eo_sterilizers_rr_proposal by c40e083630b38297


									     61404                  Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Proposed Rules

     remainder of the rule, EPA may adopt                    0197 (Legacy Docket A–88–03), by one                     Docket: All documents in the docket
     as final those provisions of the rule that              of the following methods:                             are listed in the EDOCKET index at
     are not the subject of an adverse                          • Federal eRulemaking Portal: http://              http://www.epa.gov/edocket. Although
     comment.                                                www.regulations.gov. Follow the on-line               listed in the index, some information is
       For additional information, see the                   instructions for submitting comments.                 not publicly available, i.e., CBI or other
     direct final rule which is located in the                  • Agency Web site: http://                         information whose disclosure is
     Rules section of this Federal Register.                 www.epa.gov/edocket. EDOCKET, EPA’s                   restricted by statute. Certain other
       Dated: August 11, 2005.                               electronic public docket and comment                  material, such as copyrighted material,
     Ira W. Leighton,                                        system, is EPA’s preferred method for                 is not placed on the Internet and will be
     Acting Regional Administrator, EPA New                  receiving comments. Follow the on-line                publicly available only in hard copy
     England.                                                instructions for submitting comments.                 form. Publicly available docket
     [FR Doc. 05–21195 Filed 10–21–05; 8:45 am]                 • E-mail: a-and-r-docket@epa.gov.                  materials are available either
     BILLING CODE 6560–50–P
                                                                • Fax: (202) 566–1741.                             electronically in EDOCKET or in hard
                                                                • Mail: Air Docket, EPA, Mailcode:                 copy at the Air and Radiation Docket,
                                                             6102T, 1200 Pennsylvania Avenue,                      EPA/DC, EPA West, Room B102, 1301
     ENVIRONMENTAL PROTECTION                                NW., Washington, DC 20460. Please                     Constitution Avenue, NW., Washington,
     AGENCY                                                  include a total of two copies.                        DC. The Public Reading Room is open
                                                                • Hand Delivery: EPA, 1301                         from 8:30 a.m. to 4:30 p.m., Monday
     40 CFR Part 63                                          Constitution Avenue, NW., Room B102,                  through Friday, excluding legal
                                                             Washington, DC 20460. Such deliveries                 holidays. The telephone number for the
     [OAR–2003–0197; FRL –7987–5]
                                                             are only accepted during the Docket’s                 Public Reading Room is (202) 566–1744,
     RIN 2060–AK09                                           normal hours of operation, and special                and the telephone number for the Air
                                                             arrangements should be made for                       and Radiation Docket is (202) 566–1742.
     Ethylene Oxide Emissions Standards                      deliveries of boxed information.
     for Sterilization Facilities                                                                                     Public Hearing. If a public hearing is
                                                                Instructions: Direct your comments to              held, it will begin at 10 a.m. and will
     AGENCY:  Environmental Protection                       Docket ID No. OAR–2003–0197 (Legacy                   be held at the EPA’s campus in Research
     Agency (EPA).                                           Docket A–88–03). The EPA’s policy is                  Triangle Park, North Carolina, or at an
     ACTION: Proposed decision; request for                  that all comments received will be                    alternate facility nearby. Persons
     public comment.                                         included in the public docket without                 interested in presenting oral testimony
                                                             change and may be made available                      or inquiring as to whether a public
     SUMMARY: On December 6, 1994, we                        online at http://www.epa.gov/edocket,                 hearing is to be held should contact Mr.
     promulgated Ethylene Oxide Emission                     including any personal information                    David Markwordt, Policy Planning and
     Standards for Sterilization Facilities (59              provided, unless the comment includes                 Standards Group, Emission Standards
     FR 62585). The national emission                        information claimed to be Confidential                Division, U.S. EPA (C439–04), Research
     standards limit and control hazardous                   Business Information (CBI) or other                   Triangle Park, NC 27711, telephone
     air pollutants (HAP) that are known or                  information whose disclosure is                       (919) 541–0837.
     suspected to cause cancer or have other                 restricted by statute. Do not submit
     serious health or environmental effect.                 information that you consider to be CBI               FOR FURTHER INFORMATION CONTACT:     For
       Section 112(f)(2) of the Clean Air Act                or otherwise protected through                        additional information on this proposed
     (CAA) directs EPA to assess the risk                    EDOCKET, regulations.gov, or e-mail.                  decision, review the reports listed in the
     remaining (residual risk) after the                     The EPA EDOCKET and the Federal                       SUPPLEMENTARY INFORMATION section.
     application of national emission                        regulations.gov Web sites are                           General and technical information.
     standards controls and revise as                        ‘‘anonymous access’’ systems, which                   Mr. David Markwordt, EPA, Office of
     necessary to protect public health. Also,               means EPA will not know your identity                 Air Quality Planning and Standards,
     CAA section 112(d)(6) requires us to                    or contact information unless you                     Emission Standards Division, Policy
     review and to revise the national                       provide it in the body of your comment.               Planning and Standards Group (C439–
     emission standards as necessary by                      If you send an e-mail comment directly                04), Research Triangle Park, North
     taking into account developments in                     to EPA without going through                          Carolina 27711, telephone (919) 541–
     practices, processes, and control                       EDOCKET or regulations.gov, your e-                   0837, facsimile number (919) 541–0942,
     technologies. The proposal announces a                  mail address will be automatically                    electronic mail (e-mail) address:
     decision and requests public comments                   captured and included as part of the                  markwordt.david@epa.gov.
     on the residual risk assessment and                     comment that is placed in the public                    Residual risk assessment information.
     technology review for the national                      docket and made available on the                      Mr. Mark Morris, EPA, Office of Air
     emission standards. We are proposing                    Internet. If you submit an electronic                 Quality Planning and Standards,
     no further action at this time to revise                comment, EPA recommends that you                      Emission Standards Division, Risk and
     the national emission standards.                        include your name and other contact                   Exposure Assessment Group (C404–01),
     DATES: Comments. Comments must be                       information in the body of your                       Research Triangle Park, North Carolina
     received on or before December 8, 2005.                 comment and with any disk or CD–ROM                   27711, telephone (919) 541–5416,
     Public Hearing. If anyone contacts EPA                  you submit. If EPA cannot read your                   facsimile number (919) 541–0840,
     requesting to speak at a public hearing                 comment due to technical difficulties                 electronic mail (e-mail) address:
     by November 8, 2005, a public hearing                   and cannot contact you for clarification,             morris.mark@epa.gov.
     will be held approximately 20 days                      EPA may not be able to consider your
     following publication of this notice in                 comment. Electronic files should avoid                SUPPLEMENTARY INFORMATION:
     the Federal Register.                                   the use of special characters, any form                 Regulated Entities. The regulated
     ADDRESSES: Submit your comments,                        of encryption, and be free of any defects             categories and entities affected by the
     identified by Docket ID No. OAR–2003–                   or viruses.                                           national emission standards include:

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                                  Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Proposed Rules                                                                                        61405

                                                                                                                                                                                          Examples of regulated
                          Category                                                                                  NAICS*                                                                      entities

     Industry ................................................   3841,   3842 ........................................................................................................   Medical suppliers.
                                                                 2834,   5122, 2831, 2833 ...................................................................................            Pharmaceuticals.
                                                                 2099,   5149, 2034, 2035, 2046 .........................................................................                Spice manufacturers.
                                                                 7399,   7218, 8091 .............................................................................................        Contract sterilizers.
        * North American Information Classification System.

