From: Amy Cole/DC/USEPA/US To: Alexander Cristofaro/DC/USEPA/US@EPA, Lesley Schaaff/DC/USEPA/US@EPA, Nicole Owens/DC/USEPA/US@EPA, Mariana Cubeddu/DC/USEPA/US@EPA, Bruce Schillo/DC/USEPA/US@EPA, Eileen Pritchard/DC/USEPA /US@EPA, Robin Kime/DC/USEPA/US@EPA, Karen Thundiyil/DC/USEPA/US@EPA Cc: Alan Rush/DC/USEPA/US@EPA, Joseph

- J Dougherty/DC/USEPA/US@EPA, Mary Henigin/DC/USEPA/US@EPA, Wanda Farrar/DC/USEPA/US@EPA, Ruthw Morgan/DC/USEPA/US @EPA Date: 12/01/2011 11:57 AM Subject: APPROVED & TRANSMITTED to OMB

- SAN 5469
- RTR NESHAP from the Pulp and Paper Industry
Today OP approved for OMB review the NPRM, SAN 5469

- Risk and Technology Review for National Emission Standards fo r Hazardous Air Pollutants from the Pulp and Paper Industry. This significant action is attached below and was developed as a tier 2 action.
(Embedded image moved to file: pic14523.gif)
(See attached file: EO12866PulpandPaper2060AQ41Proposal20111201.d oc) Amy L. Cole Regulatory Management Division US Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460 Phone: 202.564.6535 Office: 6440T ARN*** E.O. 12866 Review

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EO12866PulpandPaper 2060 AQ41 Proposal2011112 8.doc

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**ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 63** 
**EPA -**  **HQ -**  **OAR -**  **2007 -**  **0544**
**RIN 2060**  **– AQ41**  **National Emission Standards for Hazardous Air**  **Pollutants from**  **the Pulp and Paper Industry** 
**AGENCY:** Environmental Protection Agency (EPA).
**ACTION:** Proposed rule.
**SUMMARY:** The EPA is proposing amendments to the national emission standards for hazardous air pollutants for the Pulp and Paper industry to address the results of the residual risk and technology review that the EPA is required to conduct under sections 112(d)(6) and (f)(2) of the Clean Air Act. These proposed amendments include revisions to the kraft pulping
process condensate s standards ; a requirement for 5

- year repeat emissions testing for selected process equipment ; revis ions to provisions addressing periods of startup, shutdown and malfunction ; additional test methods for measuring methanol ; and technical and editorial changes
.*** E.O. 12866 Review

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**DATES:** Comments
. Comments must be received on or before **[INSERT**
**DATE 45 DAYS**  **FR OM DATE OF PUBLICATION**  **OF THIS PROPOSED RULE 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 receives a copy of you r comments on or before **[INSERT DATE 30 DAYS FROM DATE O**  **F PUBLICATION OF THIS PROPOSED RULE**  **IN**
**THE FEDERAL REGISTER**  **].** Public Hearing
. If anyone contacts the EPA requesting to speak at a public hearing by **[INSERT DATE 10 DAYS FROM DATE OF**
**PUBLICATION OF THI**  **S PROPOSED RULE IN THE**  **FEDERAL REGISTER ]**  , a public hearing will be held on **[INSERT DATE 15 DAYS FROM DATE OF**
**PUBLICATION OF THIS PROPOSED RULE**  **IN THE FEDERAL REGISTER**  **]**
. **ADDRESSES:** Submit your comments, identified by Docket ID N umber
EPA

- HQ

- OA R

- 2007

- 0544, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov
. Follow the online instructions for submitting comments.

• Agency Website: http://www.epa.gov/oar/docket.html . Follow the instructions for submitting comments on the EPA Air and Radiation Docket website
. • Email: a - and

- r - docket@epa.gov
. Include EPA

- HQ

- OAR

- 2007

- 0544 in the subject line of the message
. • Fax: Fax your comments to: (202) 566

- 9744, Attention Docket ID Number EPA

- HQ

- OAR

- 2007

- 0544.

• Mail: Send your comments to: EPA D ocket Center (EPA/DC), Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Ave., NW, Washington, DC 20460 , Attention: Docket ID Number EPA

- HQ

- OAR

- 2007

- 0544. Please include a*** E.O. 12866 Review

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total of two copies. In addition, please mail a copy of your comme nts 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 or Courier : In person or by couri er, deliver comments to the EPA Docket Center, EPA West (Air Docket), Room 3334, 1301 Constitution Ave., NW, Washington, DC 2 0460 , Attention Docket ID Number EPA

- HQ

- OAR

- 2007

- 0544. Such deliveries are only accepted during the Docket’s normal hours of operat ion (8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays) , and special arrangements should be made for deliveries of boxed information. Please include two copies. Instructions **.** Direct your comments to Docket ID Number EPA

HQ

- OAR

- 2007

- 0544. The EPA policy is that all comments received will be included in the public docket without change and may be made available online at http:// www.regulations.gov , including any personal information provided, unless the comment includes information cla imed to be confidential business information or other information whose disclosure is restricted by statute. Do not submit information that you consider to be confidential business information or otherwise protected through http:// www.regulations.gov or em ail. The http:// www.regulations.gov website is an “anonymous access” system, which means the EPA will not know your identity or contact information unless you provide it in the body of your
comment. If you send an email comment directly to the EPA without going through http:// www.regulations.gov , your email*** E.O. 12866 Review

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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, the EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD ROM you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the 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 the EPA 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 EP A

- HQ

- OAR

- 2007

- 0544. A ll documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some infor mation is not publicly available ( e.g. , confidential business information or other information whose disclosure is restricted by statute )
. Certain other material, such as copyrighted material, will be publicly available only in hard
copy. Publicly availabl e docket materials are available either electronically in http://www.regulations.gov or in hard copy at the EPA Docket Center, EPA West, Room 3334, 1301 Constitution*** E.O. 12866 Review

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Ave., NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Mon day 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**
**OF THIS PROPOSED RULE IN THE**  **FEDERAL REGISTER ]**  and will be held
at the EPA campus in Research Triangle Park, North Carolina, or at an alternate facility nearby. Persons interested in presenting oral testimo ny or inquiring as to whether a public hearing is to be held should contact Ms. Joan Rogers, Office of Air Quality Planning and Standards, Sector Policies and Programs Division, Natural Resources Group (E143

- 0 3 ), U.S. Environmental Protection Agency, Resea rch Triangle Park, North Carolina 27711; telephone number: (919) 541

– 4487.
**FOR FURTHER INFORMATION CONTACT** : For questions about this proposed action, contact Mr. John Bradfield , Office of Air Quality Planning and Standards, ( E143

- 03) , Environmental
Protec tion Agency, Research Triangle Park, North Carolina 2 7711 ;
t elephone number: (919) 541

- 3062 ; fax number: (919) 541

- 3470 **;** and email address: bradfield.john@epa.gov
. For specific information regarding the risk modeling methodology, contact Mr.*** E.O. 12866 Review

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James Hirtz , H ealth and Environmental Impacts Divisio n (C539

- 02), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27 711; t elephone number: (919) 541

– 0881; fax number: (919) 541

– 0840 ; and email ad dress: hirtz.james@epa.gov
. For information about the applicability of the national emission standards for hazardous air pollutants 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 s 2 Pulp and Paper Sara Ayres (202)564

- 5391 ayres.sara@epa.gov John Bradfield (919) 541

- 3062 bradfield.john@epa.gov 1 EPA’s Office of Enforcement and Compliance Assurance
. 2 EPA’s Office of Air Quality Planning and Standards.
**SUPPLEMENTARY INFORMATION** : Preamble Acronyms and Abbreviations
Sev eral acronyms and terms used to describe industrial processes, data inventories and risk modeling are included in this preamble. Wh ile 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:
ACGIH American Conference of Government al Industrial Hygienists ADAF Age

- D ependent Adjustment Factor s*** E.O. 12866 Review

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AEGL Acute Exposure Guideline Levels AERMOD Air dispersion model used by the HEM

- 3 model ASME American Society of Mechanical Engineers ATSDR Agency for Toxic Substances and Disease Registry BACT Best Available Control Technology BBDR B iologically based Dose Response CAA Clean Air Act CalEPA California Environmental Protection Agency CBI Confidential Business Information CCA Clean Condensate Alternative CD ROM Compact Disk Read Only Memory CDX Central Data Exchange CEEL Community Emergency Exposure Leve ls CEMS Continuous Emissions Monitoring System CFR Code of Federal Regulations CIIT Chemical Industry Institute of Toxicology EIA Econo mic Impact Analysis EJ Environmental Justice EPA Environmental Protection Agency ERPG Emergency Response Planning Guidel ines ERT Electronic Reporting Tool ft Feet ft 3 Cubic Feet FTE F ull

- T ime E quivalents HAP Hazardous Air Pollutants HEM

- 3 Human Exposure Model version 3 HI Hazard Index HON Hazardous Organic National Emissions Standards for Hazardous Air Pollutants HQ Hazard Quotient hr Hour HVLC High Volume Low Concentration ICR Information C ollection R equest IRIS Integrated Risk Information System ISIS Industrial Sectors Integrated Solution Model k m Kilometer LAER Lowest Achievable Emission Rate lb Pounds LVHC Low Volume Hi gh Concentration m 3 Cubic M eters MACT Maximum Achievable Control Technology MACT Code Code within the NEI used to identify processes included in a source category MEK Methyl Ethyl Ketone mg Milligrams*** E.O. 12866 Review

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MIR Maximum Individual Risk MRL Minimal Risk Level NAC / AEGL 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 NCASI National Council for Air and Strea m Improvement NEI National Emissions Inventory NESHAP National Emissions Standards for Hazardous Air Pollutants NIOSH National Institutes for Occupa tional Safety and Health NRC National Research Council NSPS New Source Performance Standard NTTAA National Technology Transfer and Advancement Act of 1995 O&M O peration and M aintenance OAQPS EPA’s Office of Air Quality Planning and Standards ODTP Oven

- D ried T ons of P ulp OECA EPA’s Office of Enforcement and Compliance Assurance OMB Office of Management and Budge t PB

- HAP Hazardous air pollutants known to be persistent and bio

- accumulative in the environment POM Polycyclic Organic Matter ppm Parts P er M illion ppmw Parts Per M illion by W eight PRA Paperwork Reduction Act QA Quality Assurance QC Quality Control RACT Reasonably Available Control Technology RBLC RACT/BACT/LAER Clearinghouse REL Reference E xposure L evel RFA Regulatory Flexibility Act RfC Reference Concentration RfD Reference Dose RTR Residual Risk and Technology Review SAB Science Advisory Board SBA Sma ll Business Administration SCC Source Classification Code Sec Second SISNOSE Significant Impact on a Substantial Number of Small Entities SOP Standard Operating Procedures*** E.O. 12866 Review

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SSM Startup, Shutdown, and Malfunction TOSHI Target Organ

- Specific Hazard Index TPY Tons Per Year TRI Toxics Release Inventory TRIM Total Risk Integrated Modeling System TRIM.FaTE Fate, Transport and Environmental Exposure module of EPA’s Total Risk Integrated Modeling System TTN Technology Transfer Network UF Uncertainty Factor UMRA Unfu nded Mandates Reform Act of 1995 URE Unit Risk Estimate VCS Voluntary Consensus Standards VOC Volatile Organic Compound WWW Worldwide Web μg Micrograms Organization of this Document
. The information in this preamble is organized as follows:
**I. General Information**  A. What is the statutory authority for this action? B. Does this action apply to me? C. Where can I get a copy of this document and other related information? D. What should I consider as I prepare my comments for the EPA?
**II. Background**  A. What is this source category and how did the MACT standard regulate its HAP emissions? B. What data collection activities were conducted to s upport this action?
**III. Analyses Performed**  A . How did we estimate risks posed by the source category? B . How did we consider the risk results in making decisions for this proposal? C
. How did we perform the technology review? D . What other issues are we addressing in this proposal?
**IV. Analytical Results and Proposed Decisions**  A . What are the results of the risk assessments? B . What are our proposed decisions regarding risk acceptability and ample margin of safety?*** E.O. 12866 Review

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C
. What are the results and proposed de cisions based on our technology review? D . What other actions are we proposing? E . Compliance Dates
**V. Summary of Cost, Environmental and Economic Impacts**  A. What are the affected sources? B. What are the air quality impacts? C. What are the cost impacts? D. What are the economic impacts? E. What are the benefits? **VI. Request for Comments VII. Submitting Data Corrections** 
**VIII. Statutory and Executive Order Reviews**  A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improv ing Regulation and Regulatory Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments G. Exe cutive 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 Advancemen t Act J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low

- Income Populations
**I. General Information** 
A. What is the statutory authority for this action? Section 112 of the CAA establishes a two

- stage r egulatory process to address emissions of HAP from stationary sources. In the first stage, after the EPA has identified categories of*** E.O. 12866 Review

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sources emitting one or more of the HAP listed in CAA section 112(b), CAA section 112(d) calls for us to promulgate NESHAP for those sources. “Major sources” are those that emit or have the potential to emit 10 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 emissio n s reductions of HAP achievable (after considering cost, energy requirements and nonair quality health and environmental impacts) and are commonly referred to as MACT standards.
M aximum achievable control technology standards must require the maximum degre e of emission s reduction through the application of measures, processes, methods, systems or techniques, including, but not limited to, measures that : (A) reduce the volume of or eliminate pollutants through process changes, substitution of materials or ot her 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 (includi ng 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 the EPA first determines either that : (A) a*** E.O. 12866 Review

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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 five sources for categories or subcategor ies 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 em issions reductions, any nonair quality health and environmental impacts and energy requirements.*** E.O. 12866 Review

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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, the EPA is not obliged to completely recalculate the prior MACT determination and , in particular, is not obligated to recalculate the MACT floors.
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 the EPA prepare a Report to
Con gress 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 EPA’s recommendations as to legislation regard ing such remaining risk. The EPA prepared and submitted this report ( Residual Risk Report to Congress , EPA

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– 001) in March 1999. Congress did not act in response to the report, thereby triggering the EPA’s obligation under CAA section 112(f)(2) to a nalyze and address residual risk. Section 112(f)(2) of the CAA requires us to determine, for source categories subject to certain MACT standards, whether those emissions standards provide an ample margin of safety to*** E.O. 12866 Review

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protect public health. If the MACT stan dards apply to a source category emitting a HAP that is “classified as a known, probable, or possible human carcinogen do not reduce lifetime excess cancer risks to the individual most exposed to emissions from a source in the category or subcategory to le ss than one in one million,” the 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)). This requirement is procedural. It mandates that the EPA establish CAA section 112(f) residual risk standards if certain risk thresholds are not satisfied but does not determine the level of those standards. NRDC v. EPA , 529 F. 3d at 1083. The second sentence of CAA section 112(f)(2) sets o ut the substantive requirements for residual risk standards: protection of public health with an ample margin of safety based on the EPA’s interpretation of this standard in effect at the time of the CAA amendments. Id. This refers to the Benzene NESHAP, d escribed in the next paragraph. The EPA may adopt residual risk standards equal to existing MACT standards (or to standards adopted after the technology review required by CAA section 112(d)(6)) if the EPA determines that the existing standards are suffici ently protective, even if (for example) excess cancer risks to a most exposed individual are not reduced to less than*** E.O. 12866 Review

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1 in 1 million. Id. at 1083, (“If EPA determines that the existing technology

- based standards provide an ‘ample margin of safety,’ then th e A gency is free to readopt those standards during the residual risk rulemaking”). Section 112(f)(2) of the CAA further authorizes the EPA to adopt more stringent standards, if necessary “to prevent, taking into consideration costs, energy, safety and othe r relevant factors, an adverse environmental effect.” 1 As just noted, CAA section 112(f)(2) expressly preserves our use of the two

- step process for developing standards to address any residual risk and our interpretation of “ample margin of safety” develo ped 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

1 “Adverse environmental effect” is defined in CAA section 112(a)(7) as any si gnificant 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

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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 define d in the
CAA. However, CAA section 112(f)(2)(B) preserves the EPA’s interpretation set out in the Benzene NESHAP, and the Court in
NRDC v. EPA concluded that the EPA’s interpretation of CAA section 112(f)(2) is a reasonable one. See NRDC v. EPA , 529 F.3d

a t 1083 (D. C. Cir. 2008), which says “[S]ubsection 112(f)(2)(B) expressly incorporates EPA’s interpretation of the Clean Air Act from the Benzene standard, complete with a citation to the Federal Register
. ” See also, A Legislative History of the Clean Air Act Amendments of 1990 , volume 1, p. 877 (Senate debate on Conference Report). We also 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

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– 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*** E.O. 12866 Review

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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 a gency also stated that, “The EPA also considers incidence (the number of persons estimated to suffer cancer or other serious he alth effects as a result of exposure to a pollutant) to be an important measure of the health risk to the exposed population. Incidence measures the extent of health risks to the exposed population as a whole, by providing an estimate of the occurrence of cancer or other serious health effects in the exposed population.” The a gency 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 Re port to Congress , the EPA does not define “rigid line[s] of acceptability,” but rather considers 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 “accept able” 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,*** E.O. 12866 Review

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quoting the D.C. Circuit’s en banc Vinyl Chloride decision at 824 F.2d 1165) recognizing that our world is not risk

- fr ee. 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 in dividual 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 risk, but displays a conservative risk level which is an upper

- bound that is unlikely to be exceeded.” Id. Understanding that there are both benefits and limitations to using maximum individual lifetime cancer risk as a metric for determining acceptability, we acknowledged in the 1989 Benzene NESHAP that “consideration of maximum individual risk
... must take into account the strengths and weaknesses of this measure of risk.” Id. Consequently, the presumptive risk level of 100 in 1 million (1 in 10 thousand) provides a benchmark for judging the*** E.O. 12866 Review

