73934 Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations 

Name of nonregulatory SIP 

provision 

Applicable geographic or 

nonattainment area 

State submittal date/adopted 

date 

EPA approval date and citation 3 Explanations 

*******

XX. Wyoming State Implementation Plan for Regional 

Haze for 309.

Statewide ................................ Submitted: 1/12/2011 ............. 12/12/2012 [Insert Federal 

Register page number 

where the document begins]. 

3 In order to determine the EPA effective date for a specific provision listed in this table, consult the Federal Register notice cited in this column for the particular provision. 

[FR Doc. 2012–29985 Filed 12–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0669; FRL–9369–3] 

Bacillus subtilis Strain QST 713 Variant 

Soil; Amendment to an Exemption 

From the Requirement of a Tolerance 

for Bacillus subtilis Strain QST 713 To 

Include Residues of Bacillus subtilis 

Strain QST 713 Variant Soil 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

existing exemption from the 

requirement of a tolerance for residues 

of the Bacillus subtilis strain QST 713 in 

or on all food commodities by including 

residues of Bacillus subtilis strain QST 

713 variant soil. Agraquest, Inc. 

submitted a petition to the EPA under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), requesting an amendment 

to an existing exemption from the 

requirement of a tolerance for Bacillus 

subtilis strain QST 713 to include 

residues of products containing Bacillus 

subtilis strain QST 713 variant soil in or 

on all agricultural commodities. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of Bacillus subtilis strain 

QST 713 variant soil under the FFDCA. 

DATES: This regulation is effective 

December 12, 2012. Objections and 

requests for hearings must be received 

on or before February 11, 2013, 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–2011–0669, 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), EPA West 

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: 

Michael Glikes, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6231; email address: 

glikes.michael@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:// 

ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 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 the EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2011–0669 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 February 11, 2013. 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 CBI) for inclusion in the public 

docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by the EPA 

without prior notice. Submit the nonCBI copy of your objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0669, 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 

Confidential Business Information (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 


emcdonald on DSK67QTVN1PROD with 
Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations 73935 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

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 

In the Federal Register of September 

7, 2011 (76 FR 55329) (FRL–8886–7), 

the EPA issued a notice pursuant to 

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

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 1F7896) 

by Agraquest, Inc., 1540 Drew Ave., 

Davis, CA 95618. The petition requested 

that 40 CFR part 180.1209 be amended 

by including residues of Bacillus 

subtilis strain QST 713 variant soil. This 

notice referenced a summary of the 

petition prepared by the petitioner, 

Agraquest, Inc., which is available in 

the docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

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

allows the 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 the 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. Pursuant to 

FFDCA section 408(c)(2)(B), in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), which require 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 * * *.’’ Additionally, 

FFDCA section 408(b)(2)(D) requires 

that the Agency 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 performs a number of 

analyses to determine the risks from 

aggregate exposure to pesticide residues. 

First, the EPA determines the toxicity of 

pesticides. Second, the EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

Consistent with FFDCA section 

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

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability, and the 

relationship of this information to 

human risk. The EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Bacillus subtilis is a rod-shaped, 

gram-positive, aerobic flagellar 

bacterium that is ubiquitous in nature 

and has been recovered from water, soil, 

air, and decomposing plant residues 

(Ref 1.). The bacterium produces an 

endospore that allows it to endure 

extreme conditions of heat and 

desiccation in the environment (Ref. 1). 

Bacillus subtilis is not considered toxic 

or pathogenic to humans, animals, or 

plants (Ref. 2). Several strains of 

Bacillus subtilis are used predominantly 

as fungicidal active ingredients in 

various pesticides registered with the 

EPA. 

In 2000, the EPA first registered 

Bacillus subtilis strain QST 713 as a 

pesticide active ingredient. EPA 

described the nature and toxicological 

profile of Bacillus subtilis strain QST 

713 in the Federal Register of July 5, 

2000 (65 FR 41365) (FRL–6555–3) as the 

basis for establishing the tolerance 

exemption for Bacillus subtilis strain 

QST 713 in or on all food commodities 

at 40 CFR 180.1209. A battery of tests, 

as described in that Federal Register 

citation, determined that Bacillus 

subtilis strain QST 713 is not pathogenic 

and has no significant toxicity. The 

petitioner is now requesting that this 

tolerance be amended to include 

residues of Bacillus subtilis strain QST 

713 variant soil. Bacillus subtilis strain 

QST 713 variant soil is a naturally 

occurring variant of Bacillus subtilis 

strain QST 713 and is present in 

products containing the active 

ingredient Bacillus subtilis strain QST 

713, although at low levels (Ref. 3). The 

variant strain is distinguished from the 

parent strain by the presence of the 

swrA gene, which is an essential gene 

for Bacillus to move over solid 

substances, and by a phenotype 

associated with enhanced biofilm 

formation, growth promotion and 

disease protection (Ref. 3). Based on its 

review of the variant and studies 

submitted by the petitioner, EPA 

concludes that the variant and the 

parent strain are substantially similar 

for the purposes of assessing toxicity, 

pathogenicity and infectivity (Ref. 3). 

