where :

CE Pb = quarterly production-based lead compound emission rate, in units of pounds of lead emissions per ton of lead produced;

E Pb = quarterly lead emissions, pounds per quarter; and

P Pb = quarterly lead production, tons per quarter. (7) To determine quarterly compliance with the emissions standard for lead compounds under §63.1543(b) , and (c) , (i) 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 paragraph s (a)(1) through (a)(4) of this

section

. , and*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 171 of 198 (ii) sum the lead compound emission rates for the current and previous three quarters for the building that contains the

furnace areas to determine c ompliance with §63.1543( c ), as determined in accordance with paragraph (a)(1) of this section. (b) Owner and operators must perform an initial compliance test to demonstrate compliance with the sinter building in-draft requirements of Sec. 63.1543( e 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 172 of 198

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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 173 of 198 (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 self-tensioning (spring loaded) devices. (6) Quarterly confirmation of the physical integrity of the baghouse through visual inspection of the baghouse interior for

air leaks. (7) Quarterly inspection of fans for wear, material buildup, and corrosion through visual inspection, vibration detectors, or equivalent means. (8) Except as provided in paragraph (h) of this section, continuous operation of a bag leak detection system. (d) The procedures specified in the standard operating procedures manual for maintenance must, at a minimum, include a preventative maintenance schedule that is consistent with the baghouse manufacturer's instructions for routine and long-term*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 174 of 198

maintenance. (e) The bag leak detection system required by paragraph (c)(9) 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 175 of 198

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 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 176 of 198 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 Sec. 63.1543(h). The percentage*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 177 of 198 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 Sec. 63.1543 are exempt from the requirement in paragraph Sec. 63.1543 (c)(9) 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)*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 178 of 198 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 Sec. 63.1543( e d ) in accordance with either paragraph (i)(1), (i)(2), or (i)(3) of this section. (1) Owners and operators must check and record on a daily basis doorway in-draft at each doorway in accordance with the methodology specified in Sec. 63.1546(b). (2) Owners and operators must establish and maintainbaseline ventilation parameters which result in a positive indraft according to paragraphs (i)(2)(i) through (i)(2)(iv) of

this section. (i) Owners and operators must install, calibrate, maintain,*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 179 of 198 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 buildingin-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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 180 of 198

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. (1) Each owner or operator may delay CEMS installation until 180 days after promulgation of performance specifications for each*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 181 of 198 applicable source subject to the emissions limits f or lead compounds under §63.1543(a) , (b) and (c)

. (i) Prior to promulgation of performance specifications for CEMS used to measure lead concentrations, an owner or operator must use the procedure described in §63.1546 (a)(1) through (a)(7) of this section to determine compliance. (2) If a CEMS used to measure lead emissions is applicable, the owner or operator must install a CERMS with a sensor in a location that provides representative measurement of the exhaust gas flow rate at the sampling location of the CEMS used to 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 182 of 198 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) and (c)

. (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.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 183 of 198 (k) The owner or operator of each source subject to §63.1544( d a ) must operate a continuous monitoring system for the measurement of lead compound concentrations in the ambient 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. At least four ambient air monitors must be located at sites

selec ted to detect expected maximum concentrations of lead compounds in the ambient air in accordance with a plan approved by the Administrator. The plan must include the sampling and analytical method used. (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 procedures and the justification for any seasonal, background, or other data adjustments within 45 days after the effective date of this subpart. The owner or operator must submit a written plan describing, and explaining the basis for, the design and Formatted: Highlight

Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 184 of 198 adequacy of the monitoring network, sampling and analytical procedures, and quality assura nce within 45 days after the effective date of this subpart. (3) Each ambient monitor must be operated continuously except for a reasonable time allowance for instrument maintenance and calibration, for changing filters, absorbent traps, or other sample c ollection media, or for replacement of equipment needing major repair. (4) Filters or other sample collection media must be changed daily and must be analyzed and concentrations calculated within 30 days after such media are collected. ( 5 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. The Administrator at any time may require changes in, or expansion of, the sampling program, includin g sampling and analytical protocols and network design.

(l) If all rolling three-month average concentration 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). Formatted: Line spacing: Double Formatted: Font: 12 pt, Complex Script Font: 12 pt Formatted: Font: 12 pt, Complex Script Font: 12 pt, Highlight

Formatted: Highlight Formatted: Font: 12 pt, Complex Script Font: 12 pt, Highlight Formatted: Highlight Formatted: Font: 12 pt, Complex Script Font: 12 pt, Highlight Formatted: Font: 12 pt, Complex Script Font: 12 pt Formatted: Highlight Formatted: Font: 12 pt, Complex Script Font: 12 pt, Highlight Formatted: Highlight Formatted: Font: 12 pt, Complex Script Font: 12 pt, Highlight Formatted: Font: 12 pt, Complex Script Font: 12 pt Formatted: Font: 12 pt, Complex Script Font: 12 pt*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 185 of 198 For any subsequent period, if any rolling three-month average lead concentration in air measured at any monitor in the monitoring system exceeds [50 percent] of the concentration limit in §63.1544(a), the owner or operator must resume monitoring pursuant to paragraph (k)(1) at all monitors until another three consecutive years of lead concentration in air measurements less than [50 percent] of the lead concentration in

air limit is demonstrated. If the daily ambient concentration of lead measured in the air is less than 50 percent of the ambient

concentration limit in § 63.1544(d) for 2 consecutive year s, the owner or operator may reduce sampling frequency to one daily sample from each monitor every 6 months. If any ambient concentration measured during one of the 6

- month monitoring events exceeds 50 percent of the ambient concentration limit in § 63.1544 (d), the owner or operator must resume daily monitoring

at all monitors until another 2 consecutive years of ambient concentration measurements less than 50 percent of the ambient

concentration 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 Sec. 63.9 of subpart A, General Provisions as specified in Table 1 of this Formatted: Highlight

Formatted: Highlight

Formatted: Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 186 of 198 subpart. (b) The owner or operator of a primary lead processor must

submit the fugitive dust control standard operating procedures manual required under Sec. 63.1544(a) and the standard operating procedures manual for baghouses required under Sec. 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 se plans 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 Sec. 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 Formatted: Not Highlight

Formatted: Not Highlight*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 187 of 198 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 Sec. 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 188 of 198 requirements practices described in the compliance monitoring system plan standard operating procedures manua l required under §63. 1544 1547 ( k a ) (2) for the control of fugitive dust emissions

. (5) Any recordkeeping required as part of the practices described in the standard operating procedures manual for baghouses required under Sec. 63.1547(a). (6) If an owner or operator chooses to demonstrate continuous compliance with the sinter building in-draft requirement under Sec. 63.1543( e d ) by employing the method allowed in Sec. 63.1547(i)(1), the records of the daily doorway in-draft checks, an identification of the periods when there was not a positive in-draft, and an explanation of the corrective

actions taken. (7) If an owner or operator chooses to demonstrate continuous compliance with the sinter building in-draft requirement under Sec. 63.1543( e d ) by employing the method allowed in Sec. 63.1547(i)(2), the records of the output from the continuous volumetric flow monitor(s), an identification of the periods when the 15-minute volumetric flow rate dropped below the minimum established during the most recent in-draft determination, and an explanation of the corrective actions

taken. (8) If an owner or operator chooses to demonstrate*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 189 of 198 continuous compliance with the sinter building in-draft requirement under Sec. 63.1543( e d ) by employing the method allowed in Sec. 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( j 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 Sec. 63.10 of subpart A, General Provisions as specified in Table 1 of this subpart. (e) In addition to the information required under Sec.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 190 of 198 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 Sec. 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 Sec. 63.1547(g). (4) If an owner or operator chooses to demonstrate continuous compliance with the sinter building in-draft requirement under §63.1543( e 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( e 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 191 of 198 below the minimum established during the most recent in-draft 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( e 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 fugitive dust control measures performed during the required reporting period, including an explanation of any periods when the procedures outlined in the compliance monitoring system plan standard operating procedures manual required by §63. 1544 1547 ( a k ) (2) were not followed and the

