Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Rules and Regulations 39369 

■ 3. Section 52.1075 is amended by 

adding paragraph (r) to read as follows: 

§ 52.1075 Base year emissions inventory. 

* * * * * 

(r) EPA approves as a revision to the 

Maryland state implementation plan the 

2011 base year emissions inventory for 

the Baltimore, Maryland moderate 

nonattainment area for the 2008 8-hour 

ozone national ambient air quality 

standards submitted by the Maryland 

Department of the Environment on 

December 30, 2016. The 2011 base year 

emissions inventory includes emissions 

estimates that cover the general source 

categories of stationary point, quasipoint, area (nonpoint), nonroad mobile, 

onroad mobile, and Marine-Air-Rail (M– 

A–R). The inventory includes actual 

annual emissions and typical summer 

day emissions for the months of May 

through September for the ozone 

precursors, VOC and NOX. 

[FR Doc. 2018–16992 Filed 8–8–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 81 

[EPA–HQ–OAR–2012–0918; FRL–9981–95– 

OAR] 

Air Quality Designations for the 2012 

Primary Annual Fine Particle (PM2.5) 

National Ambient Air Quality Standard 

(NAAQS) for Areas in Florida 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is establishing initial air 

quality designations for the 2012 

primary annual fine particle (PM2.5) 

National Ambient Air Quality Standard 

(NAAQS) for the remaining 

undesignated areas in the state of 

Florida. When the EPA designated the 

majority of areas in the country for this 

NAAQS in December 2014 and March 

2015, the EPA deferred initial area 

designations for certain areas, including 

all of the Florida, because the EPA 

could not determine using available 

data whether the areas were meeting or 

not meeting the NAAQS. In August 

2016, the EPA designated most of the 

state of Florida (62 of 67 counties). 

Following the August 2016 designation 

action, two areas (five counties) in 

Florida remained undesignated. The 

EPA could not determine at that time 

whether the areas were meeting or not 

meeting the NAAQS. Florida has now 

submitted complete, quality-assured, 

and certified air quality monitoring data 

for the period 2015–2017 for the areas 

identified in this action. Based on these 

data, the EPA is designating the 

remaining five counties as 

unclassifiable/attainment for the 2012 

primary annual PM2.5 NAAQS. 

DATES: This final rule is effective on 

September 10, 2018. 

ADDRESSES: The EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–OAR–2012–0918. All 

documents in the docket are listed in 

the index at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

i.e., Confidential Business Information 

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 either 

electronically in the docket or in hard 

copy at the EPA Docket Center, William 

Jefferson Clinton West Building, Room 

3334, 1301 Constitution Avenue NW, 

Washington, DC. The Public Reading 

Room is open from 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

legal holidays. The telephone number 

for the Public Reading Room is (202) 

566–1744 and the telephone number for 

the Air Docket is (202) 566–1742. 

In addition, the EPA has established 

a website for the rulemakings to initially 

designate areas for the 2012 primary 

annual PM2.5 NAAQS at: https://

www.epa.gov/particle-pollutiondesignations. This website includes the 

EPA’s final PM2.5 designations actions, 

as well as state and tribal initial 

recommendation letters, the EPA’s 

modification letters, technical support 

documents, responses to comments and 

other related technical information. 

FOR FURTHER INFORMATION CONTACT: For 

general questions concerning this 

action, please contact: Carla Oldham, 

U.S. EPA, Office of Air Quality Planning 

and Standards, Air Quality Policy 

Division, C539–04, Research Triangle 

Park, NC 27711, telephone (919) 541– 

3347, email at oldham.carla@epa.gov. 

The Region 4 contact is Madolyn 

Sanchez, U.S. EPA, Air Regulatory 

Management Section, Air Planning and 

Implementation Branch, Air, Pesticides 

and Toxics Management Division, 61 

Forsyth Street SW, Atlanta, Georgia 

30303–8960, telephone (404) 562–9644, 

email at sanchez.madolyn@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 14, 2012, the EPA 

promulgated a revised primary annual 

PM2.5 NAAQS to provide increased 

protection of public health from fine 

particle pollution (78 FR 3086; January 

15, 2013). In that action, the EPA 

strengthened the primary annual PM2.5

standard from 15.0 micrograms per 

cubic meter (mg/m3) to 12.0 mg/m3, 

which is attained when the 3-year 

average of the annual arithmetic means 

does not exceed 12.0 mg/m3. Section 

107(d) of the Clean Air Act (CAA), 42 

U.S.C. 7407(d), governs the process for 

initial area designations after the EPA 

establishes a new or revised NAAQS. 

