Response to Comments for the Federal Register Notice for Air Quality State Implementation Plans; Promulgation of State Implementation Plan Revisions; Infrastructure Requirements for the 2008 Lead, 2008 Ozone, 2010 NO2, 2010 SO2, and 2012 PM2.5 National Ambient Air Quality Standards; Utah

                       Docket No. EPA-R08-OAR-2013-0561

                                 July 19, 2016

                                Public Comments

Note: This response-to-comment (RTC) document contains EPA's responses to comments received by the close of the public comment period for this action, May 26, 2016. EPA has paraphrased the comments.

Sierra Club Comments on EPA Approval of Utah iSIP Pertaining to SO2
Document No. EPA-R08-OAR-2013-0561-0023

Comment 1: National Ambient Air Quality Standards and Implementation of the NAAQs
      The Sierra Club (hereinafter referred to as "Commenter") states that the main objective of the infrastructure SIP process "is to ensure that all areas of the country meet the NAAQS" and that nonattainment areas are addressed through "nonattainment SIPs." The Commenter asserts the NAAQS "are the foundation upon which air emission standards for the entire country are set" including specific emission limitations for most large stationary sources, such as coal-fired power plants. The Commenter discusses the CAA's framework whereby states have primary responsibility to assure air quality within the state pursuant to CAA section 107(a). States carry out section 107(a) through SIPs such as infrastructure SIPs required by section 110(a)(2). The Commenter points to air monitoring and modeling requirements of infrastructure SIPs and cites to the EPA's Data Requirements Rule for determining the SO2 NAAQS compliance status (80 FR 51052 (Aug. 21, 2015)).
      The Commenter also states that the plain language of the CAA requires infrastructure SIPs "to be adequate to prevent exceedances of the NAAQS." In support, the Commenter quotes language in section 110(a)(1) which requires states to adopt a plan for implementation, maintenance, and enforcement of the NAAQS. The Commenter also quotes language in section 110(a)(2)(A) requiring SIPs to include enforceable emissions limitations as may be necessary to meet the requirements of the CAA, which the Commenter claims includes attainment and maintenance of the NAAQS. The Commenter contends that EPA interpretations in rulemakings require the inclusion of enforceable emission limits in infrastructure SIPs when new or revised NAAQS are promulgated. The Commenter also contends that infrastructure SIPs must address interstate transport of pollution and quotes language from section 110(a)(2)(D)(i)(I).

Response 1: The EPA disagrees that section 110 is clear "on its face" and must be interpreted in the manner suggested by the Commenter. As we have previously explained in response to similar comments the Commenter has made on EPA's actions approving other states' infrastructure SIPs, section 110 is only one provision that is part of the complicated structure governing implementation of the NAAQS program under the CAA, as amended in 1990, and it must be interpreted in the context of not only that structure, but also of the historical evolution of that structure.
      The EPA interprets infrastructure SIPs as more general planning SIPs, consistent with the CAA as understood in light of its history and structure. When Congress enacted the CAA in 1970, it did not include provisions requiring states and the EPA to label areas as attainment or nonattainment. Rather, states were required to include all areas of the state in ``air quality control regions'' (AQCRs) and section 110 set forth the core substantive planning provisions for these AQCRs. At that time, Congress anticipated that states would be able to address air pollution quickly pursuant to the very general planning provisions in section 110 and could bring all areas into compliance with a new NAAQS within five years. Moreover, at that time, section 110(a)(2)(A)(i) specified that the section 110 plan provide for ``attainment'' of the NAAQS and section 110(a)(2)(B) specified that the plan must include ``emission limitations, schedules, and timetables for compliance with such limitations, and such other measures as may be necessary to insure attainment and maintenance [of the NAAQS].''
      In 1977, Congress recognized that the existing structure was not sufficient and many areas were still violating the NAAQS. At that time, Congress for the first time added provisions requiring states and the EPA to identify whether areas of a state were violating the NAAQS (i.e., in nonattainment) or were meeting the NAAQS (i.e., in attainment) and established specific planning requirements in section 172 for areas not meeting the NAAQS. In 1990, many areas still had air quality not meeting the NAAQS and Congress again amended the CAA and added yet another layer of more prescriptive planning requirements for each of the NAAQS. At that time, Congress modified section 110 to remove references to the section 110 SIP providing for attainment, including removing pre-existing section110(a)(2)(A) in its entirety and renumbering subparagraph (B) as section 110(a)(2)(A). Additionally, Congress replaced the clause ``as may be necessary to insure attainment and maintenance [of the NAAQS]'' with ``as may be necessary or appropriate to meet the applicable requirements of this chapter.'' Thus, the CAA has significantly evolved in the more than 40 years since it was originally enacted. While at one time section 110 of the CAA did provide the only detailed SIP planning provisions for states and specified that such plans must provide for attainment of the NAAQS, under the structure of the current CAA, section 110 is only the initial stepping-stone in the planning process for a specific NAAQS. More detailed, later-enacted provisions govern the substantive planning process, including planning for attainment of the NAAQS.
      Thus, the EPA believes that section 110 of the CAA is only one provision that is part of the complicated structure governing implementation of the NAAQS program under the CAA, as amended in 1990, and it must be interpreted in the context of that structure and the historical evolution of that structure. In light of the revisions to section 110 since 1970 and the later promulgated and more specific planning requirements of the CAA, the EPA reasonably interprets the requirement in section 110(a)(2)(A) of the CAA that the plan provide for ``implementation, maintenance and enforcement'' to mean that the SIP must contain enforceable emission limits that will aid in attaining and/or maintaining the NAAQS and that the state demonstrates it has the necessary tools to implement and enforce a NAAQS, such as adequate state personnel and an enforcement program. The EPA has interpreted the requirement for emission limitations in section 110 to mean that the state may rely on measures already in place to address the pollutant at issue or any new control measures that the state may choose to submit. Furthermore, as the EPA stated in the Infrastructure SIP Guidance which specifically provides guidance to states in addressing the 2008 ozone and 2010 SO2 NAAQS, ``[t]he conceptual purpose of an infrastructure SIP submission is to assure that the air agency's SIP contains the necessary structural requirements for the new or revised NAAQS, whether by establishing that the SIP already contains the necessary provisions, by making a substantive SIP revision to update the SIP, or both.'' Infrastructure SIP Guidance at p. 2.
      The Commenter makes general allegations that Utah does not have sufficient protective measures to prevent SO2 NAAQS exceedances. The EPA addressed the adequacy of Utah's infrastructure SIP for 110(a)(2)(A) purposes to meet applicable requirements of the CAA in the proposed rulemaking  (80 FR 24527, April 26, 2016) and explained why the SIP includes enforceable emission limitations and other control measures necessary for maintenance of the 2010 SO2 NAAQS throughout the State. Finally, the EPA addresses the Commenter's statement that a state must demonstrate the "Good Neighbor" requirements of section 110(a)(2)(D)(i)(I) to protect the NAAQS of neighboring states in Response 15.

Comment 2: The 2010 Sulfur Dioxide NAAQS
      The Commenter provides a history of the establishment of the SO2 NAAQS and discusses the adverse health impacts of SO2 exposure. The Commenter asserts that modeling is the appropriate tool for implementation of the 2010 SO2 NAAQS. The Commenter cites to several cases upholding EPA's use of modeling in NAAQS implementation actions, including the Montana Sulphur case, Sierra Club v. Costle, 657 F.2d 298 (D.C. Cir. 1981), Republic Steel Corp. v. Costle, 621 F.2d 797 (6th Cir. 1980), and Catawba County v. EPA, 571 F.3d 20 (D.C. Cir. 2009). The Commenter cites to prior EPA statements in the 2010 SO2 NAAQS preamble and EPA's 2012 Draft White Paper for Discussion on Implementing the 2010 SO2 NAAQS, as support that modeling could better address the source-specific impacts of SO2 emissions and the historic challenges of monitoring SO2 emissions.

Response 2: The EPA agrees with the Commenter that air dispersion modeling can be an important tool in the CAA section 107 designations process for SO2 and in developing SIPs for nonattainment areas as required by sections 172 and 191 - 192, including providing support for required attainment demonstrations. The EPA agrees that prior EPA statements, EPA guidance, and case law support the use of air dispersion modeling in the SO2 designations and attainment demonstration processes, the interstate impact of transported emissions, and whether existing approved SIPs remain adequate to show attainment and maintenance of the SO2 NAAQS. Moreover, while the EPA supports the use of modeling as a tool in such contexts, the EPA notes that under the Data Requirements Rule, states still have the option of choosing between modeling and monitoring to characterize air quality. Thus, the EPA reiterates that while infrastructure SIPs must provide the state's authority to conduct air quality monitoring and modeling, they need not provide specific air dispersion modeling for large stationary sources of pollutants as the Commenter suggests. Specific air dispersion modeling for large stationary sources are helpful support as part of the designations and attainment demonstration process, but are outside the scope of this action.

