82 FR 52651 - Determination of Attainment by the Attainment Date for the 2008 Ozone National Ambient Air Quality Standard; District of Columbia, Maryland, and Virginia; Washington, DC-MD-VA Area
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 218 (November 14, 2017)
Federal Register Volume 82, Issue 218 (November 14, 2017)
| Page Range | 52651-52655 | |
| FR Document | 2017-24537 |
[Federal Register Volume 82, Number 218 (Tuesday, November 14, 2017)] [Rules and Regulations] [Pages 52651-52655] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24537] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2016-0369; FRL-9970-70-Region 3] Determination of Attainment by the Attainment Date for the 2008 Ozone National Ambient Air Quality Standard; District of Columbia, Maryland, and Virginia; Washington, DC-MD-VA Area AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Environmental Protection Agency (EPA) is making a final determination that the Washington, DC-MD-VA marginal ozone nonattainment area (the Washington Area) attained the 2008 ozone national ambient air quality standard (NAAQS) by the July 20, 2016 attainment date. This determination is based on complete, certified, and quality assured ambient air quality monitoring data for the Washington Area for the 2013-2015 monitoring period. The effect of this determination of attainment is that the Washington Area will not be bumped up or reclassified as a moderate nonattainment area. This determination of attainment is not equivalent to a redesignation, and the states in the Washington Area and the District of Columbia must meet the statutory requirements for redesignation in order to be redesignated to attainment. This determination is also not a clean data determination. This action is being taken under the Clean Air Act (CAA). DATES: This final rule is effective on December 14, 2017. ADDRESSES: EPA established a docket for this action under Docket ID Number EPA-R03-OAR-2016-0369. All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the docket index, some information is not publicly available, e.g., confidential business information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available through http://www.regulations.gov, or please contact the person identified in the FOR FURTHER INFORMATION CONTACT section below for additional availability information. FOR FURTHER INFORMATION CONTACT: Gavin Huang, (215) 814-2042, or by email at huang.gavin@epa.gov. SUPPLEMENTARY INFORMATION: I. Background On April 25, 2017 (82 FR 19011), EPA published a notice of proposed rulemaking (NPR) for the Washington Area. The Washington Area consists of the Counties of Calvert, Charles, Frederick, Montgomery, and Prince George's in Maryland; the Counties of Arlington, Fairfax, Loudoun, and Prince William and the Cities of Alexandria, Fairfax, Falls Church, Manassas, and Manassas Park in Virginia; and the entirety of the District of Columbia. In the NPR, EPA proposed to determine, in accordance with its statutory obligations under section 181(b)(2)(A) of the CAA and the Provisions for Implementation of the 2008 Ozone National Ambient Air Quality Standards (40 CFR part 51, subpart AA), that the Washington Area attained the 2008 ozone NAAQS by the applicable attainment date of July 20, 2016. II. EPA's Evaluation Section 181(b)(2)(A) of the CAA requires that EPA determine whether an area has attained the NAAQS by its attainment date based on complete and certified air quality data from the three full calendar years preceding an area's attainment date. The 2008 ozone NAAQS level is 0.075 parts per million (ppm). See 73 FR 16436 (March 27, 2008). Consistent with the requirements contained in 40 CFR part 50, appendix P, EPA reviewed the ozone ambient air quality monitoring data for each monitoring site within the Washington Area for the monitoring period from 2013 through 2015, as recorded in the Air Quality System (AQS) database. Federal, state, and local agencies responsible for ozone air monitoring networks supplied and quality assured the data. EPA determined that all the Washington Area monitoring sites with valid data had design values equal to or less than 0.075 ppm based on the 2013-2015 monitoring period. Therefore, based on 2013-2015 certified air quality [[Page 52652]] data, EPA concludes that the Washington Area has attained the 2008 ozone NAAQS. The specific requirements of this determination of attainment by the attainment date and the rationale for EPA's proposed action are explained in the NPR and will not be restated here. EPA received comments that are addressed in Section III of this rulemaking action. III. Public Comments and EPA's Responses EPA received adverse comments from one commenter, the Center for Biological Diversity (hereinafter referred to as the ``Commenter''). The Commenter expressed general concern about the ``increasing trend in ozone levels'' and the lack of data at monitoring stations. The Commenter's specific concerns are summarized and addressed in this section. EPA also received non-adverse comments. Comment 1: The Commenter notes that ``the 2013-2015 design values show 3 year averages below 70 ppm,'' but that ``there are many exceedances of 70 ppm on an annual basis and an increasing trend of values above 70 ppm from 2013-2015.'' Response 1: The 2008 ozone NAAQS is the relevant standard for this determination of attainment by the attainment date, and the level of that NAAQS is 0.075 ppm and not 0.070 ppm. Therefore, the Commenter's statements as to the Washington Area's design value in relation to 0.070 ppm are not relevant. As stated in the NPR, the 2008 ozone NAAQS is attained at a monitoring site when the three-year average of the annual fourth-highest daily maximum 8-hour average ambient air quality concentration, which is quality assured and certified, is less than or equal to 0.075 ppm. See 82 FR 19011, 19012. Design values are the metrics (i.e., statistics) that are compared to the NAAQS levels to determine compliance with the standard. See 40 CFR part 50, appendix P, section 1(b). The 8-hour, concentration-based ozone NAAQS was designed so that the ``public health risks associated with exposure to a pollutant without