Under CAA section 107(d), each 

governor is required to, and each tribal 

leader may, if they so choose, 

recommend air quality designations to 

the EPA by a date that cannot be later 

than 1 year after the promulgation of a 

new or revised NAAQS. The EPA 

considers these recommendations as 

part of its duty to promulgate the area 

designations and boundaries for the new 

or revised NAAQS. If, after careful 

consideration of these 

recommendations, the EPA believes that 

it is necessary to modify a state’s 

recommendation and intends to 

promulgate a designation different from 

a state’s recommendation, the EPA must 

notify the state at least 120 days prior 

to promulgating the final designation 

and the EPA must provide the state an 

opportunity to demonstrate why any 

proposed modification is inappropriate. 

These modifications may relate either to 

an area’s designation or to its 

boundaries. 

On December 18, 2014, the 

Administrator of the EPA signed a final 

action promulgating initial designations 

for the 2012 PM2.5 NAAQS for the 

majority of the United States, including 

areas of Indian country (80 FR 2206 FR; 

January 15, 2015). In that action, the 

EPA also deferred initial area 

designations for certain areas where 

available data, including air quality 

monitoring data, were insufficient to 

determine whether the area met or did 

not meet the NAAQS, but where 

forthcoming data were likely to result in 

complete and valid air quality data 

sufficient to determine whether these 

areas meet the NAAQS. Accordingly, 

the EPA stated that it would use the 

additional time available as provided 

under section 107(d)(1)(B) of the CAA to 

assess relevant information and 

subsequently promulgate initial 

designations for the identified areas 

through a separate rulemaking action or 

actions. The deferred areas included the 

entire state of Tennessee, except three 

counties in the Chattanooga area; 

several areas in the state of Georgia, 

including two neighboring counties in 


sradovich on DSK3GMQ082PROD with RULES
39370 Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Rules and Regulations 

1See also the technical support document for the 

deferred Florida areas in the rulemaking docket, 

documents numbered EPA–HQ–OAR–2012–0918– 

0323 and EPA–HQ–2012–0918–0332. 

2Monitoring requirements are in accordance with 

40 CFR part 58. Design values are calculated in 

accordance with 40 CFR part 50, Appendix N. 

the bordering states of Alabama and 

South Carolina; the entire state of 

Florida; and areas of Indian country 

located in these areas. 

In separate actions published on April 

15, 2015 (80 FR 18535), September 6, 

2016 (81 FR 61136), and May 19, 2017 

(82 FR 22888), the EPA promulgated 

designations of unclassifiable/ 

attainment for all remaining deferred 

areas in the state of Georgia (including 

two neighboring counties in the 

bordering states of Alabama and South 

Carolina), all of the remaining deferred 

areas in the state of Tennessee, and 62 

counties in the state of Florida, 

including areas of Indian country 

located in those areas. 

II. Purpose and Designation Decisions 

Based on 2015–2017 Data 

The purpose of this action is to 

announce and promulgate initial area 

designations of unclassifiable/ 

attainment for the 2012 PM2.5 NAAQS 

for the remaining five undesignated 

counties in the state of Florida. The 

counties are: Alachua County, Broward 

County, Gilchrist County, Miami-Dade 

County, and Palm Beach County. 

Alachua and Gilchrist Counties make up 

the Gainesville, FL Core Based 

Statistical Area (CBSA). Broward, 

Miami-Dade, and Palm Beach Counties 

make up the Miami-Fort LauderdaleWest Palm Beach Counties CBSA. The 

EPA initially deferred designating these 

counties in the EPA’s January 15, 2015, 

rulemaking.1 Since then, the state of 

Florida has submitted to the EPA 

complete, quality-assured, and certified 

air quality monitoring data from 2015– 

2017 for the two CBSAs.2 The air 

quality data indicate that the CBSAs are 

attaining the 2012 PM2.5 NAAQS. In 

addition, because there are no nearby 

violating areas, the counties in these 

CBSAs are not causing or contributing 

to a violation of the 2012 PM2.5 NAAQS 

in a nearby area. Therefore, the EPA is 

designating the remaining five 

undesignated counties in these CBSAs 

as unclassifiable/attainment. These 

designations are consistent with 

Florida’s recommended area 

designations and boundaries for these 

areas for the 2012 PM2.5 NAAQS. The 

table at the end of this final rule 

(amendments to 40 CFR 81.310— 

Florida) lists all areas for which the EPA 

has promulgated an initial designation 

in Florida. Areas of Indian country 

located in the listed areas are included 

in the designated areas. 