corrective actions taken. The reports must not contain copies of*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 192 of 198 the daily records required to demonstrate compliance with the requirements of the standard operating procedures manuals required under §63.1544(a) and §63.1547(a). (9) If there was a malfunction during the reporting period, the report shall also include the number, duration, and a brief description for each type of malfunction which occurred during the reporting period and which caused or may have caused any applicable emission limitation to be exceeded. The report must also include a description of actions taken by an owner or operator during a malfunction of an affected source to minimize emissions in accordance with §§63.1543( j i ) and 63.1544( e 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.** *** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 193 of 198 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 194 of 198 inadequate design, operation, or maintenance; and (2) Repairs were made as expeditiously as possible when the applicable emission limitations were being exceeded. Off-shift and overtime labor were used, to the extent practicable to make these repairs; and (3) The frequency, amount and duration of the excess emissions (including any bypass) were minimized to the maximum extent practicable during periods of such emissions; and (4) If the excess emissions resulted from a bypass of control equipment or a process, then the bypass was unavoidable to prevent loss of life, 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*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 195 of 198 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 (d)(1) of this section. 12. Table 1 to Subpart TTT of Part 63 is revised to read as

follows: Table 1 of Subpart TTT – General Provisions Applicability to Subpart TTT*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 196 of 198

**Reference Applies**  **to s**  **ubpart TTT Comment**  * * * * * * * 63.6(a), (b), (c) Yes 63.6 (d) No Section reserved. 63.6(e)(1)(i) No See 63.1543( j i ) and 63.1544( e 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 N o 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) N o 63.8(c)(1)(ii) Yes 63.8(c)(1)(iii) No*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 197 of 198

63.8(c)(2)-(d)(2) Yes 63.8(d)(3) Yes, except f or 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) Y es 63.(10)(b)(3) Yes 63.10(c)(1)-(9) Yes 63.10(c)(10)-(11) No See 63.1549(b) ( 9) and (10) for recordkeeping of malfunctions. 63.10(c)(12)-(c)(14) Yes 63.10(c)(15) No 63.10(d)(1)-(4) Yes 63.10(d)(5) No S ee 63.1549(e)(9) for reporting of malfunctions.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review *** Page 198 of 198

63.10(e)-((f) Yes * * * * * * *

### Primary Lead Smelting NESHAP Technical Support Document



# Risk and Technology Review National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Primary Lead Smelting Source Category Technical Support Document 

# REVISED DRAFT 1/24/11

Docket No. EPA-HQ-OAR-2004-0305 January 31, 2011

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## Table of Contents

1.0 Residual Risk Analysis - Development of the Emissions Dataset for the Primary Lead Smelting Source Category ............................................................................................................... ................ 1 1.1 Emissions Data Sources .................................................................................................... .. 2 1.2 Risk Analysis Emissions Data Set ...................................................................................... 2 1.2.1 Actual Emissions ................................................................................................... 3 1.2.2 Allowable Emissions ............................................................................................. 5 2.0 Calculation of Proposed Risk-Based Emission Limits Based on Modele d Concentrations ............ 7 3.0 Estimated Costs of Proposed Revisions to the Primary Lead Smelting NESHAP ........................ 10 3.1 Emission Control Costs for Ample Margin of Safety Reductions .................................... 10 3.2 Additional Testing and Monitoring Costs ......................................................................... 13

Appendix A 2005 NATA - Volatile Organic HAP from Boilers Risk Screening



## Tables Table 2.1 Calculations of Risk-Based Emi ssion Limits Based on Modeled Concentrations Table 2.2 Calculation of Pr oposed Refinery Operation E mission Limit based on Modeled Concentrations Table 3.1 Cost Effectivene ss of Upgrading to Membrane Bags for Main Stack Table 3.2 Cost Effectiveness of Adding an Additional Baghous e to Control Emissions for Main Stack Table 3.3 Additional Tes ting and Monitoring Costs

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## 1.0 Residual Risk Analysis ­ Development of the Emissions Dataset for the Primary Lead Smelting Source Category This technical support document describes the de velopment of the dataset used to conduct the residual risk analysis under S ection 112 (f)(2) of the Clean Air Act (CAA) for the Primary Lead Smelting source category. Section 112 of the Clean Air Act (CAA) establis hes a two-stage regulator y process to address emissions of hazardous air polluta nts (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, sec tion 112(d) of the CAA calls for us to promulgate a National Emission Standard for Hazardous Air Pollu tants (NESHAP) for those sour ces. These technology-based standards must reflect the maxi mum degree of emission reducti ons of HAP achievable (after considering cost, energy requirements, and non- air quality health and e nvironmental impacts) and are commonly referred to as maximum achie vable control technology (MACT) standards. The NESHAP for the Primary L ead Smelting source category was promulgated on June 4, 1999. The EPA is then required to review these tec hnology-based standards and to revise them “as necessary (taking into account developments in practices, processes, an d 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 recalc ulate 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 remaini ng “residual” risk according to CAA section 112(f)(2) and requires EP A to determine for so urce categories subject to certain MACT standards, whether the emission s standards provide an am ple margin of safety to protect public health. If th e MACT standards apply to a so urce category emi tting a HAP that is “classified as a known, proba ble, or possible hum an 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,” EP A 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 th at the existing standards are sufficiently protective. In order to conduct the risk analysis of sources in the Primary Lead Sm elting source category, a dataset was developed that included estimate s of individual HAP em issions from each HAP emitting source as well as source characteristics . The dataset used includes both actual and allowable facility emissions and was used in the emissions modeling exercise to determine concentrations of various HAPs at the modeled receptor locations . Those concentrations were compared to the established ri sk-based threshold for each HAP to determine th e potential for

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## residual risk from the e missions. The methods, thresholds, and results of risk analysis and modeling are described in the “Residual Risk Assessment for the Primary Lead Smelting Source Category” memorandum included in this docket. Below is a discussion of the sources of the actual and allowable emissions data and source ch aracteristics used in the risk analysis and modeling exercise.

1.1 Emissions Data Sources The preliminary sources used to gather emissions and source characteristic data included the 

## 2002 National Emissions Inventory (N EI) Final Inventory, Version 1 (made publicly available on February 26, 2006), and the 2005 National Emi ssions 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 th e state of MO to EPA. These data sets include 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 character istic data such as emission release height, temperature, and velocity, and location latitude/l ongitude coordinates. We review ed the NEI datasets, checked geographic coordinates, and made cha nges based on available information. The sole remaining facility in this source category is the Doe Run Company in Herculaneum, Missouri. The Doe Run f acility has been the subject of ma ny compliance and regulatory actions by the State of Missouri and by EPA Region 7 related to compliance with the lead National Ambient Air Quality Standard (NAAQS). The controls applicable to the fac ility in order to meet the NAAQS were adopted by the State and submitt ed to EPA for approval into the Lead State Implementation Plan. The most recent SIP sub mission to address the lead NAAQS was made in 2007 and it included modeling of fa cility emissions to determine compliance with the lead NAAQS. EPA reviewed the emissions data used relied on in that submission to update the risk analysis data set. Since many improvements in emissions contro ls have been implemented from 2001 through 2007 due to the 2001 SIP and the 2007 SI P revision, EPA determined that the most recent data should be considered to determine ri sk based on actual emissions from the facility. EPA requested emissions and source control information through a s ection 114 information collection request (ICR) in Oc tober, 2009. The February, 2010 response from Doe Run included copies of the emissions inventor ies that were provided to the Missouri Department of Natural Resources (MDNR) for CY 2000 through 2008.