        This table is not intended to be                                      F. How are we addressing GACT at area                                     generally available control technology
     exhaustive, but rather provides a guide                                     sources for purposes of section 112(f)?                                (GACT) standards.
     for readers regarding entities likely to be                              G. What are the results of the technology                                    On December 6, 1994 (59 FR 62585),
     affected by the national emission                                           review?                                                                we promulgated national emission
                                                                           II. Statutory and Executive Order Reviews                                    standards for Ethylene Oxide
     standards. To determine whether your
                                                                              A. Executive Order 12866: Regulatory                                      Commercial Sterilization and
     facility would be affected by the                                           Planning and Review
     national emission standards, you should                                                                                                            Fumigation Operations. In that final
                                                                              B. Paperwork Reduction Act
     examine the applicability criteria in 40                                 C. Regulatory Flexibility Act
                                                                                                                                                        rule, we set MACT for major sources
     CFR 63.360. If you have any questions                                    D. Unfunded Mandates Reform Act                                           under section 112(d)(2). As for area
     regarding the applicability of the                                       E. Executive Order 13132: Federalism                                      sources, we established MACT
     national emission standards to a                                         F. Executive Order 13175: Consultation                                    standards for certain emission points
     particular entity, consult either the air                                   and Coordination With Indian Tribal                                    pursuant to section 112(d)(2) and GACT
     permit authority for the entity or your                                     Governments                                                            standards for other emission points
     EPA regional representative as listed in                                 G. Executive Order 13045: Protection of                                   pursuant to section 112(d)(5).
     40 CFR 63.13.                                                               Children from Environmental Health &                                      Section 112(d)(6) provides that EPA
                                                                                 Safety Risks                                                           review these technology-based
        Worldwide Web (WWW). In addition                                      H. Executive Order 13211: Actions That
     to being available in the docket, an                                                                                                               standards and revise them ‘‘as necessary
                                                                                 Significantly Affect Energy Supply,                                    (taking into account developments in
     electronic copy of today’s proposed                                         Distribution, or Use
     decision will also be available on the                                                                                                             practices, processes and control
                                                                              I. National Technology Transfer
     WWW through the Technology Transfer                                         Advancement Act                                                        technologies)’’ no less frequently than
     Network (TTN). Following signature, a                                                                                                              every 8 years.
                                                                           I. Background                                                                   The second stage in standard setting
     copy of the proposed decision will be
                                                                                                                                                        is described in section 112(f) of the
     posted on the TTN’s policy and                                        A. What is the statutory authority for                                       CAA. This provision requires, first, that
     guidance page for newly proposed or                                   these actions?                                                               EPA prepare a Report to Congress
     promulgated rules at the following
                                                                                                                                                        discussing (among other things)
     address: http://www.epa.gov/ttn/oarpg/.                                 Section 112 of the CAA establishes a                                       methods of calculating risk posed (or
     The TTN provides information and                                      two-stage regulatory process to address                                      potentially posed) by sources after
     technology exchange in various areas of                               emissions of HAP from stationary                                             implementation of the MACT standards,
     air pollution control.                                                sources. In the first stage, after EPA has                                   the public health significance of those
        Reports for Public Comment. We have                                identified categories of sources emitting                                    risks, the means and costs of controlling
     prepared two summary memoranda                                        one or more of the HAP listed in the                                         them, actual health effects to persons in
     covering the rationale for the proposed                               CAA, section 112(d) calls for us to                                          proximity to emitting sources, and
     decision and the residual risk analyses.                              promulgate national technology-based                                         recommendations as to legislation
     These memoranda are entitled:                                         emission standards for sources within                                        regarding such remaining risk. EPA
     ‘‘Technology Review and Residual Risk                                 those categories that emit or have the                                       prepared and submitted the ‘‘Residual
     Development for the Ethylene Oxide                                    potential to emit any single HAP at a                                        Risk Report to Congress,’’ EPA–453/R–
     Commercial Sterilization NESHAP,’’                                    rate of 10 tons or more per year or any                                      99–001, in March 1999. The Congress
     and ‘‘Residual Risk Assessment for the                                combination of HAP at a rate of 25 tons                                      did not act on any of the
     Ethylene Oxide Commercial                                             or more per year (known as ‘‘major                                           recommendations in the report,
     Sterilization Source Category.’’ Both                                 sources’’), as well as for certain ‘‘area                                    triggering the second stage of the
     reports are in the Docket No. OAR–                                    sources’’ emitting less than those                                           standard-setting process, the residual
     2003–0197 (Legacy Docket A–88–03).                                    amounts. These technology-based                                              risk phase.
     See the preceding Docket section for                                  national emission standards must reflect                                        Section 112(f)(2) requires us to
     docket information and availability.                                  the maximum reductions of HAP                                                determine for each section 112(d) source
                                                                           achievable (after considering cost,                                          category whether the national emission
                                                                           energy requirements, and non-air health                                      standards protect public health with an
       The information presented in this                                   and environmental impacts) and are                                           ample margin of safety. If the national
     preamble is organized as follows:                                     commonly referred to as maximum                                              emission standards for HAP ‘‘classified
     I. Background                                                         achievable control technology (MACT)                                         as a known, probable, or possible
        A. What is the statutory authority for these                       standards.                                                                   human carcinogen do not reduce
          actions?                                                           For area sources, CAA section                                              lifetime excess cancer risks to the
        B. What is our approach for developing                             112(d)(5) provides that in lieu of MACT,                                     individual most exposed to emissions
          residual risk standards?                                         the Administrator may elect to                                               from a source in the category or
        C. What are the current standards?
        D. What are the results of the residual risk
                                                                           promulgate standards or requirements                                         subcategory to less than one in one
          assessment?                                                      which provide for the use of generally                                       million,’’ EPA must promulgate residual
        E. What are our conclusions regarding the                          available control technologies or                                            risk standards for the source category (or
          need for more stringent standards under                          management practices and such                                                subcategory) as necessary to provide an
          section 112(f)(2)?                                               standards are commonly referred to as                                        ample margin of safety. EPA must also

