1890 Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Rules and Regulations 

Subpart AA—Missouri 

■ 2. Section 52.1320(e) is amended by 

adding new entry (68) at the end of the 

table to read as follows: 

§ 52.1320 Identification of plan. 

* * * * * 

(e) * * * 

EPA-APPROVED MISSOURI NONREGULATORY SIP PROVISIONS

Name of nonregulatory SIP 

provision 

Applicable geographic or nonattainment area State submittal 

date EPA approval date Explanation 

*******

(68) Missouri Early Progress 

Plan.

St. Louis ................................. 8/26/13 1/14/16 [Insert Federal Register citation].[EPA–R07–OAR–2015–0587; 

FRL–9941–01–Region 7]. 

[FR Doc. 2016–00428 Filed 1–13–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 52 and 70 

[EPA–R07–OAR–2013–0765; FRL–9940–97– 

Region 7] 

Approval and Promulgation of 

Implementation Plans; State of 

Kansas; Annual Emissions Fee and 

Annual Emissions Inventory 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule; technical 

amendment. 

SUMMARY: The Environmental Protection 

Agency (EPA) inadvertently approved 

and codified this action under both part 

52 (Approval and Promulgation of 

Implementation Plans) and part 70 

(State Operating Permit Programs). This 

technical amendment removes the part 

52 approval and codification and makes 

a clarification to part 70. 

DATES: This action is effective January 

14, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Lachala Kemp at (913) 551–7214, or by 

email at kemp.lachala@epa.gov. 

SUPPLEMENTARY INFORMATION: On 

January 27, 2014 (79 FR 4274), EPA 

published a direct final rule approving 

a SIP revision for Kansas that included 

revisions to K.A.R. 28–19–202 ‘‘Annual 

Emission Fees.’’ The rule revision 

amended KAR 28–19–202 ‘‘Annual 

Emissions Fees’’ to align the state’s 

reporting requirements with EPA’s 

reporting requirements, and was 

incorrectly approved and codified under 

part 52 and part 70. 

This rule also included revisions to 

the operating permits program, K.A.R 

28–19–517 ‘‘Class I Operating Permits; 

Annual Emissions Inventory.’’ This part 

70 appendix A revision added new 

paragraph (f) ‘‘The Kansas Department 

of Health and Environment submitted 

revisions to Kansas Administrative 

Record (KAR) 28–19–202 and 28–19– 

517 on April 15, 2011; approval of 

section (c) effective March 28, 2014.’’ 

This technical amendment removes 

the erroneous part 52 approval of KAR 

28–19–202 ‘‘Annual Emissions Fees’’ 

and recodifies the table. This action also 

revises paragraph (f) to read as follows: 

(f) ‘‘The Kansas Department of Health 

and Environment submitted revisions to 

Kansas Administrative Record (KAR) 

28–19–202 and 28–19–517 on April 15, 

2011; effective March 28, 2014.’’ 

List of Subjects 

40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Lead, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

40 CFR Part 70 

Administrative practice and 

procedure, Air pollution control, 

Intergovernmental relations, Operating 

permits, Reporting and recordkeeping 

requirements. 

Dated: December 23, 2015. 

Becky Weber, 

Acting Regional Administrator, Region 7. 

Chapter I, title 40 of the Code of 

Federal Regulations 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. 

§ 52.870 [Amended] 

■ 2. In § 52.870, paragraph(c) is 

amended by removing the table entry 

‘‘K.A.R. 28–19–202.’’ 

PART 70—STATE OPERATING PERMIT 

PROGRAMS 

■ 3. The authority citation for part 70 

continues to read as follows: 

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

■ 4. Appendix A is amended by revising 

paragraph (f) under Kansas to read as 

follows: 

Appendix A to Part 70—Approval 

Status of State and Local Operating 

Permits Programs 

* * * * * 

Kansas 

* * * * * 

(f) The Kansas Department of Health and 

Environment submitted revisions to Kansas 

Administrative Record (KAR) 28–19–202 and 

28–19–517 on April 15, 2011; effective March 

28, 2014. 

* * * * * 

[FR Doc. 2016–00573 Filed 1–13–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0538; FRL–9939–53] 

Aspergillus flavus AF36; Time Limited 

Exemption From the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited exemption from the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA) section 408(a) requirement of a 

tolerance for residues of the pesticide 

Aspergillus flavus AF36 in or on dried 

figs resulting from use in accordance 

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Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Rules and Regulations 1891 

with the terms of an emergency 

exemption issued under section 18 of 

the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA). This action is 

in response to the issuance of a crisis 

emergency exemption under FIFRA 

section 18 authorizing use of the 

pesticide on dried figs. The time-limited 

exemption from the requirement of a 

tolerance expires on December 31, 2017. 

