Federal Register / Vol. 77, No. 7 / Wednesday, January 11, 2012 / Rules and Regulations 1633 

small entities. The term ‘‘small entity’’ 

is defined to have the same meaning as 

the terms ‘‘small business,’’ ‘‘small 

organization,’’ and ‘‘small governmental 

jurisdiction,’’ as defined in the RFA. 

As authorized by 5 U.S.C. 553(d)(3), 

the Department finds that good cause 

exists for dispensing with the 30-day 

delay in the effective date of this rule. 

These regulations exempt certain 

investigative records maintained by the 

Department from notification, access, 

and amendment of a record. In order to 

protect the confidentiality of such 

investigatory records the Department 

finds that it is in the public interest to 

make these regulations effective upon 

publication. 

List of Subjects in 31 CFR Part 1 

Privacy. 

Part 1, Subpart C of title 31 of the 

Code of Federal Regulations is amended 

as follows: 

PART 1—[AMENDED] 

■ 1. The authority citation for part 1 

continues to read as follows: 

Authority: 5 U.S.C. 301 and 31 U.S.C. 321. 

Subpart A also issued under 5 U.S.C. 552 as 

amended. Subpart C also issued under 5 

U.S.C. 552a. 

■ 2. In § 1.36, redesignate paragraphs 

(g)(1)(i) through (xiii) as (g)(1)(ii) 

through (xiv), respectively, and add new 

paragraph (g)(1)(i) to read as follows: 

§ 1.36 Systems exempt in whole or in part 

from provisions of 5 U.S.C. 552a and this 

part. 

* * * * * 

(g) * * * 

(1) * * * 

(i) Treasury: 

Number System name 

Treasury 

.013.

Department of the Treasury Civil 

Rights Complaints and Compliance Review Files. 

* * * * * 

Dated: December 22, 2011. 

Melissa Hartman, 

Deputy Assistant Secretary for Privacy, 

Transparency, and Records. 

[FR Doc. 2012–338 Filed 1–10–12; 8:45 am] 

BILLING CODE 4810–25–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0104; FRL–9330–9] 

Bacillus Subtilis Strain CX–9060; 

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 residues of the microbial 

pesticide Bacillus subtilis strain CX– 

9060 in or on all food commodities 

when applied/used in accordance with 

good agricultural practices. Certis 

U.S.A., L.L.C. 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 Bacillus 

subtilis strain CX–9060. 

DATES: This regulation is effective 

January 11, 2012. Objections and 

requests for hearings must be received 

on or before March 12, 2012, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0104. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Denise Greenway, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8263; email address: 

greenway.denise@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. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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 harmonized 

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 EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0104 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 


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1634 Federal Register / Vol. 77, No. 7 / Wednesday, January 11, 2012 / Rules and Regulations 

received by the Hearing Clerk on or 

before March 12, 2012. 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 that does not contain any 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 a copy of your non-CBI 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2010–0104, by one of the following 

methods: 

• Federal eRulemaking Portal: 

http://www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of March 10, 

2010 (75 FR 11171) (FRL–8810–8), EPA 

issued a notice pursuant to section 

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

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

pesticide tolerance petition (PP 9F7643) 

by Certis U.S.A., L.L.C., 9145 Guilford 

Road, Suite 175, Columbia, MD 21046. 

The petition requested that 40 CFR part 

180 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of the microbial 

pesticide, Bacillus subtilis strain CX– 

9060. This notice referenced a summary 

of the petition prepared by the 

petitioner, Certis U.S.A., L.L.C., which 

is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Although the Certis U.S.A., L.L.C. 

pesticide tolerance petition (PP 9F7643) 

specified that the requested exemption 

include residues resulting from postharvest uses, the removal on December 

8, 2010 of 40 CFR 180.1(h) (75 FR 

76284, FRL–8853–8) eliminates the 

option for the expression of tolerances 

or exemptions from the requirement of 

a tolerance to include any reference to 

post-harvest use patterns. Therefore, the 

exemption established today by this rule 

does not specify post-harvest 

applications. Incidentally, there 

currently are no post-harvest uses 

proposed for the product containing 

Bacillus subtilis strain CX–9060. The 

addition of such uses to a Bacillus 

subtilis strain CX–9060 product label 

should be sought by amendment of the 

pesticide product under the Federal 

Insecticide, Fungicide and Rodenticide 

Act (FIFRA). 