Comment 3: Utah's SO2 NAAQS Infrastructure SIP is Inadequate with Respect to the Air Monitoring and Modeling Requirements of Sections 110(a)(2)(K) and 110(a)(2)(B).
      The Commenter references the Data Requirements Rule for the 2010 1-Hour Sulfur Dioxide (SO2) Primary NAAQS (80 FR 51052 (Aug. 21, 2015)), which requires states to characterize SO2 air quality either by air quality monitoring or modeling data. According to the Commenter, the Data Requirements Rule requires Utah to notify the EPA whether it will use air quality modeling or monitoring to characterize SO2 air quality associated with sources that have SO2 emissions exceeding a 2,000 tons per year annual threshold. The Commenter states that the EPA should evaluate and determine that the Utah Division of Air Quality's (UDAQ) modeling and monitoring procedures are inadequate to ensure implementation of CAA programs to attain and maintain the 1-hour SO2 NAAQS. The Commenter obtained air modeling conducted by the UDAQ which was used to determine SO2 concentrations around the Hunter, Huntington, and Intermountain Power Plants. The Commenter asserts that UDAQ may be relying on modeling analyses to demonstrate that the area around these power plants are attaining the 1-hour SO2 NAAQS rather than for the purpose of informing SO2 ambient air monitor placement.
	The Commenter contends that independent analyses of the Hunter and Huntington Power Plant's impacts on 1-hour average SO2 concentrations in the area through third-party modeling "showed the maximum actual plant wide SO2 emissions from each of the power plants were projected to cause violations on the 1-hour SO2 NAAQS" while UDAQ's SO2 air modeling results indicated no violations of the 1-hour SO2 NAAQS at the receptors modeled for the Hunter and Huntington plants based on the modeling of actual emissions from 2012-2014.
	The Commenter contends that "UDAQ has applied an approach to modeling that greatly understates SO2 air quality in the vicinity around the Hunter and Huntington plants and most likely resulted in un-reported violations of the 1-hour SO2 NAAQS." The Commenter states that "UDAQ arbitrarily excluded areas where it was supposedly not feasible to locate an air monitor, and questions the validity of UDAQ's modeling infrastructure and its ability to capture maximum SO2 concentrations." The Commenter contends that UDAQ's modeling and monitoring methodologies are not adequate to ensure that the 1-hour SO2 NAAQS is met throughout Utah.

Response 3: The EPA disagrees with the Commenter that Utah's SO2 NAAQS infrastructure SIP is inadequate with respect to the ambient air quality monitoring and modeling requirements of sections 110(a)(2)(B) and 110(a)(2)(K) respectively. Infrastructure SIPs are general planning SIPs to ensure that a state has adequate resources and authority to implement a NAAQS. Infrastructure SIP submissions are not intended to act or fulfill the obligations of the Data Requirements Rule. While infrastructure SIPs must address modeling authorities in general for section 110(a)(2)(K), that section requires infrastructure SIPs to provide the state's authority for air quality modeling and for submission of modeling data to the EPA, not specific air dispersion modeling for large stationary sources of pollutants." In the proposal for this rulemaking action, the EPA provided a detailed explanation of Utah's authority to conduct air quality modeling and to submit modeling data to the EPA. Furthermore, as stated in the proposal, the EPA is not acting on section 110(a)(2)(B) for the 2010 SO2 NAAQS. The EPA provides further details on the Commenter's statement that Utah's infrastructure SIP is inadequate for purposes of the infrastructure SIP elements (B) and (K) in subsequent responses, including Responses 4 and 5.
      On April 12, 2012, the EPA explained its expectations regarding implementation of the 2010 SO2 NAAQS via letters to each of the states. The EPA communicated in the April 2012 letters that all states were expected to submit SIPs meeting the ``infrastructure'' SIP requirements under section 110(a)(2) of the CAA by June 2013. At the time, the EPA was undertaking a stakeholder outreach process to continue to develop possible approaches for determining attainment status under the SO2 NAAQS and implementing this NAAQS. The EPA was abundantly clear in the April 2012 letters that the EPA did not expect states to submit substantive attainment demonstrations or modeling demonstrations showing attainment for areas not designated nonattainment in infrastructure SIPs due in June 2013. Although the EPA had previously suggested in its 2010 SO2 NAAQS preamble and in prior draft implementation guidance in 2011 that states should, in the unique SO2 context, use the section 110(a) SIP process as the vehicle for demonstrating attainment of the NAAQS, this approach was never adopted as a binding requirement and was subsequently discarded in the April 2012 letters to states. The April 2012 letters recommended that states focus on infrastructure SIPs due in June 2013, such as Utah's SO2 infrastructure SIP, on traditional ``infrastructure elements'' in section 110(a)(1) and (2) rather than on modeling demonstrations for future attainment for areas not designated as nonattainment.
	Although the Commenter's evaluations of modeling demonstrations could be considered in the context of NAAQS designations, they are not relevant at the earlier stage of reviewing an infrastructure SIP submission. No areas in Utah have been designated for the 2010 SO2 NAAQS at this point in time. The CAA does not provide explicit requirements for demonstrating attainment of a NAAQS for areas that have not yet been designated for that NAAQS.
      As stated previously, the proper inquiry in this action is whether Utah has met the basic structural SIP requirements appropriate at the point in time the EPA is acting upon the infrastructure submittal. Determination of attainment status under the SO2 NAAQS is due on a different schedule from the section 110 infrastructure elements. A state, like Utah, may reference preexisting SIP rules and emission reduction measures that control emissions of SO2. These provisions were discussed in the proposed rulemaking and have the ability to reduce SO2 overall. Although the Utah SIP relies on measures and programs used to implement previous SO2 NAAQS, these provisions are not limited to reducing SO2 levels to meet one specific NAAQS and will continue to provide benefits for the 2010 SO2 NAAQS.

Comment 4: UDAQ Improperly Excluded Parts of Ambient Air from Its Modeling Analysis of the Hunter and Huntington Power Plants' Impacts on 1‐Hour Average SO2 Concentrations.
      The Commenter states that "EPA cannot approve [110(a)(2)(K)] of Utah's SO2 NAAQS infrastructure SIP when it is clear that UDAQ's modeling will not ensure compliance with the SO2 NAAQS."  The Commenter explains that "UDAQ's SO2 modeling methodology is not protective of the 1-Hour SO2 NAAQS because UDAQ improperly excludes ambient air receptors where violations of the 1-Hour SO2 NAAQS are likely occurring." The Commenter states that UDAQ excluded receptors from its modeling analyses based on a claim that it would not be feasible to place a monitor due to steep and inaccessible terrain. According to the Commenter, UDAQ cited the EPA's "SO2 NAAQS Designations Modeling Technical Assistance Document," February 2016 Draft, for support in excluding receptors from its modeling of the Hunter and Huntington plants.
	The Commenter then points to the EPA's proposed approval of 110(a)(2)(K) of Utah's infrastructure SIP, and contends that R308-405-13, which incorporates the EPA's Guideline on Air Quality Models in 40 CFR 51, appendix W, does not allow for exclusion of receptors in areas where it is not feasible to place an ambient air monitor and references Sections <IP_ADDRESS>.a., b. and 7.2.2. of Appendix W. The Commenter claims that one benefit and purpose of air dispersion modeling is to predict pollutant concentrations in all locations potentially impacted by a source(s) because it may not be feasible to locate a monitor in all areas impacted by a source(s).
	The Commenter cites to the EPA's SO2 NAAQS Modeling Technical Assistance Document ("SO2 Modeling TAD") which states that one of the differences between the modeling TAD and Appendix W is the placement of receptors only in areas where it is feasible to place a monitor. The Commenter references the EPA's February 2016 Draft "SO2 NAAQS Source‐Oriented Monitoring Technical Assistance Document" ("SO2 Monitoring TAD"), which includes two examples of water bodies and facility property to illustrate "areas feasible to place a monitor." The Commenter contends that "it is inconceivable that EPA intended areas of steep terrain to be excluded in a SO2 modeling analysis" and cites to the EPA's SO2 Monitoring TAD to illustrate that valleys can have significant impacts on pollution transport and dispersion.
	The Commenter contends that UDAQ's approach is inconsistent with the EPA's historic interpretation of "ambient air." Citing to a 1980 EPA letter, the Commenter asserts "that the only exemption from ambient air is an area within a facility boundary and only if it is fenced or otherwise physically precludes access to the general public." The Commenter states that the receptors Utah is excluding in the Hunter and Huntington modeling are on public land and are in the ambient air, and therefore the 1‐hour average SO2 NAAQS must apply at those ambient air receptors.
	The Commenter then goes on to compare the third-party modeling results to the UDAQ's modeling and states that the third-party modeling scenarios showed "that the maximum actual plantwide SO2 emissions emitted over an hour at each of the plants could cause exceedances of the 1‐hour SO2 (based on the 99[th] percentile value or 4th‐highest for a given year) at various locations near the two power plants." The Commenter contends that UDAQ's excluded receptors in its modeling demonstration "very likely excluded areas that would have been modeled to violate the 1‐Hour SO2 NAAQS" and that emails obtained from UDAQ "strongly imply that the exclusion of receptors allowed UDAQ to demonstrate attainment at the Hunter and Huntington sites." The Commenter asserts that the EPA has "approved" UDAQ's modeling protocol including its excluded receptors from its attainment modeling for the Hunter and Huntington units.

Response 4: As provided in previous responses, the EPA disagrees with the Commenter that the EPA must disapprove the modeling component of Utah's SO2 infrastructure SIP because UDAQ modeling does not ensure compliance with the SO2 NAAQS. In acting to approve or disapprove an infrastructure SIP, the EPA is not required to make findings regarding current air quality status of areas within the state, such area's projected future air quality status, or whether modeling methodologies for future attainment demonstrations are sufficient to meet a NAAQS in the area. The EPA finds the Commenter's discussion of UDAQ's modeling methodology (regardless of whether the modeling is intended to inform SO2 monitor placement or to demonstrate 1-hour SO2 NAAQS attainment) to be irrelevant to the analysis of Utah's infrastructure SIP. Rather, for the infrastructure SIP requirements of section 110(a)(2)(K), EPA considers  whether the SIP provides Utah officials with the legal authority to (1) conduct air quality modeling to predict the effect on ambient air quality of any emissions of any air pollutant for which a NAAQS has been promulgated, and (2) provide such modeling data to the EPA Administrator upon request. As explained previously, that determination is separate from the NAAQS designations process for which the State prepared its modeling protocols.
      Furthermore, to the extent the Commenter believes certain UDAQ emails "indicate that EPA has `approved' UDAQ's modeling protocol," and that any such approval should have been a final agency action subject beforehand to public comment, the Commenter is mistaken. Although the EPA may informally advise states about whether it believes that their modeling protocols conform with applicable EPA guidance, that advice does not constitute final agency action, and is not subject to notice and comment rulemaking.