a clear, discernable threshold can be appropriately addressed through a standard that allows for multiple exceedances to provide increased stability, but that also significantly limits the number of days on which the level may be exceeded and the magnitude of such exceedances.'' See 73 FR 16435. As of its July 20, 2016 attainment date, the Washington Area's three-year average of the annual fourth-highest daily maximum 8-hour average ambient air quality concentration is less than or equal to the 0.075 ppm standard. Comment 2: The Commenter states that the proposed rule failed to address the 2016 data from monitoring stations and whether that data achieves the 2008 ozone NAAQS. Response 2: To determine whether an area attained by the 2008 ozone NAAQS attainment date of July 20, 2016, EPA is required to rely on the three previous full years of data, which are 2013-2015. CAA section 181(b)(2)(A); 40 CFR part 50, appendix P, section 2.3(b). Any data occurring in calendar year 2016 cannot be used in this determination because July 20, 2016 is in the middle of the 2016 ozone season and would produce only incomplete, non-quality assured, and uncertified data as of the July 20, 2016 attainment date. The statutory provision governing the type of determination of attainment EPA is finalizing today is very clear: ``the Administrator shall determine, based on the area's design value (as of the attainment date), whether the area attained the standard by that date.'' CAA section 181(b)(2)(A) (emphasis added). When making determinations of attainment by the attainment deadline, EPA has consistently applied this unambiguous language as restricting its analysis to the years of data that constitute the basis for an area's design value as of the specific attainment deadline. EPA's regulations at 40 CFR part 50, appendix P further clarify that the design value be derived from ``three consecutive, complete calendar years of air quality monitoring data.'' 40 CFR part 50, appendix P, section 2.3(b) (emphasis added). Taken together with the language of section 181(b)(2), for an attainment date of July 20, 2016, EPA is required to rely on the three previous, complete calendar years of data, which would be 2013-2015. The Commenter's request that EPA use calendar year 2016 data for this section 181(b)(2)(A) determination of attainment is not permitted under the statute and regulations. Comment 3: The Commenter is concerned with EPA's data substitution analysis because EPA does not have complete data to make its determination. Pursuant to 40 CFR part 50, appendix P, section 2.3(b), attainment demonstrations must be based upon ``three consecutive, complete calendar years of air quality monitoring data.'' Response 3: The Commenter is correct that appendix P of 40 CFR part 50 sets minimum data completeness requirements for quality assured monitoring data that must be met in order to make a determination of attainment for the ozone NAAQS; however, appendix P also permits adding missing days assumed less than the level of the standard where appropriate in order to meet the completeness requirements. 40 CFR part 50, appendix P, section 2.3(b) states that: ``meteorological or ambient data may be sufficient to demonstrate that meteorological conditions on missing days were not conducive to concentrations above the level of the standard. Missing days assumed less than the level of the standard are counted for the purpose of meeting the data completeness requirement, subject to the approval of the appropriate Regional Administrator.'' As discussed in this rulemaking action, EPA and the District of Columbia Department of Energy and Environment (DC DOEE) provided analyses that showed the strong probability that the missing days would not have shown an exceedance of the 2008 ozone NAAQS, in accordance with appendix P, and was approved by the Region 3 Regional Administrator on December 12, 2016. Comment 4: The Commenter states that ``the data substitution analysis performed by the Takoma Recreation Center monitoring station (Site ID 110010050) and lack of data at Site ID 110010041 is incomplete and contradictory.'' The Commenter points out that the proposed rule states that data substitution analyses were performed using ``an analysis of the meteorological data and a regression analysis in order to meet the data completeness requirements'' and that ``EPA also conducted for these two monitors a substitution analysis as a check on the validity of the meteorological analysis and regression analysis.'' 82 FR 19013. However, the document, the ``District of Columbia-- Submittal Letter for Data Substitution Analysis'' (Docket ID EPA-R03- OAR-2016-0369-0008) fails to disclose or provide the regression analysis, and implies that the only analysis that was conducted was based on ``meteorological and ambient monitoring data.'' Response 4: First, EPA notes that the document entitled ``Data Substitution Analysis 2013 Ozone Season, Takoma Recreation Center Station (AQS Site ID 11-001-0050)'' was created by DC DOEE (Docket Number EPA-OAR-2016-0369-0007), and not the Takoma Recreation Center, as stated in the comment. Second, for the River Terrace monitor (AQS ID #11-001-0041), EPA did not conduct any data substitution analysis. As explained in the NPR, the reason for the lack of 2014 and 2015 data at the [[Page 52653]] River Terrace monitor was a planned temporary monitor shutdown due to site renovation and construction that EPA approved into DC DOEE's annual network monitoring plan. Therefore, EPA would not look for a valid design value at this monitor, because three years of complete data was not available. See 82 FR 19013. Planned shutdowns of monitors are normal occurrences and are reviewed and approved by EPA in a state's annual network monitoring plan, and the remaining monitors in the Washington Area's network are sufficient to support a valid design value. See 40 CFR 58.10(a)(2). The Washington-Arlington-Alexandria, DC- VA-MD-WV metropolitan statistical area (MSA) is only required to have three ozone monitoring sites, but the area has a robust monitoring network with sixteen ozone monitoring sites spread across three states. Therefore, data from the River Terrace monitor (AQS ID #11-001-0041) was not used in this determination of attainment by the attainment date. Third, as to the Commenter's concerns about what type of analysis was performed to achieve data completeness at the Takoma Recreation Center monitor, EPA's preamble in the NPR incorrectly stated that ``EPA also conducted for these two monitors a substitution analysis as a check on the validity of the meteorological analysis and regression analysis.'' See 82 FR 19013. The DC DOEE analysis for the Takoma Recreation Center monitor did not in fact include a separate substitution analysis as a check on the validity of the temperature analysis or the regression analysis--rather, DC DOEE's analysis as a whole was comprised of both a temperature analysis and a regression analysis.