The applicant, Agraquest, Inc., cited 

or submitted adequate mammalian 

toxicology data and information to 

support the exemption from the 

requirement of a tolerance for residues 

of Bacillus subtilis strain QST 713 

variant soil in or on all raw agricultural 

commodities. These data are cited and 

described in the EPA’s March 2012 

Bacillus subtilis Final Registration 

Review Decision (Ref. 1). In addition, 

Agraquest submitted an acute injection 

toxicity/pathogenicity study (OCSPP 

Guideline 885.3200; MRID 48530909) 

that showed that Bacillus subtilis strain 

QST 713 variant soil TGAI was not 

toxic, infective, or pathogenic to rats 

when injected intravenously at a dose of 

6.6 × 108 colony forming units. 

The applicant reported that no 

hypersensitivity incidents occurred 

during research, development, or testing 

of Bacillus subtilis strain QST 713 

variant soil. Acceptable Tier I 

mammalian toxicology data and 

information support registration of the 

proposed end-use product, Serenade 

Soil DPZ. In light of the results of the 

acute toxicity/pathogenicity data and 

the absence of hypersensitivity 

incidents, the EPA did not require 

testing at higher tiers (i.e., Tiers II and 

III). 

IV. Aggregate Exposures 

In examining aggregate exposure, 

FFDCA section 408 directs 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). 

A. Dietary Exposure 

1. Food exposure. Due to the 

ubiquitous nature of the Bacillus subtilis 

and the concentrations of Bacillus 

subtilis and other closely related 

Bacillus species that already exist in the 

environment, the EPA expects human 

exposure to Bacillus subtilis strain QST 

713 variant soil resulting from the 

proposed pesticidal uses will be no 

greater than existing human exposure to 

background levels of Bacillus subtilis. 

The EPA in its registration review 

decision (Ref. 1) concluded ‘‘the risk 

posed to adults, infants, and children is 

likely to be minimal because of the low 

acute oral toxicity/pathogenicity 


emcdonald on DSK67QTVN1PROD with 
73936 Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations 

potential of Bacillus subtilis strain QST 

713.’’ Based on the EPA’s evaluation of 

the Bacillus subtilis strain QST 713 data 

and the EPA’s conclusion that Bacillus 

subtilis strain QST 713 and Bacillus 

subtilis strain QST 713 variant soil are 

substantially similar for the purposes of 

assessing toxicity, pathogenicity, and 

infectivity (Ref. 3), no adverse effects 

from dietary exposure to Bacillus 

subtilis strain QST 713 variant soil from 

its pesticidal uses are expected (see Unit 

III.). 

2. Drinking water exposure. Because 

Bacillus subtilis is ubiquitous in the 

environment, exposure to the microbe 

through drinking water may already be 

occurring and likely will continue (Ref. 

3). EPA expects exposures to Bacillus 

subtilis strain QST 713 variant soil to be 

not much greater than background 

levels because the proposed use patterns 

are soil directed and/or soil 

incorporated, thereby limiting contact 

with surface water by drift and runoff. 

Furthermore, ground water is not 

expected to have significant exposure to 

Bacillus subtilis strain QST 713 variant 

soil since, like other microorganisms, 

this microbial pesticide would likely be 

filtered out by the particulate nature of 

many soil types. If residues of Bacillus 

subtilis strain QST 713 variant soil were 

to be transferred to surface or ground 

waters that are intended for eventual 

human consumption (e.g., through spray 

drift or runoff) and directed to 

wastewater treatment systems or 

drinking water facilities, Bacillus 

subtilis strain QST 713 variant soil 

likely would not survive the conditions 

water is subjected to in such systems or 

facilities, including chlorination, pH 

adjustments, filtration, and/or 

occasional high temperatures. As 

discussed in the EPA’s Bacillus subtilis 

Case 6012, Final Registration Review 

Decision (Ref. 1), intake of low levels of 

ubiquitous Bacillus subtilis in drinking 

water may occur, but exposure would 

represent a minimal risk due to the low 

toxicity of the strain. Similarly, 

exposure to other strains of Bacillus 

subtilis would not represent a greater 

risk. It is reasonable to conclude, based 

on the similarity in product 

composition and production, measured 

physical/chemical, and pathogenicity/ 

infectivity toxicity data, that the risk 

from any potential exposure to Bacillus 

subtilis strain QST 713 variant soil 

resulting from the proposed pesticidal 

use would be minimal and equivalent to 

the risk from exposure to Bacillus 

subtilis strain QST 713. 