III. Environmental Justice 

Considerations 

When the EPA establishes a new or 

revised NAAQS, the CAA requires the 

EPA to designate all areas of the U.S. as 

either nonattainment, attainment, or 

unclassifiable. The EPA provided a 

meaningful opportunity for members of 

the public to participate in the 

development of the 2012 primary 

annual PM2.5 NAAQS that underlies the 

present action, including conducting an 

outreach and information call with 

environmental justice organizations on 

August 9, 2012. 

As part of the process of reviewing the 

PM air quality criteria and revising the 

primary annual PM2.5 NAAQS, the EPA 

identified persons from lower 

socioeconomic strata as an at-risk 

population for PM-related health effects. 

As a result, the EPA carefully evaluated 

the potential impacts on low-income 

and minority populations. Based on this 

evaluation and consideration of public 

comments, the EPA eliminated spatial 

averaging provisions as part of the form 

of the primary annual PM2.5 NAAQS in 

order to avoid potential 

disproportionate impacts on at-risk 

populations, including populations 

from lower socioeconomic strata. See 78 

FR at 3267 (January 15, 2013). 

This final action addresses 

designation determinations for certain 

areas in Florida for the 2012 primary 

annual PM2.5 NAAQS. The CAA 

requires the EPA to determine through 

a designation process whether an area 

meets or does not meet any new or 

revised national primary or secondary 

NAAQS. The promulgation of area 

designations facilitates public 

understanding and awareness of the air 

quality in an area. For this action, the 

complete and valid monitoring data 

from Florida indicate that all the areas 

at issue in this action are meeting the 

2012 primary annual PM2.5 NAAQS. 

Furthermore, no area affected by this 

action is contributing to a violation of 

the 2012 primary annual PM2.5 NAAQS 

in a nearby area. 

IV. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

This action is exempt from review by 

the Office of Management and Budget 

because it responds to the CAA 

requirement to promulgate air quality 

designations after promulgation of a 

new or revised NAAQS. 

B. Executive Order 13771: Reducing 

Regulations and Controlling Regulatory 

Costs 

This action is not an Executive Order 

13771 regulatory action because actions 

such as air quality designations after 

promulgating a new revised NAAQS are 

exempt from review under Executive 

Order 12866. 

C. Paperwork Reduction Act (PRA) 

This action does not impose an 

information collection burden under the 

PRA. This action fulfills the nondiscretionary duty for the EPA to 

promulgate air quality designations after 

promulgation of a new or revised 

NAAQS and does not contain any 

information collection activities. 

D. Regulatory Flexibility Act (RFA) 

This designation action under CAA 

107(d) is not subject to the RFA. The 

RFA applies only to rules subject to 

notice and comment rulemaking 

requirements under the Administrative 

Procedure Act (APA), 5 U.S.C. 553, or 

any other statute. Section 107(d)(2)(B) of 

the CAA explicitly provides that 

designations are exempt from the notice 

and comment provisions of the APA. In 

addition, designations under CAA 

section 107(d) are not among the list of 

actions that are subject to the notice and 

comment procedures of CAA section 

307(d). 

E. Unfunded Mandates Reform Act 

(UMRA) 

This action does not contain any 

unfunded mandate as described in 

UMRA, 2 U.S.C. 1531–1538 and does 

not significantly or uniquely affect small 

governments. The action implements 

mandates specifically and explicitly set 

forth in the CAA for the 2012 primary 

annual PM2.5 NAAQS (40 CFR 50.18). 

The CAA establishes the process 

whereby states take primary 

responsibility for developing plans to 

meet the 2012 primary annual PM2.5

NAAQS. 