\1\ The Technical Support Document for the Takoma Recreation Center monitor, which was included in the docket with the proposed action, reflects the correct analysis for that monitor, which used both a temperature analysis and a regression analysis to achieve minimum data completeness. However, the preamble's misstatement does not invalidate the analyses or the choice of days assumed to be less than the ozone standard in the analyses. As noted in this rulemaking action, appendix P of 40 CFR part 50 allows missing days to be added to the site completeness using meteorological or ambient data, and that missing days assumed less than the level of the standard can be counted for the purpose of meeting the data completeness requirement, subject to the approval of the appropriate Regional Administrator. The Takoma Recreation Center analysis generated valid missing days that can be counted for the purpose of meeting the data completeness requirement in 40 CFR part 50, appendix P. --------------------------------------------------------------------------- \1\ As discussed in Comment 6, the EPA Clean Air Markets Division (CAMD) analysis for the Beltsville CASTNET monitor also did not perform a substitution analysis. --------------------------------------------------------------------------- Contrary to the Commenter's suggestion, the regression analysis was included in the docket with the proposed action. The submittal letter from the DC DOEE cited in the comment (Docket EPA-R03-OAR-2016-0369- 0008) included a 21-page document entitled ``Data Substitution Analysis 2013 Ozone Season, Takoma Recreation Center Station'' (Docket EPA-R03- OAR-2016-0369-0007). The document makes it clear that DC DOEE compared seven years of temperature data from 2009 through 2015 from Reagan International Airport with actual measured ozone concentrations from 2009 through 2015 at eight nearby ozone ambient monitors to determine whether there was a measured temperature below which none of those monitors recorded an exceedance of the 0.075 ppm ozone standard. Docket EPA-R03-OAR-2016-0369-0007, pp. 5-7. This analysis determined that during this seven-year period, none of these monitors exceeded the 0.075 ppm ozone standard when the temperature was below 84 degrees Fahrenheit. Based on this finding, DC DOEE concluded that any ozone season day during 2013 (the year with missing data) for which the high temperature did not exceed 84 degrees Fahrenheit would likely measure below the 0.075 ppm ozone standard. Based on this assumption, DC DOEE flagged 68 days during the 2013 ozone season in the Takoma Recreation Center monitor's data as ``BG,'' meaning ``missing ozone data [but] not likely to exceed the level of the standard.'' Docket EPA-R03-OAR-2016- 0369-0007, pp. 5-7. Adding these 68 days in 2013 determined to be days below the ozone standard to the existing data set did not result in enough data points to meet the minimum yearly 75% completeness standard for ozone at this monitor. Therefore, the DC DOEE's analysis then used a regression analysis to determine whether additional ozone season days with missing data could be assumed to be below the ozone standard at the Takoma Recreation Center monitor. Docket EPA-R03-OAR-2016-0369- 0007, p. 7. Using this regression analysis, measured ozone values at the nearby McMillan ozone monitor were found to correlate strongly with measured ozone values at the Takoma Recreation Center monitor, such that an equation could be developed to predict missing ozone values at the Takoma Recreation Center monitor by using actual measured values from the McMillan monitor in the equation for those missing days. The regression equation identified a number of days in 2013 at the Takoma Recreation Center monitor where the temperature exceeded 85 degrees but the predicted ozone values did not exceed 0.075 ppm. Using this method, DC DOEE added 4 days in September 2013 with temperatures above 85 degrees and 5 days in October 2013 with temperatures exceeding 85 degrees to the 2013 ozone data for the Takoma Recreation Center monitor, also using the ``BG'' flag. In total, 77 days were added to the Takoma Recreation Center monitoring station. Comment 5: The Commenter noted that EPA relies upon the ``null code'' submission for 77 days for the Takoma Recreation Center monitoring station. A null qualifier is required when submitting a null (i.e., nothing was collected) sample measurement. The Commenter stated there is no analysis to demonstrate that the data collected on those 77 days was below the 2008 ozone NAAQS. Furthermore, the inclusion of a lack of data, instead of modeled data projections, fails to meet the data completeness requirements. Response 5: The analysis showing that 77 days at the Takoma Recreation Center monitor meets the minimum data completeness requirement is contained in the DC DOEE's ``Data Substitution Analysis 2013 Ozone Season, Takoma Recreation Center Station'' (Docket Number EPA-R03-OAR-2016-0369-0007). Also, see the response to Comment 4. The lack of data, as represented by a ``BG'' or other null code, for those days when the Takoma Recreation Center monitor did not measure valid ozone readings, does not automatically mean a failure to meet the data completeness requirements of 40 CFR part 50, appendix P. Nor does appendix P require ``modeled data projections.'' Rather, when there is a lack of data