DATES: This regulation is effective 

January 14, 2016. Objections and 

requests for hearings must be received 

on or before March 14, 2016, 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–2015–0538, 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: 

Susan T. Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@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 section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

21 U.S.C. 346a, 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–2015–0538 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 March 14, 2016. 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– 

2015–0538, 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 and Statutory Findings 

EPA, on its own initiative, in 

accordance with FFDCA sections 408(e) 

and 408(l)(6), 21 U.S.C. 346a(e) and 

346a(1)(6), is establishing a time-limited 

exemption from the requirement of a 

tolerance for residues of Aspergillus 

flavus AF36, in or on dried figs. This 

time-limited exemption from the 

requirement of a tolerance expires on 

December 31, 2017. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under FIFRA section 18. Such 

tolerances or exemptions from the 

requirement of a tolerance must be 

consistent with the safety standard in 

408(b)(2) and (c)(2), respectively, and 

can be established without providing 

notice or period for public comment. 

EPA does not intend for its actions on 

FIFRA section 18 related time-limited 

tolerances or exemptions from the 

requirement of a tolerance to set binding 

precedents for the application of FFDCA 

section 408 and the safety standard to 

other tolerances and exemptions. 

Section 408(e) of FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party. 

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

allows EPA to establish an exemption 

from the requirement of 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 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. In evaluating the 

safety of an exemption, section 

408(c)(2)(B) requires EPA to take into 

account the considerations set forth in 

408(b)(2)(C) and (D). Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

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1892 Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Rules and Regulations 

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’ 

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemption for 

Aspergillus flavus AF36 on Dried Figs 

and FFDCA Tolerances 

The California Department of 

Pesticide Regulation asserted that an 

emergency condition, brought on by an 

ongoing drought in California, existed in 

accordance with the criteria for 

approval of an emergency exemption, 

and utilized a crisis exemption under 

FIFRA section 18 to allow the use of 

Aspergillus flavus AF36 to reduce 

aflatoxin-producing fungi on dried figs 

in California. The California Department 

of Pesticide Regulation invoked the 

crisis exemption provision on June 15, 

2015. After having reviewed the crisis 

exemption, EPA concurred on the 

emergency action in order to meet the 

emergency needs of fig growers in 

California. The crisis exemption 

program expired on July 31, 2015. 

As part of its evaluation of the 

emergency exemption application, EPA 

assessed the potential risks presented by 

residues of Aspergillus flavus AF36 in 

or on dried figs. In doing so, EPA 

considered the safety standard in 

FFDCA section 408(c)(2), and EPA 

decided that the necessary exemption 

from the requirement of a tolerance 

under FFDCA section 408(l)(6) would be 

consistent with the safety standard and 

with FIFRA section 18. Consistent with 

the need to move quickly on the crisis 

exemption in order to address an urgent, 

non-routine situation and to ensure that 

the resulting food is safe and lawful, 

EPA is issuing this exemption from the 

requirement of a tolerance without 

notice and opportunity for public 

comment as provided in FFDCA section 

408(l)(6). This time-limited exemption 

from the requirement of a tolerance 

expires on December 31, 2017. EPA will 

take action to revoke the time-limited 

exemption from the requirement of a 

tolerance earlier if any experience with 

scientific data, or other relevant 

information on this pesticide indicates 

that the residues are not safe. 

Because this time-limited exemption 

from the requirement of a tolerance is 

being approved under emergency 

conditions, EPA has not made any 

decisions about whether Aspergillus 

flavus AF36 meets FIFRA’s registration 

requirements for use on dried figs or 

whether permanent tolerances or 

exemption from the requirement of a 

tolerance for this use would be 

appropriate. Under these circumstances, 

EPA does not believe that this timelimited exemption from the requirement 

of a tolerance serves as a basis for 

registration of Aspergillus flavus AF36 

by a State for special local needs under 

FIFRA section 24(c). Nor does this 

exemption from the requirement of a 

tolerance by itself serve as the authority 

for persons in any State other than 

California to use this pesticide on the 

applicable crop under FIFRA section 18 

absent the issuance of an emergency 

exemption applicable within that State. 