1.2 Risk Analysis Emissions Data Set The analysis performed considers HAPs that em itted by the sources with in the source category addressed by the existing MACT standard. The risk analysis considers both the actual emissions of the facility and the emissions allowed under th e MACT rule. Once the analysis is complete,

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## EPA determines if any further emission reductions are necessary to assure that an acceptable level of risk is achieved and must promulgate additional standards, if necessary, to protect public health and welfare with an ample margin of safe ty. For the Doe Run facility, we determined the actual and allowable emissions as described below.

1.2.1 Actual Emissions We reviewed the NEI datasets, checked geogra phic coordinates, and made changes based on available information. We also re viewed the emissions and other da ta to identify data anomalies that could affect risk estimates. Since the 2008 emissions inventory is th e most recent emissions data source available, and reflects the implem entation of the numerous SIP emission reduction requirements (as evidenced by the ICR response) , EPA determined that the emissions reported for the facility in the CY2008 emissions inventor y report are the most re presentative of current facility operations. The dataset derived from the review of th e 2002 and 2005 NEI/NATA data was updated to include the emissions for all sources from the CY2008 emissions inventory report. Any differences in the data between the NEI a nd the CY2008 emission inventory were noted and analyzed. If data found in the NEI was not included in the CY2008 emission inventory, but was found to be pertinent, then it wa s included in the data set used for the risk analysis. Any discrepancies found between the NEI and the CY2008 emission inventory was discussed with the facility. One specific change to the dataset derived from the combination of the NEI data and the CY2008 emission inventory pertained to organic HAP (VOC) emissions. The 2005 NEI file included several boiler sources that emitted trace leve ls of 25 organic HAP (VOC) from na tural gas combustion sources and from combustion of small amounts of coke fed to the blast furnace. During the original MACT development in 199 7, EPA believed these levels of organic HAP emissions were not significant enough to warrant regulation and were far below what the EPA has historically considered achievable with add-on controls (e.g., th ermal oxidizers). VOC emission levels as reported in the ICR response were consistent with the 1997 levels, however; the ICR did not include individual VOC HAP emissions data. We did a screening of the VOC HAP from the 2005 NEI file (NATA) and found the maximum cancer risk was 0.0002 in a million at any off site lo cation, the maximum hazard index was 0.000002 and the maximum acute exposure was for formaldehyde with an REL of 0.1. Based on the very low emission levels and the anticipated low concentrations (and corresponding risk) th at would result from modeling these emission points, the organic HAP em issions sources were removed from the modeling dataset and not considered during the risk analysis. The dataset and results of the VOC HAP risk screening analysis are included as Appendix A.

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## The final dataset included emissions of lead compounds and other meta l HAP (i.e. antimony, arsenic, cadmium, chromium, cobalt, and nickel). “Lead compounds” is the primar y HAP emitted from the Doe Run facility and accounts for approximately 99 percent of the total HAP emitted. Of the lead compound emissions, approximately 86 percent is emitted through stacks (point or vertical sources) with the remainder being fugitive emissions. The point or verti cal sources include stacks that discharge from baghouses, heat stacks and roof ve nts. The MACT emission limi t applies to operations that discharge through 2 stacks, the main and the fu rnace area stacks which account for 15.1 of the total 17.9 TPY stack lead compound emissions. Since promulgation of the MACT rule, the facility has captured and controlled all re fining operations with two additional baghouses (baghouse #8 which vents to a stack and baghouse #9 which vents to a common stack with the furnace area ). These emissions are included in the table below. Fugitive sources include material handling and plant yard and roadwa y dust. Table 1.1 summarizes the types and volumes of HAP emitted from fugitive and point sour ces that were included in the dataset for the Doe Run Company facility. Tota l actual lead emissions includ ing fugitive e missions are 20.7 tons per year (TPY). The ri sk dataset includes 137 data poi nts for lead compound emissions. Emissions sources of lead include 115 individual fugitive emission sources (o r data points in the dataset) and 22 point sources (stacks). The 22 point sources include the main stack and the furnace area stacks which together account for 98 percent of the total stack lead emissions and are the two sources that are subject to the MACT standard emission lim it. It should be noted that non-volatile metal HAP other than lead are re ported by Doe Run base d on speciation tests conducted for the various sources. Table 1.1 - Summary of Doe Run Comp any Risk Dataset Emission Sources Fugitive Point (stack) Total

HAP Number of Sources TPY Number of Sources TPY Number of Sources TPY Lead 115 2.8053 22* 17.9030 137 20.7083 Antimony 6 0.0028 4 0.0252 10 0.0280 Arsenic 10 0.0005 6 0.0210 4 0.0215 Cadmium 12 0.0296 7 0.0823 19 0.1118 Chromium 0 0.0000 3 0.0056 3 0.0056 Cobalt 6 0.0005 6 0.0049 12 0.0054 Nickel 8 0.0019 7 0.0154 15 0.0172 *2 stacks (main and furnace area) account for 17.6 or th e total 17.9 TPY and are subject to the MACT emission limit. 

## The actual emissions dataset for this facility repr esents the entire source category. Likewise, all emission points located at this facility and th at emit HAP are included in the risk analysis

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## dataset; therefore, the facility-wide emission dataset for this source category is the same as the risk analysis dataset.

1.2.2 Allowable Emissions Allowable emissions are emissions that would be allowed under the current MACT standard for primary lead smelters. Under the Primary Lead Smelting MACT, l ead HAP emissions are regulated and lead emissions serve as a surroga te for all other non-vola tile metal HAP emitted from the source.. For the Doe Run facility, allo wable emissions are summarized in Table 1.2. Under the NESHAP, an aggregate emission limit of 1.0 pound of l ead per ton of lead produced (lb/ton) applies to the following nine sources: 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 a nd sizing equipment 9) Sinter machine area Applying the allowable emissions rate of 1.0 lb /ton to the Doe Run’s 2008 lead production of 149,564 tons, the aggregate allowable emissions resu lts in aggregate lead emissions of 74.8 TPY from the above nine sources. A ll emissions from the source’s nine emission points listed above are captured and controlled by baghouses, which vent to the main stack or the furnace area stack. The total allowable emissions were prorated be tween the two stacks based on the ratio of actual emissions reported for the two stacks. Note that refining operations are not listed above and are not subject to th e 1.0 lb/ton limit in the original MACT. At the time the NESHAP was promulgated, the refining operations were not enclosed and emissions from this operation were regulated u nder the provisions addressing fugitive emissions sources, however, based on more recent requirements adopted by the State, refinery emissions are now captured, controlled by a baghouse, and vented through two stacks. We were unable to calculate an allowabl e emission level for refining operations. Under the NESHAP, fugitive emissions are governed by work practices, which under §63.1544 are defined as the measures that will be “put into place to contro l fugitive dust emissions.” Thus, the actual fugitive emissions, whic h reflect the measures that have been put in place, would be equivalent to the allowable emissions. Fug itive emissions levels were taken from Doe Run’s 2008 Emissions Inventory that is s ubmitted annually to the MDNR.

### Primary Lead Smelting NESHAP Technical Support Document

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### Emission Point Processes Actual Emissions

(TPY) Allowable Lead Emissions

(TPY) Main Stack (BH # 3, 5, 6) Sintering, blast furnace, dross furnace 13.31 65.8 Furnace Area (BH # 7) Smelter building 1.81 8.94 Refining (BH # 8, 9) Refining kettles and building 2.74 N/A Fugitives Roadways, storage piles, materials handling and transport 2.85 2.85

N/A = not available



## The MACT-allowable emissions from this sour ce category are based on the MACT limit (1 lb/ton) applied to 2008 production data . The modeling file for this risk analysis can be reviewed in the EXCEL spreadsheet “ PrimLead_RTR_Modeli ngFile_102110_2008_DOE _RUN.xls ” available in the docket.