F. Executive Order 13132: Federalism 

This action does not have federalism 

implications. It will not have substantial 

direct effects on the states, on the 

relationship between the national 

government and the states, or on the 

distribution of power and 

responsibilities among the various 

levels of government. 


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Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Rules and Regulations 39371 

G. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have tribal 

implications. It will neither impose 

substantial direct compliance costs on 

federally recognized tribal governments, 

nor preempt tribal law. The CAA 

provides for states and eligible tribes to 

develop plans to regulate emissions of 

air pollutants within their areas, as 

necessary, based on the designations. 

The TAR provides tribes the 

opportunity to apply for eligibility to 

develop and implement CAA programs, 

such as programs to attain and maintain 

the PM2.5 NAAQS, but it leaves to the 

discretion of the tribe the decision of 

whether to apply to develop these 

programs and which programs, or 

appropriate elements of a program, the 

tribe will seek to adopt. This rule does 

not have a substantial direct effect on 

one or more Indian tribes. 

H. Executive Order 13045: Protection of 

Children From Environmental Health 

and Safety Risks 

The EPA interprets Executive Order 

13045 as applying to those regulatory 

actions that concern environmental 

health or safety risks that the EPA has 

reason to believe may 

disproportionately affect children, per 

the definition of ‘‘covered regulatory 

action’’ in section 2–202 of the 

Executive Order. This action is not 

subject to Executive Order 13045 

because it does not establish an 

environmental standard intended to 

mitigate health or safety risks. 

I. Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution or Use 

This action is not subject to Executive 

Order 13211, because it is not a 

significant regulatory action under 

Executive Order 12866. 

J. National Technology Transfer and 

Advancement Act (NTTAA) 

This rulemaking does not involve 

technical standards. 

K. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

The EPA believes that this action does 

not have disproportionately high and 

adverse human health of environmental 

effects on minority populations, lowincome populations and/or indigenous 

peoples, as specified in Executive Order 

12898 (59 FR 7629, February 16, 1994). 

The documentation for this 

determination is contained in Section III 

of this preamble, ‘‘Environmental 

Justice Considerations.’’ 

L. Congressional Review Act (CRA) 

This action is subject to the CRA, and 

the EPA will submit a rule report to 

each House of the Congress and to the 

Comptroller General of the U.S. This 

action is not a ‘‘major rule’’ as defined 

by 5 U.S.C. 804(2). 

M. Judicial Review 

Section 307 (b)(1) of the CAA 

indicates which Federal Courts of 

Appeal have venue for petitions of 

review of final actions by the EPA. This 

section provides, in part, that petitions 

for review must be filed in the Court of 

Appeals for the District of Columbia 

Circuit: (i) When the agency action 

consists of ‘‘nationally applicable 

regulations promulgated, or final actions 

taken by the Administrator,’’ or (ii) 

when such action is locally or regionally 

applicable, if ‘‘such action is based on 

a determination of nationwide scope or 

effect and if in taking such action the 

Administrator finds and publishes that 

such action is based on such a 

determination.’’ 

This final action, in conjunction with 

the previous final actions designating 

areas across the U.S. for the 2012 

primary annual PM2.5 NAAQS, is 

‘‘nationally applicable’’ within the 

meaning of section 307(b)(1). At the core 

of this final action is the EPA’s 

interpretations of the definitions of 

nonattainment, attainment and 

unclassifiable under section 107(d)(1) of 

the CAA, and its application of those 

interpretations to areas across the 

country. For the same reasons, the 

Administrator is also determining that 

the final designations are of nationwide 

scope and effect for the purposes of 

section 307(b)(1) of the CAA. This is 

particularly appropriate because, in the 

report on the 1977 Amendments that 

revised section 307(b)(1) of the CAA, 

Congress noted that the Administrator’s 

determination that an action is of 

‘‘nationwide scope or effect’’ would be 

appropriate for any action that has a 

scope or effect beyond a single judicial 

circuit. H.R. Rep. No. 95–294 at 323, 

324, reprinted in 1977 U.S.C.C.A.N. 

1402–03. Here, the scope and effect of 

this final action extends to numerous 

judicial circuits since the designations 

apply to areas across the country. In 

these circumstances, section 307(b)(1) 

and its legislative history calls for the 

Administrator to find the action to be of 

‘‘nationwide scope or effect’’ and for 

venue to be in the D.C. Circuit. 