Comment 5: UDAQ Improperly Determined Areas Not to Be Feasible for Ambient Air Monitoring Around the Hunter and Huntington Plants, and Thus EPA Must Disapprove the SO2 Monitoring Element of Utah's Infrastructure SIP as Inadequate to Protect the 1‐Hour SO2 NAAQS.
      The Commenter states that the EPA must disapprove the SO2 monitoring element of Utah's infrastructure SIP because it is inadequate to protect the 1-hour SO2 NAAQS. The Commenter explains that UDAQ improperly determined that areas around the Hunter and Huntington Plants are not feasible for ambient air monitor placement and excluded monitor locations in areas where violations of the 1‐Hour SO2 NAAQS are likely occurring. The Commenter contends that UDAQ's approach in determining locations that are not feasible for location of air monitors "is entirely inconsistent with EPA's historic interpretation of ambient air" and is not protective of public health...
	The Commenter contends that the areas excluded from UDAQ's Hunter and Huntington modeling is unjustified because if the EPA were to allow for certain terrain exclusions from SO2 modeling attainment designation analyses, then sources located within complex terrain and/or more remote areas could avoid having to reduce SO2 emissions to comply with the 1‐hour average SO2 NAAQS. The Commenter cites to the EPA's Guideline on Air Quality Models which notes that "[o]ften the highest concentrations are predicted to occur under very stable conditions, when the plume is near, or impinges on, the terrain." Section <IP_ADDRESS>.b. of EPA's Guideline on Air Quality Models in 40 C.F.R. Part 51, Appendix W.
      The Commenter states that the primary objective of the location of ambient air monitoring for SO2 NAAQS designation is to determine peak 1‐hour average SO2 concentrations in the area around a source. According to the Commenter, the EPA's SO2 Monitoring TAD suggests conducting air modeling to aid in monitoring site identification. The Commenter states that based on the EPA's SO2 Monitoring TAD, the modeling the Commenter conducted for the Hunter and Huntington Power Plants are the types of analyses the EPA would use to inform the proper siting of ambient air monitors at areas of likely maximum SO2 concentrations near such facilities. The Commenter contends that UDAQ excluded many of the locations that, according to third-party modeling, could have been in violation of the 1‐hour SO2 NAAQS due to actual emissions from the Hunter and Huntington Power Plants. The Commenter further contends that the UDAQ excluded these areas from its Hunter and Huntington modeling for being "inaccessible," but that the areas actually are accessible via various roads, off‐highway vehicle trails, and hiking trails. The Commenter also notes the availability of sulfur dioxide air monitors designed for transportation and operation in remote locations. Thus, the Commenter contends that the areas UDAQ excluded from monitoring must be considered as feasible locations for ambient monitors.

Response 5: The EPA disagrees with the Commenter that it must disapprove the SO2 monitoring element of Utah's infrastructure SIP as inadequate to protect the 2010 SO2 NAAQS due to ambient air monitoring around the Hunter and Huntington plants. First, the EPA did not propose action on element 110(a)(2)(B) for the 2010 SO2 NAAQS. We only proposed to act on this element for the 2008 ozone NAAQS. The Commenter does not identify any way in which their concerns are relevant to ambient air monitoring for the 2008 ozone NAAQS. The EPA will act on Utah's submission for element 110(a)(2)(B) for the 2010 SO2 NAAQS in a separate action.

Comment 6: Utah's SO2 Infrastructure SIP Lacks Necessary Enforceable Emission Limitations in Violation of CAA Section 110(a)(2)(A).
      The Commenter contends that Utah's infrastructure SIP does not meet basic structural requirements of section 110(a)(2)(A) for the 2010 1-hour SO2 NAAQS because rules containing emission limits and control measures for emitting activities were not analyzed for the 2010 SO2 standard and that establishing such limits and measures through SIP‐approved permits is insufficient. The Commenter points to air dispersion modeling  of the Hunter and Huntington plants it had conducted, and contends that emission limitations relied on in the State's infrastructure SIP do not prevent exceedances and therefore Utah's infrastructure SIP must be disapproved under sections 110(a)(1) and (a)(2). The Commenter contends that the State's infrastructure SIP must include enforceable emission limitations under section 110(a)(2)(A) as section 110(a)(2)(E) is a separate component requiring adequate personnel, funding, and authority to carry out state implementation plans.

Response 6:  The EPA disagrees with the Commenter that the EPA must disapprove Utah's SO2 infrastructure SIP for the reasons provided by the Commenter, including the Commenter's modeling results and insufficient SO2 emission limits. The EPA is not, in this action, making a determination regarding Utah's current air quality status or whether its control strategy is sufficient to attain and maintain the NAAQS. Therefore, the EPA is not making any judgment on whether the Commenter's submitted modeling demonstrates the NAAQS exceedances that the Commenter claims.
      The EPA disagrees with the Commenter that infrastructure SIP submissions are required to contain emission limits assuring in-state attainment of the NAAQS. However, the EPA does recognize that in the past, states have, in their discretion, used infrastructure SIP submittals as a "vehicle" for incorporating regulatory revisions or source-specific emission limits into the state's plan. See 78 FR 73442 (Dec. 6, 2013) (approving regulations Maryland submitted for incorporation into the SIP along with the 2008 ozone infrastructure SIP to address ethics requirements for State Boards in sections 128 and 110(a)(2)(E)(ii)). While these SIP revisions are intended to help the state meet the requirements of section 110(a)(2), these "ride-along" SIP revisions are not intended to signify that all infrastructure SIP submittals must, in order to be approved by the EPA, have similar regulatory revisions or source specific emission limits. Rather, the regulatory provisions and source specific emission limits the state relies on when showing compliance with section 110(a)(2) have, in many cases, likely already been incorporated into the state's SIP prior to each new infrastructure SIP submission; in some cases this was done for entirely separate CAA requirements, such as for previous NAAQS.
	As stated in previous responses, the EPA's longstanding position regarding infrastructure SIPs is that they are general planning SIPs to ensure that the state has adequate resources and authority to implement a NAAQS in general throughout the state. Infrastructure SIPs do not determine whether each individual area of the state is meeting the applicable NAAQS, as this question is addressed through the NAAQS designations process. As previously mentioned, the EPA has interpreted this to mean, with regard to the requirement for emission limitations, that states may rely on measures already in place to address the pollutant at issue or any new control measures that the state may choose to submit.

Comment 7: EPA Must Disapprove Utah's SO2 I‐SIP Certification as it Lacks Enforceable Emission Limitations That Ensure Attainment and Maintenance of the NAAQS.
      The Commenter asserts that the EPA must disapprove Utah's SO2 infrastructure SIP certification because it lacks enforceable emission limitations that ensure attainment and maintenance of the NAAQS. In support, the Commenter cites: CAA section 110(a)(2)(A); 79 FR 18648 (noting that infrastructure SIPs must contain enforceable emission limit to aid in attaining and/or maintaining NAAQS); and CAA section 110(a)(2)(H) (providing for revisions of SIPs when the Administrator finds that a plan is "substantially inadequate to attain the [NAAQS] which it implements"). The Commenter relies on Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto Ins. Co., 463 U.S. 29, 43 (1983) and NRDC v. EPA, 571 F.3d 1245, 1254 (D.C. Cir. 2009) to contend that the EPA must consider the Commenter's modeling data on Utah EGUs including the Hunter and Huntington Plants as additional information provided during a rulemaking process under administrative law principles.

Response 7: The EPA disagrees with the Commenter's statement that EPA must disapprove Utah's infrastructure SIP. Furthermore, the EPA finds that the Commenter's submitted modeling is not relevant to the approvability of Utah's proposed infrastructure SIP for the 2010 SO2 NAAQS for the reasons previously explained. The purpose for which the Commenter submitted the modeling -- namely, to assert that current air quality in the areas in which those sources are located does not meet the NAAQS -- is not relevant to the EPA's action on this infrastructure SIP, and consequently the EPA is not required to consider the modeling in evaluating the approvability of the infrastructure SIP. Infrastructure SIPs are not required to contain emission limitations informed by air dispersion modeling in order to meet the requirements of section 110(a)(2)(A). As previously discussed, in acting to approve or disapprove an infrastructure SIP, the EPA is not required to make findings regarding current air quality status of areas within the state, regarding such areas' projected future air quality status, or regarding whether existing emissions limits in such areas are sufficient to meet a NAAQS.  The EPA has made no judgment regarding whether the Commenter's submitted modeling is sufficient to show violations of the NAAQS.

Comment 8: The Plain Language and Legislative History of the Clean Air Act Require that Infrastructure SIPs Contain Enforceable Emission Limits that Ensure Attainment and Maintenance of the NAAQS.
      The Commenter cites two excerpts from the legislative history of the 1970 CAA claiming they support an interpretation that SIPs under CAA section 110 must include emissions limitations sufficient to show maintenance of the NAAQS in all areas of the state. The Commenter also contends that the legislative history of the CAA supports the interpretation that infrastructure SIPs under section 110(a)(2) must include enforceable emission limitations, citing the Senate Committee Report and the subsequent Senate Conference Report accompanying the 1970 CAA.