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     61406                  Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Proposed Rules

     adopt more stringent standards to                       Congress in its Residual Risk Report that             D. What are the results of the residual
     prevent an adverse environmental effect                 we intended to use the Benzene                        risk assessment?
     (defined in section 112(a)(7) as ‘‘any                  NESHAP approach in making CAA
     significant and widespread adverse                      section 112(f) residual risk                             Pursuant to CAA section 112(f)(2), we
     effect * * * to wildlife, aquatic life, or              determinations.3                                      prepared a risk assessment to determine
     natural resources * * *.’’), but must                                                                         the residual risk posed by ethylene
                                                               In the Benzene NESHAP (54 FR                        oxide sterilization facilities after
     consider cost, energy, safety, and other                38044–45, September 14, 1989), we
     relevant factors in doing so.                                                                                 implementation of the ethylene oxide
                                                             stated as an overall objective:                       national emission standards. The
        Section 112(f)(5) expressly provides,
     however, that EPA is not required to                       * * * in protecting public health with an          number of facilities in the source
     conduct any review under section 112(f)                 ample margin of safety, we strive to provide          category has decreased since the
     or promulgate any emissions limitations                 maximum feasible protection against risks to          development of the national emission
     under that subsection for any area                      health from hazardous air pollutants by: (1)          standards for various reasons, including
     source listed pursuant to section                       protecting the greatest number of persons             industry consolidation. We developed a
     112(c)(3) for which EPA has issued
                                                             possible to an individual lifetime risk level         list of 76 facilities that currently
     GACT standards. Thus, although EPA
                                                             no higher than approximately 1 in 1 million;          comprises both the major and area
                                                             and (2) limiting to no higher than                    source categories, based on information
     has discretion to conduct a residual risk
                                                             approximately 1 in 10 thousand [i.e., 100 in          primarily from the following three
     review under section 112(f) for area                    a million] the estimated risk that a person
     sources for which it has established                                                                          sources: (1) The 1999 National
                                                             living near a facility would have if he or she        Emissions Inventory (NEI), (2) the 2000
     GACT, it is not required to do so. See                  were exposed to the maximum pollutant
     CAA section 112(f)(5).                                                                                        Toxics Release Inventory (TRI), and (3)
                                                             concentrations for 70 years.                          the Ethylene Oxide Sterilization
     B. What is our approach for developing                                                                        Association (EOSA). We used these data
     residual risk standards?                                  As explained more fully in our
                                                                                                                   sources for emissions and emission
                                                             Residual Risk Report to Congress, these
        Following our initial determination                                                                        point release parameters in dispersion
                                                             goals are not ‘‘rigid line[s] for
     that the individual most exposed for the                                                                      modeling.
                                                             acceptability,’’ but rather broad
     emissions category considered exceeds a                 objectives to be weighed ‘‘with a series                 As stated previously, consistent with
     1-in-1 million lifetime excess cancer                   of other health measures and factors.’’ 4             section 112(f)(2), EPA must determine
     risk, our approach to developing                                                                              for each section 112(d) source category
     residual risk standards is based on a                   C. What are the current standards?                    whether the MACT standards protect
     two-step determination of acceptable                                                                          public health with an ample margin of
                                                               The Ethylene Oxide Emission                         safety. Because MACT and GACT are
     risk and ample margin of safety. The                    Standards for Sterilization Facilities
     first step, consideration of acceptable                                                                       both required of some area sources, risk
                                                             were promulgated on December 6, 1994                  attributed to GACT emission points are
     risk, is only a starting point for the                  (59 FR 62585) and cover ethylene oxide,
     analysis that determines the final                                                                            included in the overall modeled risks
                                                             the only HAP emitted from the                         for MACT. Therefore, the risks
     standards. The second step determines                   sterilization/fumigation process. The
     the ample margin of safety which                                                                              presented below are higher than just
                                                             national emission standards regulate                  those risks attributed solely to emission
     corresponds to the levels at which the                  both major and area sources; the
     standards are set.                                                                                            points for which we established MACT
                                                             emission points regulated are the main                in 1994.
        The terms ‘‘individual most exposed,’’               sterilization and aeration room vents.
     ‘‘acceptable level,’’ and ‘‘ample margin                The standards for major sources require                  Using the above-noted information,
     of safety’’ are not specifically defined in             that sources reduce main sterilization                we modeled ambient concentrations
     the CAA. However, CAA section                           and aeration room vent emissions by 99                near these facilities and calculated the
     112(f)(2)(B) refers positively to the                   percent. The standards for area sources               risk of possible chronic cancer and
     interpretation of these terms in our 1989               require that sources reduce main                      noncancer health effects and evaluated
     rulemaking (54 FR 38044, September 14,                  sterilization vent emissions by 99                    whether acute exposures might exceed
     1989), ‘‘National Emission Standards for                percent.                                              relevant health thresholds. We found
     Hazardous Air Pollutants (NESHAP):                                                                            that individual lifetime cancer risks
     Benzene Emissions from Maleic                             During the development of the                       exceeded 1-in-1 million in areas near 44
     Anhydride Plants, Ethylbenzene/                         national emission standards, we                       of the 76 modeled sources, and
     Styrene Plants, Benzene Storage Vessels,                estimated that there were approximately               approximately 250,000 people live in
     Benzene Equipment Leaks, and Coke                       188 facilities nationwide, of which 47                these areas. Individual lifetime cancer
     By-Product Recovery Plants,’’ (Benzene                  were major sources. Usually, these                    risks exceeded 10-in-1 million in areas
     NESHAP). We read CAA section                            operations are not located at facilities              near 19 sources, and approximately
     112(f)(2)(B) as essentially directing us to             with other types of HAP-emitting                      7,300 people live in these areas. The
     use the interpretation set out in that                  sources. The majority of sterilization                highest calculated individual lifetime
     notice 1 or to utilize approaches                       facilities process on a contract basis, but           cancer risk was 90-in-1 million at one
     affording at least the same level of                    some medical supply and spice                         facility.
     protection.2 We likewise notified                       manufacturers sterilize their own
                                                                                                                      An EPA assessment for ethylene oxide
                                                             products. We estimated that the national
                                                                                                                   is currently under way. The EPA has not
        1 This reading is confirmed by the Legislative       emission standards would reduce
                                                                                                                   yet completed a full evaluation of the
     History to CAA section 112(f); see, e.g., ‘‘A           emissions of ethylene oxide by 1,000
     Legislative History of the Clean Air Act                                                                      data on which it will determine an EPA
                                                             tons annually.
     Amendments of 1990,’’ vol. 1, page 877 (Senate                                                                cancer unit risk estimate for ethylene
     Debate on Conference Report).                                                                                 oxide. The EPA is also developing an
        2 Legislative History, vol. 1, p. 877, stating,      individual than the policy set forth in the
                                                             Administrator’s benzene regulations * * *.’’
                                                                                                                   acute reference exposure value for
     ‘‘* * * the managers intend that the Administrator
     shall interpret this requirement [to establish            3 ‘‘Residual Risk Report to Congress,’’ March       ethylene oxide. The schedule for both of
     standards reflecting an ample margin of safety] in      1999, EPA–453/R–99–001, page ES–11.                   these actions can be found at: http://
     a manner no less protective of the most exposed           4 Id.                                               cfpub.epa.gov/iristrac.