References: 1. Curran, D., Stinson Morrison Hecker, for The Do e Run Company, to Nizich, S., US EPA, Response to Section 114 Information Collection Request, February 5, 2010.

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## 2.0 Calculation of Proposed Emission Limits Based on Modeled Concentrations The risk analysis process included modeling of ac tual and allowable emissions to determine the anticipated concentration at individual recepto r locations. For this source category, the emissions for the lead emissions sources were individually m odeled for each receptor location and the results were compared to the Primary National Ambient Air Quality Standard (NAAQS) for lead (0.15 μ g/m 3 

## ). If the modeled emissions exceeded th e lead NAAQS, those locations were considered to be exposed to unacceptable risk. Th e results indicated multiple locations exceeded the level of the NAAQS to various degrees. Our modeling results indicated that the highe st concentration location was a point on the property boundary. Emissions contributing to this exceedance were found to be cumulative fugitive dust emissions. Other emission points with modeled emission showing an exceedance of the lead NAAQS we re the furnace area stack and the Baghouse #9 stack for the refinery building. Both of these stacks showed modele d levels above the NAAQS at various census block locations. The emissions from the main stack did not exceed NAAQS within the 50 km radius modeled area. Each emission point (with fugiti ve dust emissions being treated as one emission point) was analyzed to determine what emission levels woul d be necessary to reduce risk to an acceptable level i.e., such that modeled emissions met or were below th e level of the NAAQS. EPA assumes that if the highest or worst-case concen tration at a receptor lo cation resulting from the emissions from each emission point were reduced to below the N AAQS level, then the risks for that emission point at any loca tion would be reduced to an ac ceptable level. Further, EPA assumes that a reduction in emissions from an emission point will re sult in a proportionate reduction in the modeled concentr ation at a given receptor locati on. For example, if emissions from a stack are reduced by 50 percent, the mode led concentration at a receptor location will be reduced by 50 percent. Since the relations hip between level of emissions and modeled concentrations is linear, a percen tage reduction could be applied to the actual emissions from the CY 2008 emissions inventory for a given emission point that would reflect the same reduction in modeled concentration. Therefor e, a calculation was made for each emission point to determine what percent reduction in concentration was re quired for each of the highest concentration locations to meet the NAAQS. The reduction necessary in fugitive dust emissi ons was determined to be 98 percent. Our analysis indicated that the maximum lead concen tration location for the furnace area and refinery stack overlapped at the same census block (cen sus block #). Theref ore, their combined concentrations at that location w ould be the driver for the reduction from thes e emission points. The reduction necessary for the combined furnace area stack and refinery stacks emissions was determined to be 80 percent. The refinery emissions are vented through Ba ghouse #8 and Baghouse #9 stacks, and ten heat stacks. For the refinery operation, only one st ack (Baghouse #9) showed an exceedance of the NAAQS. The emission reducti on found necessary from Baghouse #9 stack is 66 percent. It

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## was also found that the furnace area and refinery stack emissions maximum lead concentration overlap at the same census block (censu s block #290997006014031). To address the overlap, these points would need to be reduced together su ch that the lead concentration at that point would be acceptable. The emission reduction necessary for the combined furnace area and refinery stacks is 80 percent. Table 2.1 summarizes the calculations and recomme nded limits for the to tal facility including furnace area/refinery stacks and fugitive dustPrimary Lead Smelting NESHAP Technical Support Document9Table 2.1 - Calculations of Risk-Based Emission Limits Based on Modeled ConcentrationsModeled Source2008 Emissions(tpy)Modeled leadconcentrationat the site of maximumimpact(μg/m3)Roll back tomeet NAAQS%Emissions afterrollback (tpy) NotesStacks- Furnace area (Baghouse #7) 1.81 0.314 52 0.86 At census block #290997006014031- Refinery stacks 2.74 0.4363 66 0.94At census block #290997006014031Combined Stacks 4.55 0.7503 80 0.91FugitivesAll Fugitives 2.94 7.289 980.06fume, sinter and concentrate handlingRoadways, plant yard, resuspensionHighest concentration at property boundaryreceptor location1) Emission LimitLead concentration in air*0.15μg/m32) Emissions CapFurance Area and refinery stacks0.91 TPYCalculations Roll back % = (Actual concentration - 0.15)/actual concentrationEmissions after rollback = 2008 emissions * (1-(rollback%/100))*MeasuredatlocationsrepresentativeofpropertyboundaryasdeterminedbytheAdministratorPROPOSED ACTIONSAll Modeled Sources

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## 3.0 Estimated Costs of Proposed Revisions to the Primary Lead Smelting NESHAP

With regard to lead emissions, we are proposing emission limits that ar e consistent with the results of our risk and technology reviews of th e current NESHAP for primary lead smelters. Under our ample margin of safety analysis, we considered addi tion controls beyond the existing level of control for the main stack to determine if additional contro ls would be warranted in order to provide an ample margin of safety. This section summarizes the impacts analysis conducted on additional emission control options that we re considered technologically feasible for achieving additional emission reductions for the main stack. Although our analysis indicated that additional controls were not warranted for the main stac k, we are proposing to lower the plant-wide emission limit to re flect performance achievable from technological improvements. In addition we are proposing to increase the frequency of mon itoring stack emission from the current annual emissions testing to quarterly te sting. This section, th erefore, also includes estimates of the impacts for the additional moni toring costs necessary to comply with proposed requirement. We note that the controls that reduce lead emi ssions are the same cont rols that would reduce emissions and risks from cad mium and other metal HAP; th erefore we ar e not proposing additional controls for other metal HAP. For the main stack emission point, we consider ed the option of upgradi ng of existing baghouses from the use of cloth bags to membrane bags and the option of adding in-series baghouses. 3.1 Emission Control Costs for Ample Margin of Safety Reductions Once we determine that risk will be reduced to a level that is acceptable, we then determine whether further reductions are appropriate to ensure an ample margin of safety. We investigated available control options that could be implemen ted by the facility to attain the additional emissions reductions that would provid e an ample margin of safety. No additional controls beyond those described above were identified to further control fugitive dust emissions or emissions from the furnace area stack or the refinery stacks. For the main stack, however, additional controls were evaluated and considered with regard to risk reduction and cost under the ample margin of safety analysis. For the main stack, our risk analysis indicates that emissions do not result in ambient lead levels exceeding the NAAQS based on either actual or allowable emission levels. However, we determined that it is technological ly feasible to reduce emissions from the main stack to a level well below the allowable level of the MACT, sinc e those levels are currently being achieved. We evaluated additional controls such as memb rane bags or add-on baghouses as a means for achieving those reductions and reducing associated risk. We determined that the additional controls would not provide an appreciable risk reduction (emission reducti on) for the associated cost. However, we have determined that e missions allowable under MA CT should be reduced