Thus, any petitions for review of final 

designations must be filed in the Court 

of Appeals for the District of Columbia 

Circuit within 60 days from the date 

final action is published in the Federal 

Register. 

List of Subjects in 40 CFR Part 81 

Environmental protection, Air 

pollution control, National parks, 

Wilderness areas. 

Dated: July 31, 2018. 

Andrew R. Wheeler, 

Acting Administrator. 

For the reasons set forth in the 

preamble, 40 CFR part 81 is amended as 

follows: 

PART 81—DESIGNATIONS OF AREAS 

FOR AIR QUALITY PLANNING 

PURPOSES 

■ 1. The authority citation for part 81 

continues to read as follows: 

Authority: 42 U.S.C. 7401, et seq. 

Subpart C—Section 107 Attainment 

Status Designations 

■ 2. Section 81.310 is amended by 

revising the table titled, ‘‘Florida—2012 

Annual PM2.5 NAAQS (Primary)’’ to 

read as follows: 

§ 81.310 Florida. 

* * * * * 

FLORIDA—2012 ANNUAL PM2.5 NAAQS 

[Primary] 

Designated area 1

Designation Classification 

Date 2 Type Date 2 Type 

Statewide: 

Alachua County ............................ 9/10/2018 Unclassifiable/Attainment.

Baker County ................................ ........................ Unclassifiable/Attainment.


sradovich on DSK3GMQ082PROD with RULES
39372 Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Rules and Regulations 

FLORIDA—2012 ANNUAL PM2.5 NAAQS—Continued 

[Primary] 

Designated area 1

Designation Classification 

Date 2 Type Date 2 Type 

Bay County ................................... ........................ Unclassifiable/Attainment.

Bradford County ............................ ........................ Unclassifiable/Attainment.

Brevard County ............................. ........................ Unclassifiable/Attainment.

Broward County ............................ 9/10/2018 Unclassifiable/Attainment.

Calhoun County ............................ ........................ Unclassifiable/Attainment.

Charlotte County ........................... ........................ Unclassifiable/Attainment.

Citrus County ................................ ........................ Unclassifiable/Attainment.

Clay County .................................. ........................ Unclassifiable/Attainment.

Collier County ............................... ........................ Unclassifiable/Attainment.

Columbia County .......................... ........................ Unclassifiable/Attainment.

DeSoto County ............................. ........................ Unclassifiable/Attainment.

Dixie County ................................. ........................ Unclassifiable/Attainment.

Duval County ................................ ........................ Unclassifiable/Attainment.

Escambia County .......................... ........................ Unclassifiable/Attainment.

Flagler County .............................. ........................ Unclassifiable/Attainment.

Franklin County ............................. ........................ Unclassifiable/Attainment.

Gadsden County ........................... ........................ Unclassifiable/Attainment.

Gilchrist County ............................ 9/10/2018 Unclassifiable/Attainment.

Glades County .............................. ........................ Unclassifiable/Attainment.

Gulf County ................................... ........................ Unclassifiable/Attainment.

Hamilton County ........................... ........................ Unclassifiable/Attainment.

Hardee County .............................. ........................ Unclassifiable/Attainment.

Hendry County .............................. ........................ Unclassifiable/Attainment.

Hernando County .......................... ........................ Unclassifiable/Attainment.

Highlands County ......................... ........................ Unclassifiable/Attainment.

Hillsborough County ..................... ........................ Unclassifiable/Attainment.

Holmes County ............................. ........................ Unclassifiable/Attainment.

Indian River County ...................... ........................ Unclassifiable/Attainment.

Jackson County ............................ ........................ Unclassifiable/Attainment.

Jefferson County ........................... ........................ Unclassifiable/Attainment.

Lafayette County ........................... ........................ Unclassifiable/Attainment.

Lake County .................................. ........................ Unclassifiable/Attainment.

Lee County ................................... ........................ Unclassifiable/Attainment.

Leon County ................................. ........................ Unclassifiable/Attainment.

Levy County .................................. ........................ Unclassifiable/Attainment.

Liberty County ............................... ........................ Unclassifiable/Attainment.