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acc eptability of maximum individual lifetime cancer risk, but does not constitute a rigid line for making that determination. Id . Further, in the Benzene NESHAP, we noted that, “Particular attention will also be accorded to the weight of evidence presented in the risk assessment of potential carcinogenicity or other health effects of a pollutant. While the same numerical risk may be estimated for an exposure to a pollutant judged to be a known human carcinogen, and to a pollutant considered a possible human ca rcinogen based on limited animal test data, the same weight cannot be accorded to both estimates. In considering the potential public health effects of the two pollutants, the Agency’s judgment on acceptability, including the MIR, will be influenced by the greater weight of evidence for the known human carcinogen.” Id . at 38046. The a gency 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 acceptabil ity, the A gency 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 lifet ime risk range and associated incidence within, typically, a 50 km exposure radius around facilities, the*** E.O. 12866 Review

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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 ris k 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 the EPA in the first step of the Vinyl Chloride inquiry are already low, th e 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.” Beyond that information, additional factors relating to the appropriate level o f 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 section 112. ”*** E.O. 12866 Review

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In NRDC v. EPA , 529 F.3d 1077, 1082 (D.C. Cir. 2008), the Court of Appeals held that section 112(f)(2) “incorporates EPA’s ‘interpretation’ of the Clean Air Act from the B enzene Standard, and the text of this provision draws no distinction between carcinogens and non

- carcinogens.” Additionally, the Court held there is nothing on the face of the statute that limits the

a gency’s section 112(f) assessment of risk to carcinogen s. Id
. at 1081

– 82. In the NRDC case, the petitioners argued, among other things, that section 112(f)(2)(B) applied only to non

carcinogens. The D.C. Circuit rejected this position, holding that the text of that provision “draws no distinction between carci nogens and non

- carcinogens,” id ., and that Congress’ incorporation of the Benzene standard applies equally to carcinogens and non

- carcinogens. In the ample margin of safety decision process, the a gency again considers all of the health risks and other heal th 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 an y other relevant factors. Considering all of these factors, the a gency will establish the standard at a level*** E.O. 12866 Review

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that provides an ample margin of safety to protect the public health, as required by CAA section 112(f). 54 FR 38046.
B. Does this action apply to me? The regulated industrial source category that is the subject of this proposal is listed in Table 2 of this preamble. Table 2 of this preamble is not intended to be exhaustive, but rather provides a guide for readers regarding the entities likely to be affected by this proposed action
. This standard, and any changes considered in this rulemaking, would be directly applicable to affected sources . Federal, s tate, local and tribal government entities are not affected by this proposed action. As defined in the S ource C ategory L isting R eport published by the EPA in 1992, the Pulp and Paper Production source category includes any facility engaged in the production of pulp and/or
paper. This category includes, but is not limited to, integrated mills (where pulp and paper or paperboard are manufactured on

site), non

- integrated mills (where either pulp or
paper / paperboard are manufactured on

- site, but not both), and secondary fiber mills (where waste paper is used as the primary raw material). Examples of pulping methods include k raft, soda, sulfite, semi

- chemical and mechanical. **TABLE 2. NESHAP and Industrial Source Categories Affected By This Proposed Action** *** E.O. 12866 Review

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**Source c**  **ategory NESHAP**  **NAICS code**  **1 MACT code**  **2** Pulp and Paper Pulp and Paper 322 1626

- 1 1 North Americ an Industry Classification System 2 Maximum Achievable Control Technology

C. 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 o n the WWW through the EPA’s TNN . 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 RTR web page at http://www.epa.gov/ttn/atw/rrisk/rtrpg.html
. This information includes source categ ory descriptions and detailed emissions estimates and other data that were used as inputs to the risk
assessments.
D. What should I consider as I prepare my comments for the EPA? Submitting CBI
. Do not submit information containing CBI to the EPA through http:// www.regulations.gov or email. Clearly*** E.O. 12866 Review

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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 the 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 submi tted 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 the EPA’ s electronic public docket without prior notice. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. Send or deliver information identified as CBI only to the following address: Roberto Morales, OAQPS Document Control Officer (C404

- 02), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, Attention Docket ID Number
EPA

- HQ

- OAR

- 2007

- 0544.
**II. Background** 
A. What is this sour ce category and how did the MACT standard regulate its HAP emissions?*** E.O. 12866 Review

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The P ulp and P aper production source category includes any facility engaged in the production of pulp and/or paper. This category includes, but is not limited to, integrated mills (wher e pulp and paper or paperboard are manufactured on

- site),

non - integrated mills (where paper/paperboard or pulp are manufactured, but not both), and secondary fiber mills (where waste paper is used as the primary raw material). The P ulp and
P aper production process include s operations such as pulping, bleaching, chemical recovery and papermaking. Different pulping processes are used, including chemical processes (kraft, soda, sulfite and semi

- chemical) and mechanical, secondary fiber or

non - wood processes. The NESHAP from the Pulp and Paper Industry (or MACT rule) was promulgated on April 15, 1998 (63 FR 18504) and codified at 40 CFR p art 63, s ubpart S. As promulgated in 1998, the s ubpart S MACT standard applies to major sources of HAP emissions from the
pu lp production areas ( e.g. , pulping system vents, pulping process condensates) at chemical, mechanical, secondary fiber and non

- wood pulp mills; bleaching operations; and papermaking systems. A separate NES H AP (40 CFR p art 63, s ubpart MM) applicable to chem ical recovery processes at kraft, soda, sulfite and stand

- alone semi

- chemical pulp mills was promulgated*** E.O. 12866 Review

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on January 12, 2001 (66 FR 3180). However, only s ubpart S is undergoing the RTR that is the subject of this proposal. This is the first in a series of rules being developed for the Pulp and Paper industrial sector. This proposal includes both a risk assessment and a technology review of the emission sources in s ubpart S , as well as a risk ass essment of the whole facility. The Pulp and Paper industrial s ector also include s boilers covered under s ubpart DDDDD , chemical recovery systems covered under subpart MM , and various sources covered under the NSPS for kraft pulp mills (40 CFR part 60, subpart BB)
. E missions from these sources and any other applicable MACT emission sources for each site were included in the facilitywide risk assessment done for this rulemaking. In the future, we will also conduct an RTR for the subpart MM category , as well as a review of the kraft pulp mill s NSPS , s ubpart BB. When we c onduct the RTR for the s ubpart MM rule, s ubpart S emission sources will be included in the facilitywide risk assessment. According to results of the EPA’s 2011 P ulp and P aper ICR, there are a total of 171 major source s in the United States including:

• 111 major sources that carry out chemical wood pulping (kraft, sulfite, soda or semi

- chemical) ;

• 3 3 major sources that carry out mechanical, groundwood, secondary fiber and non

- wood pulping*** E.O. 12866 Review

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(without chemical wood pulping) ;

• 9 4 major source s that perform bleach ing ; and

• 156 major source s that manufacture paper or paperboard products. Facilities in the category perform at least one of several pulp and papermaking operations ( e.g. , chemical pulping, bleaching and papermaking; pulping and unbleached papermaking; etc.). Facilities that only purchase pre

- consumer paper or paperboard stock products and convert them into other products ( i.e. , converting operations) are not part of the s ubpart S source category and are not affected by today’s action. Subpart S includes numerical emission limits for pulping system vents, pulping process condensates and bleaching system
vents. The control systems used by most mills to meet the

s ubpart S emission limits are as follows:

• Pulping system vents

— thermal oxidizers, power boil ers, lime kilns and recovery furnaces.

• Pulping process condensates

— steam strippers, biological treatment and recycling to pulping equipment that is controlled by the pulping vent standards.

• Bleaching system vents

– caustic scrubbers (for chlorinate d HAPs, other than chloroform) and process modifications to eliminate the use of chlorine and hypochlorite.
B. What data collection activities were conducted to support this action?*** E.O. 12866 Review

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In February 2011 , the EPA issued a n ICR , pursuant to CAA section 114, to United States pulp and paper manufacturers to gather information needed to conduct the regulatory reviews required under CAA sections 112(d)(6) and (f)(2). T he ICR was divided into three parts, with each part due on a different date. Part I requested avail able information regarding s ubpart S process equipment, control devices, pulp and paper production, bleaching and other aspects of facility operations , to support the s ubpart S technology review and a later review of the kraft pulp m ills NSPS under 40 CFR p art 60, s ubpart BB
. Part II requested updated inventory data for all pulp and paper emission
sources, to support the residual risk assessment for the Pulp and Paper Sector (including s ubparts S and MM ) and to both supplement and update the NEI for the sou rce category . Part III requested available information on s ubpart MM chemical recovery combustion equipment, control devices , etc., to support a later

s ubpart MM technology review ( which will include a source category and a facilitywide risk assessment ) an d a s ubpart BB NSPS review
. Responses to all three parts of the ICR have been received and data from the first two parts of the ICR have been compiled. The response rate for all three parts of the ICR was effectively 100 percent.
**III. Analyses Performed** *** E.O. 12866 Review

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I n this section, we describe the analyses performed to support the proposed decisions for the RTR for this source category.
A . How did we estimate risks posed by the source category? The EPA conducted risk assessment s that provided estimates of (1) the MIR posed by the HAP emissions from the 171 pulp and paper mills in the source category , (2) the distribution of

cancer and noncancer risks within the exposed populations, (3) the total cancer incidence, (4) estimates of the maximum TOSHI for chronic exposure s to HAP with the potential to cause chronic noncancer health effects, (5) worst

- case screening estimates of HQ for acute exposures to HAP with the potential to cause noncancer health effects and (6) 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 Pulp and Paper Source Category . The methods used to assess risks (as described in the seven primary steps below) are consistent with those peer

reviewed by a panel of the EPA’s SAB in 2009 and described in their peer review report issued in 2010; they are also*** E.O. 12866 Review

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consistent with the key recommendations contained in that report. 1. Establishing the Nature and Magnitude of Actual Emissions and Identifying the Emissions Release Characteristics
As discussed in section II.B of this preamble , we used data from P art II of the Pulp and Paper ICR as the basis for the risk
assessment. Part II of the ICR, which concluded in June 2011, targeted facilities that are major sources of HAP emissions and involved an update of pre

- populated NEI data spreadsheets (or creation of new NEI dataset s). 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 actual annual air pollutant emissions from point and volume sources; emissi on release characteristic data such as emission release height, temperature, diameter, velocity and flow rate; and location latitude/longitude coordinates. The actual annual emissions data in the NEI database were based on data from actual emissions tests and estimates of actual emissions (based on emission factors) provided by s ubpart S sources surveyed in Part II of the ICR. We received a comprehensive set of emissions test data and emissions estimates that enabled us to conduct risk modeling of detectabl e HAP*** E.O. 12866 Review

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emissions for all major source facilities in the Pulp and Paper category. Two substantial QA efforts were conducted on the Part II data in order to create the modeling files needed for the residual risk assessment, which included : (1) QA of the updat ed inventory spreadsheets submitted by each mill prior to import into the compiled database ; and (2) QA and standardization of the compiled database. We reviewed the NEI data set s to ensure that the major pulp and paper processes and pollutants were include d and properly identified, to ensure that emissions from the various processes were allocated to the correct source category ( e.g. , MACT code 1626

- 1), and to identify emissions and other data anomalies that could affect risk estimates . We also standardized the various codes ( e.g. , SCCs , pollutant codes), eliminated duplicate records and checked geographic coordinates. We reviewed emissions release parameters for data gaps and errors, assigned the proper default parameters where necessary, segregated the emi ssion points into logical emission process groups and ensured that fugitive release dimensions were specified or given default values where necessary. We made changes based on available information, including updated information voluntarily submitted by pu lp and paper mills. (F or more information , see the*** E.O. 12866 Review

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memorandum in the docket entitled, Inputs to the Pulp and Paper Industry October 2011 Residual Risk Modeling
. ) We assigned emissions process groups to distinguish between processes with related SCCs. For m ills with VOC emissions data but no HAP emissions data, we developed HAP

- to

- VOC ratios to estimate HAP emissions, using HAP and VOC emission factors provided by NCASI
. However, as noted above, most emissions factors were based on actual tests or actual tes ts conducted at similar sources (reference NCASI Technical Bulletin 973). Additionally, the largest HAP emission compound in the category, methanol , at approximately 86 percent of the HAP in the category , is required to be quantified in each compliance tes t referenced in the standard. Consequently, the greatest proportion of HAP emissions at each facility are based on emission factors derived from actual source specific tests. For purposes of risk modeling, we reviewed emissions data for chromium, mercury, POM and glycol ether in order to properly speciate emissions. Chromium emissions were speciated as hexavalent chromium (chromium VI) and trivalent chromium (chromium III). Mercury emissions were speciated as particulate divalent mercury, gaseous divalent m ercury and elemental gaseous mercury. Total POM emissions were speciated differently for each emission unit type ( e.g. , gas - or oil

- fired paper machine*** E.O. 12866 Review

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dryer s) based on the most common POM compounds emitted from that unit ( e.g. , phenanthrene, fluorene, pyr ene, fluoranthene and/or 2

- methylnaphthalene). We speciated all total glycol ether records as 1,2

- dimethoxyethane , since that pollutant is the most commonly emitted glycol ether f rom pulp and paper emission

sources. Acrolein emissions were removed from the subpart S modeling file due to uncertainty in the emissions estimates. (For more information, see the memorandum in the docket entitled, Inputs to the Pulp and Paper Industry October 2011 Residual Risk Modeling .)
In addition, we reviewed facility wide data included in the NEI dataset from the EPA’s TRI to ensure that combustion

- related dioxin/furan emissions were apportioned to the proper MACT code (0107 or 1626

- 2). As expected, t here were no dioxin/furan emissions data for s ubpart S sources (MACT code 1626

- 1). (For more information, see the memorandum in the docket entitled, Inputs to the Pulp and Paper Industry October 2011 Residual Risk Modeling .) The Part II NEI emissions dataset for the Pulp and Paper ( s ubpart S) source category shows 45,000 tpy of tota l HAP emissions from the 171 mills in the dataset
. M ethanol, acetaldehyde, cresol/cresylic acid (mixed isomers), phenol, chloroform, formaldehyde, hydrochloric acid, biphenyl,*** E.O. 12866 Review

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hexachloroethane, xylenes, propionaldehyde and 1 ,2,4

- t richlorobenzene account fo r the majority of the HAP emissions reported for pulp and paper production (approximately 43,900 tpy , or 97 percent). Hazardous air pollutants reported in lesser quantities include acetophenone, benzene, cumene, carbon disulfide, chlorine, methyl isobutyl ketone, methylene chloride (dichloromethane), naphthalene, styrene, tetrachloroethylene (perchloroethylene), toluene, trichloroethylene and 5 6 other
HAP . Methanol, which accounts for about 86 percent of the total HAP mass emissions, is the HAP emitted by t he largest number of facilities, with methanol estimated for 1 66 out of 1 71 mills in the dataset (or 97 percent). Emission s of the following PB

- HAP were identified in the emissions inventory for the Pulp and Paper ( s ubpart S) source category : cadmium compo unds, lead compounds, mercury compounds and POM. As a standard practice in conducting risk assessments for categories where emissions of
PB

- HAP are present, the EPA conducts a two

- step process to justify a complete multipathway analysis for population risk from the source category. Further information about the analysis performed in this category follows in section III.B.4 of this preamble
. 2. Establishing the Relationship between Actual Emissions and
MACT

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The available emissions data in the Part II NEI emissions dataset include estimates of the mass of HAP actually emitted during the 2009 time period covered under the survey
. These “actual” emissions levels are often lower than the emissions levels that a facility might be allowe d to emit and still comply with the MACT standards. The emissions level s allowed to be emitted by the MACT standards are referred to as the “MACT

allowable” emissions level s . Th ese represent the highest emissions level s that could be emitted by the facilit y 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

– 1999 9 , April 15, 2005) and in the proposed and final HON residual risk rules (71 FR 3 4428, 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 at which sources could emi t while still comply ing with the MACT standards. However, 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*** E.O. 12866 Review

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typically seek to perform better than required by emissions standards to provide an operational cushion to accommodate the variability in manufacturing processes and control device
p erformance. Facilities’ actual emissions may also be significantly lower than MACT

- allowable emissions for other reasons such as s tate requirements, better performance of control devices than required by the MACT standards or reduced production. As descri bed earlier in this section, a ctual emissions were based on the Part II NEI emissions dataset
. To estimate emissions at the MACT

- allowable level, we developed a ratio of
MACT

- a llowable to actual emissions for each source type for the facilities in the sour ce category. This ratio is based on the level of control required by the s ubpart S MACT standards compared to the level of reported actual emissions and available information from the Part I survey on the level of control achieved by the emissions controls in use
. For example, if survey data indicated that an emission point type was being controlled by 9 2 percent , while the MACT standard required only 87 percent control, we would estimate that MACT

- allowable emissions from that emission point type could be as much as 1.6 times higher (13 percent allowable emissions compared with 8*** E.O. 12866 Review

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percent actually emitted), and the ratio of MACT

- allowable to actual would be 1.6:1 for this emission point type. After developing these ratios for each emission point type in th is source category, we next applied these ratios on an emission process unit basis to the Part II actual emissions data to obtain risk estimates based on MACT

- allowable emissions . (See the memorandum, Inputs to the Pulp and Paper Industry October 2011 Resi dual Risk Modeling , for more on the development of allowable multipliers for the Pulp and Paper source category .) 3. Conducting Dispersion Modeling, Determining Inhalation Exposures and Estimating Individual and Population Inhalation Risks Both long

- term a nd short

- term inhalation exposure concentrations and health risks from the source categor y addressed in this proposal were estimated using the HEM

- 3 human exposure model . The HEM

– 3 performs three of the primary risk

asses sment activities listed above: (1) c onducting dispersion modeling to estimate the concentrations of HAP in ambient air, (2) estimating long