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                            Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Proposed Rules                                             61407

        Under section 112(o)(7) of the CAA,                     We also consider an adverse                         represent acceptable risk without the
     we are required to issue revised cancer                 environmental effect as a part of a                    need for further more stringent controls.
     guidelines prior to the promulgation of                 residual risk assessment. Regarding the                   In the second step of the ample
     the first residual risk rule under section              inhalation exposure pathway for                        margin of safety framework under
     112(f) (an implication being that we                    terrestrial mammals, we conclude that                  section 112(f)(2), we consider setting
     should consider these revisions in the                  human toxicity values for the inhalation               standards at a level which may be equal
     various residual risk rules). We have                   pathway are generally protective of                    to, or lower than, the acceptable risk
     issued revised cancer guidelines and                    terrestrial mammals. Because the                       level and which protects public health
     also supplemental guidance which deal                   maximum cancer and noncancer                           with an ample margin of safety. In
     specifically with assessing the potential               hazards to humans from inhalation                      making the determination, we
     added susceptibility from early-life                    exposure are relatively low, we expect                 considered the estimate of health risk
     exposure to carcinogens. The                            no significant and widespread adverse                  and other health information along with
     supplemental guidance provides an                       effects to terrestrial mammals from                    additional factors relating to the
     approach for adjusting risk estimates to                inhalation exposure to ethylene oxide                  appropriate level of control, including
     incorporate the potential for increased                 from commercial sterilization facilities.              costs and economic impacts of controls,
     risk due to early-life exposures to                                                                            technological feasibility, uncertainties,
                                                                Some HAP which are persistent and
     chemicals that are thought to be                                                                               and other relevant factors.
                                                             bioaccumulative can also pose risks via
     carcinogenic by a mutagenic mode of                                                                               Because our conservative risk
                                                             pathways other than inhalation (e.g., by               estimates suggest facilities in the
     action. We are currently evaluating the                 depositing to the ground and entering
     available scientific information                                                                               category continue to pose risks
                                                             the food chain). The EPA has developed                 exceeding 1-in-1 million after the
     associated with ethylene oxide to see if                a list of persistent, bioaccumulative, and
     ‘‘age dependent adjustment factors’’                                                                           application of MACT, we considered
                                                             toxic (PBT) HAP based on information                   additional controls, such as new
     should be applied when assessing                        from the Pollution Prevention program,
     cancer risk for early-life exposures                                                                           technology or alternative controls, to
                                                             the Great Waters program, the TRI, and                 reduce emissions and associated risks.
     which cause cancer through a                            additional analysis conducted by the
     mutagenic mode. If the scientific                                                                              In 2001, while investigating the safety
                                                             Office of Air Quality Planning and                     issue associated with chamber exhaust
     information indicates that it is                        Standards. Ethylene oxide is not on the
     appropriate to apply age dependent                                                                             vents, we did not find any new
                                                             list of PBT. Consequently, we conclude                 technology or alternative controls for
     adjustment factors, then we will                        the noninhalation risks to be minimal,
     reassess the risks from exposure to                                                                            any of the vents—chamber, sterilizer or
                                                             and we conclude that a quantitative risk               aeration room vents. We also found no
     ethylene oxide prior to the                             assessment for multipathway exposures
     promulgation of the final rule.                                                                                data to support the addition of down
                                                             is unnecessary.                                        stream control devices to existing
        Estimated annual cancer incidence                       The details of this analysis can be                 control means as a way of further
     rates were also calculated from                         found in our ‘‘Memorandum: Data and                    reducing emissions. This discussion can
     predicted individual cancer risks for the               Assumptions Used for the Screening-                    be found in our ‘‘Memorandum:
     people reported to reside in the U.S.                   level Residual Risk Analysis of the                    Technology Review and Residual Risk
     census blocks within the modeled area                   Commercial Ethylene Oxide Sterilizers                  Data Development for the Ethylene
     around each facility (i.e., within 50                   and Fumigators Source Category’’ and                   Oxide Commercial Sterilization
     kilometers). For the 44 facilities for                  the supporting ‘‘Memorandum: Residual                  NESHAP.’’ We concluded that further
     which estimated maximum individual                      Risk Assessment for Ethylene Oxide                     controls would not meaningfully reduce
     cancer risk is greater than 1-in-1                      Commercial Sterilization Source                        emissions from emission vents
     million, the summed estimated annual                    Category.’’ See ‘‘Reports for Public                   controlled with MACT at both major
     cancer incidence is 0.01 cases per year.                Comment’’ in the SUPPLEMENTARY                         and area sources.
     Across all 76 modeled facilities, the                   INFORMATION section above for                             While no additional control measures
     total estimated annual incidence is 0.04                information on obtaining these reports.                for emission vents controlled with
     cases per year. We estimated that values                                                                       MACT have been identified that would
     presented here are incremental rates                    E. What are our conclusions regarding                  result in a meaningful reduction of
     based on modeled concentrations and                     the need for more stringent standards                  emissions, we are aware of existing
     2000 U.S. census data, and they should                  under section 112(f)(2)?                               State rules which have control limits
     not be interpreted as actual cancer                                                                            exceeding the 99 percent MACT
                                                               In the first step of the decision-
     incidence rates derived from                                                                                   requirement. The State of California’s
                                                             making process under section 112(f)(2),
     observations of disease occurrence over                                                                        emissions reductions requirement for
                                                             the determination of acceptability, we
     time (such as cancer incidence rates that                                                                      the main sterilizer vent is 99.9 percent;
                                                             note that the maximum individual
     may be reported based on                                                                                       this requirement was enacted prior to
                                                             excess lifetime cancer risk associated
     epidemiological studies).                                                                                      promulgation of the Federal
                                                             with any facility with MACT is less than
        The highest chronic noncancer hazard                 what we would normally consider as                     requirements.
     index was 0.03. This means that the                     the upper limit of acceptable risk (i.e.,                 We do not have data to confirm that
     highest lifetime exposures to ethylene                  less than 100-in-1 million).5 Therefore,               all facilities are capable of achieving
     oxide were only 3 percent of the chronic                we are satisfied that these sources                    99.9 percent on a continuous basis. In
     noncancer reference concentration                                                                              1994, in support of the Federal control
     (RfC). Finally, we found that acute                       5 Although we conducted a risk assessment which
                                                                                                                    limit, we concluded both rules are
     exposures, which were calculated by                     included emissions from those vents for which we       sufficiently stringent to require
     assuming the maximum hourly                             set GACT in 1994, we are exercising our discretion     application of the same technologies.
     emissions rate and worst-case                           under section 112(f)(5) not to undertake the section   We concluded it reasonable to assume
     meteorological conditions, did not                      112(f)(2) analysis for those GACT emission points.     the same technologies perform
                                                               See CAA sections 112(f)(2)(A), (B) and (f)(5). The
     exceed any of the relevant health                       discussion in this section of the preamble,
                                                                                                                    similarly, i.e., those facilities outside of
     thresholds for acute effects for ethylene               therefore, is limited to those emission points for     California are on average likely to
     oxide.                                                  which we established MACT in 1994.                     achieve emissions reductions similar to