Response 8: The EPA disagrees with the Commenter's statement that the legislative history provides support for the interpretation of CAA section 110 in the manner that the Commenter suggests. As provided in response 1, the CAA, as enacted in 1970, including its legislative history, cannot be interpreted in isolation from the later amendments that refined the CAA framework and deleted relevant language from section 110 concerning demonstration of attainment. See also 79 FR at 17046 (responding to comments on Virginia's ozone infrastructure SIP). The two excerpts of legislative history the Commenter cites merely provide that states should include enforceable emission limits in their SIPs, and they do not mention or otherwise address whether states are required to include maintenance plans for all areas of the state as part of the infrastructure SIP. As provided in response to another comment in this rulemaking, the proposed rule explains why the Utah's SIP includes enforceable emissions limitations for SO2.

Comment 9: EPA Regulations Implementing the Clean Air Act Require that Infrastructure SIPs Contain Enforceable Emission Limits that Ensure Attainment and Maintenance of the NAAQS.
      The Commenter cites to 40 CFR 51.112(a), which provides that ``[e]ach plan must demonstrate that the measures, rules, and regulations contained in it are adequate to provide for the timely attainment and maintenance of the [NAAQS].'' The Commenter asserts that this regulation requires infrastructure SIPs to include emissions limits necessary to ensure attainment and maintenance of the NAAQS. The Commenter states that the provisions of 40 CFR 51.112 are not limited to nonattainment SIPs and instead applies to infrastructure SIPs which are required to attain and maintain the NAAQS in areas not designated nonattainment. The Commenter relies on a statement in the preamble to the final rule promulgating 40 CFR 51.112 which stated that ``[i]t is beyond the scope of th[is] rulemaking to address the provisions of Part D of the Act . . .'' 51 FR 40656, 40656 (Nov. 7, 1986).

Response 9: The EPA disagrees that 40 CFR 51.112 requires infrastructure SIPs to contain enforceable emission limits adequate to ensure attainment and maintenance of the NAAQS. As an initial matter, the EPA notes that this regulatory provision was initially promulgated and later restructured and consolidated prior to the CAA Amendments of 1990, in which Congress removed all references to ``attainment'' in section 110(a)(2)(A). And, it is clear on its face that 40 CFR 51.112 applies to plans specifically designed to attain the NAAQS. The EPA interprets these provisions to apply when states are developing ``control strategy'' SIPs such as the detailed attainment and maintenance plans required under other provisions of the CAA, as amended in 1977 and again in 1990, such as sections 175A, 181 - 182, and 191 - 192. The Commenter suggests that these provisions must apply to section 110 SIPs because in the preamble to the EPA's action ``restructuring and consolidating'' provisions in part 51, the EPA stated that the new attainment demonstration provisions in the 1977 Amendments to the CAA were ``beyond the scope'' of the rulemaking. It is important to note, however, that the EPA's action in 1986 was not to establish new substantive planning requirements, but rather was meant merely to consolidate and restructure provisions that had previously been promulgated. The EPA noted that it had already issued guidance addressing the new ``Part D'' attainment planning obligations. Also, as to maintenance regulations, the EPA expressly stated that it was not making any revisions other than to re-number those provisions (51 FR 40657(Nov. 7, 1986)).
      Although the EPA was explicit that it was not establishing requirements interpreting the provisions of new ``Part D'' of the CAA, it is clear that the regulations being restructured and consolidated were intended to address control strategy plans. In the preamble, the EPA clearly stated that 40 CFR 51.112 was replacing 40 CFR 51.13 (``Control strategy: SOx and PM (portion)''), 51.14 (``Control strategy: CO, HC, Ox and NO2 (portion)''), 51.80 (``Demonstration of attainment: Pb (portion)''), and 51.82 (``Air quality data (portion)''). 51 FR 40657, 40660. Thus, the present-day 40 CFR 51.112 contains consolidated provisions that are focused on control strategy SIPs, and the infrastructure SIP is not such a plan.

Comment 10: EPA Interpretations of Section 110 in Other Rulemakings Require that Infrastructure SIPs Contain Enforceable Emission Limits that Ensure Attainment and Maintenance of the NAAQS.
      The Commenter also references a prior EPA SIP disapproval to claim that it shows that the EPA relied on section 110(a)(2)(A) and 40 CFR 51.112 to reject the SIP. The Commenter points to a 2006 partial approval and partial disapproval of revisions to Missouri's existing control strategy plans addressing the SO2 NAAQS. The Commenter claims the EPA cited section 110(a)(2)(A) for disapproving a revision to the state plan on the basis that the State failed to demonstrate the SIP was sufficient to ensure maintenance of the SO2 NAAQS after revision of an emission limit. Similarly, the Commenter claims the EPA cited to 40 CFR 51.112 as requiring that a plan demonstrates the rules in a SIP are adequate to attain the NAAQS. The Commenter claims the revisions to Missouri's control strategy SIP for SO2 were rejected by the EPA because the revised control strategy limits were also in Missouri's infrastructure SIP, and thus the weakened limits would have impacted the infrastructure SIP's ability to aid in attaining and maintaining the NAAQS.

Response 10: The EPA does not agree that the prior Missouri rulemaking action referenced by the Commenter establishes how the EPA reviews infrastructure SIPs. It is clear from the final Missouri rule that the EPA was not reviewing initial infrastructure SIP submissions under section 110 of the CAA, but rather reviewing revisions that would make an already approved SIP designed to demonstrate attainment of the NAAQS less stringent. The EPA's partial approval and partial disapproval of revisions to restrictions on emissions of sulfur compounds for the Missouri SIP in 71 FR 12623 addressed a control strategy SIP and not an infrastructure SIP. Nothing in that action addresses the necessary content of the initial infrastructure SIP for a new or revised NAAQS.

Comment 11: Supreme and Appellate Court Opinions Hold that Infrastructure SIPs Must Contain Enforceable Emission Limits that Ensure Attainment and Maintenance of the NAAQS.
      The Commenter discusses several cases applying the CAA which the Commenter claims support its contention that courts have been clear that section 110(a)(2)(A) requires enforceable emissions limits in infrastructure SIPs to prevent exceedances of the NAAQS. The Commenter first cites to language in Train v. NRDC, 421 U.S. 60, 78 (1975), addressing the requirement for "emission limitations" and stating that emission limitations "are the specific rules to which operators of pollution sources are subject, and which, if enforced, should result in ambient air which meets the national standards." The Commenter also cites to Pennsylvania Dept. of Envtl. Resources v. EPA, 932 F.2d 269, 272 (3d Cir. 1991) for the proposition that the CAA directs the EPA to withhold approval of a SIP where it does not ensure maintenance of the NAAQS, and to Mision Industrial, Inc. v. EPA, 547 F.2d 123, 129 (1st Cir. 1976), which quotes section 110(a)(2)(B) of the CAA of 1970. The Commenter contends that the 1990 Amendments do not alter how courts have interpreted the requirements of section 110, quoting Alaska Dept. of Envtl. Conservation v. EPA, 540 U.S. 461, 470 (2004) which in turn quoted section 110(a)(2)(A) of the CAA and also stated that "SIPs must include certain measures Congress specified" to ensure attainment of the NAAQS. The Commenter also quotes several additional opinions in this vein. Mont. Sulphur & Chem. Co. v. EPA, 666 F.3d 1174, 1180 (9th Cir. 2012) ("The Clean Air Act directs states to develop implementation plans-SIPs-that `assure' attainment and maintenance of [NAAQS] through enforceable emissions limitations"). The Commenter cites to Hall v. EPA 273 F.3d 1146, 1157-61 (9th Cir. 2001) to conclude that "[j]ust as a plan revision must not interfere with attainment of the NAAQS under section 110(l), an infrastructure SIP must, in the first place, include enforceable limits sufficient to ensure attainment and maintenance of the NAAQS under 110(a)(2)(A)." Finally, the Commenter cites Mich. Dept. of Envtl. Quality v. Browner, 230 F.3d 181 (6th Cir. 2000) for the proposition that "EPA's deference to a state is conditioned on the state's submission of a plan `which satisfies the standards of § 110(a)(2)' and which includes emission limitations that result in compliance with the NAAQS."