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## under the section 112(d)(6) tec hnology review as described in the technology review memorandum found in this docket. Table 3.1 summarizes the costs and cost-effectivene ss for the main stack of replacing cloth bags with membrane bags. Table 3.3 summarizes the costs and cost-effectiveness of adding an inseries baghouse. The calculations supporting the costs reflected in the summary are included in EXCEL spreadsheet DRAFT ImpactsEst_P rimLeadRTR_122210.xls found in the docket.Primary Lead Smelting NESHAP Technical Support Document12Total CostInvestmentTotalAnnualizedCost2008 BaselinePb Emissions(tpy)Emission Reductionfrom upgrade*(tpy)CE($/ton)Main Stack 1,958,851 322,823 13.31 8.0 40,424*We estimate removal efficiency for membrane bag update to be between 50 and 70 percent.Cost of Upgrade toMembrane BagsTable 3.1 - Cost Effectiveness of Upgrading to Membrane Bags for Main StackImpactsSourcePb emissions (tpy)reported in 2008EIPb emission reductionwith additional BHassuming 50% RE (tpy)Pb emission reductionwith additional BHassuming 97% RE (tpy)Annualized cost ofadding extra BH's($/yr)Cost effectivenessassuming 50% RE($/ton)Cost effectivenessassuming97% RE($/ton)Main Stack 13.31 6.7 12.9 $1,529,730 $229,862 $118,4851Reflects costs for pulsejet baghouses2See DRAFT ImpactsEst_PrimLeadRTR_122210.xls for detail on cost analysis.RE = Removal efficiencyTable 3.2 - Cost Effectiveness of Adding an Additional Baghouse to Control Emissions for the Main Stack1,2

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## 3.2 Additional Testing and Monitoring Costs To demonstrate compliance with the new plant-wi de emission limit, EPA is proposing to require quarterly stack testing. Although the method for testing is the same as it was under the current MACT, the quarterly frequency requirement imposes a dditional impact with re gard to the cost of additional testing. The proposed additional testing and monitoring re quirements will result in additional cost as summarized in Table 3.3 below.

Table 3.3 - Additional Testing and Monitoring Costs Type of Testing/Monitoring Notes Cost Annual Cost 1 

### Stack Testing Method 12 $13,000 per test $39,000 1 

### Includes 3 additional stack tests

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## APPENDIX A

Doe Run Company, Herculaneum, MO 2005 NEI (NATA) - Volatile Organic HAP from Boilers Risk Screening

### Primary Lead Smelting NESHAP Technical Support Document

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## Risk and Technology Review National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Primary Lead Smelting Source Category Technical Support Document 

# REVISED DRAFT 1/ 2 45 18 /11

Docket No. EPA-HQ-OAR-2004-0305 January 31, 2011Primary Lead Smelting NESHAP Technical Support Document

i 

### Table of Contents

1.0 Residual Risk Analysis - Development of the Emissions Dataset for the Primary Lead Smelting Source Category ............................................................................................................... ................ 1 1.1 Emissions Data Sources .................................................................................................... .. 2 1.2 Risk Analysis Emissions Data Set ...................................................................................... 2 1.2.1 Actual Emissions ................................................................................................... 3 1.2.2 Allowable Emissions ........................................................................................... 5 4 2.0 Calculation of Proposed Risk-Based Emission Limits Based on Modeled Concentrations ............ 7 3.0 Estimated Costs of Proposed Revisions to the Primary Lead Smelting NESHAP .................... 12 10 Error! Hyperlink reference not valid. 3.1

............. Emission Control Costs for Risk Acceptability Reduction s .................................................................................................................... 12 10 3. 1 2 Emission Control Costs for Ample Margin of Safety Reductions ................................ 13 11 3. 2 3 Additional Testing and Monitoring Costs ..................................................................... 15 13

Appendix A 2005 NATA - Volatile Organic HAP from Boilers Risk Screening

Tables Table 2.1 Calculations of Risk-Based Emissi on Limits Based on Modeled Concentrations Table 2.2 Calculation of Proposed Refinery Operation Emission Limit based on Modeled Concentrations Table 3.1 Cost Effectiveness of Upgrading to Membrane Bags for Baghouses 7, 8 and 9 Table 3.2 Cost Effectiveness of Adding an Additional Baghouse to Control Emissions for Baghouses 7, 8 and 9 Table 3. 1 3 Cost Effectiveness of Upgrading to Membrane Bags for Main Stack Table 3. 2 4 Cost Effectiveness of Adding an Additional Baghouse to Control Emissions for Main Stack Table 3. 3 5 Additional Testing and Monitoring CostsPrimary Lead Smelting NESHAP Technical Support Document

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### 1.0 Residual Risk Analysis ­ Development of the Emissions Dataset for the Primary Lead Smelting Source Category

This memo technical support document describes the development of the dataset used to conduct the residual risk analysis under Section 112 (f)( 2) of the Clean Air Act (CAA) for the Primary Lead Smelting source category. 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 ca lls for us to promulgate a National Emission Standard for Hazardous Air Pollutants (NESHAP) for those 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. The NESHAP for the Primary Lead Smelting source category was promulgated on June 4, 1999. 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)(2) and requires EP A 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 standard s apply to a source category emitting a HAP that is “classified as a known, probable, or poss ible 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. In order to conduct the risk analysis of sources in the Primary Lead Smelting source category, a dataset was developed that included estimates of individual HAP emissions from each HAP emitting source as well as source characteristics. The dataset used includes both actual and allowable facility emissions and was used in the emissions modeling ex ercise to determine concentrations of various HAPs at the modeled receptor locations. Those concentrations were compared to the established risk-based thresh old for each HAP to determine the potential forPrimary Lead Smelting NESHAP Technical Support Document

2 residual risk from the emissions. The methods, thresholds, and results of risk analysis and modeling are described in the “Residual Risk Assessment for the Primary Lead Smelting Source Category” memorandum included in this docket. Below is a discussion of the sources of the actual and allowable emissions data and source characteristics used in the risk analysis and modeling exercise.

1.1 Emissions Data Sources The preliminary sources used to gather emissions and source characteristic data included 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. These data sets include information about sources that emit crite ria 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, and velocity, and location latitude/longitude coordinates. We reviewed the NEI datasets, checked geographic coordinates, and made changes based on available information. The sole remaining facility in this source cate gory is the Doe Run Company in Herculaneum, Missouri. The Doe Run facility has been the subject of many compliance and regulatory actions by the State of Missouri and by EPA Region 7 related to compliance with the lead National Ambient Air Quality Standard (NAAQS). The controls applicable to the facility in order to meet the NAAQS were adopted by the State and submitted to EPA for approval into the Lead State Implementation Plan. The most recent SIP submission to address the lead NAAQS was made in 2007 and it included modeling of facility emissions to determine compliance with the lead NAAQS. EPA reviewed the emissions data used relied on in that submission to update the risk analysis data set. Since many improvements in emissions controls have been implemented from 2001 through 2007 due to the 2001 SIP and the 2007 SIP revision, EPA determined that the most recent data should be considered to determine ri sk based on actual emissions from the facility. EPA requested emissions and source control information through a section 114 information collection request (ICR) in October, 2009. The February, 2010 response from Doe Run included copies of the emissions inventories that were provided to the Missouri Department of Natural Resources (MDNR) for CY 2000 through 2008.

1.2 Risk Analysis Emissions Data Set The analysis performed considers HAPs that emitted by the sources within the source category addressed by the existing MACT standard. The risk analysis considers both the actual emissions of the facility and the emissions allowed under the MACT rule. Once the analysis is complete,Primary Lead Smelting NESHAP Technical Support Document

3 EPA determines if any further emission reductions are necessary to assure that an acceptable level of risk is achieved and must promulgate additional standards, if necessary, to protect public health and welfare with an ample margin of safety. For the Doe Run facility, we determined the actual and allowable emissions as described below.