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     61408                  Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Proposed Rules

     those in California. We concluded that                  have to reconsider the device and                     and that changes to the national
     tightening the current standards would                  packaging material, its compatibility                 emission standards are not required to
     not meaningfully reduce risks.                          with the nontraditional sterilizing agent,            satisfy section 112(f) of the CAA.
        The EPA requests comments                            the packaging configuration, the ability                As discussed above, the EPA is
     specifically addressing our conclusion                  of the nontraditional sterilant to                    developing a cancer unit risk estimate
     that the tightening of the current                      penetrate the packaging, the cost, and                for ethylene oxide. If the EPA value
     standards would not meaningfully                        availability. Because these                           becomes available before the
     reduce emissions or risks. Both EPA’s                   nontraditional sterilization methods are              promulgation of the final rule, we will
     and California’s rules require a test to                less known, manufacturers would have
                                                                                                                   reevaluate whether the risks are
     demonstrate compliance with the                         to submit to FDA their validation data
     emissions reductions limit and                                                                                acceptable and whether an ample
                                                             for review. Nontraditional sterilization
     continuous monitoring of the control                                                                          margin of safety has been achieved.
                                                             operations cannot be used to sterilize
     equipment to ensure proper operation                    materials until they have been                        F. How are we addressing GACT at area
     and maintenance. Initial compliance                     validated. Prohibiting the use of                     sources for purposes of section 112(f)?
     tests are performed one time and on a                   ethylene oxide carries the risk of
     very narrow set of operating conditions.                creating a void where some products                      As noted above, section 112(f)(5)
     The test results are too limited to                     may not be able to be sterilized until                provides that EPA may, but is not
     determine if there are any meaningful                   newer systems are designed and                        required to, conduct any review under
     differences in control technology                       validated. Until such time as these                   section 112(f) or promulgate any
     lifetime performance associated with a                  nontraditional sterilization techniques               emissions limitations under that
     99 percent and 99.9 percent                             may be used under FDA rules, these                    subsection for any area source for which
     performance limit. Specifically, there                  techniques are not considered available               an emissions standard is promugated as
     are several questions on which we are                   for the purpose of reducing emissions.                GACT. The CAA clearly permits EPA to
     requesting public comment:                                 Radiation (gamma and electron beam)                review area source emissions under
        • Are there available test data                      can be used to sterilize many products.               section 112(f)(2), even when the agency
     demonstrating achievability of 99.9                     Radiation sterilization has been used for             issued GACT standards under section
     percent emissions reductions on a                       about half of the products sterilized in              112(d)(5) during its initial review. What
     continuous basis for the main sterilizer                the U.S. However, these sterilization                 is less clear is what the approach should
     vent?                                                   techniques are limited in their                       be when the agency has ‘‘mixed’’ its
        • Are there available test data                      applications. For example, gamma                      emission standards (i.e., issued both
     demonstrating a meaningful difference                   radiation has potentially damaging                    MACT and GACT standards) for an area
     in lifetime control performance between                 effects on products, particularly those               source category. In this instance, for
     the same technology when it is subject                  products that contain polymers. And,                  example, EPA has issued MACT
     to either the 99 or 99.9 percent                        radiation technology is completely                    standards, under section 112(d)(1), for
     emissions reductions requirement?                       different from chamber sterilization.                 sterilizer vents and chamber exhaust
        • Are there available test data                      Ethylene oxide and radiation                          vents; and GACT standards, under
     demonstrating all similar existing                      technologies (both gamma and e-beam)                  section 112(d)(5), for aeration room
     control technology is capable of                        share no common equipment. Any                        vents. This leaves open the question of
     achieving 99.9 percent emissions                        conversion would involve scrapping the                which emissions points should be
     reductions on a continuous basis?                       ethylene oxide chambers and the related
        • Are there available data showing                                                                         reviewed under a subsequent section
                                                             specialized equipment and systems, and                112(f)(2) review. In this instance, EPA
     the variance in long-term performance                   likely displacing the existing workforce.
     for similar technology complying with                                                                         has undertaken an analysis under
                                                             Additionally, the ethylene oxide
     the 99 or 99.9 percent emissions                                                                              section 112(f)(2) for the area emissions
                                                             sterilization facility would not meet
     reductions limit?                                                                                             standards that were issued as MACT
                                                             requirements for a radiation facility. To
        • Are there additional costs                                                                               standards, but the Agency has exercised
                                                             construct a radiation facility, special
     associated with increasing the percent                                                                        its discretion and chosen not to perform
                                                             shielding (huge concrete/lead shields)
     reduction from 99 to 99.9 percent?                      and storage pools need to be                          an section 112(f)(2) analysis for those
        We also considered prohibiting the                   incorporated into the design of both the              emissions points for which we
     use of ethylene oxide for new facilities,               building and the process.                             established GACT. The Agency may
     which would necessitate the use of an                      As stated previously, further controls             have other alternatives legally available,
     alternative sterilization process. The                  for emission vents controlled with                    however. For example, because the
     Food and Drug Administration (FDA)                      MACT at both major and area sources                   Administrator is not required to perform
     has primary authority to regulate the use               do not meaningfully reduce emissions                  a residual risk analysis for any area
     of sterilization methods. The FDA                       or the corresponding risks. Further, the              source category when the Agency has
     issued guidance (510(k) Sterility Review                review has shown that both the                        previously promulgated ‘‘an emissions
     Guidance K90–1, August 30, 2002                         noncancer and acute risks from this                   standard’’ pursuant to section 112(d)(5),
     (‘‘FDA Guidance’’)) to facilitate                       source category are below their relevant              it is at least arguable that, by using the
     nontraditional sterilization methods.                   health thresholds. As a result, we                    singular article ‘‘an,’’ Congress intended
     The FDA stated in the guidance that the                 conclude that no additional control                   to permit the Agency discretion to
     FDA ‘‘has had little or no experience                   should be required because an ample                   decline to review the area source
     with these methods for achieving                        margin of safety (considering cost,                   category, in its entirety, under section
     sterilization and is concerned about a                  technical feasibility, and other factors)             112(f)(2) in appropriate ‘‘mixed’’ cases.
     manufacturer’s ability to successfully                  has been achieved by the national                     The Agency seeks comment on the
     use such methods without adversely                      emission standards.                                   Agency’s range of discretion under
     affecting the sterility assurance level                    Thus, we conclude that the level of                section 112(f)(5) and suggestions on
     * * *.’’ If the use of ethylene oxide                   risk resulting from the limits in the                 what factors should guide decisions
     were prohibited, manufacturers of                       national emission standards is                        about its approach in future
     products requiring sterilization would                  acceptable for these source categories,               rulemakings.

