Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations 52651 

information in part 807, subpart E, 

regarding premarket notification 

submissions, have been approved under 

OMB control number 0910–0120; and 

the collections of information in 21 CFR 

part 801, regarding labeling, have been 

approved under OMB control number 

0910–0485. 

List of Subjects in 21 CFR Part 876 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 876 is 

amended as follows: 

PART 876—GASTROENTEROLOGY– 

UROLOGY DEVICES 

■ 1. The authority citation for part 876 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Add § 876.5550 to subpart F to read 

as follows: 

§ 876.5550 Prostatic artery embolization 

device. 

(a) Identification. A prostatic artery 

embolization device is an intravascular 

implant intended to occlude the 

prostatic arteries to prevent blood flow 

to the targeted area of the prostate, 

resulting in a reduction of lower urinary 

tract symptoms related to benign 

prostatic hyperplasia. This does not 

include cyanoacrylates and other 

embolic agents which act by in situ 

polymerization or precipitation, or 

embolization devices used in 

neurovascular applications (see 21 CFR 

882.5950). 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The device must be demonstrated 

to be biocompatible. 

(2) Non-clinical performance testing 

must demonstrate that the device 

performs as intended under anticipated 

conditions of use. The following 

performance characteristics must be 

tested: 

(i) Evaluation of suitability for 

injection through catheters intended for 

use in embolization; and 

(ii) Evaluation of the size distribution 

of the device. 

(3) Performance data must support the 

sterility and pyrogenicity of the device. 

(4) Performance data must support the 

shelf life of the device by demonstrating 

continued sterility, package integrity, 

and device functionality over the 

identified shelf life. 

(5) Clinical data must evaluate postembolization damage due to non-target 

embolization under anticipated use 

conditions. 

(6) The labeling must include: 

(i) Specific instructions on safe device 

preparation and use; 

(ii) The device shelf life; 

(iii) Data regarding urinary retention; 

and 

(iv) Data regarding post-prostatic 

artery embolization syndrome. 

Dated: November 7, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–24586 Filed 11–13–17; 8:45 am] 

BILLING CODE 4164–01–P 

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 


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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 fourthhighest 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 


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1As discussed in Comment 6, the EPA Clean Air 

Markets Division (CAMD) analysis for the Beltsville 

CASTNET monitor also did not perform a 

substitution analysis. 

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-ArlingtonAlexandria, 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. 

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 


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52654 Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations 

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, 


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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 

■ 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 

■ 2. In § 52.475, paragraph (c) is added 

to read as follows: 

§ 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, DCMD-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 

■ 3. In § 52.1082, paragraph (k) is added 

to read as follows: 

§ 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, DCMD-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 

■ 4. In § 52.2430, paragraph (c) is added 

to read as follows: 

§ 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, DCMD-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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R01–OAR–2009–0436; FRL–9970–66– 

Region 1] 

Air Plan Approval; Rhode Island; 

Enhanced Motor Vehicle Inspection 

and Maintenance Program 

AGENCY: Environmental Protection 

Agency. 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving State 

Implementation Plan (SIP) revisions 

submitted by the State of Rhode Island. 

These revisions include regulations to 

update the enhanced motor vehicle 

inspection and maintenance (I/M) 

program in Rhode Island. The revised 

program includes a test and repair 

network consisting of on-board 

diagnostic (OBD2) testing for model year 

1996 and newer vehicles and tailpipe 

exhaust test, using a dynamometer, for 

model year 1995 and older vehicles. The 

intended effect of this action is to 

approve the revised program into the 

Rhode Island SIP. This action is being 

taken in accordance with the Clean Air 

Act (CAA). 

DATES: This direct final rule will be 

effective January 16, 2018, unless EPA 

receives adverse comments by 

December 14, 2017. If adverse 

comments are received, EPA will 

publish a timely withdrawal of the 

direct final rule in the Federal Register 

informing the public that the rule will 

not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R01– 

OAR–2009–0436 at 

www.regulations.gov, or via email to 

garcia.ariel@epa.gov. For comments 

submitted at Regulations.gov, follow the 

online instructions for submitting 

comments. Once submitted, comments 

cannot be edited or removed from 

Regulations.gov. For either manner of 

submission, the EPA may publish any 

comment received to its public docket. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. Multimedia 

submissions (audio, video, etc.) must be 

accompanied by a written comment. 

The written comment is considered the 

official comment and should include 

discussion of all points you wish to 

make. The EPA will generally not 

consider comments or comment 

contents located outside of the primary 

submission (i.e., on the Web, cloud, or 


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