represented by a null code, section 2.3(b) of appendix P provides that those missing days may be used if they are reasonably assumed to be less than the level of the standard. The detailed temperature and regression analyses approved by the Regional Administrator, and included in the docket, establish the basis for EPA's conclusion that certain missing days at the Takoma Recreation Center monitor can be assumed to be less than the level of the NAAQS and therefore may be [[Page 52654]] counted towards the data completeness requirement. Comment 6: It is also unclear whether the CAMD--Data Substitution Analysis (Docket ID: EPA-R03-OAR-2016-0369-0006) for the CASTNET ozone monitor at the Beltsville, Maryland site provides the meteorological and substitution analysis as stated in the proposed rule and as required by the CAA. 40 CFR part 50, appendix P, section 2.3(b). Response 6: As noted in response to Comment 4, the preamble to the NPR incorrectly stated that a meteorological analysis, regression analysis, and a data substitution analysis were performed for both monitors. As shown in the analysis for the Beltsville CASTNET monitor (AQS ID #24-033-9991) (Docket Number: EPA-R03-OAR-2016-0369-0006), the EPA CAMD analysis was a linear regression analysis only. The regression analysis uses ambient data from a nearby monitor that closely correlates to readings from the monitor with the missing days. In accordance with appendix P, where the regression analysis projects that monitored values on the missing days would be less than the level of the NAAQS, EPA includes those in its completeness calculations. Comment 7: The Commenter stated that the proposed rule is clear that it fails to include the data for Site ID 110010041 for all of 2014 and 2015 and fails to achieve the data completeness standards as required by 40 CFR part 50, appendix P. Response 7: As discussed in Response 4, EPA explained in the NPR that the reason for lack of 2014 and 2015 data at the River Terrace monitor (AQS ID #11-001-0041) was a planned monitor shutdown approved into DC DOEE's annual network monitoring plan. Planned shutdowns of monitors are normal occurrences and are reviewed and approved by EPA in a state's annual network monitoring plan. See 40 CFR 58.10(a)(2). Therefore, this monitor was not relied on for this determination of attainment by the attainment date. See 82 FR 19013. The data completeness requirements of appendix P do not apply to this monitor. Comment 8: EPA also received comments and an inquiry from a student supporting the environment and seeking more information regarding how air monitoring is performed and why the 2008 ozone standard is still discussed even though it is no longer 2008. Response 8: More information regarding the ozone NAAQS and air monitoring standards is available at www.epa.gov. For the Washington Area, the area had to attain the 2008 ozone NAAQS by the applicable attainment date of July 20, 2016. As stated in the NPR, in a final rulemaking action published on May 4, 2016, EPA determined that the Washington Area did not attain the 2008 ozone NAAQS by its July 20, 2015 attainment date, based on ambient air quality monitoring data for the 2012-2014 monitoring period. In that same action, EPA determined that the Washington Area qualified for a 1-year extension of its attainment date. See 81 FR 26697. This ruling determines that the Washington Area attained the 2008 ozone NAAQS by this extended attainment date, using the required 2013-2015 air quality data. Comment 9: EPA also received comments that were not germane to this final ruling but referred generally to air quality standards and regulations. The comments included support of keeping EPA regulations in place to protect human health and the environment. Response 9: EPA appreciates the supportive comments, and notes that ozone air quality monitoring will continue and existing air quality standards and regulations will remain in place. These include all standards and regulations that apply to the Washington Area marginal nonattainment area, which include those pertaining to its membership in the ozone transport region (OTR). This determination of attainment by the attainment date does not reduce or revoke any existing ozone monitoring or control requirements. IV. Final Action EPA is making a final determination, in accordance with its statutory obligations under section 181(b)(2)(A) of the CAA and the Provisions for Implementation of the 2008 Ozone NAAQS (40 CFR part 51, subpart AA), that the Washington Area attained the 2008 ozone NAAQS by the applicable attainment date of July 20, 2016. This determination of attainment does not constitute a redesignation to attainment or a clean data determination. V. Statutory and Executive Order Reviews A. General Requirements This rulemaking action finalizes a determination of attainment by the attainment date for the 2008 ozone NAAQS based on air quality data and does not impose additional requirements. For that reason, this determination of attainment:Is not a ``significant regulatory action'' subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011); is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866; does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.); is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.); does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4); does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the Washington Area marginal nonattainment area does not include any Indian country located in these states, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. B. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, [[Page 52655]] the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). C. Petitions for Judicial Review Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 16, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action determining that the Washington Area attained the 2008 ozone NAAQS by its July 20, 2016 attainment date may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Ozone, Reporting and recordkeeping requirements. Dated: October 27, 2017. Cosmo Servidio, Regional Administrator, Region III. 40 CFR part 52 is amended as follows: PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 0 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 et seq. Subpart J--District of Columbia 0 2. In Sec. 52.475, paragraph (c) is added to read as follows: Sec. 52.475 Determinations of attainment. * * * * * (c) Based upon EPA's review of the air quality data for the 3-year period 2013 to 2015, the Washington, DC-MD-VA marginal ozone nonattainment area has attained the 2008 8-hour ozone national ambient air quality standard (NAAQS) by the applicable attainment date of July 20, 2016. Therefore, EPA has met the requirement pursuant to Clean Air Act section 181(b)(2)(A) to determine, based on the area's air quality as of the attainment date, whether the area attained the standard. EPA also determined that the Washington, DC-MD-VA marginal nonattainment area will not be reclassified for failure to attain by its applicable attainment date pursuant to section 181(b)(2)(A). Subpart V--Maryland 0 3. In Sec. 52.1082, paragraph (k) is added to read as follows: Sec. 52.1082 Determinations of attainment. * * * * * (k) Based upon EPA's review of the air quality data for the 3-year period 2013 to 2015, the Washington, DC-MD-VA marginal ozone nonattainment area has attained the 2008 8-hour ozone national ambient air quality standard (NAAQS) by the applicable attainment date of July 20, 2016. Therefore, EPA has met the requirement pursuant to Clean Air Act section 181(b)(2)(A) to determine, based on the area's air quality as of the attainment date, whether the area attained the standard. EPA also determined that the Washington, DC-MD-VA marginal nonattainment area will not be reclassified for failure to attain by its applicable attainment date pursuant to section 181(b)(2)(A). Subpart VV--Virginia 0 4. In Sec. 52.2430, paragraph (c) is added to read as follows: Sec. 52.2430 Determinations of attainment. * * * * * (c) Based upon EPA's review of the air quality data for the 3-year period 2013 to 2015, the Washington, DC-MD-VA marginal ozone nonattainment area has attained the 2008 8-hour ozone national ambient air quality standard (NAAQS) by the applicable attainment date of July 20, 2016. Therefore, EPA has met the requirement pursuant to Clean Air Act section 181(b)(2)(A) to determine, based on the area's air quality as of the attainment date, whether the area attained the standard. EPA also determined that the Washington, DC-MD-VA marginal nonattainment area will not be reclassified for failure to attain by its applicable attainment date pursuant to section 181(b)(2)(A). [FR Doc. 2017-24537 Filed 11-13-17; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations 52651
information in part 807, subpart E, (6) The labeling must include: information (CBI) or other information
regarding premarket notification (i) Specific instructions on safe device whose disclosure is restricted by statute.
submissions, have been approved under preparation and use; Certain other material, such as
OMB control number 0910–0120; and (ii) The device shelf life; copyrighted material, is not placed on
the collections of information in 21 CFR (iii) Data regarding urinary retention; the Internet and will be publicly
part 801, regarding labeling, have been and available only in hard copy form.
approved under OMB control number (iv) Data regarding post-prostatic Publicly available docket materials are
0910–0485. artery embolization syndrome. available through http://
List of Subjects in 21 CFR Part 876 Dated: November 7, 2017. www.regulations.gov, or please contact
Lauren Silvis, the person identified in the FOR FURTHER
Medical devices. INFORMATION CONTACT section below for
Therefore, under the Federal Food, Chief of Staff.
[FR Doc. 2017–24586 Filed 11–13–17; 8:45 am]
additional availability information.
Drug, and Cosmetic Act and under
FOR FURTHER INFORMATION CONTACT:
authority delegated to the Commissioner BILLING CODE 4164–01–P
of Food and Drugs, 21 CFR part 876 is Gavin Huang, (215) 814–2042, or by
amended as follows: email at huang.gavin@epa.gov.
ENVIRONMENTAL PROTECTION SUPPLEMENTARY INFORMATION:
PART 876—GASTROENTEROLOGY– AGENCY I. Background
UROLOGY DEVICES
40 CFR Part 52 On April 25, 2017 (82 FR 19011), EPA
■ 1. The authority citation for part 876 published a notice of proposed
continues to read as follows: [EPA–R03–OAR–2016–0369; FRL–9970–70–
Region 3]
rulemaking (NPR) for the Washington
Authority: 21 U.S.C. 351, 360, 360c, 360e, Area. The Washington Area consists of
360j, 360l, 371. Determination of Attainment by the the Counties of Calvert, Charles,
■ 2. Add § 876.5550 to subpart F to read Attainment Date for the 2008 Ozone Frederick, Montgomery, and Prince
as follows: National Ambient Air Quality Standard; George’s in Maryland; the Counties of
District of Columbia, Maryland, and Arlington, Fairfax, Loudoun, and Prince
§ 876.5550 Prostatic artery embolization William and the Cities of Alexandria,
device. Virginia; Washington, DC-MD-VA Area
Fairfax, Falls Church, Manassas, and
(a) Identification. A prostatic artery AGENCY: Environmental Protection Manassas Park in Virginia; and the
embolization device is an intravascular Agency (EPA). entirety of the District of Columbia. In
implant intended to occlude the ACTION: Final rule. the NPR, EPA proposed to determine, in
prostatic arteries to prevent blood flow accordance with its statutory obligations
to the targeted area of the prostate, SUMMARY: The Environmental Protection under section 181(b)(2)(A) of the CAA
resulting in a reduction of lower urinary Agency (EPA) is making a final and the Provisions for Implementation
tract symptoms related to benign determination that the Washington, DC– of the 2008 Ozone National Ambient Air
prostatic hyperplasia. This does not MD–VA marginal ozone nonattainment Quality Standards (40 CFR part 51,
include cyanoacrylates and other area (the Washington Area) attained the subpart AA), that the Washington Area
embolic agents which act by in situ 2008 ozone national ambient air quality attained the 2008 ozone NAAQS by the
polymerization or precipitation, or standard (NAAQS) by the July 20, 2016 applicable attainment date of July 20,
embolization devices used in attainment date. This determination is 2016.