For additional information regarding the 

crisis exemption for Aspergillus flavus 

AF36, contact the Agency’s Registration 

Division at the address provided under 

FOR FURTHER INFORMATION CONTACT. 

IV. Toxicological Profile 

Consistent with the FFDCA section 

408(b)(2)(D), the EPA reviewed the 

available scientific data and other 

relevant information for Aspergillus 

flavus AF36, and considered its validity, 

completeness, and reliability, as well as 

the relationship of this information to 

human risk. The EPA also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. 

Aspergillus flavus refers to a diverse 

group of saprophytic soil fungi strains, 

which are ubiquitously distributed 

throughout the United States. This 

fungal group includes strains that 

produce aflatoxin (i.e., toxigenic strains) 

and strains that do not produce 

aflatoxins (i.e., atoxigenic strains). The 

toxigenic strains can cause aflatoxin 

contamination in seed, nut, and grain 

crops pre- and postharvest. In addition, 

toxigenic strains of several Aspergillus 

spp. can cause aspergillosis disease in 

humans (Ref. 1, 2). 

Aspergillus flavus AF36 is an 

atoxigenic strain registered as a 

microbial pesticide for use on cotton, 

corn, and pistachios. The AF36 strain is 

a soil colonizing fungus and displaces 

toxigenic strains through competition, 

thereby reducing aflatoxin levels on 

crops contaminated with toxigenic 

strains of Aspergillus spp. (Ref. 3). 

The toxicological profile of 

Aspergillus flavus were previously 

described in the Federal Register July 

14, 2003 (68 FR 41535) (FRL–7311–6) 

and the data were used to establish the 

tolerance exemption for Aspergillus 

flavus AF36 in or on cotton (see the 

Federal Register of July 14, 2003), corn 

(see the Federal Register of March 23, 

2011 (76 FR 16297) (FRL–8868–7)), and 

pistachio (see the Federal Register of 

March 9, 2012 (77 FR 14287) (FRL– 

9341–5). The studies used to establish 

the tolerance exemptions in or on 

cotton, corn, and pistachio tested the 

toxicity/pathogenicity of Aspergillus 

flavus AF36 to rats through acute oral 

and pulmonary exposures and did not 

find any evidence of toxicity or 

infection (Ref. 1). Further, when 

exposed through intratracheal dosing, 

rats cleared Aspergillus flavus AF36 

from their systems within 8 days. 

Moreover, rats exposed to Aspergillus 

flavus AF36 cleared the fungus from 

their body without compromising their 

immune system. After more than a 

decade of agricultural use in cotton and 

several years of use in corn and 

pistachio, there have not been any 

reports of hypersensitivity or other 

problems from workers exposed to 

Aspergillus flavus AF36. Therefore, 

based on the atoxigenic profile of 

Aspergillus flavus AF36, and previous 

toxicological evaluations to establish 

tolerance exemptions in or on cotton 

(see the Federal Register of July 14, 

2003), corn (see the Federal Register of 

March 23, 2011), and pistachio (see the 

Federal Register of March 9, 2012), EPA 

concludes that there are no toxicological 

endpoints of concern for Aspergillus 

flavus AF36 and that there are no 

hazards associated with this particular 

isolate; therefore, any expected residues 

on food would be safe to consume. 

V. Aggregate Exposure 

In examining aggregate exposure, 

FFDCA section 408 directs the EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

Food exposure: Aspergillus flavus 

AF36 will be applied as a single 

broadcast application to soil in 

California fig orchards from mid-June to 

mid-July 2015. The proposed method of 

application is by grain seed (wheatinfested Aspergillus flavus AF36 

inoculum) applied to the orchard floor 

by ground. Grain seed inoculum is 

directed under the fig tree canopy where 

soil is wetted before and after the 

application. After application, 

Aspergillus flavus AF36 germinates 

using a grain carrier as a nutrient source 

and displaces aflatoxin-producing 

strains of Aspergillus flavus. Thus, the 

use of Aspergillus flavus AF36 in fig 

orchards should not increase the total 

Aspergillus flavus population in the 

environment (Ref. 1). Although, total 

Aspergillus flavus populations may 

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Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Rules and Regulations 1893 

increase immediately after applying 

Aspergillus flavus AF36, populations of 

Aspergillus flavus AF36 decline by 

spring of the year after application and 

there is no evidence of long term 

increases in populations of Aspergillus 

flavus resulting from application of 

Aspergillus flavus AF36. In addition, 

levels of natural Aspergillus flavus 

populations can fluctuate greatly over 

the course of a year (Ref. 1). Therefore, 

a temporary increase in Aspergillus 

flavus populations resulting from an 

application of Aspergillus flavus AF36 

are not expected to produce effects that 

do not already occur from exposure to 

natural Aspergillus flavus populations. 