1.2.1 Actual Emissions We reviewed the NEI datasets, checked geographic coordinates, and made changes based on available information. We also reviewed the emi ssions and other data to identify data anomalies that could affect risk estimates. Since the 200 8 emissions inventory is the most recent emissions data source available, and reflects the implem entation of the numerous SIP emission reduction requirements (as evidenced by the ICR response), EPA determined that the emissions reported for the facility in the CY2008 emissions inventory report are the most representative of current facility operations. The dataset derived from the review of the 2002 and 2005 NEI/NATA data was updated to include the emissions for all sources from the CY2008 emissions inventory report. Any differences in the data between the NEI and the CY2008 emission inventory were noted and analyzed. If data found in the NEI was not included in the CY2008 emission inventory, but was found to be pertinent, then it was included in the data set used for the risk analysis. Any discrepancies found between the NEI and the CY 2008 emission inventory was discussed with the facility. One specific change to the dataset derived from the combination of the NEI data and the CY2008 emission inventory pertained to organic HAP (VOC) emissions. The 2005 NEI file included several boiler sources that emitted trace levels of 25 organic HAP (VOC) from natural gas combustion sources and from combustion of small amounts of coke fed to the blast furnace. During the original MACT development in 19 97, EPA believed these levels of organic HAP emissions were not significant enough to warrant regulation and were far below what the EPA has historically considered achievable with add-on controls (e.g., thermal oxidizers). VOC emission levels as reported in the ICR response were consistent with the 1997 levels, however; the ICR did not include individual VOC HAP emi ssions data. We did a screening of the VOC HAP from the 2005 NEI file (NATA) and found the maximum cancer risk was 0.0002 in a million at any off site location, the maximum hazard index was 0.000002 and the maximum acute exposure was for formaldehyde with an REL of 0.1. Based on the very low emission levels and the anticipated low concentrations (and corresponding risk) that would result from modeling these emission points, the organic HAP emissions sources were removed from the modeling dataset and not considered during the risk analysis. The dataset and results of the VOC HAP risk screening analysis are included as Appendix A.Primary Lead Smelting NESHAP Technical Support Document

4 The final dataset included emissions of lead compounds and other metal HAP (i.e. antimony, arsenic, cadmium, chromium, cobalt, and nickel). “Lead compounds” is the primary HAP emitted from the Doe Run facility and accounts for approximately 99 percent of the total HAP em itted. Of the lead compound emissions, approximately 86 percent is emitted through stacks (point or vertical sources) with the remainder being fugitive emissions. The point or vert ical sources include stacks that discharge from baghouses, heat stacks and roof vents. The MACT emission limit applies to operations that discharge through 2 stacks, the main and the furnace area stacks which account for 15.1 of the total 17.9 TPY stack lead compound emissions. Since promulgation of the MACT rule, the facility has captured and controlled all refining operations with two additional baghouses (baghouse #8 which vents to a stack and baghouse #9 which vents to a common stack with the furnace area ). These emissions are included in the table below. Fugitive sources include material handling and plant yard and roadway dust. Table 1.1 summarizes the types and volumes of HAP emitted from fugitive and point sources that were included in the dataset for the Doe Run Company facility. Total actual lead em issions including fugitive emissions are 20.7 tons per year (TPY). The risk dataset includes 137 data points for lead compound emissions. Emissions sources of lead include 115 individual fugitive emission sources (or data points in the dataset) and 22 point sources (stacks). The 22 point sources include the main stack and the furnace area stacks which together account for 98 percent of the total stack lead emissions and are the two sources that are subject to the MACT st andard emission limit. It should be noted that non-volatile metal HAP other than lead are reported by Doe Run based on speciation tests conducted for the various sources. Table 1.1 - Summary of Doe Run Company Risk Dataset Emission Sources Fugitive Point (stack) Total

HAP Number of Sources TPY Number of Sources TPY Number of Sources TPY Lead 115 2.8053 22* 17.9030 137 20.7083 Antimony 6 0.0028 4 0.0252 10 0.0280 Arsenic 10 0.0005 6 0.0210 4 0.0215 Cadmium 12 0.0296 7 0.0823 19 0.1118 Chromium 0 0.0000 3 0.0056 3 0.0056 Cobalt 6 0.0005 6 0.0049 12 0.0054 Nickel 8 0.0019 7 0.0154 15 0.0172 *2 stacks (main and furnace area) account for 17.6 or the total 17.9 TPY and are subject to the MACT emission limit. The actual emissions dataset for this facility re presents the entire source category. Likewise, all emission points located at this facility and that emit HAP are in cluded in the risk analysisPrimary Lead Smelting NESHAP Technical Support Document

5 dataset; therefore, the facility-wide emission data set for this source category is the same as the risk analysis dataset.

1.2.2 Allowable Emissions Allowable emissions are emissions that would be allowed under the current MACT standard for primary lead smelters. Under the Primary Lead Smelting MACT, lead HAP emissions are regulated and lead emissions serve as a surrogate for all other non-volatile metal HAP emitted from the source.. For the Doe Run facility, allowable emissions are summarized in Table 1.2. Under the NESHAP, an aggregate emission limit of 1.0 pound of lead per ton of lead produced (lb/ton) applies to the following nine sources: 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 Applying the allowable emissions rate of 1.0 lb/ton to the Doe Run’s 2008 lead production of 149,564 tons, the aggregate allowable emissions re sults in aggregate lead emissions of 74.8 TPY from the above nine sources. All emissions from the source’s nine emission points listed above are captured and controlled by baghouses, which vent to the main stack or the furnace area stack. The total allowable emissions were prorated between the two stacks based on the ratio of actual emissions reported for the two stacks. Note that refining operations are not listed above and are not subject to the 1.0 lb/ton limit in the original MACT. At the time the NESHAP was pr omulgated, the refining operations were not enclosed and emissions from this operation were regulated under the provisions addressing fugitive emissions sources, however, based on more recent requirements adopted by the State, refinery emissions are now captured, controlled by a baghouse, and vented through two stacks. We were unable to calculate an allowable emission level for refining operations. Under the NESHAP, fugitive 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 fugitive emissions, which reflect the measures that have been put in place, would be equivalent to the allowable emissions. Fug itive emissions levels were taken from Doe Run’s 2008 Emissions Inventory that is submitted annually to the MDNR.Primary Lead Smelting NESHAP Technical Support Document

6 Table 1.2 Summary of Actual and Allowable Lead Emissions for the Doe Run Primary Lead Smelter, 2008 1

Emission Point Processes Actual Emissions

(TPY) Allowable Lead Emissions

(TPY) Main Stack (BH # 3, 5, 6) Si ntering, blast furnace, dross furnace 13.31 65.8 Furnace Area (BH # 7) Sm elter building 1.81 8.94 Refining (BH # 8, 9) Refining kettles and building 2.74 N/A Fugitives Roadways, storage piles, materials handling and transport 2.85 2.85

N/A = not available The MACT-allowable emissions from this source category are based on the MACT limit (1 lb/ton) applied to 2008 production data . The modeling file for this risk analysis can be reviewed in the EXCEL spreadsheet “ PrimLead_RTR_ModelingFile_102110_2008_DOE_RUN.xls ” available in the docket.