Response 11: The EPA disagrees with the Commenter's contention that these cases support the proposition that section 110(a)(2)(A) clearly requires infrastructure SIPs to include detailed plans providing for attainment and maintenance of the NAAQS in all areas of the state, nor do they shed light on how section 110(a)(2)(A) may reasonably be interpreted. With the exception of Train v. NRDC, none of the cases the Commenter cites concerned the interpretation of CAA section 110(a)(2)(A) (or section 110(a)(2)(B) of the pre-1990 Act). Rather, the courts reference section 110(a)(2)(A) (or section 110(a)(2)(B) of the pre-1990 CAA) in the background sections of decisions in the context of a challenge to an EPA action on revisions to a SIP that was required and approved or disapproved as meeting other provisions of the CAA or in the context of an enforcement action. In Train, 421 U.S. 60, the Court was addressing a state revision to an attainment plan submission made pursuant to section 110 of the CAA, the sole statutory provision at that time regulating such submissions. The issue in that case concerned whether changes to requirements that would occur before attainment was required were variances that should be addressed pursuant to the provision governing SIP revisions or were "postponements" that must be addressed under section 110(f) of the CAA of 1970, which contained prescriptive criteria. The Court concluded that the EPA reasonably interpreted section 110(f) not to restrict a state's choice of the mix of control measures needed to attain the NAAQS and that revisions to SIPs that would not impact attainment of the NAAQS by the attainment date were not subject to the limits of section 110(f). Thus the issue was not whether a section 110 SIP needs to provide for attainment or whether emissions limits to ensure attainment are needed as part of the SIP; rather the issue was which statutory provision governed when the state wanted to revise the emission limits in its SIP if such a revision would not impact attainment or maintenance of the NAAQS. To the extent the holding in the case has any bearing on how section 110(a)(2)(A) might be interpreted, it is important to realize that in 1975, when the opinion was issued, section 110(a)(2)(B) (the predecessor to section 110(a)(2)(A)) expressly referenced the requirement to attain the NAAQS, a reference that was removed in 1990.
      The decision in Pennsylvania Dept. of Envtl. Resources was also decided based on the pre-1990 provision of the CAA. At issue was whether the EPA properly rejected a revision to an approved plan where the inventories relied on by the state for the updated submission had gaps. The Court quoted section 110(a)(2)(B) of the pre-1990 CAA in support of the EPA's disapproval, but did not provide any interpretation of that provision. Yet, even if the Court had interpreted that provision, the EPA notes that it was modified by Congress in 1990; thus, this decision has little bearing on the issue here.
      At issue in Mision Industrial, 547 F.2d 123, was the definition of "emissions limitation," not whether section 110 requires the state to demonstrate how all areas of the state will attain and maintain the NAAQS as part of their infrastructure SIPs. The language from the opinion the Commenter quotes does not interpret but merely describes section 110(a)(2)(A). The Commenter does not raise any concerns about whether the measures Utah relied on in its infrastructure SIPs are "emissions limitations" and the decision in this case has no bearing here. In Mont. Sulphur & Chem. Co., 666 F.3d 1174, the Court was not reviewing an infrastructure SIP, but rather the EPA's disapproval of a SIP and promulgation of a federal implementation plan (FIP) after a long history of the state failing to submit an adequate SIP in response to the EPA's finding under section 110(k)(5) that the previously approved SIP was substantially inadequate to attain or maintain the NAAQS. The Court cited generally to sections 107 and 110(a)(2)(A) of the CAA for the proposition that SIPs should assure attainment and maintenance of NAAQS through emission limitations, but this language was not part of the Court's holding in the case, which focused instead on whether the EPA's finding of SIP inadequacy, disapproval of the state's required responsive attainment demonstration under section 110(k)(5), and adoption of a remedial FIP under section 110(c) were lawful. The Commenter suggests that Alaska Dept. of Envtl. Conservation, 540 U.S. 461, stands for the proposition that the 1990 CAA Amendments do not alter how courts interpret section 110. This claim is inaccurate. Rather, the Court quoted section 110(a)(2)(A), which, as noted previously, differs from the pre-1990 version of that provision and the Court made no mention of the changed language. Furthermore, the Commenter also quotes the Court's statement that "SIPs must include certain measures Congress specified," but that statement specifically referenced the requirement in section 110(a)(2)(C), which requires an enforcement program and a program to regulate the modification and construction of new sources. Notably, at issue in that case was the state's "new source" permitting program, not its infrastructure SIP.
      Two of the other cases the Commenter cites, Mich. Dept. of Envtl. Quality, 230 F.3d 181, and Hall v. EPA, 273 F.3d 1146, interpret CAA section 110(1), the provision governing "revisions" to plans, and not the initial plan submission requirement under section 110(a)(2) for a new or revised NAAQS, such as the infrastructure SIP at issue in this instance. In those cases, the courts cited to section 110(a)(2)(A) solely for the purpose of providing a brief background of the CAA.

Comment 12: The Emission Limitations Relied Upon by the State in Its I‐SIP are Insufficient To Attain and Maintain the NAAQS, as Demonstrated by Air Dispersion Modeling of the Hunter and Huntington Power Plants  --  Two Sources Currently Permitted to Cause Exceedances of the NAAQS.
      Citing section 110(a)(2)(A) of the CAA, the Commenter contends that the EPA may not approve Utah's proposed 2010 SO2 infrastructure SIP because emission limitations fail to prevent exceedances of the NAAQS and, therefore, do not provide for implementation, maintenance, and enforcement of the 2010 SO2 NAAQS. The Commenter states coal-fired electric generating units (EGUs) are large contributors to SO2 emissions but contends Utah did not demonstrate that emissions allowed by the proposed infrastructure SIP from such large sources of SO2 will ensure compliance with the 2010 1-hour SO2 NAAQS. The Commenter then refers to air dispersion modeling it conducted for two EGUs in Utah, including the Hunter and Huntington Plants. The Commenter asserts the results of the air dispersion modeling it conducted employing the EPA's AERMOD program for modeling used the plants' "allowable emissions and/or maximum actual hourly emissions and demonstrated that the levels of SO2 emissions allowed to be emitted under current regulations and permits allow for exceedances of the 2010 one‐hour SO2 NAAQS." The Commenter asserts that the infrastructure SIP fails to include adequate enforceable emission limitations for sources of SO2 sufficient to ensure attainment and maintenance of the 2010 SO2 NAAQS. The Commenter asserts that the Hunter and Huntington plant permits have exemptions for periods of SSM and maintenance/planned outages during which no specific emission limit applies. The Commenter claims that the limits in Utah's infrastructure SIP are insufficiently protective of the NAAQS and that actual SO2 emissions while operating pursuant to the allowable SO2 emission limitations can be expected to cause violations of the SO2 NAAQS.
      The Commenter claims that Utah's infrastructure SIP is inadequate to attain and maintain the NAAQS which it implements because emission limits under the laws and regulations cited to in the SO2 infrastructure certification allow for exceedances of the NAAQS. The Commenter contends that, where infrastructure SIPs are due within the same timeframe as area designations, Congress intends states to set forth enforceable emission limitations and other substantive measures in their infrastructure SIPs. The Commenter asserts that the EPA "must set forth a Federal Implementation Plan ("FIP") which incorporates necessary and appropriate source‐specific enforceable emission limitations (preferably informed by modeling) on the Hunter Power Plant and the Huntington Power Plant, as well as any other major sources of SO2 pollution in the State which are not presently located in nonattainment areas and have modeled exceedances of the NAAQS," and states that emission limits must apply at all times, including during periods of start‐up, shutdown, and malfunction.

Response 12: For reasons explained in response 6, the EPA disagrees with the Commenter that the EPA must disapprove Utah's SO2 infrastructure SIP regarding modeling results and insufficient SO2 emission limits. As discussed previously, EPA reasonably interprets section 110(a)(2)(A) of the CAA to require states to submit infrastructure SIPs that reflect the first step in their planning for attainment and maintenance of a new or revised NAAQS. These SIP revisions should contain a demonstration that the state has the available tools and authority to develop and implement plans to attain and maintain the NAAQS and show that the SIP has enforceable control measures.
      As for the AERMOD air dispersion modeling conducted by the Commenter for the Hunter and Huntington facilities, as stated in previous responses, the EPA does not find the modeling information relevant at this time for review of an infrastructure SIP. While the EPA has extensively discussed the use of modeling for attainment demonstration purposes and for designations, the EPA has affirmatively stated such modeling was not needed to demonstrate attainment for the SO2 infrastructure SIPs under the 2010 SO2 NAAQS. See April 12, 2012 letters to states regarding SO2 implementation and Implementation of the 2010 Primary 1-Hour SO2 NAAQS, Draft White Paper for Discussion, May 2012, available at http://www.epa.gov/airqualitysulfurdioxide/implement.html.
	The EPA has promulgated a Data Requirements Rule which requires state air agencies to characterize air quality around SO2 sources through ambient air monitoring, air quality modeling, or by providing a federally enforceable emission limitation which limits source emissions to less than 2,000 tons per year of SO2. 80 FR 51052 (Aug. 21, 2015). The rule includes a lengthy discussion of how the EPA anticipates addressing modeling that informs determinations of states' air quality status under the 2010 SO2 NAAQS.
      Finally, the EPA disagrees with the Commenter's statements that EPA must disapprove Utah's infrastructure SIP submission because it does not establish specific enforceable SO2 emission limits, either for coal-fired EGUs or other large SO2 sources, in order to demonstrate attainment and maintenance with the NAAQS at this time.

Comment 13: EPA May Not Approve the SO2 I‐SIP Certification As it Fails to Include Enforceable SO2 Emission Limitations With a One‐Hour Averaging Period that Applies at All Times.
The Commenter cites to CAA section 302(k) which requires emission limits to apply on a continuous basis. The commenter claims the EPA has stated that 1-hour averaging times are necessary for the 2010 SO2 NAAQS citing  EPA's April 23, 2014 Guidance for 1-Hour S02 Nonattainment Area SIP Submissions, a February 3, 2011, EPA Region 7 letter to the Kansas Department of Health and Environment regarding the need for 1- hour SO2 emission limits in a PSD permit, an EPA Environmental Appeals Board (EAB) decision rejecting use of a 3-hour averaging time for an SO2 limit in a PSD permit, and the EPA's disapproval of a Missouri SIP which relied on annual averaging for SO2 emission rates. Thus, the Commenter contends the EPA must disapprove Utah's infrastructure SIP which the Commenter claims fails to require emission limits with adequate averaging times.