Drinking water exposure: Similar to 

previous drinking water exposures for 

cotton and corn uses (see Federal 

Register of July 14, 2003 and March 23, 

2011) exposure to residues of 

Aspergillus flavus AF36 ensuing from 

application in fig orchards is possible as 

a result of consuming drinking water, 

but it is not likely to be greater than 

existing exposures to naturally 

occurring strains of Aspergillus flavus 

AF36. This time-limited exemption 

from the requirement of a tolerance will 

only allow for applications in California 

in an area where the climate is arid, 

which minimizes the potential for 

contamination of surface or ground 

water that may serve as a source of 

drinking water. Further, because 

Aspergillus flavus AF36 will only be 

applied as a granular formulation to 

terrestrial sites, offsite movement into 

water is not anticipated. If Aspergillus 

flavus AF36 residues should be present 

in drinking water, the results of a study 

assessing acute oral toxicity and 

pathogenicity found that no toxicity, 

pathogenicity, and/or infectivity is 

likely to occur from exposure to any 

level of Aspergillus flavus AF36 

resulting from an application of 

Aspergillus flavus AF36 made in 

accordance with good agricultural 

practice. 

Other non-occupational exposure: 

Non-occupational dermal and 

inhalation exposure is expected to be 

minimal to non-existent for the use of 

Aspergillus flavus AF36 on figs. As 

previously described in the Federal 

Register of July 14, 2003, March 23, 

2011, and March 9, 2012; Aspergillus 

flavus AF36 will be applied to 

agricultural sites and not in the 

proximity of schools, residential areas, 

nursing homes, or daycare facilities. 

Moreover, Aspergillus flavus AF36 will 

be applied in a granular form which will 

minimize drift and exposure. 

VI. Cumulative Effects From Substances 

With a Common Mechanism of Toxicity 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the EPA consider ‘‘available 

information concerning the cumulative 

effects of a particular pesticide’s . . . 

residues and other substances that have 

a common mechanism of toxicity.’’ 

The EPA has not found Aspergillus 

flavus AF36 to share a common 

mechanism of toxicity with any other 

substances, and Aspergillus flavus AF36 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

exemption from the requirement of a 

tolerance action, therefore, the EPA has 

assumed that Aspergillus flavus AF36 

does not have a common mechanism of 

toxicity with other substances since 

there is no indication of mammalian 

toxicity or pathogenicity resulting from 

exposure to Aspergillus flavus AF36. 

For information regarding the EPA’s 

efforts to determine chemicals that have 

a common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see the EPA’s Web site at 

http://www.epa.gov/pesticides/

cumulative. 

VII. Determination of Safety for the U.S. 

Population, Infants and Children 

In considering the establishment of a 

time-limited exemption from the 

requirement of a tolerance for a 

pesticide chemical residue, FFDCA 

section 408(b)(2)(C) requires that EPA 

assess the available information about 

consumption patterns among infants 

and children, special susceptibility of 

infants and children to pesticide 

chemical residues, and the cumulative 

effects on infants and children of the 

residues and other substances with a 

common mechanism of toxicity. In 

addition, FFDCA section 408(b)(2)(C) 

provides that EPA shall apply an 

additional tenfold (10X) margin of 

exposure (safety) for infants and 

children in the case of threshold effects 

to account for prenatal and postnatal 

toxicity and the completeness of the 

database on toxicity and exposure 

unless EPA determines that a different 

margin of exposure (safety) will be safe 

for infants and children. This additional 

margin of exposure (safety) is commonly 

referred to as the Food Quality 

Protection Act Safety Factor. In 

applying this provision, EPA either 

retains the default value of 10X or uses 

a different additional safety factor when 

reliable data available to EPA support 

the choice of a different factor. 

In this instance, based on all the 

available information, EPA concludes 

that there are no effects of concern to 

infants, children, or adults when 

Aspergillus flavus AF36 is used in 

accordance with the crisis exemption. 

As a result, EPA concludes that no 

additional margin of exposure (safety) is 

necessary to protect infants and 

children. 