References: 1. Curran, D., Stinson Morrison Hecker, for The Doe Run Company, to Nizich, S., US EPA, Response to Section 114 Information Collection Request, February 5, 2010.Primary Lead Smelting NESHAP Technical Support Document

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### 2.0 Calculation of Proposed Emission Limits Based on Modeled Concentrations The risk analysis process included modeling of actual and allowable emissions to determine the anticipated concentration at individual recepto r locations. For this source category, the emissions for the lead emissions sources were individually modeled for each receptor location and the results were compared to the Primary National Ambient Air Quality Standard (NAAQS) for lead (0.15 μ g/m 3 ). If the modeled emissions exceeded the lead NAAQS, those locations were considered to be exposed to unacceptable risk. The results indicated multiple locations exceeded the level of the NAAQS to various degrees. Our modeling results indicated that the high est concentration location was a point on the property boundary. Emissions contributing to this exceedance were found to be cumulative fugitive dust emissions. Other emission points with modeled emission showing an exceedance of the lead NAAQS were the furnace area stack and the Baghouse #9 stack for the refinery building. Both of these stacks showed mode led levels above the NAAQS at various census block locations. The emissions from the main stack did not exceed N AAQS within the 50 km radius modeled area. Each emission point (with fugitive dust emission s being treated as one emission point) was analyzed to determine what emission levels would be necessary to reduce risk to an acceptable level i.e., such that modeled emissions met or were below the level of the NAAQS. EPA assumes that if the highest or worst-case concentration at a receptor location resulting from the emissions from each emission point were reduced to below the NAAQS level, then the risks for that emission point at any location would be reduced to an acceptable level. Further, EPA assumes that a reduction in emissions from an emission point will result in a proportionate reduction in the modeled concentration at a given receptor location. For example, if emissions from a stack are reduced by 50 percent, the modeled concentration at a receptor location will be reduced by 50 percent. Since the relationship between level of emissions and modeled concentrations is linear, a percentage reduction could be applied to the actual emissions from the CY 2008 emissions inventory for a given emission point that would reflect the same reduction in modeled concentration. Therefore, a calculation was made for each emission point to determine what percent reduction in concentration was required for each of the highest concentration locations to meet the NAAQS. The reduction necessary in fugitive dust emissi ons was determined to be 98 percent. Our analysis indicated that the maximum lead concentration location for the furnace area and refinery stack overlapped at the same census block (census block #). Therefore, their combined concentrations at that location would be the driver for the reduction from these emission points. The The reduction necessary for the combined furnace area stack and refinery stacks emissions was determined to be 80 52 percent. The refinery emissions are vented through Baghouse #8 and Baghouse #9 stacks, and ten heat stacks. For the refinery operation, only one stack (Baghouse #9) showed an exceedance of the NAAQS. The emission reduction found necessary from Baghouse #9 stack is 66 percent. ItPrimary Lead Smelting NESHAP Technical Support Document

8 was also found that the furnace area and refinery stack emissions maximum lead concentration overlap at the same census block (census block #290997006014031). To address the overlap, these points would need to be reduced together such that the lead concentration at that point would be acceptable. The emission reduction necessary for the combined furnace area and refinery stacks is 80 percent. Table 2.1 summarizes the calculations and recomm ended limits for the total facility including furnace area /refinery stack s and , fugitive dust , and the refinery operations. Table 2 .2 summarizes just the refining operation calculation , considering all contributing emission points.Primary Lead Smelting NESHAP Technical Support Document9Table 2.1 - Calculations of Risk-Based Emission Limits Based on Modeled ConcentrationsModeled Source2008 Emissions(tpy)Modeled leadconcentrationat the site of maximumimpact(μg/m3)Roll back tomeet NAAQS%Emissions afterrollback (tpy) NotesStacks- Furnace area (Baghouse #7) 1.81 0.314 520.86At census block #290997006014031- Refinery stacks 2.74 0.4363 660.94Baghouses #8, #9 and heat stacksSee Table 2.2 Refinery calculationFugitivesAll Fugitives 2.94 7.289 980.06fume, sinter and concentrate handlingRoadways, plant yard, resuspensionHighest concentration at property boundaryreceptor location1) Emission LimitAmbient lead concentration atproperty boundary*0.15μg/m32) Emissions CapFurance Area stack (BH#7)0.86 TPYRefinery stacks0.94 TPYCalculations Roll back % = (Actual concentration - 0.15)/actual concentrationEmissions after rollback = 2008 emissions * (1-(rollback%/100))PROPOSED ACTIONSAll Modeled SourcesPrimary Lead Smelting NESHAP Technical Support Document10Table 2.1 - Calculations of Risk-Based Emission Limits Based on Modeled ConcentrationsModeled Source2008 Emissions(tpy)Modeled leadconcentrationat the site of maximumimpact(μg/m3)Roll back tomeet NAAQS%Emissions afterrollback (tpy) NotesStacks- Furnace area (Baghouse #7) 1.81 0.314 52 0.86 At census block #290997006014031- Refinery stacks 2.74 0.4363 66 0.94At census block #290997006014031Combined Stacks 4.55 0.7503 80 0.91FugitivesAll Fugitives 2.94 7.289 980.06fume, sinter and concentrate handlingRoadways, plant yard, resuspensionHighest concentration at property boundaryreceptor location1) Emission LimitLead concentration in air*0.15μg/m32) Emissions CapFurance Area and refinery stacks0.91 TPYCalculations Roll back % = (Actual concentration - 0.15)/actual concentrationEmissions after rollback = 2008 emissions * (1-(rollback%/100))*MeasuredatlocationsrepresentativeofpropertyboundaryasdeterminedbytheAdministratorPROPOSED ACTIONSAll Modeled SourcesFormatted:Border: Top: (Single solid line,Auto, 0.5 pt Line width)Primary Lead Smelting NESHAP Technical Support Document11Table 2.2 - Calculation of Proposed Refinery Operation Emission Limit based on Modeled ConcentrationsModeled SourceModeled lead concentration at thesite of maximum impact for refinerystack sources(μg/m3)*50007 Baghouse #8 Stack 0.070750008 Baghouse #9 Stack 0.315050011 Refinery Kettle Heat Stack 0.001050012 Refinery Kettle Heat Stack 0.001050013 Refinery Kettle Heat Stack 0.001050014 Refinery Kettle Heat Stack 0.001050015 Refinery Kettle Heat Stack 0.001050016 Refinery Kettle Heat Stack 0.001050017 Refinery Kettle Heat Stack 0.001050018 Refinery Kettle Heat Stack 0.0011All refinery stacks 0.4363Ratio of NAAQS to refinery max 0.34 or 0.15/.4363Percent reduction required to meet NAAQS 0.66 or 1- 0.34TPY emission cap 0.94 or (NAAQS limit * TPY refinery current)/refinery max*Highest impact for refinery stacks occurs at census block 290997006014031.Refinery Maximum CalculationPrimary Lead Smelting NESHAP Technical Support Document

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### 3.0 Estimated Costs of Proposed Revisions to the Primary Lead Smelting NESHAP

With regard to lead emissions, we are proposin g emission limits that are consistent with the results of our risk and technology reviews of the current NESHAP for primary lead smelters. Under our ample margin of safety analysis, we considered addition controls beyond the existing level of control for the main stack to determine if additional contro ls would be warranted in order to provide an ample margin of safety. EPA has determined that lead compound emissions must be reduced to provide an acceptable level of risk for fugitive dust emissions and emissions from the furnace area stack and the r efining operation

. As a result, the facility will need to implement emission controls or to take other actions that will reduce lead emissions to an acceptable level and to meet the new emission limits/caps in this proposed rule. In order to demonstrate compliance with these limits, additional ambien t lead continuous monitoring is being required. Also we are proposing to lower the plant