- term and short

- term inhalation exposures to individuals residing within 50 km of the modeled sources, and (3) estimating individual and population

- leve l inhalation risks using the exposure estimates and quantitative dose

- response information.*** E.O. 12866 Review

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The dispersion model used by HEM

– 3 is AERMOD, which is one of the EPA’s preferred models for assessing pollutant concentrations from industrial facilities. 2 To perf orm 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
upp er air observations for 130 meteorological stations, selected to provide coverage of the U nited S tates and Puerto Rico
. A second library of United States Census Bureau census block 3 internal point locations and populations provides the basis o f human expos ure calculations based on the year 2000 U.S. Census
. 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 an d other health benchmarks is used to estimate health risks. These risk factors and health benchmarks are the latest values recommended by the EPA for HAP and other toxic air pollutants. These values are available at

2 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). 3 A census block is generally the small est geographic area for which census statistics are tabulated.*** E.O. 12866 Review

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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 primarily used as a surrogate for the chronic inhalation exposure concentration for all the people who reside in that census block. There were two exceptions to t his. In those cases where we identified census block centroids which were located on

- site, these centroids were

re - assigned to a nearby residential location. In those cases where nearby census blocks were abnormally large, additional residential receptors were placed within those census blocks at observable residences to ensure an adequate representation of chronic risks to the nearby residences. We calculated the MIR for each facility as the cancer risk associated with a continuous lifetime (24 hours per d ay, 7 days per week and 52 weeks per year for a 70

- year period) 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 concen tration of each of the HAP (in micrograms per cubic meter) by its URE , which is*** E.O. 12866 Review

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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

a ir. In general, f or residual risk assessments, we use URE values from the EPA’s I RIS
. 4 F or carcinogenic pollutants without the EPA IRIS values, we look to other reputable sources of cancer dose

- response values, often using CalEPA URE values, where availabl e. 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 the EPA, we may use such dose

- response values in place of, o r in addition to , other values , if appropriate. In 2004, the EPA determined that the CIIT cancer dose

response value for formaldehyde (5.5 x 10 - 9 per μg/m 3 ) was based on better science than the IRIS dose

- response value (1.3 x 10 - 5 per μg/m 3 ), and we switched from using the IRIS value to the CIIT value in risk assessments supporting regulatory actions. Based on subsequent published research, however , the EPA changed its determination regarding the CIIT model, and in 2010 , the EPA returned to using the 1991 IRIS value. The NAS completed its review of the EPA’s draft assessment in April of 2011

4 The IRIS information is available at http://www.epa.gov/IRIS.*** E.O. 12866 Review

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( http://www.nap.edu/catalog.php?record id=13142), and the EPA has been working on revising the formaldehyde assessment. The EPA will follow the NAS Report recommendations and will present results obtained by implementing the BBDR model for formaldehyde. The EPA will compare these estimates with those currently pr esented in the External Review draft of the assessment and will discuss their strengths and weaknesses. As recommended by the NAS committee, appropriate sensitivity and uncertainty analyses will be an integral component of implementing the BBDR model. In t he interim, we will present findings using the 1991 IRIS value as a primary estimate and may also consider other information as the science evolves
. We note here that POM, a carcinogen ic HAP with a mutagenic mode of action , is emitted by some of the facil ities in this category . 5 For th is compound , 6 the ADAF described in the EPA’s Supplemental Guidance for Assessing Susceptibility from Early

Life Exposure to Carcinogens 7 were applied. This adjustment has the effect of increasing the estimated lifetime risks for th i s

5 U.S. EPA, 2005. Performing risk assessments that include carcinogens described in the Supplemental Guidance as having a mutagen ic mode of action. Science Policy Council Cancer Guidelines Implementation Work Group Communication II : Memo from W.H. Farland, dated October 4, 2005. 6 See the Risk Assessment for Source Categories document available in the docket for a list of HAP with a mutagenic mode of action. 7 U.S. EPA, 2005. Supplemental Guidance for Assessing Early

- Life Exposure to Carcinogens
. EPA/630/R

- 03/003F. http://www.epa.gov/ttn/atw/childrens_supplement_final.pdf
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pollutant by a factor of 1.6. In addition, although only a small fraction of the total POM emissions were not reported as individual compounds, the EPA expresses carcinogenic potency for compounds in this group in terms of benzo[a]pyrene equivale nce, based on evidence that carcinogenic POM ha s the same mutagenic mechanism of action as does benzo[a]pyrene. For this reason, the
EPA’s Science Policy Council 8 recommends applying the Supplemental Guidance to all carcinogenic polycy clic aromatic hydroca rbons for which risk estimates are based on relative potency. Accordingly, we have applied the ADAF to the benzo[a]pyrene equivalent portion of all POM mixtures. Incremental individual lifetime cancer risks associated with emissions from the source categor y 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 9 ) emitted by the modeled source. Cancer i ncidence and

8 U.S. EPA, 2006. Science Policy Council Cancer Guidelines Im plementation Workgroup Communication II : Memo from W.H. Farland, dated June 14, 2006. 9 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 the ir 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/214C6E915BB04E14852570CA007A682C/$ File/ecadv02001.pdf
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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 ana lysis supporting the 1989 Benzene NESHAP (54 FR 38044) and the limitations of Gaussian dispersion models, including AERMOD. To assess risk of noncancer health effects from chronic exposures, we summed the HQ for each of the HAP that affects a common targe t organ system to obtain the HI for that target organ system (or TOSHI ). The HQ is the estimated exposure divided by the chronic reference value , which is either the EPA RfC , defined as “an estimate (with uncertainty spanning perhaps an order of magnitude) of a continuous inhalation exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime,” or, in cases where a RfC is not available, the ATSDR chronic MRL or the CalEPA Chronic REL
. The REL is defined as “the concentration level at or below which no adverse health effects are anticipated for a specified exposure duration.” As noted above, in cases where new, scientifically credible dose

- response values have been d eveloped in a manner consistent with EPA guidelines and have undergone a peer review*** E.O. 12866 Review

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process similar to that used by the EPA, we may use those dose

response values in place of, or in addition to other values.
Worst

- case s creening estimates of acute exposur es and risks were also evaluated for each of the HAP at the point of highest offsite 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 occur red
. In general, a cute HQ values were calculated using best available, short

- term dose

- response value. These acute dose

- response value s include REL, AEGL and ERPG for
1

- hour exposure durations. As discussed below, we u sed 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 f or 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 .”
R eference exposure level values a re based on the most sensitive, relevant, adverse health effect reported in the medical and toxicological literature. R eference exposure level values are designed to protect the most sensitive individuals in the*** E.O. 12866 Review

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population by the inclusion of margins of sa fety. Since margins of safety are incorporated to address data gaps and uncertainties, exceeding the REL does not automatically indi cate an adverse health impact. Acute Exposure Guideline Levels were derived in response to recommendations from the NRC. As described in Standing Operating Procedures (SOP) of the National Advisory Committee on Acute Exposure Guideline Levels for Hazardous Substances (http:// www.epa.gov/opptintr/aegl/pubs/ sop.pdf) , 10 “the NRC’s previous name for acute exposure levels

— CEEL

— was re placed by the term AEGL to reflect the broad application of these values to planning, response, and prevention in the community, the workplace, transportation, the military, and the remediation of Superfund sites.” This document also states that AEGL value s “represent threshold exposure limits for the general public and are applicable to emergency exposures ranging from 10 minutes to 8 hours.” The document lays out the purpose and objectives of AEGL by stating (page 21) that “the primary purpose of the AEGL program and the NAC/AEGL Committee is to develop guideline levels for once

- in

- a - lifetime, short

- term exposures to airborne concentrations of acutely toxic, high

- priority chemicals.” In

10 NAS, 2001. Standing Operating Procedures for Developing Acute Exposure Levels for Hazardous Chemicals , page 2.*** E.O. 12866 Review

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detailing the intended application of AEGL values, the document
states (page 31) that ”[i]t is anticipated that the AEGL values will be used for regulatory and nonregulatory purposes by United
States f ederal and s tate agencies, and possibly the international community in conjunction with chemical emergency response, planning and prevention programs. More specifically, the AEGL values will be used for conducting various risk assessments to aid in the development of emergency preparedness and prevention plans, as well as real

- time emergency response actions, for accidental chem ical releases at fixed facilities and from transport carriers.” The AEGL

– 1 value is then specifically defined as “the airborne concentration of a substance above which it is predicted that the general population, including susceptible individuals, could ex perience notable discomfort, irritation, or certain asymptomatic nonsensory effects. However, the effects are not disabling and are transient and reversible upon cessation of exposure.” The document also notes (page 3) that, “Airborne concentrations below AEGL

– 1 represent exposure levels that can produce mild and progressively increasing but transient and nondisabling odor, taste, and sensory irritation or certain asymptomatic, nonsensory effects.” Similarly, the document defines AEGL

– 2 values as “the airbo rne concentration (expressed*** E.O. 12866 Review

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as ppm or mg/m 3 ) of a substance above which it is predicted that the general population, including susceptible individuals, could experience irreversible or other serious, long

- lasting adverse health effects or an impaired abil ity to escape.” Emergency Response Planning Guidelines values are derived for use in emergency response, as described in the American Industrial Hygiene Association’s document entitled, Emergency Response Planning Guidelines (ERPG) Procedures and Responsib ilities ( http://www.aiha.org/1documents/committees/ERPSOPs2006.pdf ) which states that, “Emergency Response Planning Guidelines were developed for emergency planning and are intended as health

- based guideline concentrations for single exposures to chemicals. ” 11 The ERPG

– 1 value is defined as “the maximum airborne concentration below which it is believed that nearly all individuals could be exposed for up to 1 hour without experiencing other than mild transient adverse health effects or without perceiving a cle arly defined, objectionable odor.” Similarly, the ERPG

– 2 value is defined as “the maximum airborne concentration below which it is believed that nearly all individuals could be exposed for up to 1 hour without

11 ERP Committee Procedures and Responsibili ties . November 1, 2006. American Industrial Hygiene Association.*** E.O. 12866 Review

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experiencing or developing irreversible or oth er serious health effects or symptoms which could impair an individual’s ability to take protective action.” As can be seen from the definitions above, the AEGL and ERPG values include the similarly

- defined severity levels 1 and 2. For many chemicals, a se verity level 1 value AEGL or ERPG has not been developed; in these instances, higher severity level
AEGL

– 2 or ERPG

– 2 values are compared to our modeled exposure levels to screen for potential acute concerns. Acute REL values for 1

- hour exposure durations a re typically lower than their corresponding AEGL

– 1 and ERPG

– 1 values. Even though their definitions are slightly different,
AEGL

– 1 values are often the same as the corresponding ERPG

– 1 values , and AEGL

– 2 values are often equal to ERPG

– 2 values. Maximum HQ values from our acute screening risk assessments typically result when basing them on the acute REL value for a particular pollutant. In cases where our maximum acute HQ value exceeds 1, we also report the HQ value based on the next highest acute threshold (usually the AEGL

– 1 and/or the ERPG

– 1 value). 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 va riable emissions. An acute*** E.O. 12866 Review

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multiplication factor of 1.6 was used for papermaking equipment ( e.g. , paper machines, stock preparation, repulping, etc.) based on a paper machine peak

- to

- mean analysis. Similarly, a peak

- to

mean multiplier of 2 was used for pul p and paper wastewater treatment units based on analysis of data from pulp and paper primary clarifiers and aerated stabilization basins. Peak

- to

mean multipliers ranging from 1 to 3.1 were developed for other types of pulp and paper equipment based on the routine annual emissions data and peak hourly emissions data obtained from Part
II survey data. More information supporting the use of these factors for Pulp and Paper p roduction is presented in the memorandum, Inputs to the Pulp and Paper Industry Octobe r 2011 Residual Risk Modeling , which is available in the docket for this actio n. 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 cas es 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. The data refinements included using site

- specific facility layo uts, as available, to distinguish facility property from an area where the public could access and be exposed. These*** E.O. 12866 Review

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refinements are discussed in the draft risk assessment documents, which are available in the docket for this source category . Ideally, we w ould 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 potent ial 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 approach. 4. Multipathway E xposure and R isk Screening 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 the 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*** E.O. 12866 Review

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dibenzodioxins and furans, dichlorodiphenyldichloroethylene, h eptachlor, hexachlorobenzene, hexachlorocyclohexane, lead compounds, mercury compounds, methoxychlor, polychlorinated biphenyls, POM, toxaphene and trifluralin. Emission s of four different PB

- HAP were identified in the Part II NEI emissions dataset for the Pulp and Paper ( s ubpart S) source category: cadmium compounds, lead compounds, mercury compounds and POM. These four compounds plus c hlorinated dibenzodioxins and furans were identified in the NEI dataset for the entire mill , which includes sources inside and outside the s ubpart S category ( e.g. , boilers, chemical recovery combustion sources ). In the second step of the screening process, we determined whether the facility

- specific emission rates of each of the emitted PB

– HAP were large enough to create the potential for significant non

inhalation human health or environmental risks. To facilitate this step, we have developed emission rate thresholds for each
PB

– HAP using a hypothetical screening exposure scenario developed for use in conjunction with the TR IM.FaTE model. The hypothetical screening scenario was subjected to a sensitivity analysis to ensure that its key design parameters were established such that environmental media concentrations were not underestimated ( i.e. , to minimize the occurrence of f alse negatives or results that suggest that risks might be acceptable*** E.O. 12866 Review

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when, in fact, actual risks are high), and to also minimize the occurrence of false positives for human health endpoints. We call this application of the TRIM.FaTE model TRIM

- Screen. The facility

- specific emission rates of each of the PB

– HAP in each source category were compared to the emission threshold values for each of the PB

– HAP identified in the source category dataset s. For all of the facilities in the source categor y addressed in this proposal, all of the PB

- HAP emission rates were less than the emission threshold values , except for one facility with POM emissions as benzo(a)pyrene that exceeded the screening emission rate by a factor of 2
. For POM, exceeding the screening emissio n rate relates to a potential for creating a cancer risk in excess of 1 in a million
. In performing the screening for potential multipathway exposures and risks of concern, we determined that emissions of POM were not significant enough to pose multipathwa y impacts of concern for human health or the environment. If the emission rates of the PB

- HAP had been determined to be significant, the source categor y would have been further evaluated for potential non

- inhalation risks and adverse environmental effects in a third step through site

specific refined assessments using the EPA’s TRIM.FaTE model.*** E.O. 12866 Review

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For f urther information on the multi pathway analysis approach, see the residual risk documentation as referenced in section IV.A of this preamble.
5. Assessing Risk s Considering Emissions Control Options This rulemaking does not require the installation of any

new emission controls to reduce risk ; therefore, no risk modeling was conducted to estimate risk reductions following installation of emission controls for th is proposal. 6. Conducting Facility w ide Risk Assessments To put the source category risks in context, we also examine the risks from the entire “facility,” where the facility includes all HAP

- emitting operations within a contiguous area and under common c ontrol. In other words, w e examine the HAP emissions not only from the source category of interest but also emissions of HAP from all other emissions sources at the facility. Nearly a ll 171 major sources in the s ubpart S category incl ude boilers , and 111 o f the 171 major sources include chemical recovery combustion sources ( e.g. , recovery furnace, smelt dissolving tank, lime kiln). Pulp and paper mills also include paper coating, landfills, petroleum storage and transfer and other operations. Therefore, whe re data were available, we perform ed a facilitywide risk assessment for these major sources as part of today’s action
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We estimated the risks due to the inhalation of HAP that are emitted “facilitywide” for the populations residing within 50 km of each fac ility, consistent with the methods used for the source category analysis descr ibed above. For these facility wide risk analyses, the modeled source category risks were compared to the facilitywide risks to determine the portion of facilitywide risks that co uld be attributed to the source categories addressed in this proposal. We specifically examined the facilities associated with the highest estimates of risk and determined the percentage of that risk attributable to the source category of interest. The ris k documentation available through the docket for this a ction provides all the facilitywide risks and the percentage of source category contribution for al l source categories assessed. The methodology and the results of the facilitywide analyses for each s ource category are included in the residual risk documentation as referenced in section IV.A of this preamble, which is available in the docket for this action.
7. Considering Uncertainties in Risk Assessment Uncertainty and the potential for bias are inh erent in all risk assessments , including th at performed for the source categor y addressed in this proposal. Although uncertainty exists, we believe the approach that we took, which used*** E.O. 12866 Review

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conservative tools and assumptions to bridge data gaps , ensures that o ur decisions are health

- protective. A brief discussion of the unce rtainties in the emissions data set, dispersion modeling, inhalation exposure estimates and dose

- response relationships follows belo w. A more thorough discussion of these uncertainties is inc luded in the risk assessment documentation ( Draft Residual Risk Assessment for the Pulp and Paper Category ) available in the docket for this action.

a. Uncertainties in the Emissions Dataset Although the development of the RTR dataset involved QA/QC
proces ses, the accuracy of emissions values will vary depending

on : (1) the source of the data, (2) the degree to which data are incomplete or missing, (3) the degree to which assumptions made to complete the datasets are accurate, (4) whether and to what
extent errors were made in estimating emissions values, (5) whether the emissions were based on or extrapolated from stack tests or estimates of fugitive emissions, and (6 ) miscellaneous other factors. The annual HAP emissions estimates used in the risk

assessme nt are derived from data provided by mills in response to the Part II survey. Many of these emissions estimates are based on emission factors, developed from the most comprehensive dataset available for this industry, p rovided by NCASI. The*** E.O. 12866 Review

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uncertainties a ssociated with emission factors include the uncertainties in the measurement of the data, limitations in the size and quality of the dataset, the presence of non

- detects and outliers in the dataset, the emission factor calculations used,
etc. b. Uncertain ties in Dispersion Modeling Although the analysis employed the 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 wh ere 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 offsite locations and census block c entroids, the approach considered in the dispersion modeling analysis should generally yield overestimates of ambient HAP concentrations.