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                            Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Proposed Rules                                           61409

     G. What are the results of the technology               controls that can be implemented                      the national emission standards under
     review?                                                 nationally, we are proposing not to                   the provisions of the Paperwork
        Section 112(d)(6) of the CAA requires                revise the National Emission Standards                Reduction Act, 44 U.S.C. 3501 et seq.,
     us to review and revise as necessary                    for Ethylene Oxide Sterilization                      and assigned OMB control number
     (taking into account developments in                    Facilities under CAA section 112(f) or                2060–0283.
                                                             112(d)(6).                                               Burden means the total time, effort, or
     practices, processes, and control
                                                                                                                   financial resources expended by persons
     technologies) emission standards                        II. Statutory and Executive Order                     to generate, maintain, retain, or disclose
     promulgated under this section no less                  Reviews                                               or provide information to or for a
     often than every 8 years. In the course
                                                             A. Executive Order 12866: Regulatory                  Federal agency. This includes the time
     of our review, we investigated emission
                                                             Planning and Review                                   needed to review instructions; develop,
     control levels and the potential for
                                                                                                                   acquire, install, and utilize technology
     additional emissions reductions from                       Under Executive Order 12866 (58 FR                 and systems for the purposes of
     existing affected facilities within the                 51735, October 4, 1993), EPA must                     collecting, validating, and verifying
     ethylene oxide commercial sterilization                 determine whether a regulation is                     information, processing and
     source category. Because the three vents                ‘‘significant’’ and, therefore, subject to            maintaining information, and disclosing
     associated with these facilities (i.e., the             Office of Management and Budget                       and providing information; adjust the
     main sterilization, aeration room, and                  (OMB) review and the requirements of                  existing ways to comply with any
     chamber exhaust emission vents) are the                 the Executive Order. The Executive                    previously applicable instructions and
     same for both major and area sources,                   Order defines ‘‘significant regulatory                requirements; train personnel to be able
     the conclusions concerning technology                   action’’ as one that is likely to result in           to respond to a collection of
     apply to both source categories. We                     a rule that may:                                      information; search data sources;
     found that additional controls for                         (1) Have an annual effect on the                   complete and review the collection of
     emission vents controlled with either                   economy of $100 million or more, or                   information; and transmit or otherwise
     MACT or GACT would achieve at best,                     adversely affect in a material way the                disclose the information.
     minimal emission and risk reductions at                 economy, a sector of the economy,                        An agency may not conduct or
     a very high cost. In our review, we did                 productivity, competition, jobs, the                  sponsor, and a person is not required to
     not identify any significant                            environment, public health or safety, or              respond to, a collection of information
     developments in practices, processes, or                State, local, or tribal government                    unless it displays a currently valid OMB
     control technologies since promulgation                 communities;                                          control number. The OMB control
     of the national emission standards in                      (2) Create a serious inconsistency or              numbers for EPA’s regulations are listed
     1994.                                                   otherwise interfere with an action taken              in 40 CFR part 9 and 48 CFR chapter 15.
        For new major sources where MACT                     or planned by another agency;                            EPA has established a public docket
     requires emissions reductions of 99                        (3) Materially alter the budgetary                 for this action, which includes the ICR,
     percent, we considered increasing the                   impact of entitlements, grants, user fees,            under Docket ID number OAR 2003–
     emissions reductions limit to 99.9                      or loan programs, or the rights and                   0197, which can be found in http://
     percent in the national emission                        obligations of recipients thereof; or                 www.epa.gov/edocket. Today’s
     standards. A new limit would only                          (4) Raise novel or policy issues arising           proposed decision will not change the
     apply to affected new sources (a new                    out of legal mandates, the President’s                burden estimates from those developed
     facility for the standards), while existing             priorities, or the principles set forth in            and approved in 1994 for the national
     sources would still be subject to the                   the Executive Order.                                  emission standards.
     current limits. As stated previously, we                   It has been determined that today’s
     do not have data to confirm that                        proposed decision is a ‘‘significant                  C. Regulatory Flexibility Act
     facilities are capable of achieving 99.9                regulatory action’’ under the terms of                   The Regulatory Flexibility Act (RFA)
     percent on a continuous basis.                          Executive Order 12866 because it raises               generally requires an agency to prepare
     Therefore, the 99 percent emissions                     novel legal or policy issues arising out              a regulatory flexibility analysis of any
     reductions requirement of the national                  of legal mandates, the President’s                    rule subject to notice and comment
     emission standards is considered to be                  priorities, or the principles set forth in            rulemaking requirements under the
     the best control level in practice                      the Executive Order. Therefore, today’s               Administrative Procedure Act or any
     nationally. We conclude that the new                    proposed decision was submitted to                    other statute unless the agency certifies
     source standard for the emissions                       OMB for review. However, today’s                      that the rule will not have a significant
     reductions limit should be kept the                     proposed decision will result in no                   economic impact on a substantial
     same as that for existing, and that no                  additional cost impacts beyond those                  number of small entities. Small entities
     further revisions to the National                       estimated for the current national                    include small businesses, small
     Emission Standards for Ethylene Oxide                   emission standards. Changes made in                   organizations, and small governmental
     Sterilization Facilities are needed.                    response to OMB suggestions or                        jurisdictions.
        In the original generally GACT                       recommendations will be documented                       For purposes of assessing the impacts
     determination for new area sources, no                  in the public record.                                 of today’s proposed decision on small
     control requirements were established                                                                         entities, small entity is defined as: (1) A
     due to the high cost (59 FR 10598–99).                  B. Paperwork Reduction Act                            small business whose parent company
     In our review, we did not identify any                    This action does not impose any new                 has fewer than 100 or 1,500 employees,
     significant developments in practices,                  information collection burden under the               or a maximum of $5 million to $18.5
     processes, or control technologies since                provisions of the Paperwork Reduction                 million in revenues, depending on the
     promulgation of the national emission                   Act, 44 U.S.C. et seq. Today’s proposed               size definition for the affected North
     standards in 1994 which would reduce                    decision will not change the burden                   American Industry Classification
     the costs of applying controls to new                   estimates from those developed and                    System (NAICS) code; (2) a small
     area sources.                                           approved for the national emission                    governmental jurisdiction that is a
        Because the national emission                        standards. In 1994, OMB approved the                  government of a city, county, town,
     standards continue to represent the best                information collection requirements for               school district or special district with a