- wide emission limit to reflect performance achievable from technological improvements. This section summarizes the impacts analysis conducted on all additional emission control options that were considered technologically feasible for achieving additional all necessary emission reductions for the main stack. Although our analysis indicated that additional controls were not warr anted for the main stack, we are proposing to lower the plant-wide emission limit to refl ect performance achievable from technological improvements. In addition we are proposing to increase the frequency of monitoring stack emission from the current annual emissions testing to quarterly testing. This section, therefore, also includes estimates of the impacts for as well as th ose the additional monitoring costs necessary to comply with proposed requirement s . We note that the controls that reduce lead emi ssions are the same controls that would reduce emissions and risks from cadmium and other metal HAP; therefore we are not proposing additional controls for other metal HAP. For fugitive dust emissions, which are c ontrolled by work practices, no add itional controls were evaluated because all reasonable practices have been or are currently being implemented. However, because we are proposing a concentration limit, we have evaluated the costs for ambient monitoring. For the main fou r stack emission point s , we considered the option of upgrading of existing baghouses from the use of cloth bags to membrane bags and the option of adding in-series baghouses. 3 .1 Emission Control Costs for Acceptability Reductions Although costs are not considered under sec tion 112(f)(1), EPA has estimated the cost impacts for these emission controls for informational purposes only. U nder the analysis of residual risk, mission reductions were required from the furnace area (baghouse #7), refining kettles (baghouse #8), refi nery building (baghouse #9) and fugitive dust to meet acceptability requirements. Emissions from the main stack did not trigger unacceptable risk levels.Primary Lead Smelting NESHAP Technical Support Document

13 EPA estimates that replacing existing cloth bags in all baghouses will provide an approximately 50 to 70 percent reduction in emissions from the emission points controlled by baghouses. The cost effectiveness of constructing a new baghouse in

- series with an existing baghouse was estimated assuming removal efficiencies of 50 and 97 percent. Table 3.1 s ummarizes the costs and cost

- effectiveness of upgrading existing baghouses from cloth bags to membrane bags. Table 3.2 summarizes the costs and cost

- effectiveness of adding an in

- series baghouse to control emissions from the three existing baghouses

. The calculations supporting the costs reflected in the summ ary are included in EXCEL spreadsheet DRAFT ImpactsEst_PrimLeadRTR_122210.xls found in the docket. 3. 1 2 Emission Control Costs for Ample Margin of Safety Reductions Once we determine that risk will be reduced to a level that is acceptable, we then determine whether further reductions are appropriate to ensure an ample margin of safety. We investigated available control options that could be implemented by the fa cility to attain the additional emissions reductions that would provide an ample margin of safety. No additional controls beyond those described above were identified to further control fugitive dust emissions or emissions from the furnace area stack or the refinery stacks. For the main stack, however, additional controls were evaluated and considered with regard to risk reduction and cost under the ample margin of safety analysis. For the main stack, our risk analysis indicates that emissions do not result in ambient lead levels exceeding the NAAQS based on either actual or allowable emission levels. However, we determined that it is technologically feasible to reduce emissions from the main stack to a level well below the allowable level of the MACT, sinc e those levels are currently being achieved. We evaluated additional controls such as membrane bags or add-on baghouses as a means for achieving those reductions and reducing associated risk. We determined that the additional controls would not provide an appreciable risk reduction (emission reduction) for the associated cost. However, we have determined that emissions allowable under MACT should be reduced under the section 112(d)(6) technology review as described in the technology review memorandum found in this docket. Table 3. 1 3 summarizes the costs and cost-effectiveness fo r the main stack of replacing cloth bags with membrane bags. Table 3. 3 4 summarizes the costs and cost-effectiveness of adding an inseries baghouse. The calculations supporting the costs reflected in the summary are included in EXCEL spreadsheet DRAFT ImpactsEst_Pri mLeadRTR_122210.xls found in the docket.Primary Lead Smelting NESHAP Technical Support Document14Total CostInvestmentTotalAnnualizedCost2008 BaselinePb Emissions(tpy)Emission Reductionfrom upgrade*(tpy)CE($/ton)Furnace area, BH 7 81,548 27,5911.81 0.9529,043Refining, BH 8 102,03217,048 0.45 0.21 81,179Refining BH 9 366,93260,471 2.03 1.3 45,467*We estimate removal efficiency for membrane bag update to be between 50 and 70 percent.Cost of Upgrade toMembrane BagsTable 3.1 - Cost Effectiveness of Upgrading to Membrane Bags for Baghouses 7, 8 and 9ImpactsSourcePb emissions (tpy)reported in 2008EIPb emission reductionwith additional BHassuming 50% RE (tpy)Pb emission reductionwith additional BHassuming 97% RE (tpy)Annualized cost ofadding extra BH's($/yr)Cost effectivenessassuming 50% RE($/ton)Cost effectivenessassuming 97% RE($/ton)BH 7 1.81 0.9 1.8BH8 0.45 0.2 0.4BH 9 2.03 1.0 2.0Total 4.29 2.1 4.2 $849,750 $396,154 $204,2031Reflects costs for pulsejet baghouses2See DRAFT ImpactsEst_PrimLeadRTR_122210.xls for detail on cost analysis.RE = Removal efficiencyTable 3.2 - Cost Effectiveness of an Adding AdditionalBaghouse to Control Emissions for Baghouses 7, 8 and 91,2Total CostInvestmentTotalAnnualizedCost2008 BaselinePb Emissions(tpy)Emission Reductionfrom upgrade*(tpy)CE($/ton)Main Stack 1,958,851 322,823 13.31 8.0 40,424*We estimate removal efficiency for membrane bag update to be between 50 and 70 percent.Cost of Upgrade toMembrane BagsTable 3.1 - Cost Effectiveness of Upgrading to Membrane Bags for Main StackImpactsSourcePb emissions (tpy)reported in 2008EIPb emission reductionwith additional BHassuming 50% RE (tpy)Pb emission reductionwith additional BHassuming 97% RE (tpy)Annualized cost ofadding extra BH's($/yr)Cost effectivenessassuming 50% RE($/ton)Cost effectivenessassuming 97% RE($/ton)Main Stack 13.31 6.7 12.9 $1,529,730 $229,862 $118,4851Reflects costs for pulsejet baghouses2See DRAFT ImpactsEst_PrimLeadRTR_122210.xls for detail on cost analysis.RE = Removal efficiencyTable 3.2 - Cost Effectiveness of Adding an Additional Baghouse to Control Emissions for the Main Stack1,2Primary Lead Smelting NESHAP Technical Support Document

15 3. 2 3 Additional Testing and Monitoring Costs Based on the elevated risk levels found for the furnace area stack and the refining operation stacks, EPA is proposing emission caps for those emission points. To demonstrate compliance with the new emission caps and the plant

- — wide emission limit, EPA is proposing to require quarterly stack testing. Although the method for testing is the same as it was under the current MACT, the quarterly frequency requirement imposes additional impact with regard to the cost of additional testing. In addition, t he risk analysis results indicate that modeled lead concentrations exceed the NAAQS at several of the property boun dary receptor locations. Since t he impact at these locations is driven by fugitive dust emissions, EPA is proposing an ambient lead concentration limit at the property boundary

. To demonstrate compliance with this limit, EPA is proposing to require ambient lead monitoring at four locations that would be most representative of the highe st modeled emissions of lead. The proposed additional testing and monitoring requirements will result in additional cost

. Because EPA assumes that monitoring equipment will be leased and not purchased, there are no anticipated capital costs associated with the new requirements. T he cost for the add itional testing and monitoring are as summarized in Table 3. 3 5 below.

Table 3. 3 5 - Additional Testing and Monitoring Costs Type of Testing/Monitoring Notes Cost Annual Cost 1 Stack Testing Method 12 $13,000 per test $ 39,000 156,000 Ambient L ead Monitoring (lab analysis) Per required monitoring plan $127 per test $185,420 Ambient Monitoring Equipment Annual Lease $2,500 per unit $10,000 1 Includes 3 12 additional stack tests (4 stacks x 3 additional tests) a nd 4 ambient monitors , each tested 365 days per year .Primary Lead Smelting NESHAP Technical Support Document



### APPENDIX A

Doe Run Company, Herculaneum, MO 2005 NEI (NATA) - Volatile Organic HAP from Boilers Risk ScreeningPrimary Lead Smelting NESHAP Technical Support Document

Appendix A

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