c. Uncertainties in Inhalation Exposure*** E.O. 12866 Review

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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. 12 The assumption of not considering short

- or long

- term population mobility does not bias the estimate of the theoretical MIR , nor d oes it affect the estimate of cancer incidence since the total population number remains the same. It does, however, affect the shape of the distribution of individual risks across the affected population, shifting it toward higher estimated individual ris ks at the upper end and reducing the number of people estimated to be at lower risks, thereby increasing the estimated number of people at specific risk levels. In addition, the assessment predicted the chronic exposures at the centroid of each populated c ensus 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 an d under

- predict exposures for people in the census block who live closer to the facility. Thus, using the census block centroid to predict chronic

12 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 life time.*** E.O. 12866 Review

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exposures may lead to a potential understatement or overstatement of the true maximum impact for any one indi vidual 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 th e length of time that modeled emissions sources at facilities actually operate ( i.e. , more or less than 70 years), and the domestic growth or decline of the modeled industry ( i.e. , the increase or decrease in the number or size of United States facilities) , will influence the future risks posed by a given source or source category. Depending on the characteristics of the industry, these factors will, in most cases, result in an overestimate both in individual risk levels and in the total estimated number of cancer cases. However, in rare cases, where a facility maintains or increases its emissions 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 poten tially 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.*** E.O. 12866 Review

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The exposure estimates used in these analyses assume chronic e xposures 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 equivale nt to ambient levels, but for very reactive pollutants or larger partic les, these levels are typically lower. This factor has the potential to result in an overstatement of 25 to 30 percent of exposures for some HAP
. 13 In addition to the uncertainties high lighted 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 meteorol ogical conditions. These assumptions would tend to be worst

- case actual exposures since it is unlikely that a person would be located at

13 U.S. EPA. National

- Scale Air Toxics Assessment for 1996 . EPA 453/R

– 01

– 003; January 2001; page 85.*** E.O. 12866 Review

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the point of maximum exposure during the time of worst

- case impact. d. Uncertainties in Dose

- Response Relationships The re are uncertainties inherent in the development of the dose

- response values used in our risk assessments for cancer effects from chronic exposures and noncancer effects from both chronic and acute exposures. Some uncertainties may be considered quantitati vely , 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 the
EPA’s 2005 Cancer Guidelines ; namely, that “the primary goal of EPA actions is protection of human health; accordingly, as an

a gency 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 app roach followed here as summarized in the next several paragraphs. A complete detailed discussion of uncertainties and variability 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*** E.O. 12866 Review

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limit to the true value of a quantity” (although this is usually
not a true s tatistical confidence limit). 14 In some circumstances, the true risk could be as low as zero; however, in other circumstances the risk could be greater. 15 When developing an upper bound estimate of risk and to provide risk values that do not underestimate ri sk, health

- protective default approaches are generally used. To err on the s ide of ensuring adequate health protection, the EPA typically uses the upper bound estimates rather than lower bound or central tendency estimates in our risk assessments, an appro ach that may have limitations for other uses ( e.g. , priority

- setting or expected benefits analysis). Chronic noncancer reference (RfC and RfD) values represent chronic exposure levels that are intended to be health

protective levels. Specifically, these v alues 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

14 IRIS glossary ( http://www.epa.gov/NCEA/iris/help_gloss.htm ). 15 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

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relies upon an UF approach (EPA 1993, 1994) which consider s uncertainty , variability and gaps in the available data
. The UF are applied to derive reference values that are intended to protect against appreciable risk of deleterious effects. The UF are commonly default values, 16 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 ref erence 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 q uantitative considerations when using observed animal (usually rodent) or human toxicity data in the

16 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, Ris k 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, def ault options are not rules that bind the a gency; rather, the a gency 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 environme nt, 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 avail able at: http://www.epa.gov/osa/pdfs/ratf

- final.pdf
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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

- individu al 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

- chroni c 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 availab le 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. U ncer tainty factors 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) h eterogeneity among humans; (2) uncertainty in extrapolating from animals to humans; (3) uncertainty in lowest observed adverse effect (exposure)*** E.O. 12866 Review

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level to no observed a dverse 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 observat ions at one exposure duration ( e.g. , 4 hours) to derive an acute reference value at another exposure duration ( e.g. , 1 hour). Not all acute reference values are developed for the same
purpose , and care must be taken when interpreting the results of

an ac ute 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 charact erization as potential uncertainties. Although every effort is made to identify peer

- reviewed reference values for cancer and noncancer effects for all pollutants emitted by the sources included in this assessment, some HAP continue to have no reference va lues for cancer or chronic noncancer 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. For a group of compo unds that are either unspeciated or do not have reference values for every*** E.O. 12866 Review

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individual compound ( e.g. , glycol ethers), we conservatively use the most protective reference value to estimate risk from individual compounds in the group of compounds. Additiona lly, chronic reference values for several of the compounds included in this assessment are curr ently under the EPA IRIS review ( e.g. , formaldehyde), and revised assessments may determine that these pollutants are more or less potent than the current value. We may re

- evaluate residual risks for the final rulemaking if these reviews are completed prior to our taking final action for th i s source categor y and if a dose

response metric changes enough to indicate that the risk assessment supporting this notice ma y significantly understate human health risk.

e. Uncertainties in the Multipathway and Environmental Effects Screening We generally assume that when exposure levels are not anticipated to adversely affect human health, they also are not anticipated to adv ersely affect the environment. For each source category, w e 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. Our screening methods use worst

- ca se scenarios to determine whether multipathway impacts might be important. The results of such a*** E.O. 12866 Review

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process are biased high for the purpose of screening out potential impacts. Thus, when individual pollutants or facilities screen out, we are confident that th e potential for multipathway impacts is negligible. On the other hand, when individual pollutants or facilities do not screen out, it does not mean that multipollutant impacts are significant, only that we cannot rule out that possibility. The site

- specifi c PB

- HAP emission levels were almost all far below levels which would trigge r a refined assessment of multi pathway impacts
. The only
PB

- HAP to exceed the screening threshold was POM with emissions exceeding the screening threshold by a factor of 2. Thus, w e are confident that these types of impacts are insignificant for th e facilities in this source catego ry . B . How did we consider the risk results in making decisions for this proposal? As discussed in the previous section of this preamble, we apply a two

- s tep process for determining whether to develop standards to address residual risk. In the first step, the EPA determines whether risks are acceptable. This determination “considers all health information, including risk estimation uncertainty, and includes a presumptive level on maximum*** E.O. 12866 Review

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individual lifetime [cancer] risk (MIR) 17 of approximately one in 10 thousand [ i.e. , 100 in 1 million].” 54 FR 38045. In the second step of the process, the EPA determines what level of the standard is needed to provide an am ple margin of safety “in consideration of all health information, including the number of persons at risk levels higher than approximately one in one million, as well as other relevant factors, including costs and economic impacts, technological feasibilit y, and other factors relevant to each particular decision.” Id
. In past residual risk actions , the EPA 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 noncancer HI; and the maximum acute noncancer hazard . See, e.g., 75 FR 65068, 65072

- 74 ( October 21, 2010 ) and 76 FR 22566, 22575 (April 21 , 2011)
. In estimating risks, the EPA considered sour ces under review that are located near each other and that affect the same population. The EPA developed risk estimates based on the actual emissions from the source category under review as well as based on the maximum emissions allowed pursuant to the so urce category MACT standards. The EPA

17 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

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also discussed and considered risk estimation uncertainties. The EPA is providing this same type of information in support of this action. The a gency is considering all available health information to inform our determ inations 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 t hat the acceptability of risk under [previous] section 112 is best judged on the basis of a broad set of health risk measures and information” ( 54 FR 38046 ) . Similarly, with regard to making the ample margin of safety determination, as stated in the Benzen e NESHAP , “[ i n the ample margin decision, the a gency 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 con sidered, including cost and economic impacts of controls, technological feasibility, uncertainties, and any other relevant factors.” Id. The a gency acknowledges that the Benzene NESHAP provides flexibility regarding what factors the EPA might consider in

m aking determinations and how they might be weighed for each source category. In responding to comment on our policy under*** E.O. 12866 Review

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the Benzene NESHAP, the EPA explained that: “The policy chosen by the Administrator permits consideration of multiple measures of heal th risk. Not only can the MIR figure be considered, but also incidence, the presence of noncancer health effects, and the uncertainties of the risk estimates. In this way, the effect on the most exposed individuals can be reviewed as well as the impact on the general public. These factors can then be weighed in each individual case. This approach complies with the Vinyl Chloride mandate that the Administrator ascertain an acceptable level of risk to the public by employing [her] expertise to assess availabl e 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 )
. Thus , the level of the MIR is only one factor to be weighed i n determining acceptability of risks. T he Benzene NESHAP explained 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*** E.O. 12866 Review

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less accep table 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 a gency may find, in a particular case, that a risk that includes MIR less than the presumptively a cceptable level is unacceptable in the light of other health risk factors” ( Id
. at 38045 )
. Similarly, with regard to the ample margin of safety analysis, the EPA stated in the Benzene NESHAP that: “... EPA believes the relative weight of the many factors that can be considered in selecting an ample margin of safety can only be determined for each specific source category. This occurs mainly because technological and economic factors (along with the health

- related factors) vary from source category to source ca tegory” ( Id. a t 38061 )
. C
. How did we perform the technology review? Our technology review focused on the identification and evaluation of developments in practices, processes and control technologies that have occurred since the 1998 NESHAP was promulgat ed. In cases where the technology review identified such developments, we conducted an analysis of the technical feasibility of applying these developments, along with the estimated impacts (costs, emission s reductions, risk reductions, etc.) of applying t hese developments. We then made decisions on*** E.O. 12866 Review

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whether it is necessary and appropriate to propose amendments to the regulation to require any of the identified developments. Based on specific knowledge of the source category, we began by identifying known d evelopments 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 devel opment of the 1998 NESHAP;

• Any improvements in add

- on control technology or other equipment (that were identified and considered during development of the 1998 NESHAP) that could result in significant additional emissions reductions ;

• Any work practi ce or operational procedure that was not identified or considered during development of the 1998 NESHAP; and

• Any process change or pollution prevention alternative that could be broadly applied to the industry and that was not identified or considered during development of the 1998 NESHAP. In addition to reviewing the practices, processes or control technologies that were not considered at the time we developed the 1998 NESHAP, we reviewed a variety of data sources in our evaluation of whether there were additional practices, processes or controls to consider for the pulp and paper industry. T o aid in our evaluation of whether there were additional practices, processes or controls to consider , o ne of these sources of data was subsequent air toxics rul es. Since the*** E.O. 12866 Review

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promulgation of the MACT standards for the source category addressed in this proposal, the EPA has developed air toxics regulations for a number of additional source categories. In these subsequent air toxic regulatory actions, we consistentl y evaluated any new practices, processes and control technologies. We reviewed the regulatory requirements and/or technical analyses associated with these subsequent regulatory actions to identify any practices, processes and control technologies considere d in these efforts that could possibly be applied to emission sources in the source category under this current RTR review. We also consulted the EPA’s RBLC to identify potential technology advances. (See the memorandum in the docket entitled, Summary of RBLC and Other Findings to Support Section 112(d)(6) Technology Review for Pulp and Paper NESHAP
. ) Control technologies, classified as RACT, BACT, or LAER apply to stationary sources depending on whether the sources are existing or new, and on the size, ag e and location of the facility. B est available control technology and LAER (and sometimes RACT) are determined on a case

- by

- case basis, usually by s tate or local permitting agencies. The EPA established the RBLC to provide a central database of air polluti on technology information (including technologies required in source

- specific permits) to*** E.O. 12866 Review

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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 it contained any practices, processes or control technologies for the types of processes covered by the Pulp and Paper source category. We also further analyzed a number of BACT determinations listed in the RBLC to obtain fur ther information. Additionally, we conducted a general search of the Internet and other sources for information on control technologies applicable to p ulp and p aper production. Finally, we conducted a search of the database containing the responses receiv ed from the Part I survey to obtain information on process and emission controls currently in use in pulp and paper production
. Each of the evaluations listed above considered and reviewed the technologies suitable to demonstrate compliance with the requi rements listed in § §63.440 through 63.44 9 ( s ubpart S). See the memorand a entitled Section 112(d)(6) Technology*** E.O. 12866 Review

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Review for Pulping and Papermaking Processes and Summary of Pulp Bleaching Technology Review , in the docket for this rulemaking.
D . What other is sues are we addressing in this proposal? In addition to the analyses described above, we also reviewed other aspects of the MACT standards for possible revision as appropriate and necessary. Based on this review , we have identified aspects of the MACT stan dards that we believe need revision. This includes proposing revisions to the SSM provisions of the MACT rule in order to ensure that they are consistent with the court decision in Sierra Club v. EPA , 551 F. 3d 1019 (D.C. Cir. 2008). In addition, we are p roposing various changes based on our review of the rule for testing and monitoring sufficien cy, including a requirement for 5

- year repeat air emissions testing for selected equipment and additional test methods for measuring methanol
. We are also proposin g minor changes with regards to editorial errors
. T he analyses and proposed decisions for these actions are presented in s ection
I V .E of this preamble.
**IV. Analytical Results and Proposed Decisions**  This section of the preamble provides the results of o ur
R TR for the Pulp and Paper source category and our proposed decisions concerning changes to the 1998 NESHAP
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A . What are the results of the risk assessments? For the Pulp and Paper source category, w e conducted an inhalation risk assessment for all HAP emi tted. 1. Inhalation R isk A ssessment R esults Table 3 provides an overall summary of the results of the inhalation risk assessment from the 171 modeled mills subject to this source category . We also conducted an assessment of facility wide risk . D etails of the risk assessments and 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. **Table 3. Pulp and Paper Production**  **Inhalation Risk Assessment Results** 

Maximum I ndividual Cancer R isk (in 1 million) 1 Estimated Population at Increased Risk of Cancer ≥ 1 in 1 M illion Estimated Annual C ancer I ncidence (cases per year) Maximum C hronic N oncancer TOSHI 2 Worst

- case Maximum Refined Screening Acute N oncancer HQ 3 Based on Actual Emissions Level Based on Allowable Emissions Level Based on Actual Emissions Level Based on Allowable Emissions Level

10 10 76,000 0.01 0.4 0.6 HQ REL = 20 HQ ERPG

- 1 = 0.4 ( acetaldehyde ) HQ REL = 6 HQ ERPG

- 1 = 0.004

(chloroform)

HQ REL = 5 HQ AEGL

- 1 = 0.2 (formaldehyde) HQ REL = 2 HQ ERPG

- 1 = 0.2

(methanol) 1 Estimated maximum individual excess lifetime cancer risk due to HAP emissions from the source category . 2 Maximum TOSHI. The target organ with the highest TOSHI for the Pulp and Paper source cat egory is the respiratory system. 3 See section I II.B of this preamble for explanation of acute dose

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As shown in Table 3 , the results of the inhalation risk assessment performed using actual emissions data indicate the maximum lifetime i ndividual cancer risk could be as high as 10 in 1 million, primarily due to hexachloroethane emi ssions; the maximum chronic non cancer TOSHI value could be as high as 0. 4 , primarily due to acetaldehyde emissions; and the maximum off site
worst

- case acute HQ value could be as high as 20 , based on the REL value for acetaldehyde
. The HQ of 20 represents an upper

bound risk estimate and is located in an uninhabited location in which public access is limited ; a worst

- case acute noncancer HQ of 3 may be more approp riate for this facility based upon public accessibility
. This would then result in the next highest HQ of 6 for this source category based on the acute REL dose

- response value for chloroform. Nine of the 171 facilities in this source category had an estima ted worst

- case HQ greater than 1. To better characterize the potential health risks associated with estimated worst

- case acute exposures to HAP, and in response to a key recommendation from the SAB’s peer review of EPA’s RTR risk assessment methodologies 18 , we examine a wider range of available acute health metrics than we do for our chronic risk assessments. This is in response to the

18 The SAB peer review of RTR Risk Assessment Methodologies is available at:

http://yosemite.epa.gov/sab/sabproduct.nsf/4AB3966E263D943A8525771F00668381/ $File/EPA

- SAB

- 10

- 007

- unsi gned.pdf*** E.O. 12866 Review

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acknowledgement that there are generally more data gaps and inconsistencies in acute reference values than there are in chr onic reference values. By definition, the acute CalEPA REL represents a health

- protective level of exposure, with no risk anticipated below those levels, even for repeated exposures; however, the health risk from higher

- level exposures is unknown. Therefor e, when a CalEPA REL is exceeded and an AEGL

- 1 or ERPG

- 1 level is available (i.e., levels at which mild effects are anticipated in the general public for a single exposure), we have used them as a second comparative measure. Historically,

c ompariso ns of th e estimated maximum offsite 1

- hour exposure levels have not been typically made to occupational levels for the purpose of characterizing public health risks in RTR
assessments . This is because o ccupat ional ceiling values are not generally considered protec tive for the general public since they are designed to protect the worker population (presumed healthy adults) for short

- duration (less than 15

- minute) increases in exposure 19 . As a result, f or most chemicals, the 15

- minute occupational ceiling values are s et at levels higher than

a 1

- hour AEGL

- 1 , making comparisons to them irrelevant unless

19 U.S. EPA. (2009) Chapter 2.9 Chemical Specific Reference Values for

Formaldehyde in Graphical Arrays of Chemical

- Specific Health Effect Reference Values for Inhalation Exposures (Final Report). U.S. Environmental Protection Agency, Washington, D C, EPA/600/R

- 09/061, and available on

- line at http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=211003*** E.O. 12866 Review

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the AEGL

- 1 or ERPG

- 1 levels are exceeded. Such is not the case when comparing the available acute inhalation health effect reference values for formaldehyde.
T he worst

- c ase maximum estimated 1

- hour exposure to formaldehyde outside the facility fence line for the pulp and
paper source category is 0.25 mg/m 3 . This estimated worst

- case exposure exceeds the 1

- hour REL by a factor of 5 (HQ REL =5) and is below the 1

- hour AEGL

- 1 (HQ AEGL

- 1 =0.2). This exposure estimate is below the AEGL

- 1, and exceeds the workplace ceiling level guideline for the formaldehyde value developed by NIOSH 20 “ for any 15 minute period in a work day ” (NIOSH REL

- ceiling value of 0.12 mg/m 3 ; HQ NIOSH = 2 ). T he es timate is at the value developed by the ACGIH 21 as “not to be exceeded at any time” (ACGIH TLV

ceiling value of 0.37 mg/m 3 ; HQ ACGIH =1). Additionally, the estimated maximum acute exposure exceeds the Air Quality Guideline value that was developed by the Worl d Health Organization 22 for 30

- minute exposures (0.1 mg/m 3 ; HQ WHO = 2.5)
.