Moreover, based on the data and EPA 

analysis presented in this document, the 

Agency is able to conclude that there is 

a reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to the residues of Aspergillus 

flavus AF36 when it is used as an 

antifungal agent in accordance with the 

crisis exemption. Such exposure 

includes all anticipated dietary 

exposures and all other exposures for 

which there is reliable information. As 

discussed previously, there is 

reasonable certainty of no harm via 

dietary exposure from this fungus when 

used as an antifungal agent because the 

microorganism is non-toxic and nonpathogenic to animals and humans. EPA 

arrived at this conclusion based on the 

very low levels of mammalian toxicity 

for acute oral and pulmonary effects 

with no toxicity or infectivity at the 

doses tested (see Unit IV. of this 

document). 

VIII. Other Considerations 

Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

IX. Conclusion 

The EPA concludes that there is a 

reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to residues of Aspergillus 

flavus AF36. Therefore, a time-limited 

exemption from the requirement of a 

tolerance is established for residues of 

Aspergillus flavus AF36 in or on dried 

figs when used in accordance with the 

crisis exemption. This time-limited 

exemption from the requirement of a 

tolerance for residues of Aspergillus 

flavus AF36 in or on dried figs will 

expire and is revoked on December 31, 

2017. 

X. References 

1. U.S. EPA. 2015. Human Health and 

Environmental Assessment for the 

California Section 18 (Emergency 

Exemption) request for the use of AF36, 

an end use formulation containing the 

active ingredient, Aspergillus flavus 

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1894 Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Rules and Regulations 

Strain AF36. Memorandum from G. 

Tomimatsu, Ph.D. and M. Djurickovic, 

M.S. to S. Borges. 

2. Jensen, A.B., K. Aronstein, J.M. Flores, S. 

Vojvodic, M.A. Palacio and M. Spivak. 

2013. Standard methods for fungal brood 

disease research. J. Apic. Res. 52 (1). 

3. Ehrlich, K.C. 2014. Non-aflatoxigenic 

Aspergillus flavus to prevent aflatoxin 

contamination in crops: Advantages and 

limitations. Front. Micro. http://dx.doi.

org/10.3389/fmicb.2014.00050. 

XI. Statutory and Executive Order 

Reviews 

This action establishes an exemption 

from the requirement of a tolerance 

under FFDCA sections 408(e) and 

408(l)(6). The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established in accordance with 

FFDCA sections 408(e) and 408(l)(6), 

such as the exemption in this final rule, 

do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

XII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 18, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.1206, add a new paragraph 

(d) to read as follows: 

§ 180.1206 Aspergillus flavus AF36; 

exemption from the requirement of a 

tolerance. 

* * * * * 

(d) Section 18 emergency exemptions. 

A time-limited exemption from the 

requirement of a tolerance is established 

for residues of Aspergillus flavus AF36, 

in or on dried figs, resulting from use of 

the pesticide pursuant to a FIFRA 

section 18 emergency exemption. This 

time-limited exemption from the 

requirement of a tolerance for residues 

of Aspergillus flavus AF36 in or on 

dried figs will expire and is revoked on 

December 31, 2017. 

[FR Doc. 2016–00665 Filed 1–13–16; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2015–0001; Internal 

Agency Docket No. FEMA–8417] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP) that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 

management requirements of the 

program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 

effective suspension date given in this 

rule, the suspension will not occur and 

a notice of this will be provided by 

publication in the Federal Register on a 

subsequent date. Also, information 

identifying the current participation 

status of a community can be obtained 

from FEMA’s Community Status Book 

(CSB). The CSB is available at http://

www.fema.gov/fema/csb.shtm. 

DATES: The effective date of each 

community’s scheduled suspension is 

the third date (‘‘Susp.’’) listed in the 

third column of the following tables. 

FOR FURTHER INFORMATION CONTACT: If 

you want to determine whether a 

particular community was suspended 

on the suspension date or for further 

information, contact Patricia Suber, 

Federal Insurance and Mitigation 

Administration, Federal Emergency 

Management Agency, 500 C Street SW., 

Washington, DC 20472, (202) 646–4149. 

SUPPLEMENTARY INFORMATION: The NFIP 

enables property owners to purchase 

Federal flood insurance that is not 

otherwise generally available from 

private insurers. In return, communities 

agree to adopt and administer local 

floodplain management measures aimed 

at protecting lives and new construction 

mstockstill on DSK4VPTVN1PROD with RULES