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     61410                  Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Proposed Rules

     population of less than 50,000; and (3)                 including tribal governments, it must                 regulatory policies that have tribal
     a small organization that is any not-for-               have developed under section 203 of the               implications.’’ ‘‘Policies that have tribal
     profit enterprise which is independently                UMRA a small government agency plan.                  implications’’ is defined in the
     owned and operated and is not                           The plan must provide for notifying                   Executive Order to include regulations
     dominant in its field. It should be noted               potentially affected small governments,               that have ‘‘substantial direct effects on
     that the small business definition                      enabling officials of affected small                  one or more Indian tribes, on the
     applied to each industry by NAICS code                  governments to have meaningful and                    relationship between the Federal
     is that listed in the Small Business                    timely input in the development of EPA                government and the Indian tribes, or on
     Administration (SBA) size standards (13                 regulatory proposals with significant                 the distribution of power and
     CFR 121).                                               Federal intergovernmental mandates,                   responsibilities between the Federal
        After considering the economic                       and informing, educating, and advising                government and Indian tribes.’’
     impacts of today’s proposed decision on                 small governments on compliance with                    Today’s proposed decision does not
     small entities, I certify that the decision             the regulatory requirements.                          have tribal implications. It will not have
     will not have a significant economic                      The EPA has determined that today’s                 substantial direct effects on tribal
     impact on a substantial number of small                 proposed decision does not contain a                  governments, on the relationship
     entities. The proposed decision will not                Federal mandate that may result in                    between the Federal government and
     impose any requirements on small                        expenditures of $100 million or more to               Indian tribes, or on the distribution of
     entities. Today’s proposal announces a                  State, local, and tribal governments in               power and responsibilities between the
     decision and requests public comments                   the aggregate, or to the private sector in            Federal government and Indian tribes,
     on the residual risk assessment and                     any 1 year. Therefore, today’s proposed               as specified in Executive Order 13175.
     technology review for the national                      decision is not subject to the                        Thus, Executive Order 13175 does not
     emission standards and imposes no                       requirements of sections 202 and 205 of               apply to today’s proposed decision.
     additional burden on facilities impacted                the UMRA. In addition, today’s
     by the national emission standards. We                  proposed decision does not significantly              G. Executive Order 13045: Protection of
     are proposing no further action at this                 or uniquely affect small governments                  Children From Environmental Health
     time to revise the national emission                    because it contains no requirements that              and Safety Risks
     standards. We continue to be interested                 apply to such governments or impose                      Executive Order 13045 (62 FR 19885,
     in the potential impacts of the proposed                obligations upon them. Therefore,                     April 23, 1997) applies to any rule that:
     decision on small entities and welcome                  today’s proposed decision is not subject              (1) Is determined to be ‘‘economically
     comments on issues related to such                      to section 203 of the UMRA.                           significant’’ as defined under Executive
     impacts.                                                                                                      Order 12866, and (2) concerns an
                                                             E. Executive Order 13132: Federalism
     D. Unfunded Mandates Reform Act                                                                               environmental health or safety risk that
                                                                Executive Order 13132, entitled                    EPA has reason to believe may have a
        Title II of the Unfunded Mandates                    ‘‘Federalism’’ (64 FR 43255, August 10,               disproportionate effect on children. If
     Reform Act of 1995 (UMRA), Public                       1999), requires EPA to develop an                     the regulatory action meets both criteria,
     Law 104–4, establishes requirements for                 accountable process to ensure                         EPA must evaluate the environmental
     Federal agencies to assess the effects of               ‘‘meaningful and timely input by State                health or safety effects of the planned
     their regulatory actions on State, local,               and local officials in the development of             rule on children, and explain why the
     and tribal governments and the private                  regulatory policies that have federalism              planned regulation is preferable to other
     sector. Under section 202 of the UMRA,                  implications.’’ ‘‘Policies that have                  potentially effective and reasonably
     EPA generally must prepare a written                    federalism implications’’ is defined in               feasible alternatives considered by the
     statement, including a cost-benefit                     the Executive Order to include                        Agency.
     analysis, for proposed and final rules                  regulations that have ‘‘substantial direct               Today’s proposed decision is not
     with ‘‘Federal mandates’’ that may                      effects on the States, on the relationship            subject to the Executive Order because
     result in expenditures by State, local,                 between the national government and                   it is not economically significant as
     and tribal governments, in aggregate, or                the States, or on the distribution of                 defined in Executive Order 12866 and
     by the private sector, of $100 million or               power and responsibilities among the                  because the Agency does not have
     more in any 1 year. Before promulgating                 various levels of government.’’                       reason to believe the environmental
     an EPA rule for which a written                            Today’s proposed decision does not                 health or safety risk addressed by this
     statement is needed, section 205 of the                 have substantial direct effects on the                action present a disproportionate risk to
     UMRA generally requires EPA to                          States, on the relationship between the               children.
     identify and consider a reasonable                      national government and the States, or
     number of regulatory alternatives and                   on the distribution of power and                      H. Executive Order 13211: Actions That
     adopt the least costly, most cost-                      responsibilities among the various                    Significantly Affect Energy Supply,
     effective, or least burdensome                          levels of government, as specified in                 Distribution, or Use
     alternative that achieves the objectives                Executive Order 13132. Thus, the                         Today’s proposed decision is not a
     of the rule. The provisions of section                  requirements of the Executive Order do                ‘‘significant energy action’’ as defined in
     205 do not apply when they are                          not apply to today’s proposed decision.               Executive Order 13211 (66 FR 28355,
     inconsistent with applicable law.                                                                             May 22, 2001), because it is not likely
     Moreover, section 205 allows EPA to                     F. Executive Order 13175, Consultation
                                                                                                                   to have a significant adverse effect on
     adopt an alternative other than the least               and Coordination With Indian Tribal
                                                                                                                   the supply, distribution, or use of
     costly, most cost-effective, or least                   Governments
                                                                                                                   energy. Further, we have concluded that
     burdensome alternative if the                              Executive Order 13175, entitled                    today’s proposed decision is not likely
     Administrator publishes with the final                  ‘‘Consultation and Coordination with                  to have any adverse energy impacts.
     rule an explanation of why that                         Indian Tribal Governments’’ (65 FR
     alternative was not adopted.                            67249, November 6, 2000), requires EPA                I. National Technology Transfer and
        Before EPA establishes any regulatory                to develop an accountable process to                  Advancement Act of 1995
     requirements that may significantly or                  ensure ‘‘meaningful and timely input by                  Under section 12(d) of the National
     uniquely affect small governments,                      tribal officials in the development of                Technology Transfer and Advancement

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                            Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Proposed Rules                                          61411