20 National Institutes for Occupational Safety and Health (NIOSH).

Occupational Safety and Health Guideline for Formaldehyde; http://www.cdc.gov/niosh/d ocs/81

- 123/pdfs/0293.pdf
21 ACGIH (2001) Formaldehyde. In Documentation of the TLVs® and BEIs® with

Other Worldwide Occupational Exposure Values. ACGIH, 1300 Kemper Meadow Drive, Cincinnati, OH 45240 (ISBN: 978

- 1

- 882417

- 74

- 2) and available on

- line at http:/ /www.acgih.org.
22 WHO (2000). Chapter 5.8 Formaldehyde, in Air Quality Guidelines for Europe,

second edition. World Health Organization Regional Publications, European Series, No. 91. Copenhagen, Denmark. Available on

- line at http://www.euro.who.int/__data/assets/pdf_file/0005/74732/E71922.pdf
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All other HAP and facilities modeled had worst

- case acute HQ values less than 1, indicating that they carry no potential to pose acute concerns. The maximum HQ based on an ERPG

- 1 dose

response value is 0.4 for acetaldehyde. In characterizing the potential for acute noncancer impacts of concern, it is important to remember the upward bias of these exposure estimates ( e.g. , worst

- case meteorology coinciding with a person located at the po int of maximum concentration during the hour) and to consider the results along with the uncertainties related to the emissions estimates and the screening methodology. However, it is acknowledged that the acute emission multipliers ranged from 1.4 to 3 an d approached the annual hourly average emission rate for the facilities within the source category. The total estimated cancer incidence from these facilities based on actual emission s levels is 0.0 1 excess cancer cases per
year, or 1 case in every 100 ye ars. There are 6 8 facilities with maximum individual cancer risks of 1 in 1 million or greater and
two facilities with maximum individual cancer risks of 10 in a million. The cancer risks at these 6 8 facilities are primarily driven by emissions of acetalde hyde and formaldehyde from papermaking and kraft wastewater operations. As explained above, o ur analysis of potential differences between actual emission s levels and emissions allowable under*** E.O. 12866 Review

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the P ulp and P aper MACT standards indicate that MACT

- allowable emission levels are roughly equal to the actual emission levels.
T he risk results from the inhalation risk assessment indicate the maximum lifetime individual cancer risk s are the same at 20 in a million , and the maximum chronic noncancer TOSHI value could be as high as 0.6 at the MACT

- allowable emissions level. 2. Multipathway R isk Screening R esults The results of a multipathway screening analysis showed that emissions of POM, cadmium and mercury were almost all below their respective screening emission r ates, thereby indicating a negligible risk of adverse health effects associated with multipathway exposures. The only PB

- HAP to exceed the screening threshold was POM, with emissions exceeding the screening threshold by a factor of 2. 3. Facilitywide R isk A ssessment R esults A facilitywide risk analysis was also conducted based on actual emissions levels. Table 4 displays the results of the facilitywide risk assessment. For detailed facility

- specific results, see Appendix 6 of the Draft Residual Risk Assess ment for Pulp and Paper in the docket for this rulemaking
. **Table 4. Pulp and Paper Facility -**  **Wide Risk Assessment Results** Number of facilities analyzed 171 Cancer Risk Estimated maximum facility wide individual cancer risk (in 1 million) 30*** E.O. 12866 Review

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Number of fac i lities with estimated facility wide individual cancer risk of 10 in 1 million or more 7
Number of pulp and papermaking operations contributing 50 percent or more to facilitywide individual cancer risk of 10 in 1 million or more 2

Num ber of facilities wi th facility wide individual cancer risk of 1 in 1 million or more 99
Number of pulp and papermaking operations contributing 50 percent or more to facility wide individual cancer risk of 1 in 1 million or more 57

Chronic Noncancer Risk Ma ximum facilitywide chronic non cancer TOSHI 2
Num ber of facilities with facility wide maximum noncancer TOSHI of 1 or more 4 Number of pulp and papermaking operations contributing 50 percent or mo re to facilitywide maximum non cancer TOSHI of 1 or more 0

The maximum ind ividual cancer whole

- facility risk from all HAP emissions at any mill is estimated to be 30 in 1 m illion based on actual emissions . Of the 171 mills included in this analysis, seven have facilitywide maximum individual cancer risks of 10 in 1 million or gr eater. At these mills , pulp and papermaking operations account for 30 percent of the total facility wide risk. There are 99 facilities with facilitywide maximum individual cancer risks of 1 in 1 million or greater. Of these 99 mills , 57 have pulp and paperm aking op erations that contribute greater than 50 percent to the facilitywide risks.*** E.O. 12866 Review

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The facilitywide cancer risks at these 57 mills , and at the 7 mills with risks of 10 in a million or more, are primarily driven by emissions of arsenic compounds, chromium compounds and nickel compounds from boiler and lime kiln operations. However, we note that there are uncertainties in the amount and form of chromium emitted from these mills . For many of the mills , the emissions inventory used for the risk assessment incl uded estimates for the two main forms of chromium (i.e., hexavalent and trivalent chromium). However, for other mills , we only had estimates of total chromium emitted. For those mills , we applied a hexavalent chromium speciation factor assigned by SCC for this source category 23 . Although, hexavalent chromium is toxic and is a known human carcinogen, trivalent chromium is less toxic and is currently “not classified as to its human carcinogenicity.” Therefore, the relative emissions of these two forms can have a significant effect on the cancer risk estimates. The facility wide maximum individual chronic non cancer TOSHI is estimated to be 2 based on actual emissions . Of the 171 mills included in this analysis, only four mills have a HI value of 1 or greater. Th e chronic non cancer risks at th ese mills are primarily driven by acrolein emissions from industrial boilers ,
23 RTI Memorandum from T. Holloway, K. Hanks, and C. Gooden to J. Bradfield and B. Schrock, EPA. November 11, 2011, Inputs to the Pul p and Paper Industry October 2011 Residual Risk Modeling
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which are not regulated under the Pulp and Paper source category . B . What are our proposed decisions regarding risk acceptability

a nd ample margin of safety? 1. Risk A cceptability As noted in section III.B of this preamble, we weigh all health risk factors and measures in our risk acceptability determination, including the MIR; the number of persons in various cancer and noncancer risk ranges; cance r incidence; the maximum noncancer HI; the maximum acute noncancer HQ; the extent of noncancer risks; the potential for adverse environmental effects; distribution of cancer and noncancer risks in the exposed population; and risk estimation uncertainty (54 FR 38044, September 14, 1989). For the Pulp and Paper source category, the risk analysis we performed indicates that the cancer risks to the individual most exposed could be as high as 10 in 1 million due to actual
or MACT

- allowable emi ssions. These risk s are considerably less than 100 in 1 million, which is the presumptive upper limit of risk acceptability. The risk analysis also shows generally low cancer incidence ( 1 case in every 100 years), no potential for adverse environmental effects or human heal th multipathway*** E.O. 12866 Review

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effects, and that chronic and acute noncancer health impacts are unlikely.
A dditional analysis of facility wide risks showed that there

are five mills with maximum facility wide risks in between a cancer risk of 10 in 1 million and 30 in a m illion and four mills with a maximum chronic noncancer TOSHI between 1 and 2; it also showed that the Pulp and Paper source category did not drive these risks
. T he number of people exposed to cancer risks of 1 in 1 million or greater due to emissions from the source category is relatively low ( 76 ,000). Considering these factors and the uncertainties discussed in section III.B of this preamble, we propose that the risks from the Pulp and Paper source category are acceptable. 2. Ample M argin of S afety Under the ample margin of safety analysis, we evaluate the cost and feasibility of available control technologies and other measures (including the controls, measures and costs reviewed under the technology review) that could be applied in this source category t o further reduce the risks due to emissions of HAP identified in our risk assessment. As noted in our discussion of the technology review below in section IV.C , no technologies (beyond those already in place) were identified for reducing HAP emissions fr om P ulp and P aper*** E.O. 12866 Review

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production processes. We are proposing to amend the kraft condensate standards to reflect increased performance of existing controls observed in the technology review, resulting in an estimated HAP reduction of approximately 4,000 tpy.
In crementally increasing the stringency of the kraft condensate standards is expected to reduce risks from kraft wastewater operations. As a result, we conclude that the current standard, as amended by the proposed modifications being proposed today, protect s public health with an ample margin of safety. Though we did not identify any new technologies to reduce risk from this source category beyond incremental improvements in the performance of existing technology used to meet the kraft condensate standards , w e are specifically requesting comment on whether there are additional cost

- effective control measures that may be able to reduce risks from the P ulp and P a per subpart S source category. In particular, we are requesting s tates to identify any controls the y have already required for these facilities, any controls they are currently considering or any other controls of wh ich they may be aware.
C
. What are the results and proposed decisions based on our technology review? We evaluated developments in practice s, processes and control technologies applicable to emission sources subject to*** E.O. 12866 Review

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the Pulp and Paper MACT . This included a search of the RBLC, the Internet and our database containing the 2011 Part I survey
responses. For chemical pulping and bleaching, w e h ave determined that there have been no advance s in emission control

measures since the s ubpart S standard was originally promulgated in 199 8
. Additional details on our techno logy review are provided in docket memoranda entitled, Section 112(d)(6) Technolog y Review for Pulping and Papermaking Processes , and Summary of Pulp Bleaching Technology Review
. For kraft pulping
process condensates, we have determined that the technology has sufficiently advanced since the 1998 MACT rule to warrant the development of an updated standard. The 1998 MACT r ule required kraft pulp mills to either : ( 1) recycle the condensates back to equipment that meet the control standards for pulping system
vents (LVHC, HVLC) , (2 ) treat the condensates to reduce or destroy the HAP by at l east 92 percent by weight, ( 3 ) treat the condensates to remove a specified amount of HAP s ( at least 10.2 lb/ODTP at mills performing bleaching or 6.6 lb/ODTP at mills without bleaching), or ( 4 ) treat the condensates to meet a specified HAP concentration at the control device outlet (330 ppmw at mills performing bleaching or 210 ppmw at mills without bleaching). The three control strategies expected to be used by*** E.O. 12866 Review

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most mills are recycling the condensates, biological treatment and steam stripping
. Our technolo gy review of kraft condensates did not yield any information about new technologies that could become the basis for regulatory options. So our next consideration was an analysis of the 2011 Pulp and Paper ICR database
. In our review of the database , we fou nd that kraft pulp mills generally chose the 92 percent control option for compliance demonstration for kraft condensates rather than recycling. Only five mills use recycling , two mills use both recycling and stea m stripping, and four mills use the aforeme ntioned ppmw option to control kraft condensates . Consequently, the focus of our technology review

wa s on the control efficiencies of wastewater treatme nt systems and steam stripping. We reviewed the 2011 Pulp and Paper ICR database to determine if, under the current control techno logies, there were mills demonstrating greater than the 92 percent minimum level of control (or any equivalent demonstrations). W e found that a substantial majority of kraft pulp mills are performing at a higher level than th e 92 percent minimum level of control. The average percent removal of k raft c ondensates currently being achieved i s estimated to be 96.2 percent .*** E.O. 12866 Review

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For regulatory options, we developed an incremental scale of improvement over the minimum 92 percent control , set u p by percent increments from 93 percent to 98 percent . An estimated four mills would be impacted under the 93 percent option, 15 mills under the 94 percent option, 28 mills under the 95 percent option, 41 mills under the 96 percent option, 54 mills under t he 97 percent option and 66 under the 98 percent option. We did not take the analysis beyond 98 percent because that level was determined to be at the limit of control efficiency for one the major control techniques, steam stripping, and it was equivalent to the control level required for non

- condens a ble gases ducted to controls from LVHC and HVLC sources in 40 CFR 63.443(d) (1)
. After setting up the percent increments, we established an equivalency between the different percent control options and the l b/OD TP and ppmw options:

**Percent control**  **, % l**  **b/ODTP option**  **ppmw option**  **Mills performing**  **bleaching) Mills without**  **bleaching) Mills**  **performing bleaching)**  **Mills without**  **bleaching)** 93 11.5 7.4 289 184 94 12.8 8.3 248 158 95 14.0 9.1 206 131 96 15.3 9.9 165 1 05 97 16.6 10.7 124 79 98 17.9 11.6 83 53

Finally, we estimated the costs and HAP emissions reductions associated with each percent control option. Total annual costs for the options ranged from $1 million to $34*** E.O. 12866 Review

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million, and HAP emissions reductions r anged from 2,000 to 12,000 tpy . Taking these costs and emissions reductions into consideration, we are proposing the 94 percent option for controlling kraft condensate s emissions, which is estimated to cost $4 million per year, with an emissions reduction of 4,000 tpy and a cost

- effectiveness of $1,000 per ton of HAP. Additional details on our kraft condensate technology review and cost analysis are provided in the memoranda , Summary of Kraft Condensate Control Technology Review , and Costs and Environmental and Energy Impacts for Subpart S Risk and Technology Review , in the docket for this proposed action.
D . What other actions are we proposing? 1. Startup, Shutdown, Malfunction The U.S. Court of Appeals for the District of Columbia Circuit vacated portions of two provisions in the EPA’s CAA

s ection 112 regulations governing the emissions of HAP during periods of SSM. S ierra 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 exempti on contained in 40 CFR 63.6(f)(1) and 40 CFR 63.6(h)(1), that are part of a regulation, commonly referred to as the “General Provisions Rule,” that the EPA promulgated under CAA section 112 (d)
. When incorporated into
CAA s ection 112(d) regulations for spec ific source categories,*** E.O. 12866 Review

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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 and operational allow ances for LVHC, HVLC and steam strippers in this rule. Consistent with Sierra Club v. EPA , the 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 a SSM plan. We also are proposing to eliminate or revise certain recordkeeping and reporting that related to the SSM exemption. The 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 suc h provisions that we have inadvertently incorporated or overlooked. We are also requesting comment on our decision to remove the operational allowances for LVHC, HVLC and steam strippers. 24 We request comment on circumstances under which

24 The basis for the promulgated allowances is discussed in the preamble to the final rule at 63 FR 18529

- 18530, April 15, 1998.*** E.O. 12866 Review

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such provisions ha ve been used, and how often the y have been enacted. EPA is interested in knowing whether the operational allowances are necessary for technological reasons. We also request comment on whether it would be more appropriate to narrow the allowances ( e.g. , to reduce or restrict them to certain operational activities , which could include work practices ), or provide an alternative standard or work practice that applies during the times addressed by these allowances (and if so, suggestions for an alternative stand ard). In proposing the standards in this rule, the EPA has taken into account startup and shutdown periods and, for the reasons explained below, has not proposed different standards for those periods. W e have no data indicating that emissions are signifi cantly higher during startup or shutdown than during normal operation. 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, infreque nt, and not reasonably preventable failure of air pollution control and monitoring equipment, process equipment or a process to operate in a normal or usual manner ...” (40 CFR 63.2). The EPA has determined that CAA section 112 does not require that emissions that occur during periods of malfunction*** E.O. 12866 Review

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be factored into development of CAA section 112 standards. Under section 112, emissions standards for new sources must be no less stringent than the level “achieved” by the best controlled similar source and for ex isting sources generally must be no less stringent than the average emission limitation “achieved” by the best performing 12 percent of sources in the category. There is nothing in section 112 that directs the a gency to consider malfunctions in determining the level “achieved” by the best performing or best controlled sources when setting emission standards. Moreover, while the EPA accounts for variability in setting emissions standards consistent with the section 112 case law, nothing in that case law requ ires the a gency to consider malfunctions as part of that analysis. Section 112 uses the concept of “best controlled” and “best performing” unit in defining the level of stringency that section 112 performance standards must meet. Applying the concept of “b est controlled” or “best performing” to a unit that is malfunctioning presents significant difficulties , as malfunctions are sudden and unexpected events. Further, accounting for malfunctions would be difficult, if not impossible, given the myriad differen t types of malfunctions that can occur across all sources in the category and given the difficulties associated with predicting or accounting for the*** E.O. 12866 Review

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frequency, degree and duration of various malfunctions that might occur. As such, the performance of units that are malfunctioning is not “reasonably” foreseeable. See, e.g. , Sierra Club v
. EPA , 167 F. 3d 658, 662 (D.C. Cir. 1999) ( The EPA typically has wide latitude in determining the extent of data

gathering necessary to solve a problem. We generally defer t o an agency's decision to proceed on the basis of imperfect scientific information, rather than to "invest the resources to conduct the perfect study."). See also, Weyerhaeuser v
. Costle , 590 F.2d 1011, 1058 (D.C. Cir. 1978) (“In the nature of things,
no g eneral 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 intoxicati on or insanity, and a variety of other eventualities, must be a matter for the administrative exercise of case

- by

- case enforcement discretion, not for specification in advance by regulation.”). In addition, the goal of a best controlled or best performing source is to operate in such a way as to avoid malfunctions of the source , and accounting for malfunctions could lead to standards that are significantly less stringent than levels that are achieved by a well