Response 13: The EPA disagrees that the EPA must disapprove the proposed Utah infrastructure SIP because the SIP does not contain enforceable SO2 emission limitations with 1-hour averaging periods that apply at all times, as this issue is not appropriate for resolution at this stage. The comment does not assert that the SO2 emission limits in the Utah's SIP are not enforceable, instead the comment focuses on the lack of 1-hour averaging times. We do not believe, as suggested by the Commenter, that the emission limits are not "continuous" within the meaning of section 302(k). As the EPA has noted previously, the purpose of the section 110(a)(2) SIP is to ensure that the State has the necessary structural components to implement programs for attainment and maintenance of the NAAQS.
      While the EPA does agree that the averaging time is a critical consideration for purposes of substantive SIP revisions, such as attainment demonstrations, the averaging time of existing rules in the SIP is not relevant for determining that the State has met the applicable requirements of section 110(a)(2) with respect to the infrastructure elements addressed in the present SIP action. Therefore, because the EPA finds Utah's SO2 infrastructure SIP approvable without SO2 emission limitations showing in-state attainment of the NAAQS, EPA finds the issue of appropriate averaging periods for such future limitations not relevant at this time. The Commenter has cited prior EPA discussion on emission limitations required in PSD permits (an EAB decision and EPA's letter to Kansas' permitting authority) pursuant to part C of the CAA, which is neither relevant nor applicable to the present SIP action. In addition, as previously discussed, the EPA disapproval of the 2006 Missouri SIP was a disapproval relating to a control strategy SIP required pursuant to part D attainment planning, and is likewise not relevant to the analysis of infrastructure SIP requirements.

Comment 14: Appropriate Enforceable Emission Limitations in the Infrastructure SIP are Necessary to Avoid Additional Nonattainment Designations.
      The Commenter states that enforceable emission limits in SIPs or permits are necessary to avoid nonattainment designations in areas where modeling or monitoring shows SO2 levels that exceed the 1-hour SO2 NAAQS and cites to a February 6, 2013 EPA document, Next Steps for Area Designations and Implementation of the Sulfur Dioxide National Ambient Air Quality Standard, which the Commenter contends discusses how states could avoid future nonattainment designations. The Commenter also quotes the final SO2 NAAQS Rule which states areas will "be designated `nonattainment' if either available monitoring data or modeling shows that a violation exists, or `attainment' if both available monitoring data and modeling indicate the area is attaining." The Commenter asserts that the EPA must ensure enforceable emission limits in the Utah infrastructure SIP to prevent "exceedances" of the SO2 NAAQS. The Commenter claims the modeling it conducted for the Hunter and Huntington power plants indicates the areas around these plants may be warranted to be designated nonattainment with the 2010 SO2 NAAQS without such enforceable SO2 limits. In summary, the Commenter asserts the EPA must disapprove the Utah infrastructure SIP and ensure emission limits will not allow large sources of SO2 to cause exceedances of the 2010 SO2 NAAQS.

Response 14: While the EPA appreciates the Commenter's concern with avoiding nonattainment designations in Utah for the 2010 SO2 NAAQS, the EPA disagrees with the Commenter's statement that an infrastructure SIP must prevent such future nonattainment designations. Congress designed the CAA such that states have the primary responsibility for achieving and maintaining the NAAQS within their geographic area by submitting SIPs which will specify the details of how the state will meet the NAAQS. Pursuant to section 107(d), the states make initial recommendations of designations for areas within each state and the EPA then promulgates the designations after considering the state's submission and other information. The EPA promulgated initial designations for the 2010 SO2 NAAQS in August 2013 for areas in which monitoring at that time showed violations of the NAAQS, but has not yet issued designations for other areas. EPA will complete the required designations pursuant to the schedule contained in the recently entered Consent Decree. EPA will designate additional areas for the 2010 SO2 NAAQS in accordance with CAA section 107 and existing EPA policy and guidance. Utah may, on its own accord, decide to impose additional SO2 emission limitations to avoid future designations of nonattainment. If additional Utah areas are designated nonattainment, Utah will then have the initial opportunity to develop additional emissions limitations needed to attain the NAAQS, and the EPA would be charged with reviewing whether the SIP is adequate to demonstrate attainment. See Commonwealth of Virginia, et al., v. EPA, 108 F.3d 1397, 1410 (D.C. Cir. 1997) (citing Natural Resources Defense Council, Inc. v. Browner, 57 F.3d 1122, 1123 (D.C. Cir.1995) (discussing that states have primary responsibility for determining an emission reductions program for its areas subject to EPA approval dependent upon whether the SIP as a whole meets applicable requirements of the CAA). However, such considerations are not required of Utah at the infrastructure SIP stage of NAAQS implementation, as the Commenter's statements concern the separate designations process under section 107. The EPA disagrees that the infrastructure SIP must be disapproved for not including enforceable emissions limitations to prevent future 1-hour SO2 nonattainment designations.

Comment 15. Utah Has Failed to Even Attempt to Satisfy Its Good Neighbor Obligations Under CAA Section 110(a)(2)(D)(i).
      The Commenter asserts that the EPA must disapprove Utah's infrastructure SIP because it does not include any information relating to the State's "good neighbor" obligation under 110(a)(2)(D)(i)(I). The Commenter states that Utah's SO2 NAAQS infrastructure SIP does not address or evaluate cross-state impacts due to sources within the state and contends that UDAQ incorrectly interprets the EPA's November 2012 memo addressing the vacatur of the 2011 Cross-State Air Pollution Rule (CSAPR). The Commenter cites to  CAA  section 110(a)(1) claiming that where infrastructure SIPs are due within the same timeframe as area designations, states are obligated to address transport in downwind states through their Infrastructure SIP submissions. The Commenter contends that "Utah's reliance on a 2012 EPA memorandum in which EPA stated that it did `not intend to make findings that states failed to submit SIPs to comply with section 110(a)(2)(D)(i)(I)' is improper, as that guidance directly contradicts the language of the Clean Air Act." The Commenter asserts that the Supreme Court has disapproved the claim that states cannot address section 110(a)(2)(D)(i) until the EPA resolves issues related to CSAPR and that there is no "prerequisite" action required before states fulfill section 110(a)(2)(D)(i) requirements. The Commenter contends that the EPA must disapprove Utah's infrastructure SIP because the State did not include a submittal with respect to section 110(A)(2)(D)(i)(I) and must "implement a FIP containing source-specific emission limitations and other measures to ensure that pollution from Utah is not preventing other states from attaining or maintaining the NAAQS." The Commenter claims that Utah has passed the June 2013 deadline to submit provisions to meet Good Neighbor obligations and urges the EPA to take "immediate action" to disapprove the State's SO2 infrastructure SIP.

Response 15: EPA did not propose taking any final action with respect to the requirements of section 110(a)(2)(D)(i)(I), and is not taking any such action today. We agree with the Commenter that Utah's June 2, 2013 infrastructure SIP submittal for the 2010 SO2 NAAQS did not address the requirements of section 110(a)(2)(D)(i)(I). In the NPR, the EPA did not propose to take any action with respect to Utah's obligations pursuant to section 110(a)(2)(D)(i)(I) for the June 2, 2013 infrastructure SIP submittal and is not, in this rulemaking action, taking any final action on the 110(a)(2)(D)(i)(I) obligations. Because Utah did not include a submission in its June 2, 2013 SIP submittal to address the requirements of section 110(a)(2)(D)(i)(I), the EPA is not required to have proposed, or actually taken, final action under CAA section 110(k) approving or disapproving the SIP for this element. In this case, there has been no substantive submission for the EPA to evaluate under section 110(k). The EPA interprets its authority under section 110(k)(3) of the CAA as affording the EPA the discretion to approve, or conditionally approve, individual elements of Utah's infrastructure SIP submissions, separate and apart from any action with respect to the requirements of section 110(a)(2)(D)(i)(I) of the CAA. Discrete infrastructure SIP requirements in section 110(a)(2), such as the requirements of 110(a)(2)(D)(i)(I), are severable from the other infrastructure elements, and the EPA interprets section 110(k)(3) as allowing the Agency to act on individual severable measures in a plan submission. Further, because Utah's infrastructure SIP submittal did not address the good neighbor provision, we disagree with the Commenter's statement that the EPA currently has a mandatory obligation to issue a FIP addressing section 110(a)(2)(D)(i)(I). Under section 110(c)(1), the EPA's authority to issue a FIP arises from limited circumstances -- either the EPA's disapproval of a required SIP submittal or the EPA's affirmative finding that a state has failed to make a required submittal.  Neither of these prerequisites has activated the EPA's FIP authority with respect to Utah's section 110(a)(2)(D)(i)(I) obligations for the 2010 SO2 NAAQS.
      The EPA acknowledges the Commenter's concern for the interstate transport of air pollutants and agrees in general that sections 110(a)(1) and 110(a)(2) of the CAA require states to submit, within three years of promulgation of a new or revised NAAQS, a plan containing adequate provisions to address interstate air pollution under section 110(a)(2)(D)(i)(I). However, in this action, consistent with the proposal, the EPA is only acting on portions of Utah's infrastructure SIP submissions for the 2010 SO2 NAAQS. The EPA intends to address Utah's obligations regarding interstate transport for the 2010 SO2 NAAQS in another rulemaking.