B. Other Non-occupational Exposures 

The use sites proposed for products 

containing Bacillus subtilis strain QST 

713 variant soil include both 

agricultural and residential garden sites, 

so the EPA expects there to be some 

non-occupational exposure as a result of 

the application of this pesticide. Given 

Bacillus subtilis strain QST 713 variant 

soil’s natural occurrence in soil, the 

EPA determined that non-occupational 

exposure to the bacterium likely is 

already occurring (Ref. 3). Additional 

exposure to the microorganism, due to 

pesticidal applications, is likely to occur 

but is not expected to exceed EPA’s 

level of concern, particularly in light of 

available data that demonstrate Bacillus 

subtilis strain QST 713 is not toxic 

(acute dermal toxicity and acute 

pulmonary toxicity/pathogenicity), nonirritating (primary dermal irritation), 

and not pathogenic (acute pulmonary 

toxicity/pathogenicity) and the EPA’s 

conclusion that Bacillus subtilis strain 

QST 713 and Bacillus subtilis strain 

QST 713 variant soil are substantially 

similar for the purposes of assessing 

toxicity, pathogenicity, and infectivity 

(Ref. 3). Based on the toxicity 

information submitted to the EPA, 

aggregate exposure to Bacillus subtilis 

strain QST 713 variant soil would be 

below the levels in the safety testing 

conducted on Bacillus subtilis strain 

QST 713 and would not represent an 

undue risk due to the lack of residues 

of toxicological concern and the low 

toxicity of the active ingredient. The 

EPA concluded that non-dietary 

exposures to the general population, 

including infants and children, would 

not be expected to pose any quantifiable 

risk due to a lack of residues of 

toxicological concern. 

V. 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 Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

Bacillus subtilis strain QST 713 

variant soil does not operate via a toxic 

mode of action and thus does not share 

a common mechanism of toxicity with 

any other substances. Therefore, section 

408(b)(2)(D)(v) does not apply. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

FFDCA section 408(b)(2)(C) provides 

that, in considering the establishment of 

a tolerance or tolerance exemption for a 

pesticide chemical residue, EPA shall 

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. 

Based on the information discussed in 

Unit III.B., EPA concludes that there are 

no threshold effects of concern to 

infants, children, or adults when 

Bacillus subtilis strain QST 713 variant 

soil is used as labeled in accordance 

with good agricultural practices. As a 

result, EPA concludes that no additional 

margin of exposure (safety) is necessary 

to protect infants and children and that 

not adding any additional margin of 

exposure (safety) will be safe for infants 

and children. 

Moreover, based on the same data and 

EPA analysis as presented directly 

above, 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 Bacillus subtilis strain QST 

713 variant soil when it is used as 

labeled and in accordance with good 

agricultural practices. Such exposure 

includes all anticipated dietary 

exposures and all other exposures for 

which there is reliable information. As 

discussed previously, there appears to 

be no potential for harm from this 

bacterium in its use as an antifungal 

agent via dietary exposure since the 

microorganism is non-toxic, nonpathogenic, and not infective. This 

conclusion is supported by the data on 

the substantially similar strain Bacillus 

subtilis strain QST 713, public literature 

and EPA’s Bacillus subtilis Case 6012, 

Final Registration Review Decision (Ref. 

1). EPA concludes that there is a 

reasonable certainty of no harm to 

infants and children from aggregate 

exposure to Bacillus subtilis strain QST 

713 variant soil. 


emcdonald on DSK67QTVN1PROD with 
Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations 73937 

VII. Other Considerations 

A. 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. 

B. International Residue Limits 

In making its tolerance decisions, the 

EPA seeks to harmonize U.S. tolerances 

with international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. The EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. The 

EPA may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for Bacillus subtilis strain QST 713 

variant soil. 

VIII. Conclusions 

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 Bacillus subtilis 

strain QST 713 variant soil. Therefore, 

the EPA is amending the tolerance 

exemption for Bacillus subtilis strain 

QST 713 to include residues of Bacillus 

subtilis strain QST 713 variant soil in or 

on all food commodities when used in 

accordance with good agricultural 

practices. 

IX. References 

1. U.S. EPA. 2010. Bacillus subtilis 

Final Registration Review Decision. 

Case 6012. March 2010. 

2. U.S. EPA. 1997. Bacillus subtilis 

Final Risk Assessment. 

3. U.S. EPA. July 11, 2012. 

Memorandum from Dr. Ibrahim S. 

Barsoum and Dr. John L. Kough to 

Michael Glikes: Review of Product 

Chemistry and Acute Toxicity Studies 

for Section 3 Registration of a new 

TGAI, Bacillus subtilis strain QST 

variant soil, and a new EP, Serenade soil 

DPZ (EPA Reg. No. 69592–EI). 

X. Statutory and Executive Order 

Reviews 

This final rule amends an exiting 

tolerance under FFDCA section 408(d) 

in response to a petition submitted to 

the Agency. 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 final rule has been exempted from 

review under Executive Order 12866, 

this final rule 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 final rule 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 on the basis of a petition 

under FFDCA section 408(d), such as 

the exemption from tolerance 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 final rule 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 final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(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 of 1995 

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

XI. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), the 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: November 26, 2012. 

Steven Bradbury, 

Director, 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. Revise § 180.1209 to read as 

follows: 

§ 180.1209 Bacillus subtilisstrain QST 713 

and strain QST 713 variant soil; exemption 

from the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of the microbial pesticides Bacillus 

subtilis strain QST 713 and strain QST 

713 variant soil when used in or on all 

food commodities. 

[FR Doc. 2012–29903 Filed 12–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0326; FRL–9371–5] 

Spirodiclofen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 


emcdonald on DSK67QTVN1PROD with