- performing non

malfunctioning source. The EPA’s approach to malfunctions is*** E.O. 12866 Review

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consistent with section 112 and is a reasonable interpretation of the statute. In the event that a source fails to comply with the applicable CAA section 112(d) standards as a result of a malfunction event, the EPA would deter mine an appropriate response based on, among other things, the good faith efforts of the source to minimize emissions during malfunction periods, including preventative and corrective actions, as well as root cause analyses to ascertain and rectify excess emissions. The EPA would also consider whether the source's failure to comply with the CAA section 112(d) standard was, in fact, “sudden, infrequent, not reasonably preventable” and was not instead “caused in part by poor maintenance or careless operation. ” 40 CFR 63.2 (definition of malfunction). Finally, the EPA recognizes that even equipment that is properly designed and maintained can sometimes fail and that such failure can sometimes cause an exceedance of the relevant emission standard. ( See, e.g. , S tate Implementation Plans: Policy Regarding Excessive Emissions During Malfunctions, Startup, and Shutdown (Sept. 20, 1999); Policy on Excess Emissions During Startup, Shutdown, Maintenance, and Malfunctions (Feb. 15, 1983)). The EPA is therefore proposing to add to the rule an affirmative defense to civil penalties for*** E.O. 12866 Review

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exceedances of emission limits that are caused by malfunctions.
See § 63. 4 56 for this proposed addition ( and see §63.441 for a defini tion of “affirmative defense” that mean s , in the context

o f an enforcement pro ceeding, 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

a re 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. 456
. ( See 40 CFR 22.24) . The criteria ensure that the affirmative defense is available only where the event that causes an exceedance of the emission limit meets the narrow definition of malfunction in 40 CFR 63.2 (sudden, infrequent, not reasonable preventable and not caused by poor maintenance and or careless operation). For example, to successfully assert the affirmative defense, the source must prove by a preponderance of the evidence that excess emissions “[w]ere caused by a sudden, infrequent, and unavoidable failure of air pollution control and monitoring equipment, process equipment, or a process to operate in a normal or usual manner....” The criteria also are designed to ensure that steps are taken to*** E.O. 12866 Review

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correct the malfunction, to minimize emissions in accordance with § 63
. 45 6 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 respon dent has not met its burden of proving all of the requirements in the affirmative defense, appropriate penalties may be assessed in accordance with s ection 113 of the
CAA (see also 40 CFR 22.27). Specifically, we are proposing the following changes to th e rule related to SSM : ( 1 ) Remove 40 CFR 63.443(e) and 63.446(g), and revise 63.459(b)(11)(ii) to eliminate reference to periods of SSM and excess emissions allowances ; (2 ) Revise 40 CFR 63.453(q) to incorporate th e general duty from 40 CFR 63.6(e)(1)(i) t o minimize emissions; ( 3 ) Add 40 CFR 63.454(g), and 40 CFR 63.455(g) to require reporting and recordkeeping requirements associated with periods of malfunction; ( 4 ) Add 40 CFR 63.456 (formerly reserved) to include an affirmative defense to civil penalties for exceedances of emissions limits caused by malfunctions, as well as criteria for establishing the affirmative defense ; ( 5 ) Add 40 CFR 63.457(o) to specify the conditions for performance tests; and*** E.O. 12866 Review

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( 6 ) Revise Table 1 to specify that 40 CFR 63.6 (e)(1)(i ) and (ii), 63.6(e)(3), 63.6(f)(1); 40 CFR 63.7(e)(1), 40 CFR 63.8(c)(1)(i) and (iii), and the last sentence of 63.8(d)(3); 40 CFR 63.10(b)(2)(i),(ii), (iv), and (v); 40 CFR 63.10(c)(10), (11), and (15); and, 40 CFR 63.10(d)(5) of the Gen eral Provisions do not apply.

We ha ve 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 ther e are any such provisions that we have inadvertently incorporated or overlooked. 2. Repeat Testing As part of an ongoing effort to improve compliance with various f ederal air emission regulations, we reviewed the testing and monitoring requirement of s ubp art S and are proposing the following change.
W e are proposing to require repeat air emissions performance testing once every 5 years for facilities complying with the standards for kraft, soda and semi

- chemical pulping vent gases (§63.443(a)); sulfite pr ocesses (§63.444); and bleaching systems (§63.445)
. Repeat performance tests are already required by perm itting authorities for some facilities. Further, we believe that requiring periodic repeat performance tests will help to ensure that control systems a re properly*** E.O. 12866 Review

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maintained over time, thereby reducing the potential for acute emissions episodes. With today’s proposal, repeat air emissions testing would be required for mills complying with the kraft condensate s standards in §63.446 using a steam strippe r (or other equipment serving the same function) since such equipment is, by definition, part of the LVHC system. Quarterly sampling for four HAP s (acetaldehyde, methanol, MEK and propionaldehyde) is currently required for biological treatment systems to demonstrate compliance with the kraft condensate s standards in §63.446(e)(2). We believe this sampling sufficiently demonstrates compliance with the revised emissions standard we are proposing for kraft condensates
. However, we are interested in receiving comment on the sampling and reporting methods used for these quarterly tests. We note that MEK was removed from the HAP list in 2005. 25 However, the s ubpart S equations were derived considering inclusion of MEK. We request comment on the appropriateness of re - deriving these equations to eliminate MEK for the final rule. We are not proposing repeat air emissions testing for facilities complying with the CCA standards due to the complexity of this compliance approach ( e.g. , comparison to

25 See 70 FR 75047, December 19, 2005.*** E.O. 12866 Review

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baseline emissions ca lculations) and the fact that it often involves both air and/or liquid sampling depending on the CCA technology being used. Nevertheless, we are requesting comment on whether repeat air emissions testing is appropriate (or overly burdensome) for the CCA. 3
. Electronic R eporting The EPA must have performance test data to conduct effective reviews of CAA sections 112 and 129 standards, as well as for many other purposes including compliance determinations, emissions factor development and annual emissions rat e determinations. In conducting these required reviews, the EPA has found it ineffective and time consuming, not only for us, but also for regulatory agencies and source owners and operators, to locate, collect and submit performance test data because of v aried locations for data storage and varied data storage methods. In recent years, though, stack testing firms have typically collected performance test data in electronic format, making it possible to move to an electronic data submittal system that would increase the ease and efficiency of data submittal and improve data accessibility. Through this proposal , the EPA is presenting a step to increase the ease and efficiency of data submittal and improve data accessibility
. Specifically, the EPA is proposing that*** E.O. 12866 Review

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owners and operators of pulp and paper facilities submit electronic copies of required performance test reports to the
EPA’s WebFIRE database. The WebFIRE database was constructed to store performance test data for use in developing emissions factors
. A description of the WebFIRE database is available at h ttp://cfpub.epa.gov/oarweb/index.cfm?action=fire.main
. As proposed above, data entry would be through an electronic emissions test report structure called the ERT . The ERT would be able to transmit the electronic report through the
EPA’s CDX network for storage in the WebFIRE database making submittal of data very straightforward and easy. A description of the ERT can be found at http://www.epa.gov/ttn/chief/ert/ert

_ tool.html
. The proposal to submit performance test data electronically
to the EPA would apply only to those performance tests conducted using test methods that will be supported by the ERT. The ERT contains a specific electronic data entry form for most of the commonly used EPA reference methods. A listing of the pollutants and test methods supported by the ERT is available at http://www.epa.gov/ttn/chief/ert/ert

_ tool.html
. We believe that industry would benefit from this proposed approach to electronic data submittal. Having these data, t he EPA would be able to*** E.O. 12866 Review

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develop improved emissions factors, make fewer information requests and promulgate better regulations. One major advantage of the proposed submittal of performance test data through the ERT is a standardized method to compile and s tore much of the documentation required to be reported by this rule. Another advantage is that the ERT clearly states what testing information would be required. Another important proposed benefit of submitting these data to the EPA at the time the source test is conducted is that it should substantially reduce the effort involved in data collection activities in the future. When the EPA has performance test data in hand, there will likely be fewer or less substantial data collection requests in conjunction with prospective required residual risk assessments or technology reviews. This would result in a reduced burden on both affected facilities (in terms of reduced manpower to respond to data collection requests) and the EPA (in terms of preparing and distr ibuting data collection requests and assessing the results). State, local and tribal agencies could also benefit from more streamlined and accurate review of electronic data submitted to them. The ERT would allow for an electronic review process rather tha n a manual data assessment , making review and evaluation of the source provided data and calculations easier*** E.O. 12866 Review

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and more efficient. Finally, another benefit of the proposed data submittal to WebFIRE electronically is that these data would greatly improve the overall quality of existing and new emissions factors by supplementing the pool of emissions test data for establishing emissions factors and by ensuring that the factors are more representative of current industry operational procedures. A common complain t heard from industry and regulators is that emissions factors are outdated or not representative of a particular source category. With timely receipt and incorporation of data from most performance tests, the EPA would be able to ensure that emissions fac tors, when updated, represent the most current range of operational practices. In summary, in addition to supporting regulation development, control strategy development and other air pollution control activities, having an electronic database populated wi th performance test data would save industry, state, local, tribal agencies and the EPA significant time, money and effort while also improving the quality of emissions inventories and, as a result, air quality regulations. Records must be maintained in a form suitable and readily available for expeditious review, according to § 63.10(b)(1). Electronic recordkeeping and reporting is available for many records, and is the form considered most suitable for*** E.O. 12866 Review

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expeditious review if available. Electronic recordkeep ing and reporting is encouraged in this proposal , and some records and reports are required to be kept in electronic format. Records required to be maintained electronically include the output of continuous monitors and the output of the bag leak detection systems. Additionally, standard operating procedures for the bag leak detection system and fugitive emissions control are required to be submitted to the Administrator for approval in electronic format.
4
. Other The following lists additional minor change s to the subpart
S NESHAP and minor changes to the part 63 General Provisions that we are proposing. This list includes proposed rule changes that address editorial and other corrections
. ( 1) Revise 40 CFR 63.457(b)(1) to specify part 60, appendix A

- 1 for Method 1 or 1A; (2) Revise 40 CFR 63.457(b)(3) to specify part 60, appendix A

- 1 for Method 2, 2A, 2C, or 2D; (3) Revise 40 CFR 63.457(b)(5)(i) to include two additional test methods

-- Method 320 of part 63, appendix A, and Method 18 of part 60, appendix A

- 6

-- for measuring methanol emissions from pulp and paper processes; (4) Revise 40 CFR 63.457(b)(5) (ii) to specify part 60, appendix A

- 8 for Method 26A; (5) Revise 40 CFR 63.457(d) to specify part 60, appendix A

7 for Method 21; and (6) Revise 40 CFR 63.457(k )(1) to specify part 60, appendix A

- 2 for Method 3A or 3B , and include ASME PTC 19.10

– Part 10 as an alternative to Method 3B ;*** E.O. 12866 Review

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(7) Revise 40 CFR 63.457(c)(3)(ii) to r eplace NCASI Method DI/MEOH

- 94.02 with the more recent version of this method, NCASI Meth od DI/MEOH

- 94.03 ; (8) Add 40 CFR 63.14(f)(5) to incorporate by reference NCASI Method DI/MEOH

– 94.03; and (9) Revise 40 CFR 63.14(i)(1) to incorporate by reference ANSI/ASME PTC 19.10

– 1981.
E . Compliance Dates We are proposing that existing facilities mus t comply with all of the requ irements in this action ( other than affirmative defense provisions and electronic reporting, which are effective upon promulgation of the final rule) no later than 2 years after the effective date of this rule. All new or recon structed facilities must comply with all requirements in this rule upon startup.
**V. Summary of Cost, Environmental and Economic Impacts** 
A. What are the affected sources? The affected source for k raft, soda, sulfite or semi

chemical pulp ing processes is th e total of all HAP emission points in the pulping and bleaching systems. The affected source for mechanical, secondary or non

- wood pulping processes is the total of all HAP emission points in the bleaching system.
B. What are the air quality impacts? Unde r the proposed amendments, an estimated 15 mills would have to upgrade their steam strippers or biological treatment systems to comply with the more stringent kraft condensates*** E.O. 12866 Review

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standard. The current proposal is estimated to reduce HAP emissions by approxim ately 4 ,000 tpy . The proposed amendments would require an estimated 114 mills to conduct repeat testing for pulping and bleaching operations and all 171 major sources in the category to operate without the SSM exemption. We were unable to quantify the
spe cific emissions reduction s associated with repeat emissions testing or eliminating the SSM exemption and excess emissions allowance
. However, repeat testing would provide incentive for facilities to maintain their control systems and make periodic adjustme nts to ensure peak performance, thereby reducing emissions and the potential for periodic episodes of acute risk
. Eliminating the SSM exemption would provide an incentive for facilities to minimize emissions during periods of SSM
. C. What are the cost impa cts? Under the proposed amendments, pulp and paper mills are expected to incur costs to upgrade their steam strippers or biological treatment systems to comply with the more stringent kraft condensates standard. These mills would also incur costs
to condu ct repeat testing and record malfunctions in support of the new affirmative defense in the rule. The total nationwide annual costs associated with these new requirements is $ 6.2 million.*** E.O. 12866 Review

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D. What are the economic impacts? The EPA per formed an EIA of the pr oposed rule. The EIA, which documents the data sources and methods used and provides detailed results, can be found in the d ocket for this proposed action . This section provides an overview of key results. The EPA performed a series of single

- market partia l

equilibrium analyses of national pulp and paper product markets to estimate the economic consequences of th e proposal. The models predict how the regulatory program might affect prices and quantities for 10 paper and paperboard products that, aggregated, constitute the entire productio n of the papermaking industry. The EPA also conducted an economic welfare analysis that estimated the consumer and producer surplus changes associate d with the regulatory program. The welfare analysis identifies how the regu latory costs are distributed across two broad classes of stakeholders: consumers and producers. The market analysis found that the proposal is likely to induce minimal c hanges in the average national price of paper and paperboard products. Paper and paperb oard product prices are predicted to increase less than 0.01 percent on average, while production levels decrease less than 0.01 percent on average , as a result of the proposal. The partial equilibrium models predict that consumers will see reductions in e conomic welfa re of about*** E.O. 12866 Review

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$3.3 million as the result of higher p rices and reduced consumption. Although producers’ welfare losses are mitigated to some degree by slightly higher prices, market conditions limit their ability to pass o n all of the compliance costs. As a result, producers are also predicted to experience a loss i n economic welfare of about $2.9 million. The EPA performed a screening analysis for impacts on small businesses by comparing estimated annualized engineering compliance costs at the c ompany - level to company sales. The screening analysis found that the ratio of compliance cost to company revenue falls below 1 percent for the three small companies that are likely to be affe cted by the proposal. Based on this analysis, the EPA presumes th ere is no SISNOSE arising from t he proposed NESHAP amendments. Additionally, the EPA estimated the annual labor required to comply with the requirements of the proposal. To do this, the EPA first estimated the labor required for emission control equipment operation and maintenance, then converted this number
to FTEs by dividing by 2,080 (40 hours per week multiplied by 52 weeks). The annual labor requirement to comply with the proposal is estimated at about five full

- time

- equivalent employees. The
EPA notes that this type of FTE estimate cannot be used to make*** E.O. 12866 Review

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assumptions about the specific number of people involved or whether new jobs are created for new employees. While a series of partial equilibrium models was used to analyze the economic impacts of this proposal, the EPA notes that it is current ly developing the ISIS model for the U nited
States pulp and paper industry. When completed, t he ISIS model for the pulp and paper industry will be a dynamic engineering

economic model that facilitates analysis of emission s reduction strategies for multiple pollutants, while taking into account plant

- level economic and technical factors , such as the type of mill, associated capacity, location, cost of production,

a pplicable controls and costs. By considering various emission s reduction strategies, the model , when completed , will provide information on optimal industry operation and determine the most
cost

- effective controls to meet the demand for pulp and paper products and the emission s reduction requirements for a given time period of interest.
E. What are the benefits? The proposed r ule is expected to result in a r eduction of approximately 4 , 000 t py of HAP. We have not quantified the monetary benefits associated with these reductions. **VI. Request for Comments***** E.O. 12866 Review

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We are soliciting comments on all aspects of this proposed action. In addition to general comments on this proposed action, we are also interested in any additional data that may help to reduce the uncertainties inherent in the risk assessments and other anal yses. We are specifically interested in receiving corrections to the site

- specific emissions profiles used for risk modeling. Such data should include supporting documentation in sufficient detail to allow characterization of the quality and representative ness of the data or information. Section VII of this preamble provides more information on submitting data. **VII. Submitting Data Corrections** The site

- specific emissions profiles used in the source category risk analyses are available for download on the RT R w eb
p age at: http://www.epa.gov/ttn/atw/rrisk/rtrpg.html
. The data files include detailed information for each HAP emissions release point for each facility included in the source category. If you believe that the data are not representative or are inac curate, 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 s uggested changes. To submit comments on the data downloaded from the RTR w eb page, complete the following steps:*** E.O. 12866 Review

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1
. Within this downloaded file, enter suggested revisions to the data fields appropriate for that information. The data fields that may be revi sed include the following:
**Data Element Definition**  Control Measure Are control measures in place? (yes or no) Control Measure Comment Select control measure from list provided, and briefly describe the control measure Delete Indicate here if the facilit y or record should be deleted Delete Comment Describes the reason for deletion Emissions Calculation Method Code For Revised Emissions Code description of the method used to derive emissions. For example, CEM S , material balance, stack test, etc. Emissio ns Process Group Enter the general type of emissions process associated with the specified emissions point

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

- dimension relative to true North, measured positive for clockwi se 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 refe rred 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 coordinat es (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*** E.O. 12866 Review