Comments from Western Resource Advocates
Document No. EPA-R08-OAR-2013-0561-0022

Comment 16: The Utah Infrastructure SIP Does Not Meet the Requirements of 110(a)(2)(A) and 110(a)(2)(C) because Excess Emissions Are Exempted from Permit Limitations.
      Western Resource Advocates (the Commenter) contends that Utah has director discretion and startup, shutdown, and malfunction (SSM) provisions in its state rules that are "contrary to Clean Air Act and existing EPA guidance." The Commenter claims that the EPA confirmed in the proposed rule to this rulemaking that "Utah law and practice runs contrary to the [CAA]" and therefore cannot ensure emissions will not cause or contribute to a violation of the NAAQS through the State's air permit program. Additionally, the Commenter states that because Utah's minor and major source PSD permits include exemptions resulting from SSM events, Utah's PSD or minor source permit programs cannot ensure emissions will not cause or contribute to a violation of the NAAQS or PSD increments. The Commenter points to SSM language in permit approval orders for the Huntington, Current Creek, and Intermountain Power Service Corporation (IPSC) power plants and claims that these examples indicate a "pattern" in which Utah has included exemptions from SSM events in permits it has issued for facilities located outside nonattainment areas. The Commenter contends that Utah has not met requirements of section 110(a)(2)(C) because permits issued under the State's minor source and PSD programs exempt emissions from permit limitations and are therefore not adequate to protect the NAAQS. The Commenter also asserts that "sources cannot demonstrate that their emissions will not violate the NAAQS pursuant to 110(a)(2)(A)... where their permits authorize essentially unlimited emissions." Finally, the Commenter contends that the EPA is also obligated to disapprove prong 3 of 110(a)(2)(D)(i)(II) because it requires states to have adequate PSD programs.

Response 16: The EPA generally disagrees with this comment. As an initial matter, the Commenter's concerns highlight an important distinction between whether an infrastructure SIP submission meets the applicable requirements of the CAA on its face (i.e., pertain to the facial sufficiency of the state's SIP), and whether a state is actually complying with the requirements of that SIP (i.e., pertain to adequacy of the state's implementation of the SIP). These comments implicate the question of the degree to which implementation concerns are relevant in the context of acting on a state's infrastructure SIP. In the context of an infrastructure SIP submission, the EPA interprets section 110(a)(1) and (2) to require the Agency to focus on whether the state has a SIP that provides the requisite legal framework for implementation, maintenance and enforcement of the NAAQS. Generally speaking, the EPA's review of infrastructure SIP submissions is limited to whether, pursuant to CAA section 110(a)(2), the submission facially meets the requirements of the statutory criteria outlined therein, as applicable (see also response 1). In the case of section 110(a)(2)(C), for example, the statute requires a state to have a SIP that ``include[s] a program to provide for . . . regulation of the modification and construction of any stationary sources . . . including a permit program as required in parts C and D of this subchapter.'' Thus, the EPA reviews a state's infrastructure SIP submission to assure that the structural elements of the state's PSD permitting program meets current CAA requirements for such programs, e.g., that it addresses GHG emissions.
      This is not to say the EPA has no role in reviewing whether a state is faithfully implementing its approved SIP, or otherwise complying with the CAA and its implementing regulations. To the contrary, there are multiple statutory tools that the EPA can use to rectify problems with state implementation of its SIP, and the existence of these tools is consistent with the EPA's interpretation of section 110(a)(2) with respect to the Agency's role in reviewing infrastructure SIP submissions. For example, as previously described, the CAA provides the EPA the authority to issue a SIP call, 110(k)(5); make a finding of failure to implement, id. §§ 110(m), 179(a)(4); and take measures to address specific permits pursuant to the EPA's case-by-case permitting oversight. See, e.g., § 505(b). The appropriateness of employing these authorities depends on the nature and extent of the particular implementation problems at issue.
      With respect to Utah's infrastructure SIP submission, the EPA analyzed the submission itself, and evaluated the text of its provisions for compliance with the relevant elements of section 110(a)(2). In the proposal, the EPA explicitly evaluated the State's submission on a requirement-by-requirement basis and explained its views on the adequacy of the State's SIP for purposes of meeting the infrastructure SIP requirements.
      With respect to the requirements related to PSD and minor NSR relevant to this approval of the infrastructure SIP submission, the EPA has determined that the State's SIP as previously approved meets the relevant structural requirements for purposes of minor source NSR and PSD in sections 110(a)(2)(C) and (D)(i)(II) prong 3. As to the PSD program in particular, these basic structural requirements include those provisions necessary for the permitting program to address all federally regulated pollutants and the proper sources. The EPA considers action on the infrastructure SIP submissions required by section 110(a)(1) and (2) to be an evaluation of a state's SIP to assure that it meets the basic structural requirements for the new or revised NAAQS, not a time to address all potential substantive defects in existing SIP provisions, including directors discretion, or language pertaining to SSM exemptions contained in PSD and minor source NSR permits. Therefore, the EPA generally considers evaluations of a state's PSD and minor source NSR permits to be outside the scope of an infrastructure SIP review..
      With respect to section 110(a)(2)(A), as discussed in our proposal (81 FR 24525, April 26, 2016), and further explained in the 2013 Guidance Memo, the EPA is not evaluating any existing SSM provisions in Utah's SIP. Although the Commenter cites EPA's "confirmation" in our proposed rulemaking that existing SSM provisions in the Utah SIP, that sentence of the proposed rulemaking was a scrivener's error, as evidenced in part by the fact that it cited a SIP call that did not implicate any provisions of Utah law. The EPA is not aware of any existing deficiencies in the Utah SIP regarding excess emissions during SSM events at this time. However, the EPA has previously addressed SSM provisions in the Utah SIP outside of the infrastructure SIP process, with more appropriate tools Congress provided to address such problems. Specifically, under the authority of CAA section 110(k)(5), the EPA issued a SIP call on April 18, 2011 requiring Utah to revise SSM SIP provisions dating back to 1980 (See "Finding of Substantial Inadequacy of Implementation Plan; Call for Utah State Implementation Plan Revision," 76 FR 21639). On February 6, 2014, the EPA finalized approval of the State's revisions to Utah rule R307-107, which corrected deficiencies related to the treatment of excess emissions during malfunction events, and therefore satisfied the EPA's April 18, 2011 SIP call (79 FR 7067).
      As relevant to this action, however, the Commenter has failed to identify a provision in Utah's SIP that grants SSM exemptions in permits and the EPA is unaware of any such provision, and we conclude that Utah's PSD program meets all requirements under Section 110(a)(2)(C). Additionally, to the extent that the Commenter points to specific permits as exempting excess emissions, if this is the case, the EPA agrees that the state should not give such exemptions in permits.  The EPA also finds that existing SSM provisions in permits should be addressed through the permitting review process rather than the SIP rulemaking process because it is an implementation issue that is outside the scope of EPA's review of this infrastructure SIP.
      With regard to director's discretion provisions.(DD) EPA is aware that the state's EPA-approved SIP contains some DD provisions. EPA reiterates that such existing DD provisions are most appropriately addressed outside the scope of EPA's infrastructure review process. However, the EPA is currently working with Utah to correct existing deficient language in its SIP through SIP processes outside the context of the State's infrastructure SIP, such as through Utah's PM10 maintenance plan and PM2.5 attainment plan.

Comment 17: The Utah Infrastructure SIP Does Not Meet the Requirements of 110(a)(2)(A) and 110(a)(2)(C) Because In Many Instances, Utah Permits Do Not Regulate Condensable PM2.5 and PM10.
      The Commenter contends that Utah's PSD and minor source permits do not regulate condensable PM emissions in accordance with the CFR and, therefore, the EPA must not "approve any aspects of the proposed infrastructure SIP relating to 2012 PM2.5 NAAQS." The Commenter points to language in the Hunter and MagCorp permit approval orders regarding condensable PM emissions and compliance demonstration. The Commenter also cites to the IPSC approval order and claims there is no limit for PM2.5 and that compliance with the PM10 emission limit is determined by Method 5B or other testing methods approved by the Director. The Commenter states that these examples show a pattern in Utah's permitting practices for not regulating condensable PM or requiring monitoring to determine condensable PM. The Commenter asserts that the EPA cannot approve Utah's 2012 PM2.5 NAAQS infrastructure SIP for section 110(a)(2)(C) because the State's PSD and minor source programs do not regulate or limit condensable PM emissions nor demonstrate that emissions from a source will not cause or contribute to a violation of the NAAQS under section 110(a)(2)(A).

Response 17: The EPA disagrees with the Commenter that the EPA must disapprove Utah's infrastructure SIP for the 2012 PM2.5 NAAQS because some state PSD and minor source permits do not regulate condensable PM. For the reasons discussed in response 16, the EPA evaluated the State's submission with respect to the requirements related to PSD and minor NSR relevant to this approval of the infrastructure SIP submission and determined that the State's SIP as previously approved meets the relevant structural requirements for purposes of minor source NSR and PSD in section 110(a)(2)(A), (C) and (D)(i)(II) element 3. To reiterate, the EPA generally considers evaluations of a state's PSD and minor source NSR permits to be an implementation issue that is outside the scope of an infrastructure SIP review, and therefore the EPA is not at this time evaluating language pertaining to condensable PM in state permit approval orders in this action.
      Finally, the EPA addressed the adequacy of Utah's infrastructure SIP for the purposes of meeting CAA requirements for PSD and minor source programs under section 110(a)(2)(C) in the proposed rulemaking for this action. In fact, Utah's PSD program incorporates the requirements for condensable PM that were specified in the EPA's 2008 PM2.5 NSR Implementation Rule. 73 FR 28321, 28349 (May 16, 2008) (changes to federal program). The Rule was promulgated in 2008, and Utah's PSD program incorporates by reference the federal program in 40 CFR 52.21 as of 2011, including the provision in 52.21(b)(50)(vi) addressing condensable PM (78 FR 63883, 63887, Oct. 25, 2013). Utah's minor source program regulates pollutants as necessary to ensure that construction of a minor stationary source or a minor modification will not interfere with the NAAQS, including the PM10 and PM2.5 NAAQS. Thus, should condensable PM from a minor source have the potential to interfere with these NAAQS, Utah can (and should) address the issue in the minor NSR permit.