neurovascular applications (see 21 CFR based on complete, certified, and
882.5950). quality assured ambient air quality II. EPA’s Evaluation
(b) Classification. Class II (special monitoring data for the Washington Section 181(b)(2)(A) of the CAA
controls). The special controls for this Area for the 2013–2015 monitoring requires that EPA determine whether an
device are: period. The effect of this determination area has attained the NAAQS by its
(1) The device must be demonstrated of attainment is that the Washington attainment date based on complete and
to be biocompatible. Area will not be bumped up or
(2) Non-clinical performance testing certified air quality data from the three
reclassified as a moderate full calendar years preceding an area’s
must demonstrate that the device nonattainment area. This determination
performs as intended under anticipated attainment date. The 2008 ozone
of attainment is not equivalent to a NAAQS level is 0.075 parts per million
conditions of use. The following redesignation, and the states in the
performance characteristics must be (ppm). See 73 FR 16436 (March 27,
Washington Area and the District of 2008). Consistent with the requirements
tested: Columbia must meet the statutory
(i) Evaluation of suitability for contained in 40 CFR part 50, appendix
requirements for redesignation in order P, EPA reviewed the ozone ambient air
injection through catheters intended for to be redesignated to attainment. This
use in embolization; and quality monitoring data for each
determination is also not a clean data monitoring site within the Washington
(ii) Evaluation of the size distribution
determination. This action is being Area for the monitoring period from
of the device.
taken under the Clean Air Act (CAA). 2013 through 2015, as recorded in the
(3) Performance data must support the
sterility and pyrogenicity of the device. DATES: This final rule is effective on Air Quality System (AQS) database.
(4) Performance data must support the December 14, 2017. Federal, state, and local agencies
shelf life of the device by demonstrating ADDRESSES: EPA established a docket responsible for ozone air monitoring
jstallworth on DSKBBY8HB2PROD with RULES
continued sterility, package integrity, for this action under Docket ID Number networks supplied and quality assured
and device functionality over the EPA–R03–OAR–2016–0369. All the data. EPA determined that all the
identified shelf life. documents in the docket are listed on Washington Area monitoring sites with
(5) Clinical data must evaluate post- the http://www.regulations.gov Web valid data had design values equal to or
embolization damage due to non-target site. Although listed in the docket less than 0.075 ppm based on the 2013–
embolization under anticipated use index, some information is not publicly 2015 monitoring period. Therefore,
conditions. available, e.g., confidential business based on 2013–2015 certified air quality
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![Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations 52653
River Terrace monitor was a planned level of the standard can be counted for measured ozone values at the Takoma
temporary monitor shutdown due to site the purpose of meeting the data Recreation Center monitor, such that an
renovation and construction that EPA completeness requirement, subject to equation could be developed to predict
approved into DC DOEE’s annual the approval of the appropriate Regional missing ozone values at the Takoma
network monitoring plan. Therefore, Administrator. The Takoma Recreation Recreation Center monitor by using
EPA would not look for a valid design Center analysis generated valid missing actual measured values from the
value at this monitor, because three days that can be counted for the purpose McMillan monitor in the equation for
years of complete data was not of meeting the data completeness those missing days. The regression
available. See 82 FR 19013. Planned requirement in 40 CFR part 50, equation identified a number of days in
shutdowns of monitors are normal appendix P. 2013 at the Takoma Recreation Center
occurrences and are reviewed and Contrary to the Commenter’s monitor where the temperature
approved by EPA in a state’s annual suggestion, the regression analysis was exceeded 85 degrees but the predicted
network monitoring plan, and the included in the docket with the ozone values did not exceed 0.075 ppm.
remaining monitors in the Washington proposed action. The submittal letter Using this method, DC DOEE added 4
Area’s network are sufficient to support from the DC DOEE cited in the comment days in September 2013 with
a valid design value. See 40 CFR (Docket EPA–R03–OAR–2016–0369– temperatures above 85 degrees and 5
58.10(a)(2). The Washington-Arlington- 0008) included a 21-page document days in October 2013 with temperatures
Alexandria, DC-VA-MD-WV entitled ‘‘Data Substitution Analysis exceeding 85 degrees to the 2013 ozone
metropolitan statistical area (MSA) is 2013 Ozone Season, Takoma Recreation data for the Takoma Recreation Center
only required to have three ozone Center Station’’ (Docket EPA–R03– monitor, also using the ‘‘BG’’ flag. In
monitoring sites, but the area has a OAR–2016–0369–0007). The document total, 77 days were added to the Takoma
robust monitoring network with sixteen makes it clear that DC DOEE compared Recreation Center monitoring station.