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**Data Element Definition**  REVISE D County Name Enter revised county name here REVISED Emissions Release Point Type Enter revised Emissions 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) REV ISED 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 Perfor mance 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 Heigh t 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 tot al 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 emissions release points Startup Emissions Enter total annual emissions due to startup events ( tpy )*** E.O. 12866 Review

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**Data Element Definition**  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 email address, commenter phone number and revision comments). 3. Gather documentation for any suggested emissions revisions ( e.g. , performance test reports, material balance calculations). 4. Send the entire downloaded file w ith suggested revisions in Microsoft® Access format and all accompanying documentation to Docket ID Number EPA

- HQ

- OAR

- 2007

- 0544 (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*** E.O. 12866 Review

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updated Microsoft® Access files, which are provided on the RTR

w eb p age at: http://www.epa.gov/ttn/atw/rrisk/rtrpg.html
. **VIII. S**  **tatutory and Executive Order Reviews**
A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is a “ significant re gulatory action ” because it raises novel legal and policy issues
. Accordingly, the EPA submitted this action to OMB for review under Executive Order 12866 and 13563 (76 FR 3821, January 21, 2011) , and any changes made in response to OMB recommendations hav e been documented in the docket for this action.
B. Paperwork Reduction Act The information collection requirements in this proposed rule have been submitted for approval to OMB under the Paperwork Reduction Act , 44 U.S.C. 3501 et seq . The ICR document p repared by the EPA has been assigned EPA ICR number 2452.01
. The information collection requirements are not enforceable until OMB approves them. The information requirements are based on notification, recordkeeping and reporting requirements in the
NESHAP General Provisions (40 CFR part 63, subpart A), which are mandatory for all operators subject to national emissions*** E.O. 12866 Review

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standards. These recordkeeping and reporting requirements are specifically authorized by CAA section 114 (42 U.S.C. 7414). All information submitted to the EPA pursuant to the recordkeeping and reporting requirements for which a claim of confidentiality is made is safeguarded according to a gency policies set forth in 40 CFR part 2, subpart B. We are proposing new paperwork requirements to th e Pulp and Paper source category in the form of repeat testing for selected process equipment, as described in 40 CFR 63.457(a)(2) and recordkeeping of malfunctions, as described in 40 CFR 63.454(g) (conducted in support of the affirmative defense provisio ns, as described in 40 CFR 63.456). More specifically, we are proposing the addition of stack testing every 5 years for total HAP for chemical pulping operations and bleaching operations at pulp and paper mills. For this proposed rule, the EPA is adding affirmative defense to the estimate of burden in the ICR. To provide the public with an estimate of the relative magnitude of the burden associated with an assertion of the affirmative defense position adopted by a source, the EPA has provided administrati ve adjustments to this ICR to show what the notification, recordkeeping and reporting requirements associated with the assertion of the affirmative defense might entail. The EPA’s*** E.O. 12866 Review

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estimate for the required notification, reports and records for any individu al incident, including the root cause analysis, totals $3,258 and is based on the time and effort required of a source to review relevant data, interview plant employees and document the events surrounding a malfunction that has caused an exceedance of an emissions limit. The estimate also includes time to produce and retain the record and reports for submission
to the EPA. The EPA provides this illustrative estimate of this burden because these costs are only incurred if there has been a violation and a so urce chooses to take advantage of the affirmative defense. Given the variety of circumstances under which malfunctions could occur, as well as differences among sources' operation and maintenance practices, we cannot reliably predict the severity and freq uency of malfunction

- related excess emissions events for a particular source. It is important to note that the EPA has no basis currently for estimating the number of malfunctions that would qualify for an affirmative defense. Current historical records wo uld be an inappropriate basis, as source owners or operators previously operated their facilities in recognition that they were exempt from the requirement to comply with emissions standards during malfunctions. Of the number of excess emissions events rep orted by source operators, only a small*** E.O. 12866 Review

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number would be expected to result from a malfunction (based on the definition above), and only a subset of excess emissions caused by malfunctions would result in the source choosing to assert the affirmative defens e. Thus we believe the number of instances in which source operators might be expected to avail themselves of the affirmative defense will be extremely small. For this reason, we estimate no more than 2 or 3 such occurrences for all sources subject to subp art S over the 3

- year period covered by this ICR. We expect to gather information on such events in the future and will revise this estimate as better information becomes available. The estimated recordkeeping and reporting burden associated with subpart S after the effective date of the propo sed rule is estimated to be 52,3 0 0 labor hours at a cost of $4.94 million per year, and total non

- la bor capital and O&M costs of $84 1,000 per year. This estimate includes reporting costs, such as reading and understan ding the rule requirements, conducting required activities ( e.g. , stack testing, inspections), and preparing notifications and compliance reports and recordkeeping costs associated with malfunctions, monitoring and inspections. The total burden for the f ed eral government is estimated to be 6,87 0 hours per ye ar at a total labor cost of $310 ,000 per year
. Burden is defined at 5 CFR 1320.3(b).*** E.O. 12866 Review

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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 the EPA's regulations in 40 CFR are listed in 40 CFR part 9. When this ICR is approved by OMB, the a gency will publish a technical amendment to 40 CFR part 9 in the **Federal Regis**  **ter** to display the OMB control numbers for the approved information collection requirements contained in the final rule. To comment on the a gency's need for this information, the accuracy of the provided burden estimates and any suggested methods for mini mizing respondent burden, the EPA has established a public docket for this rule which includes this ICR, under Docket ID N umber EPA

- HQ

- OAR

- 2007

- 0544. Submit any comments related to the ICR to the EPA and OMB. See ADDRESSES section at the beginning of this notice for where to submit
comments to the 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 the EPA. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after **[ INSERT** 
**DATE OF PUBLICATION OF THIS PROPOSED RULE**  **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 FROM DATE O**  **F***** E.O. 12866 Review

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**PUBLICATION OF THIS PROPOSED RULE**  **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 RFA generally requires an agen cy 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 , unle ss the a gency certifies that the rule will not have a significant economic i mpact 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 this proposed rule on small entities, small entity is defined as: ( 1) A small business as defined by the SBA ’s regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organi zation that is any not

- for

- profit enterprise which is independently owned and operated and is not dominant in its field. For this source category, which has the general NAICS code 322 ( i.e. , Paper Manufacturing) , the SB A small business size standard is 500 to 750 employees (depending on the specific NAICS code)*** E.O. 12866 Review

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according to the SBA small business standards definitions. We have estimated the cost impacts of the proposed rule and have determined that the impacts do not constitute a significant economic impact on a substantial number of small entities
. After considering the economic impacts of this proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. (See the EIA in t he docket for this proposed rule.) Only three of the companies affected are considered small entities per the definition provided in this section. W e estimate that this proposed action will not have a significant economic impact on those three companies. T he impact of this proposed action will be an annualized compliance cost of less than 1 percent of each company’s revenues. Although this proposed rule will not have a significant economic impact on a substantial number of small entities, the EPA nonethele ss has tried to reduce the impact of this rule on small entities. T he proposed repeat testing requirement w as established in a way that minimizes the costs for testing and reporting while still providing the a gency the necessary information needed to ensur e continuous complianc e with the proposed standards. The proposed malfunction recordkeeping requirement was designed to provide all pulp and paper*** E.O. 12866 Review

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companies, including small entities, with a means of supporting an affirmative defense in the event of an exc eedance occurring during a malfunction. 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 contai n a federal mandate that may result in expenditures of $100 million or more for state, local and tribal governments, in the aggregate or the private sector in any 1 year. This proposed rule is not expected to impact state, local or tribal governments. The nationwide annual cost of this proposed rule for affected sources is $ 6
. 2 million
. Thus, this rule is not subject to the requirements of sections 202 and 205 of the UMRA. This 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. This rule will not apply to such governments and will not impose any 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 s tates, on*** E.O. 12866 Review

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the relationship between the national government and the s tates, or on the distribution of power and responsibilities among the various levels of government, as spe cified in Executive Order 13132. None of the facilities subject to this action are owned or operated by s tate governments, and, nothing in this proposal will supersede s tate regulations. The burden to the respondents and the states is less than $ 6.2 millio n for the entire source category. Thus, Executive Order 13132 does no t apply to this proposed rule. In the spirit of Executive Order 13132, and consistent with the EPA policy to promote communications between the EPA and

s tate and local governments, the EP A specifically solicits comment on this proposed rule from s tate and local officials.
F. Executive Order 13175: Consultation and Coordination with
I ndian Tribal Governments This proposed rule does not have tribal implications, as specified in Executive Ord er 13175 (65 FR 67249, November 9, 2000)
. It will not have substantial direct effect on tribal governments, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the f ederal gover nment and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action. However, the EPA did*** E.O. 12866 Review

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outreach and consultation on this rule. The EPA presen ted this information to the tribes prior to proposal of th is rule via a call with the National Tribal Air Association. In addition, the EPA presented the information o n the sources and the industry at the National Triba l Forum in Spokane Washingto n. The EPA also offere d consultation by letters sent to all tribal leaders. We held that consultation with the Nez Perce, Forest County Potowatomi and Leech Lake Band of Ojibewa on October 6, 2011. The EPA specifically solicits additional comment on this proposed action from tribal officials.
G. Executive Order 13045: Pro tection 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 , and because the

a gency does not believe the environmental health risks or safety risks addressed by this action present a disproportionate risk to children. This action’s health and risk assessments are contained in sections III and IV of this preamble. The public is invi ted to submit comments or identify peer

reviewed studies and data that assess effects of early life exposure to HAP from Pulp and Paper Production sources.*** E.O. 12866 Review

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H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Di stribution or Use This action is not a “significant energy action” as defined under Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a 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 NTTAA, Public Law No. 104

- 113 , (15 U.S.C. 272 note), directs the EPA to use VCS 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 VCS bodies. The NTTAA directs the EPA to provide Congress, through OMB, explanations when the a gency decides not to use available and applicable VCS. This proposed rulemaking involve s technical standards. The EPA proposes to use two VCS in this proposed rule. One VCS, NCASI Method DI/MEOH

– 94.03, “ Methanol in Process Liquids and Wastewaters by GC/FID, ” is cited in this proposed rule for its*** E.O. 12866 Review

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method of measuring methanol concentrations in process liquid and wastewater. This s tandard is freely available to the public
at http://www.ncasi.org , or can be requested in document form by

e mail at publications@ncasi.org , by phone at (919) 941

- 6400, or by mail at P.O. Box 13318, Research Triangle Park, NC 27709

- 3318. Another VCS, ASME PTC 19.10

- 1981, “Flue and Exhaust Gas Analyses,” is cited in this proposed rule for its manual method of measuring the content of the exhaust gas as an acceptable alternativ e to EPA Method 3B of appendix A

- 2. This standard is available at http://www.asme.org or by mail at the American Society of Mechanical Engineers (ASME), P.O. Box 2900, Fairfield, NJ 07007

– 2900; or at Global Engineering D ocuments, Sales Department, 15 Inverness Way East, Englewood, CO 80112. While the EPA has identified

__ VCS as being potentially applicable to this proposed rule, we have decided not to use these VCS in this rulemaking
. The use of these VCS would be impra ctical because they do not meet the objectives of the standards cited in this rule. See the docket for this proposed rule for the reasons for these determinations. Under 40 CFR 63.7(e )(2)(ii) and (f) and 63.8(f) of the NESHAP General Provisions, a source may apply to the EPA for permission to use alternative test methods or alternative*** E.O. 12866 Review

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monitoring requirements in place of any required testing methods, performance specifications, or procedures in the final rule and any amendments. The EPA welcomes comments on this aspect of the proposed rulemaking and, specifically, invites the public to identify potentially applicable VCS and to explain why such standards should be used in this regulation.
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 f ederal executive policy on environmental justice. Its main provision directs f ederal 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 popu lations and low income populations in the U nited States. EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority, low income, indigenous populations because it increase s the level of environmental*** E.O. 12866 Review

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protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority, low income, or indigenous population s . These propo sed standards will improve public health and welfare, now and in the future, by reducing HAP emissions contributing to environmental and human health impacts
. These reductions in HAP associated with the rule are expected to benefit all populations. Additi onally , the a gency has reviewed this rule to determine if there is an overrepresentation of minority, low income, or indigenous populations near the sources such that they may face disproportionate exposure from pollutants that could be mitigated by this r ulemaking. Although this analysis gives some indication of populations that may be exposed to levels of pollution that cause concern, it does not identify the demographic characteristics of the most highly affected individuals or communities. The demograp hic data show that while most demographic categories are below , or within , 2 percentage points of national averages, the African

- American population exceeds the national average by 3 percentage points (15 percent versus 12 percent ), or +25 percent . The fac ility

- level demographic analysis results*** E.O. 12866 Review

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are presented in the November 2011 memorandum entitled Review of Environmental Justice Impacts , a copy of which is available in the docket for this action (EPA

– HQ

– OAR

– 2007

- 0544). The analysis of demographic data use d proximity

- to

- a - source as a surrogate for exposure to identify those p opulations considered to be living near affected sources, such that they have notable exposures to current emissions from these sources. The demographic data for this analysis were extr acted from the 2000 census data, which w ere provided to the EPA by the United
States Census Bureau. Distributions by race are based on demographic information at the census block level , and all other demographic groups are based on the extrapolation of cen sus block group level data to the census block level
. The socio

demographic parameters used in the analysis included the following categories: Racial (White, African American, Native American, Other or Multiracial, and All Other Races); Ethnicity (Hispanic ); and Other (Number of people below the poverty line, Number of people with ages between 0 and 18, Number of people with ages greater than or equal to 65 , Number of people with no high school diploma )
. In determining the aggregate demographic makeup of the communities near affected sources , t he EPA focused on those census blocks within 3 miles of affected sources and determined*** E.O. 12866 Review

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the demographic composition (e.g., race, income, etc.) of these census blocks and compared them to the corresponding composition s nationally. Th e radius of 3 miles (or approximately
5 km ) is consistent with other demographic analyses focused on areas around potential sources. 26 , 27 , 28 , 29 In addition, air quality modeling experience has shown that the area within 3 miles of an individual source of emissions can generally be considered the area with the highest ambient air levels of the primary pollutants being emitted for most sources, both in absolute terms and relative to the contribution of other sources (assuming there are other sourc es in the area, as is typical in urban areas). While facility processes and fugitive emissions may have more localized impacts, the EPA acknowledges that because of various stack heights, there is the potential for dispersion beyond 3 miles. To the extent that any minority, low income, or indigenous subpopulation is disproportionately impacted by the current emissions as a result of the proximity of their homes to these sources, that subpopulation also stands

26 U.S. GAO (Government Accountab ility Office). Demographics of People Living Near Waste Facilities. Washington DC: Government Printing Office; 1995. 27 Mohai P, Saha R. “Reassessing Racial and Socio

- economic Disparities in Environmental Justice Research”. Demography . 2006;43(2): 383

– 399. 28 Mennis J. “Using Geographic Information Systems to Create and Analyze Statistical Surfaces of Populations and Risk for Environmental Justice Analysis”. Social Science Quarterly , 2002;83(1):281

- 297. 29 Bullard RD, Mohai P, Wright B, Saha R, et al. Toxic Wa ste and Race at Twenty 1987

- 2007 . United Church of Christ. March, 2007.*** E.O. 12866 Review

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to see increased environmental and health benefi t from the emission s reductions called for by this rule. **List of Subjects in 40 CFR Part 63** Environmental protection, Air pollution control, Hazardous substances, Reporting and recordkeeping requirements.

____________________________ Dated:

____________________________ Lisa P. Jackson, Administrator.*** E.O. 12866 Review

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For the reasons stated in the preamble, the Environmental Protection Agency proposes to amend title 40, chapter I of the Code of Federal Regulations as follows: **PART 63 -**  **– [A**  **MENDED ]**  1. The authority cita tion for part 63 continues to read as follows: Authority: 42 U.S.C. 7401 et seq. **Subpart A —**  **[Amended]** 2. Section 63.14 is amended by adding paragraph (f)(5) and revising paragraph (i)(1) to read as follows: **§ 63.14 Incorporations by reference.**
* * * * * ( f) * * * (5) NCASI Method DI/MEOH

– 94.0 3 , Methanol in Process Liquids and Wastewaters by GC/FID, May 2000 , NCASI, Research Triangle Park, NC, IBR approved for
§ §63.457(c)(3)(ii) , 63.459(b)(5)(iv)(A), 63.459(b)(5)(iv)(A)(2), and 63.459(b)(8)(iii) of subpart S of this part.
* * * * * (i) * * * (1) ANSI/ASME PTC 19.10

– 1981, “Flue and Exhaust Gas Analyses [Part 10, Instruments and Apparatus],” IBR*** E.O. 12866 Review

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approved for §§63.309(k)(1)(iii), 63.457(k)(1), 63.865(b), 63.3166(a)(3), 63.3360(e)(1)(iii), 63.3545(a)(3), 63.3 555(a)(3), 63.4166(a)(3), 63.4362(a)(3), 63.4766(a)(3), 63.4965(a)(3), 63.5160(d)(1)(iii), 63.9307(c)(2), 63.9323(a)(3), 63.11148(e)(3)(iii), 63.11155(e)(3), 63.11162(f)(3)(iii) and (f)(4), 63.11163(g)(1)(iii) and (g)(2), 63.11410(j)(1)(iii), 63.11551(a)(2 )(i)(C), table 5 to subpart DDDDD of this part, table 1 to subpart ZZZZZ of this part, and table 4 to subpart JJJJJJ of this part.
* * * * * **Subpart S —**  **[Amended]**
* * * * * 3 . Section 63.441 is amended by adding a definition for “affirmative defense” to read as follows: **§63.441 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 indepen dently and objectively evaluated in a judicial or administrative proceeding.