Comment 18: The Utah Infrastructure SIP Does Not Meet the Requirements of 110(a)(2)(F) Because In Many Instances Monitoring Frequency is Inadequate to Show Continuous Compliance with Emission Limitations.
      The Commenter states that "EPA's reliance on [Utah Administrative Code] R307-165 is ill-founded and its finding of compliance with section 110(a)(2)(F) is improper." First, the Commenter explains that Utah's emissions testing requirement of "at least once every five years" under R307-165-2 is "insufficient to demonstrate that the requirement to limit emissions `on a continuous basis' or to show that continuous compliance with an emission limitation has been met."  In support, the Commenter cites the definition of "emission limitation" and "emission standard" under Section 302(k) of the CAA as well as several other EPA sources to conclude that states must enforce and monitor emissions standards and limitations "on a continuous basis."  The Commenter adds that "even yearly testing is inadequate" unless a state demonstrates how yearly testing can show continuous compliance or continuous emissions monitoring, and that the"EPA's reliance on R307-165 is" thus "ill-founded."
      Second, the Commenter states that "[t]he inadequacy of Utah's monitoring provision is further established in [Utah's permitting] practice." In support, the Commenter refers to the MagCorp approval order which "routinely requires stack testing only once every five years."

Response 18: The EPA agrees with the Commenter's statement that emissions limitations must be complied with at all times. However, the EPA disagrees with the Commenter's argument that the EPA must therefore disapprove Utah's infrastructure SIP submission for element 110(a)(2)(F) because Utah's emission testing requirements under R307-165-1 only requires a stack test at least once every five years. Although emission limits must impose continuous emission reduction requirements on the affected sources, it does not follow that sources must conduct stack tests continuously in order for emission limitations to be continuous so long as the state imposes other appropriate requirements on sources sufficient to assure compliance by sources.
      In the case of Utah, the requirements the state imposes are not restricted exclusively to the stack tests contemplated in R307-165-2.  This is not the only mechanism the state uses to verify compliance with emission limitations in permits. In addition to that requirement, the state's SIP also provides for other forms of compliance assurance such as continuous emissions monitoring. For example, R307-170 requires certain large sources to install and maintain continuous emission monitors on sources to prove a means to make sure that the emission limitations are legally and practically enforceable. Under the Credible Evidence Rule, any of these may be used to support enforcement actions against affected sources for violation of emission limitations.
      Finally, the EPA acknowledges the commenter's concern with the adequacy of monitoring requirements in practice. However, to the extent that the State has issued approval orders for specific sources that contain insufficient monitoring requirements, this is not an issue that the EPA is addressing in the context of evaluating infrastructure SIP submissions. As explained elsewhere in this response to comments, the EPA has other tools to address problems with permits that have been issued under an approved program.

Comment 19: EPA Errs When it Cites SIP Section XVI as Meeting the General Requirements of Section 127.
       The Commenter states that the EPA's reliance on Section XVI as meeting the requirements of section 127 is improper. First, the Commenter states that "section XVI is completely out of date, having been adopted in 1992" and that the phone number that section XVI lists no longer works. Second, the Commenter states that "calculation of API [Air Pollution Index] is not adequate to let the public know the condition of the air or compliance with the NAAQS." Finally, the Commenter states that "[r]eliance on section XVI's description of the Annual Report is also ill-conceived." The Commenter explains that an Annual Report that provides "only once a year `a description of the regulatory, SIP, and public hearing process and an indication of the ways the public may participate in these processes in an effort to improve air quality' does not meet section 127 mandates."

Response 19: The EPA disagrees with the Commenter's argument that the Utah SIP does not meet the requirements of section 127. Among other requirements, section 110(a)(2)(J) of the CAA requires states to meet the public notification requirement under section 127. Section 127 requires a state's infrastructure SIP to contain measures to notify the public upon the exceedance of a NAAQS, to advise the public of the health hazards related to such exceedances, and to enhance public awareness of measures that can prevent such exceedances and means for which the public can participate in efforts to improve air quality. CAA 127; see also 40 CFR 51.285. Section 127 further states that "[s]uch measures may include the posting of warning signs on interstate highway access points to metropolitan areas or television, radio, or press notices or information." As long as the infrastructure SIP meets section 127 requirements, it is largely irrelevant when Utah adopted Section XVI. The measures that the State uses to notify the public may vary over time. Utah has a phone line which members of the public may call into, and also maintains a website that enables Utahans to learn about air quality issues, view a current air quality index, review annual reports submitted to the EPA, and access air quality alerts for ozone and PM2.5. The site contains sections to enhance public awareness of measures to take to prevent exceedance for the NAAQS. The EPA agrees with the Commenter, however, that the measures that the SIP identifies to notify the public to meet section 127 requirements should be current, including the phone number listed in Utah's Section XVI (if it no longer functions as the Commenter alleges), as well as adding the State's air quality monitoring website. However, given the other methods that the State uses to meet the requirements of section 127, we do not regard this deficiency to indicate that the SIP as a whole fails to meet those requirements.
      Second, we disagree with the Commenter's contention that the API inadequately informs the public of the condition or compliance status of NAAQS, and note that the Commenter does not provide support for its statement. Section XVI of Utah's SIP requires UDAQ to calculate an API on a daily basis.  In measuring and reporting its daily API, states are to follow criteria as established in Part 58's Ambient Air Quality Surveillance. Pursuant to Section XVI of its SIP, Utah posts API information on a daily basis. Furthermore, we disagree with the Commenter's statement that a once a year Annual Report that provides the public a description of the public's potential involvement in improving air quality fails to satisfy section 127 requirements. EPA again notes that the Commenter has failed to provide support for its statement. Neither section 127 nor any regulations requires the state to provide such information at a greater frequency beyond an annual one.


[Federal Register Volume 83, Number 129 (Thursday, July 5, 2018)]
[Notices]
[Pages 31399-31400]
[FR Doc No: 2018-14429]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5670]

Abbreviated New Drug Application Submissions--Amendments to
Abbreviated New Drug Applications Under the Generic Drug User Fee Act;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``ANDA
Submissions--Amendments to Abbreviated New Drug Applications Under
GDUFA.'' This guidance finalizes the October 2017 draft guidance for
industry ``ANDA Submissions--Amendments to Abbreviated New Drug
Applications Under GDUFA.'' This guidance is intended to explain to
applicants how the review goals established as part of the Generic Drug
User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to
amendments to either abbreviated new drug applications (ANDAs) or prior
approval supplements (PASs) submitted to FDA under the Federal Food,
Drug, and Cosmetic Act (FD&C Act). This guidance describes amendment
classifications and categories and explains how amendment submissions
may affect an application's review goal dates. The guidance also
describes how FDA will review amendments submitted to ANDAs and PASs
received prior to October 1, 2017, the effective date to implement the
GDUFA II review goals.

DATES: The announcement of the guidance is published in the Federal
Register on July 5, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-5670 for ``ANDA Submissions--Amendments to Abbreviated New
Drug Applications Under GDUFA.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto Friedman, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002,
240-

402-7930, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``ANDA Submissions--Amendments to Abbreviated New Drug
Applications Under GDUFA.'' This guidance finalizes the October 2017
draft guidance for industry ``ANDA Submissions--Amendments to
Abbreviated New Drug Applications Under GDUFA.'' This guidance is
intended to assist applicants preparing to submit amendments to ANDAs
or to PASs to FDA under section 505(j) of the FD&C Act (21 U.S.C.
355(j)) by explaining how the review goals established as part of GDUFA
II apply to these submissions. In accordance with the GDUFA
Reauthorization Performance Goals and Program Enhancements Fiscal Years
2018-2022 (GDUFA II Commitment Letter: https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/ucm525234.pdf), FDA agreed to
certain review goals and procedures for the review of amendments
pending as of or received on or after the GDUFA II effective date.
    The GDUFA II Commitment Letter reflects significant changes in the
classification of and review goals for amendments to ANDAs and PASs
under the Generic Drug User Fee Amendments of 2012 (GDUFA I). Under
GDUFA I, amendments were classified into a complex Tier system based on
the following factors: (1) Whether the amendment was solicited
(submitted in response to a complete response letter) or unsolicited
(submitted on the applicant's own initiative); (2) whether the
amendment was major or minor; the number of amendments submitted to the
ANDA or PAS; and (3) whether an inspection was necessary to support the
information contained in the amendment.
    GDUFA II simplified the amendment review goals and no longer
subjects them to a Tier system; however, review goals are still
dependent on several factors. In general, under GDUFA II, amendments
will be designated as either standard or priority; will be classified
as major or minor, and will receive a goal date based on the factors
discussed in the draft guidance, including whether a preapproval
inspection is needed. This guidance supersedes the December 2001
guidance for industry ``Major, Minor, and Telephone Amendments to
Abbreviated New Drug Applications'' and the July 2014 draft guidance
for industry ``ANDA Submissions--Amendments and Easily Correctable
Deficiencies Under GDUFA,'' both of which will be withdrawn. This
guidance finalizes the October 2017 draft guidance for industry ``ANDA
Submissions--Amendments to Abbreviated New Drug Applications Under
GDUFA.'' The final guidance contains clarifications to the draft
guidance of the same title that published in October 2017.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``ANDA Submissions--Amendments to
Abbreviated New Drug Applications Under GDUFA.'' It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 314.96 have been approved under
OMB control number 0910-0001.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: June 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14429 Filed 7-3-18; 8:45 am]
 BILLING CODE 4164-01-P