Madison County ............................ ........................ Unclassifiable/Attainment.

Manatee County ........................... ........................ Unclassifiable/Attainment.

Marion County .............................. ........................ Unclassifiable/Attainment.

Martin County ............................... ........................ Unclassifiable/Attainment.

Miami-Dade County ...................... 9/10/2018 Unclassifiable/Attainment.

Monroe County ............................. ........................ Unclassifiable/Attainment.

Nassau County ............................. ........................ Unclassifiable/Attainment.

Okaloosa County .......................... ........................ Unclassifiable/Attainment.

Okeechobee County ..................... ........................ Unclassifiable/Attainment.

Orange County ............................. ........................ Unclassifiable/Attainment.

Osceola County ............................ ........................ Unclassifiable/Attainment.

Palm Beach County ...................... 9/10/2018 Unclassifiable/Attainment.

Pasco County ............................... ........................ Unclassifiable/Attainment.

Pinellas County ............................. ........................ Unclassifiable/Attainment.

Polk County .................................. ........................ Unclassifiable/Attainment.

Putnam County ............................. ........................ Unclassifiable/Attainment.

St. Johns County .......................... ........................ Unclassifiable/Attainment.

St. Lucie County ........................... ........................ Unclassifiable/Attainment.

Santa Rosa County ...................... ........................ Unclassifiable/Attainment.

Sarasota County ........................... ........................ Unclassifiable/Attainment.

Seminole County .......................... ........................ Unclassifiable/Attainment.

Sumter County .............................. ........................ Unclassifiable/Attainment.

Suwanee County .......................... ........................ Unclassifiable/Attainment.

Taylor County ............................... ........................ Unclassifiable/Attainment.

Union County ................................ ........................ Unclassifiable/Attainment.

Volusia County .............................. ........................ Unclassifiable/Attainment.

Wakulla County ............................. ........................ Unclassifiable/Attainment.

Walton County .............................. ........................ Unclassifiable/Attainment.

Washington County ...................... ........................ Unclassifiable/Attainment.

1 Includes areas of Indian country located in each county or area, except as otherwise specified. 

2This date is October 6, 2016, unless otherwise noted. 


sradovich on DSK3GMQ082PROD with RULES
Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Rules and Regulations 39373 

* * * * * 

[FR Doc. 2018–17080 Filed 8–8–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0315; FRL–9980–51] 

Cerevisane (Cell Walls of 

Saccharomyces cerevisiae Strain 

LAS117); Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for cerevisane (cell walls of 

Saccharomyces cerevisiae strain 

LAS117) in or on all food commodities 

when used in accordance with label 

directions and good agricultural 

practices. Lesaffre Yeast Corporation 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA) requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of cerevisane (cell walls of 

Saccharomyces cerevisiae strain 

LAS117) under FFDCA. 

DATES: This regulation is effective 

August 9, 2018. Objections and requests 

for hearings must be received on or 

before October 9, 2018, and must be 

filed in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2017–0315, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW, Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Robert McNally, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; main telephone number: 

(703) 305–7090; email address: 

BPPDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/text-idx?&c=

ecfr&tpl=/ecfrbrowse/Title40/40tab_

02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a(g), any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2017–0315 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before October 9, 2018. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2017–0315, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW, Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

available at http://www.epa.gov/ 

dockets. 

II. Background 

In the Federal Register of March 6, 

2018 (83 FR 9471) (FRL–9973–27), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

tolerance petition (PP 6F8535) by 

Technology Sciences Group Inc., 712 

Fifth Street, Suite A, Davis, CA 95616 

(on behalf of Lesaffre Yeast Corporation, 

7475 W Main St., Milwaukee, WI 

53214). The petition requested that 40 

CFR 180 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of the systemic 

resistance inducer (SRI) cerevisane (cell 

walls of Saccharomyces cerevisiae 

strain LAS117) in or on all food 

commodities. That document referenced 

a summary of the petition prepared by 

the petitioner, Technology Sciences 

Group Inc., (on behalf of Lesaffre Yeast 

Corporation), which is available in the 

docket via http://www.regulations.gov. 

There were no relevant comments 

received in response to the notice of 

filing. 

III. Final Rule 

A. EPA’s Safety Determination 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 


sradovich on DSK3GMQ082PROD with RULES