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4. Section 63.443 is amended by deleting paragraph (e). 5. Section 63.446 is amended as follows: a. By revising paragraph (e)(3); b. By revising paragraph (e)(4); c. By revising paragraph (e)(5); and d. By removing and reserving paragraph (g). **§ 63.446 Standards for kraft pulping process condensates.** 

* * * * * (e) * * * (3) Treat the pulping process condensates to reduce or destroy the total HAPs by at least 92 percent or more by weight on or before **[INSERT DATE 2**  **YEARS FROM DATE OF** 
**PUBLICATION OF FINAL RULE**  **IN THE FEDERAL REGISTER] .**  After **[INSERT DATE 2**  **YEARS FROM DATE OF PUBLICATION**  **OF FINAL RULE IN THE FEDERAL REGISTER]**  **,** treat pulping process condensates to reduce or destroy the total HAPs by at least 94 percent or more by weight; or (4) At mills that do not perform bleaching, on or before **[INSERT DATE 2**  **YEARS FROM DATE OF PUBLICATION**  **OF**
**FINAL RULE IN THE FEDERAL REGISTER]**  treat the pulping process condensates to remov e 3.3 kilograms or more of total HAP per megagram (6.6 pounds per ton) of ODP, or*** E.O. 12866 Review

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achieve a total HAP concentration of 210 parts per million or less by weight at the outlet of the control device
. After **[INSERT DATE 2**  **YEARS FROM DATE OF PUBLICATION**  **OF**
**FINAL RULE**  **IN THE FEDERAL REGISTER] ,**  treat the pulping process condensates to remove 4.2 kilograms or more of total HAP per megagram ( 8.3 pounds per ton) of ODP, or achieve a total HAP concentration of 158 parts per million or less by weight at the outlet of th e control device ; or (5) At mills that perform bleaching, on or before **[INSERT**
**DATE 2**  **YEARS FROM DATE OF PUBLICATION**  **OF FINAL RULE IN THE**  **FEDERAL REGISTER]** treat the pulping process condensates to remove 5.1 kilograms or more of total HAP per megagram (10. 2 pounds per ton) of ODP, or achieve a total HAP concentration of 330 parts per million or less by weight at the outlet of the control device. After **[INSERT DATE 2** 
**YEARS FROM DATE OF PUBLICATION**  **OF FINAL RULE IN THE FEDERAL**  **REGISTER] ,**  treat the pulping pro cess condensates to remove 6.4 kilograms or more of total HAP per megagram ( 12.8 pounds per ton) of ODP, or achieve a total HAP concentration of 248 parts per million or less by weight at the outlet of the control device.

* * * * * (g) [Reserved]*** E.O. 12866 Review

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* * * * * 6. Section 63.453 is amended by adding paragraph (q) to read as follows: **§ 63.453 Monitoring requirements.** 

* * * * * (q) At all times, the owner or operator must operate and maintain any affected source, including associated air pollution control equipm ent 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.
7 . Section 63.454 is amended by revising paragraph (a ) and adding paragraph (g) to read as follows: **§63.454 Recordkeeping requirements.**  (a) The owner or operator of each affected source subject to the requirements of this subpart shall comply with the recordkeeping requirements of §63.10, as shown in table 1 of this subpart, and the requirements specified in*** E.O. 12866 Review

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paragraphs (b) through ( g ) of this section for the monitoring parameters specified in §63.453.

* * * * * (g) Recordkeeping of malfunctions
. The owner or operator must maintain the following records of

ma lfunctions: (1) Records of the occurrence and duration of each malfunction of operation (i.e., process equipment) or the air pollution control and monitoring equipment. (2) Records of actions taken during periods of malfunction to minimize emissions in acc ordance with §63.453(q), including corrective actions to restore malfunctioning process and air pollution control and monitoring equipment to its normal or usual manner of operation. 8. Section 63.455 is amended by adding paragraphs (g) and (h) to read as follows: **§ 63.455 Reporting requirements.** 

* * * * * (g) Malfunction reporting requirements . If a malfunction occurred during the reporting period, the report must include the number, duration, and a brief description for each type of malfunction which oc curred*** E.O. 12866 Review

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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 mini mize emissions in accordance with §63.453(q), including actions taken to correct a malfunction. (h) You must submit performance test reports as specified in paragraphs (h)(1) through (4). (1) The owner or operator of an affected source shall report the re sults of the performance test before the close of business on the 60th day following the completion of the performance test, unless approved otherwise in writing by the Administrator. A performance test is “completed” when field sample collection is termin ated. Unless otherwise approved by the Administrator in writing, results of a performance test shall include the analysis of samples, determination of emissions, and raw data. A complete test report must include the purpose of the test; a brief process des cription; a complete unit description, including a description of feed streams and control devices; sampling site description; pollutants measured; description of sampling and analysis procedures and any modifications to standard procedures; quality assura nce procedures; record*** E.O. 12866 Review

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of operating conditions, including operating parameters for which limits are being set, during the test; record of preparation of standards; record of calibrations; raw data sheets for field sampling; raw data sheets for field and la boratory analyses; chain

- of

- custody documentation; explanation of laboratory data qualifiers; example calculations of all applicable stack gas parameters, emission rates, percent reduction rates, and analytical results, as applicable; and any other informa tion required by the test method and the Administrator. (2) As of January 1, 2012 and within 60 days after the date of completing each performance test, you must submit performance test data, except opacity data, electronically to EPA’s Central Data Excha nge (CDX) by using the Electronic Reporting Tool (ERT) (see http://www.epa.gov/ttn/chief/ert/ert_tool.html ) and also report the results of the performance test to the appropriate permitting authority in the form and

- or format specified by the permitting au thority. Only data collected using test methods compatible with ERT are subject to this requirement to be submitted electronically to EPA’s CDX. (3) Within 60 days after the date of completing each CEMS performance evaluation test, as defined in §63.2 and*** E.O. 12866 Review

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required by this subpart, you must submit the relative accuracy test audit data electronically into EPA’s CDX by using the ERT as mentioned in paragraph (h)(2) of this section and also report the results of the performance test to the appropriate permitti ng authority in the form and

- or format specified by the permitting authority. Only data collected using test methods compatible with ERT are subject to this requirement to be submitted electronically
to EPA’s CDX. (4) All reports required by this subpart n ot subject to the requirements in paragraphs (h)(2) and (3) of this section must be sent to the Administrator at the appropriate address listed in §63.13. The Administrator or the delegated authority may request a report in any form suitable for the specif ic case (e.g., by electronic media such as Excel spreadsheet, on CD or hard copy). The Administrator retains the right to require submittal of reports subject to paragraphs (h)(2) and (3) of this section in paper format. 9. Section 63.456 is revised to rea d as follows: **§ 63.456 Affirmative Defense for Exceedance of Emission**  **Limit During Malfunction.***** E.O. 12866 Review

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In response to an action to enforce the standards set forth in paragraphs §§63.443(c) and (d), 63.444(b) and (c), 63.445(b) and (c), 63.446(c), (d), and (e), 63 .447(b) or §63.450(d) the owner or operator may assert an affirmative defense to a claim for civil penalties for exceedances of such standards that are caused by malfunction, as defined at 40 CFR 63.2. Appropriate penalties may be assessed, however, if the owner or operator fails to meet the burden of proving all of 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 su ch a limit, the owner or operator must timely meet the notification requirements in paragraph (b) of this section, and must prove by a preponderance of evidence that: (1) The excess emissions: (i) Were caused by a sudden, infrequent, and unavoidable failu re of air pollution control and monitoring equipment, process equipment, or a process to operate in a normal or usual manner, and*** E.O. 12866 Review

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(ii) Could not have been prevented through careful planning, proper design or better operation and maintenance practices; and (iii) Did not stem from any activity or event that could have been foreseen and avoided, or planned for; and (iv) Were not part of a recurring pattern indicative of inadequate design, operation, or maintenance; and (2) Repairs were made as expeditiously as possible when the applicable emission limitations were being exceeded. Off

- shift and overtime labor were used, to the extent practicable to make these repairs; and (3) The frequency, amount and duration of the excess emissions (including any bypass) we re minimized to the maximum extent practicable during periods of such emissions; and (4) If the excess emissions resulted from a bypass of control equipment or a process, then the bypass was unavoidable to prevent loss of life, personal injury, or

severe property damage; and (5) All possible steps were taken to minimize the impact of the excess emissions on ambient air quality, the environment and human health; and*** E.O. 12866 Review

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(6) All emissions monitoring and control systems were kept in operation if at all possible , consistent with safety and good air pollution control practices; and (7) All of the actions in response to the excess emissions were documented by properly signed, contemporaneous operating logs; and (8) At all times, the affected source was operated in a manner consistent with good practices for minimizing emissions; and (9) A written root cause analysis has been prepared, the purpose of which is to determine, correct, and eliminate the primary causes of the malfunction and the excess emissions resultin g 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 affected source 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 malfun ction, if it wishes to avail itself of an affirmative defense to civil*** E.O. 12866 Review

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penalties for that malfunction. The owner or operator seeking to assert an affirmative defense shall also submit a written report to the Administrator within 45 days of the initial occu rrence of the exceedance of the standard in paragraphs §§63.443(c) and (d), 63.444(b) and (c), 63.445(b) and (c), 63.446(c), (d), and (e), 63.447(b) or §63.450(d) to demonstrate, with all necessary supporting documentation, that it has met the requirements set forth in paragraph (a) of this section. The owner or operator may seek an extension of this deadline for up to 30 additional days by submitting a written request to the Administrator before the expiration of the 45 day period. Until a request for an e xtension has been approved by the Administrator, the owner or operator is subject to the requirement to submit such report within 45 days of the initial occurrence of the exceedance. 10. Section 63.457 is amended as follows: a. By revising paragraph (a); b . By adding paragraphs (a)(1) and (a)(2); c. By revising paragraphs (b)(1), (b)(3), (b)(4), (b)(5)(i), and (b)(5)(ii); d. By revising paragraph (c)(3)(ii); e. By revising paragraph (d)(1);*** E.O. 12866 Review

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f. By revising paragraph (k)(1); and g. By adding paragraph (o). **§ 63.457**  **Test methods and procedures.** (a) Performance tests . Initial and repeat performance tests are required for the emissions sources specified in paragraphs (a)(1) and (2) on this section, except for emission sources controlled by a combustion device tha t is designed and operated as specified in §63.443(d)(3) or (d)(4). (1) Conduct an initial performance test for all emission sources subject to the limitations in §§63.443, 63.444, 63.445, 63.446, and 63.447. (2) Conduct repeat performance tests at five ye ar intervals for all emission sources subject to the limitations in §§63.443, 63.444, and 63.445.

* * * * * (b) * * * (1) Method 1 or 1A of part 60, appendix A

- 1, as appropriate, shall be used for selection of the sampling site as follows:
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(3) T he vent gas volumetric flow rate shall be determined using Method 2, 2A, 2C, or 2D of part 60, appendix A

- 1, as appropriate. (4) The moisture content of the vent gas shall be measured using Method 4 of part 60, appendix A

- 3. (5) * * * (i) Method 308 or 32 0 in Appendix A of this part or Method 18 in appendix A

- 6 of part 60 shall be used to determine the methanol concentration. (ii) Except for the modifications specified in paragraphs (b)(5)(ii)(A) through (b)(5)(ii)(K) of this section, Method 26A of part 6 0, appendix A

- 8 shall be used to determine chlorine concentration in the vent stream.

* * * * * (c) * * * (3) * * * (ii) For determining methanol concentrations, NCASI Method DI/MEOH

– 94.0 3 , Methanol in Process Liquids and
Wastewaters by GC/FID, May 2000 , NCASI, Research Triangle Park, NC. This test method is incorporated by reference in §63.14(f) (5) of subpart A of this part.
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(1) Method 21, of part 60, appendix A

- 7; and
* * * * * (k) * * * (1) The emission rate correction factor and excess air integrated sampling and analysis procedures of Methods 3A or 3B of part 60, appendix A

- 2 shall be used to determine the oxygen concentration. The samples shall be taken at the same time that the HAP samples are taken. As an altern ative to Method 3B, ASME PTC 19. 10

- 1981

- Part 10 may be used (incorporated by reference, see §63.14 ( i )( 1 ) ).
* * * * * (o) 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. 11. Section 63.459 is amended by revising paragraph s (b)(11)(ii) and (iii) to read as follows: **§ 63.459 Alternative standards.** 

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(11) * * * (ii) All periods of excess emission shall be reported, and shall include:

* * * * * (iii) Any excess emissions that present an imminent threat to public health or the environment, or may cause serious harm to public health or the environment, shall constitute a violation. 12. Table 1 to subpart S is revised to read as follows: **Table 1 to Subpart S of Part 63 —**  **General Provisions Applicabilit**  **y to Subpart S a** 
**Reference Applies to**  **Subpart S Comment**  63.1(a)(1)

– (3) Yes 63.1(a)(4) Yes Subpart S (this table) specifies applicability of each paragraph in subpart A to subpart S. 63.1(a)(5) No Section reserved. 63.1(a)(6)

– (8) Yes 63.1(a)(9) No Section reserved. 63.1(a)(10) No Subpart S and other cross

- referenced subparts specify calendar or operating day. 63.1(a)(11)

– (14) Yes 63.1(b)(1) No Subpart S specifies its own applicability. 63.1(b)(2)

– (3) Yes 63.1(c)(1)

– (2) Yes 63.1(c)(3) No Section reserved. 63.1(c)(4)

– (5) Yes 63.1(d) No Section reserved. 63.1(e) Yes 63.2 Yes 63.3 Yes 63.4(a)(1) Yes 63.4(a)(3) 63.4(a)(4) No Section reserved. 63.4(a)(5) Yes*** E.O. 12866 Review

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**Reference Applies to**  **Subpart S Comment**  63.4(b) Yes 63.4(c) Yes 63.5(a) Yes 63.5(b)(1) Yes 63.5(b) (2) No Section reserved. 63.5(b)(3) Yes 63.5(b)(4)

– (6) Yes 63.5(c) No Section reserved. 63.5(d) Yes 63.5(e) Yes 63.5(f) Yes 63.6(a) Yes 63.6(b) No Subpart S specifies compliance dates for sources subject to subpart S. 63.6(c) No Subpart S specifies compliance dates for sources subject to subpart S. 63.6(d) No Section reserved. 63.6(e)(1)(i) No See §63.453(q) 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(f)(2) Yes 63.6(f)(3) Yes 63.6(g) Yes 63.6(h) No Pertains to continuous opacity monitors that are not part of this standard. 63.6(i) Yes 63.6(j) Yes 63.7 Yes, except for 63.7(e)(1). Section 63.7(e)(1) is replaced with §63.457(o) wh ich specifies performance testing conditions under Subpart S. 63.8(a)(1) Yes 63.8(a)(2) Yes 63.8(a)(3) No Section reserved. 63.8(a)(4) Yes 63.8(b)(1) Yes 63.8(b)(2) No Subpart S specifies locations to conduct monitoring. 63.8(b)(3) Yes 63.8( c)(1)(i) No See §63.453(q) for general duty requirement (which includes monitoring equipment) 63.8(c)(1)(ii) Yes 63.8(c)(1)(iii) No 63.8(c)(2) Yes*** E.O. 12866 Review

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**Reference Applies to**  **Subpart S Comment**  63.8(c)(3) Yes 63.8(c)(4) No Subpart S allows site specific determination of monitoring frequency i n §63.453(n)(4). 63.8(c)(5) No Pertains to continuous opacity monitors that are not part of this standard. 63.8(c)(6) Yes 63.8(c)(7) Yes 63.8(c)(8) Yes 63.8(d) Yes, except for last sentence, which refers to an SSM plan. SSM plans are not required
.

63.8(e) Yes 63.8(f)(1)

– (5) Yes 63.8(f)(6) No Subpart S does not specify relative accuracy test for CEMs. 63.8(g) Yes 63.9(a) Yes 63.9(b) Yes Initial notifications must be submitted within one year after the source becomes subject to the relev ant standard. 63.9(c) Yes 63.9(d) No Special compliance requirements are only applicable to kraft mills. 63.9(e) Yes 63.9(f) No Pertains to continuous opacity monitors that are not part of this standard. 63.9(g)(1) Yes 63.9(g)(2) No Pertains to continuous opacity monitors that are not part of this standard. 63.9(g)(3) No Subpart S does not specify relative accuracy tests, therefore no notification is required for an alternative. 63.9(h) Yes 63.9(i) Yes 63.9(j) Yes 63.10(a) Yes 63.10(b )(1) Yes 63.10(b)(2)(i) No 63.10(b)(2)(ii) No. See §63.454(g) for recordkeeping of (1) occurrence and duration and (2) actions taken during malfunction. 63.10(b)(2)(iii) Yes*** E.O. 12866 Review

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**Reference Applies to**  **Subpart S Comment**  63.10(b)(2)(iv) No 63.10(b)(2)(v) No 63.10(b)(2)(vi) Yes 63.10(b)(2) (vii)

- (ix) Yes 63.10(b)(3) Yes 63.10(c)(1)

- (7) Yes 63.10(c)(8) Yes 63.10(c)(9) No Section reserved. 63.10(c)(10)

- (11) No See §63.454(g) for malfunction recordkeeping requirements. 63.10(c)(12)

- (14) Yes 63.10(c)(15) No 63.10(d)(1) Yes 63.10( d)(2) Yes 63.10(d)(3) No Pertains to continuous opacity monitors that are not part of this standard. 63.10(d)(4) Yes 63.10(d)(5) No See §63.455(g) for malfunction reporting requirements. 63.10(e)(1) Yes 63.10(e)(2)(i) Yes 63.10(e)(2)(ii) No Per tains to continuous opacity monitors that are not part of this standard. 63.10(e)(3) Yes 63.10(e)(4) No Pertains to continuous opacity monitors that are not part of this standard. 63.10(f) Yes 63.11

– 63.15 Yes a Wherever subpart A specifies “postmar k” dates, submittals may be sent by methods other than the U.S. Mail (e.g., by fax or courier). Submittals shall be sent by the specified dates, but a postmark is not required.