ozone monitoring sites spread across Comment 5: The Commenter noted
seven years of temperature data from
three states. Therefore, data from the that EPA relies upon the ‘‘null code’’
2009 through 2015 from Reagan
River Terrace monitor (AQS ID #11– submission for 77 days for the Takoma
International Airport with actual
001–0041) was not used in this Recreation Center monitoring station. A
measured ozone concentrations from
determination of attainment by the null qualifier is required when
2009 through 2015 at eight nearby ozone
attainment date. submitting a null (i.e., nothing was
ambient monitors to determine whether collected) sample measurement. The
Third, as to the Commenter’s there was a measured temperature
concerns about what type of analysis Commenter stated there is no analysis to
below which none of those monitors demonstrate that the data collected on
was performed to achieve data recorded an exceedance of the 0.075
completeness at the Takoma Recreation those 77 days was below the 2008 ozone
ppm ozone standard. Docket EPA–R03– NAAQS. Furthermore, the inclusion of
Center monitor, EPA’s preamble in the OAR–2016–0369–0007, pp. 5–7. This
NPR incorrectly stated that ‘‘EPA also a lack of data, instead of modeled data
analysis determined that during this projections, fails to meet the data
conducted for these two monitors a seven-year period, none of these
substitution analysis as a check on the completeness requirements.
monitors exceeded the 0.075 ppm ozone Response 5: The analysis showing
validity of the meteorological analysis standard when the temperature was
and regression analysis.’’ See 82 FR that 77 days at the Takoma Recreation
below 84 degrees Fahrenheit. Based on Center monitor meets the minimum data
19013. The DC DOEE analysis for the this finding, DC DOEE concluded that
Takoma Recreation Center monitor did completeness requirement is contained
any ozone season day during 2013 (the in the DC DOEE’s ‘‘Data Substitution
not in fact include a separate year with missing data) for which the
substitution analysis as a check on the Analysis 2013 Ozone Season, Takoma
high temperature did not exceed 84 Recreation Center Station’’ (Docket
validity of the temperature analysis or degrees Fahrenheit would likely
the regression analysis—rather, DC Number EPA–R03–OAR–2016–0369–
measure below the 0.075 ppm ozone 0007). Also, see the response to
DOEE’s analysis as a whole was standard. Based on this assumption, DC
comprised of both a temperature Comment 4.
DOEE flagged 68 days during the 2013 The lack of data, as represented by a
analysis and a regression analysis.1 The ozone season in the Takoma Recreation ‘‘BG’’ or other null code, for those days
Technical Support Document for the Center monitor’s data as ‘‘BG,’’ meaning when the Takoma Recreation Center
Takoma Recreation Center monitor, ‘‘missing ozone data [but] not likely to monitor did not measure valid ozone
which was included in the docket with exceed the level of the standard.’’ readings, does not automatically mean a
the proposed action, reflects the correct Docket EPA–R03–OAR–2016–0369– failure to meet the data completeness
analysis for that monitor, which used 0007, pp. 5–7. Adding these 68 days in requirements of 40 CFR part 50,
both a temperature analysis and a 2013 determined to be days below the appendix P. Nor does appendix P
regression analysis to achieve minimum ozone standard to the existing data set require ‘‘modeled data projections.’’
data completeness. However, the did not result in enough data points to Rather, when there is a lack of data
preamble’s misstatement does not meet the minimum yearly 75% represented by a null code, section
invalidate the analyses or the choice of completeness standard for ozone at this 2.3(b) of appendix P provides that those
days assumed to be less than the ozone monitor. Therefore, the DC DOEE’s missing days may be used if they are
standard in the analyses. As noted in analysis then used a regression analysis reasonably assumed to be less than the
this rulemaking action, appendix P of 40 to determine whether additional ozone level of the standard. The detailed
CFR part 50 allows missing days to be season days with missing data could be temperature and regression analyses
jstallworth on DSKBBY8HB2PROD with RULES
added to the site completeness using assumed to be below the ozone standard approved by the Regional
meteorological or ambient data, and that at the Takoma Recreation Center Administrator, and included in the
missing days assumed less than the monitor. Docket EPA–R03–OAR–2016– docket, establish the basis for EPA’s
1 As discussed in Comment 6, the EPA Clean Air
0369–0007, p. 7. Using this regression conclusion that certain missing days at
Markets Division (CAMD) analysis for the Beltsville
analysis, measured ozone values at the the Takoma Recreation Center monitor
CASTNET monitor also did not perform a nearby McMillan ozone monitor were can be assumed to be less than the level
substitution analysis. found to correlate strongly with of the NAAQS and therefore may be
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![Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations 52655
the U.S. House of Representatives, and MD-VA marginal nonattainment area ENVIRONMENTAL PROTECTION
the Comptroller General of the United will not be reclassified for failure to AGENCY
States prior to publication of the rule in attain by its applicable attainment date
the Federal Register. A major rule pursuant to section 181(b)(2)(A). 40 CFR Part 52
cannot take effect until 60 days after it [EPA–R01–OAR–2009–0436; FRL–9970–66–
is published in the Federal Register. Subpart V—Maryland Region 1]
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2). ■ 3. In § 52.1082, paragraph (k) is added Air Plan Approval; Rhode Island;
to read as follows: Enhanced Motor Vehicle Inspection
C. Petitions for Judicial Review
and Maintenance Program
Under section 307(b)(1) of the CAA, § 52.1082 Determinations of attainment.
petitions for judicial review of this AGENCY: Environmental Protection
* * * * * Agency.