     Act of 1995 (NTTAA), Public Law No.                     prevent an adverse environmental                      claimed to be confidential business
     104–113, all Federal agencies are                       effect. Also, section 112(d)(6) of the                information (CBI) or other information
     required to use voluntary consensus                     CAA requires EPA to review and revise                 whose disclosure is restricted by statute.
     standards (VCS) in their regulatory and                 the NESHAP as necessary at least every                Do not submit information that you
     procurement activities unless to do so                  8 years, taking into account                          consider to be CBI or otherwise
     would be inconsistent with applicable                   developments in practices, processes,                 protected through EDOCKET,
     law or otherwise impractical. Voluntary                 and control technologies. Based on our                regulations.gov, or e-mail. The EPA
     consensus standards are technical                       findings from the residual risk review                EDOCKET and the Federal
     standards (e.g., materials specifications,              and technology review, we are                         regulations.gov Web sites are
     test methods, sampling procedures,                      proposing no further action at this time              ‘‘anonymous access’’ systems, which
     business practices) developed or                        to revise the NESHAP. This proposed                   means EPA will not know your identity
     adopted by one or more voluntary                        action requests public comments on the                or contact information unless you
     consensus bodies. The NTTAA requires                    residual risk review and technology                   provide it in the body of your comment.
     Federal agencies to provide Congress,                   review for the NESHAP.                                If you send an e-mail comment directly
     through annual reports to OMB, with                     DATES: Comments. Comments must be                     to EPA without going through
     explanations when the agency does not                   received on or before December 8, 2005.               EDOCKET or regulations.gov, your e-
     use available and applicable VCS.                          Public Hearing. If anyone contacts                 mail address will be automatically
       Today’s proposed decision does not                    EPA requesting to speak at a public                   captured and included as part of the
     involve technical standards. Therefore,                 hearing by November 8, 2005, a public                 comment that is placed in the public
     the requirements of the NTTAA are not                   hearing will be held approximately 20                 docket and made available on the
     applicable.                                             days following publication of this action             Internet. If you submit an electronic
                                                             in the Federal Register.                              comment, EPA recommends that you
     List of Subjects in 40 CFR Part 63
                                                             ADDRESSES: Submit your comments,                      include your name and other contact
       Environmental protection,                                                                                   information in the body of your
                                                             identified by Docket ID No. OAR–2004–
     Administrative practice and procedures,                                                                       comment and with any disk or CD–ROM
                                                             0004, by one of the following methods:
     Air pollution control, Intergovernmental                                                                      you submit. If EPA cannot read your
                                                                • Federal eRulemaking Portal: http://
     relations, Reporting and recordkeeping                                                                        comment due to technical difficulties
                                                             www.regulations.gov. Follow the on-line
     requirements.                                                                                                 and cannot contact you for clarification,
                                                             instructions for submitting comments.
       Dated: October 18, 2005.                                 • Agency Web site: http://                         EPA may not be able to consider your
     Stephen L. Johnson,                                     www.epa.gov/edocket. EDOCKET, EPA’s                   comment. Electronic files should avoid
     Administrator.                                          electronic public docket and comment                  the use of special characters, any form
     [FR Doc. 05–21187 Filed 10–21–05; 8:45 am]              system, is EPA’s preferred method for                 of encryption, and be free of any defects
                                                             receiving comments. Follow the on-line                or viruses. (For additional information
     BILLING CODE 6560–50–P
                                                             instructions for submitting comments.                 about EPA’s public docket visit
                                                                • E-mail: a-and-r-docket@epa.gov and               EDOCKET on-line or see the Federal
     ENVIRONMENTAL PROTECTION                                mulrine.phil@epa.gov.                                 Register of May 31, 2002 (67 FR 38102.)
     AGENCY                                                     • Fax: (202) 566–1741 and (919) 541–                  Docket: All documents in the docket
                                                             5450.                                                 are listed in the EDOCKET index at
     40 CFR Part 63                                             • Mail: U.S. Postal Service, send                  http://www.epa.gov/edocket. Although
                                                             comments to: EPA Docket Center                        listed in the index, some information is
     [OAR–2004–0004, FRL–7987–4]
                                                             (6102T), Attention Docket Number                      not publicly available, i.e., CBI or other
     RIN 2060–AK16                                           OAR–2004–0004, 1200 Pennsylvania                      information whose disclosure is
                                                             Ave., NW., Washington, DC 20460.                      restricted by statute. Certain other
     National Emission Standards for                            • Hand Delivery: In person or by                   material, such as copyrighted material,
     Hazardous Air Pollutants for Industrial                 courier, deliver comments to: EPA                     is not placed on the Internet and will be
     Process Cooling Towers                                  Docket Center (6102T), Attention Docket               publicly available only in hard copy
     AGENCY:  Environmental Protection                       ID Number OAR–2004–0004, 1301                         form. Publicly available docket
     Agency (EPA).                                           Constitution Avenue, NW., Room B–                     materials are available either
                                                             102, Washington, DC 20004. Such                       electronically in EDOCKET or in hard
     ACTION: Proposed action; request for
                                                             deliveries are only accepted during the               copy at the EPA Docket Center, Docket
     public comment.                                                                                               ID Number OAR–2004–0004, EPA West
                                                             Docket’s normal hours of operation, and
     SUMMARY: On September 8, 1994, we                       special arrangements should be made                   Building, Room B102, 1301 Constitution
     promulgated national emission                           for deliveries of boxed information.                  Ave., NW., Washington, DC. The Public
     standards for hazardous air pollutants                  Please include a total of two copies. We              Reading Room is open from 8:30 a.m. to
     (NESHAP) from industrial process                        request that a separate copy of each                  4:30 p.m., Monday through Friday,
     cooling towers (59 FR 46350). The                       public comment also be sent to the                    excluding legal holidays. The telephone
     NESHAP eliminated the use of                            contact person for the proposed action                number for the Public Reading Room is
     chromium-based water treatment                          listed below (see FOR FURTHER                         (202) 566–1744, and the telephone
     chemicals that are known or suspected                   INFORMATION CONTACT).                                 number for the EPA Docket Center is
     to cause cancer or have a serious health                   Instructions: Direct your comments to              (202) 566–1742. A reasonable fee may
     or environmental effect.                                Docket ID No. OAR–2004–0004. The                      be charged for copying docket materials.
       Section 112(f)(2) of the Clean Air Act                EPA’s policy is that all comments                     FOR FURTHER INFORMATION CONTACT: For
     (CAA) directs EPA to assess the risk                    received will be included in the public               questions about the proposed action,
     remaining (residual risk) after the                     docket without change and may be                      contact Mr. Phil Mulrine, U.S. EPA,
     application of the NESHAP and                           made available online at http://                      Office of Air Quality Planning and
     promulgate additional standards if                      www.epa.gov/edocket, including any                    Standards, Emission Standards
     warranted to provide an ample margin                    personal information provided, unless                 Division, Metals Group (C439–02),
     of safety to protect public health or                   the comment includes information                      Research Triangle Park, North Carolina

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