action must be filed in the United States
Court of Appeals for the appropriate (k) Based upon EPA’s review of the air ACTION: Direct final rule.
circuit by January 16, 2018. Filing a quality data for the 3-year period 2013
to 2015, the Washington, DC-MD-VA SUMMARY: The Environmental Protection
petition for reconsideration by the Agency (EPA) is approving State
Administrator of this final rule does not marginal ozone nonattainment area has
attained the 2008 8-hour ozone national Implementation Plan (SIP) revisions
affect the finality of this action for the submitted by the State of Rhode Island.
purposes of judicial review nor does it ambient air quality standard (NAAQS)
These revisions include regulations to
extend the time within which a petition by the applicable attainment date of July
update the enhanced motor vehicle
for judicial review may be filed, and 20, 2016. Therefore, EPA has met the inspection and maintenance (I/M)
shall not postpone the effectiveness of requirement pursuant to Clean Air Act program in Rhode Island. The revised
such rule or action. section 181(b)(2)(A) to determine, based program includes a test and repair
This action determining that the on the area’s air quality as of the network consisting of on-board
Washington Area attained the 2008 attainment date, whether the area diagnostic (OBD2) testing for model year
ozone NAAQS by its July 20, 2016 attained the standard. EPA also 1996 and newer vehicles and tailpipe
attainment date may not be challenged determined that the Washington, DC- exhaust test, using a dynamometer, for
later in proceedings to enforce its MD-VA marginal nonattainment area model year 1995 and older vehicles. The
requirements. (See section 307(b)(2).) will not be reclassified for failure to intended effect of this action is to
List of Subjects in 40 CFR Part 52 attain by its applicable attainment date approve the revised program into the
Environmental protection, Air pursuant to section 181(b)(2)(A). Rhode Island SIP. This action is being
pollution control, Incorporation by taken in accordance with the Clean Air
reference, Ozone, Reporting and
Subpart VV—Virginia Act (CAA).
recordkeeping requirements. DATES: This direct final rule will be
■ 4. In § 52.2430, paragraph (c) is added effective January 16, 2018, unless EPA
Dated: October 27, 2017. receives adverse comments by
to read as follows:
Cosmo Servidio, December 14, 2017. If adverse
Regional Administrator, Region III. § 52.2430 Determinations of attainment. comments are received, EPA will
40 CFR part 52 is amended as follows: * * * * * publish a timely withdrawal of the
(c) Based upon EPA’s review of the air direct final rule in the Federal Register
PART 52—APPROVAL AND informing the public that the rule will
quality data for the 3-year period 2013
PROMULGATION OF not take effect.
to 2015, the Washington, DC-MD-VA
IMPLEMENTATION PLANS ADDRESSES: Submit your comments,
marginal ozone nonattainment area has
attained the 2008 8-hour ozone national identified by Docket ID No. EPA–R01–
■ 1. The authority citation for part 52
ambient air quality standard (NAAQS) OAR–2009–0436 at
continues to read as follows:
www.regulations.gov, or via email to
Authority: 42 U.S.C. 7401 et seq. by the applicable attainment date of July
garcia.ariel@epa.gov. For comments
20, 2016. Therefore, EPA has met the
submitted at Regulations.gov, follow the
Subpart J—District of Columbia requirement pursuant to Clean Air Act online instructions for submitting
section 181(b)(2)(A) to determine, based comments. Once submitted, comments
■ 2. In § 52.475, paragraph (c) is added on the area’s air quality as of the
to read as follows: cannot be edited or removed from
attainment date, whether the area Regulations.gov. For either manner of
§ 52.475 Determinations of attainment. attained the standard. EPA also submission, the EPA may publish any
* * * * * determined that the Washington, DC- comment received to its public docket.
(c) Based upon EPA’s review of the air MD-VA marginal nonattainment area Do not submit electronically any
quality data for the 3-year period 2013 will not be reclassified for failure to information you consider to be
to 2015, the Washington, DC-MD-VA attain by its applicable attainment date Confidential Business Information (CBI)
marginal ozone nonattainment area has pursuant to section 181(b)(2)(A). or other information whose disclosure is
attained the 2008 8-hour ozone national [FR Doc. 2017–24537 Filed 11–13–17; 8:45 am] restricted by statute. Multimedia
ambient air quality standard (NAAQS) BILLING CODE 6560–50–P
submissions (audio, video, etc.) must be
by the applicable attainment date of July accompanied by a written comment.
jstallworth on DSKBBY8HB2PROD with RULES
20, 2016. Therefore, EPA has met the The written comment is considered the
requirement pursuant to Clean Air Act official comment and should include
section 181(b)(2)(A) to determine, based discussion of all points you wish to
on the area’s air quality as of the make. The EPA will generally not
attainment date, whether the area consider comments or comment
attained the standard. EPA also contents located outside of the primary
determined that the Washington, DC- submission (i.e., on the Web, cloud, or
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Document Created: 2018-10-25 10:33:13
Document Modified: 2018-10-25 10:33:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This final rule is effective on December 14, 2017. | |
| Contact | Gavin Huang, (215) 814-2042, or by email at [email protected] | |
| FR Citation | 82 FR 52651 | |
| CFR Associated | Environmental Protection; Air Pollution Control; Incorporation by Reference; Ozone and Reporting and Recordkeeping Requirements |
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