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 

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 

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

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

408(b)(2)(C) of FFDCA, 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, section 408(b)(2)(D) of 

FFDCA 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.’’ EPA performs a 

number of analyses to determine the 

risks from aggregate exposure to 

pesticide residues. First, EPA 

determines the toxicity of pesticides. 

Second, 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 section 408(b)(2)(D) 

of FFDCA, 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. 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, which 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 

Agency. 

A new strain, Bacillus subtilis strain 

CX–9060, proposed as a microbial 

pesticide by Certis U.S.A., L.L.C., is the 

subject of this final rule. Bacillus 

subtilis strain CX–9060 was isolated 

from a peat medium containing a 

naturally occurring strain of the Bacillus 

subtilis bacterium. The progenitor 

strain, Bacillus subtilis MBI 600, is a 

currently registered pesticide. Data and 

information, submitted by Certis U.S.A., 

L.L.C. and reviewed by the Agency, 

indicate that both Bacillus subtilis strain 

CX–9060 and Bacillus subtilis MBI 600 

are in the B. subtilis/amyloliquifaciens 

group, and are closely related. The 

established level of equivalency is such 

that citation of existing data on the 

progenitor strain supports the Bacillus 

subtilis strain CX–9060 petition for an 

exemption from the requirement of a 

tolerance. 

The toxicological data on Bacillus 

subtilis MBI 600 cited by Certis U.S.A., 

L.L.C. were previously submitted to 

support an exemption from the 

requirement of a tolerance for residues 

of that active ingredient in or on all raw 

agricultural commodities resulting from 

its use in the treatment of seeds used for 

growing agricultural crops (June 8, 1994; 

59 FR 29543; FRL–4865–8), and later to 

support an amendment that established 

a broader exemption for use of Bacillus 

subtilis MBI 600 in or on all food 

commodities, including residues 

resulting from post-harvest uses, when 

applied or used in accordance with 

good agricultural practices (April 8, 

2009; 74 FR 15865; FRL–8408–7). The 

previously submitted studies on 

Bacillus subtilis MBI 600 include the 

following: 

• An acceptable acute oral toxicity/ 

pathogenicity study performed in rats 


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Federal Register / Vol. 77, No. 7 / Wednesday, January 11, 2012 / Rules and Regulations 1635 

(MRID 419074–02) demonstrated the 

lack of mammalian toxicity at high 

levels of exposure to Bacillus subtilis 

MBI 600. In this study, Bacillus subtilis 

MBI 600 was not toxic, infective nor 

pathogenic to rats given an oral dose of 

2 × 108 colony forming units (CFU) per 

animal. The study resulted in a 

classification of Toxicity Category IV for 

this strain of Bacillus subtilis. 

• An acceptable acute pulmonary 

toxicity/pathogenicity study in rats 

(MRID 419074–04) demonstrated that 

Bacillus subtilis MBI 600 was neither 

toxic, pathogenic nor infective to rats 

dosed intratracheally with 3.4 × 108

CFU of the test material. The study 

resulted in a classification of Toxicity 

Category IV for this strain of Bacillus 

subtilis. 

• An acceptable acute intravenous 

injection toxicity/pathogenicity study in 

rats (MRID 419074–05) demonstrated 

that Bacillus subtilis MBI 600 was 

neither toxic, pathogenic nor infective 

to rats dosed intravenously with 

approximately 4 × 107 CFU of the test 

material. Although the microbe was 

detected in every organ tested, the test 

material displayed a distinct pattern of 

clearance from all organs. The study 

resulted in a classification of Toxicity 

Category IV for this strain of Bacillus 

subtilis. 

New studies submitted by Certis 

U.S.A., L.L.C., and conducted with a 

formulation containing 25.0% Bacillus 

subtilis strain CX–9060 (at a 

concentration of 5 × 1010 spores per 

gram), include the following: 

• An acceptable acute eye irritation 

study in rabbits (MRID 478203–05) 

demonstrated that the undiluted test 

article was mildly irritating when a 

single 0.1 mL ocular dose was 

administered. At one hour posttreatment, one animal showed signs of 

corneal opacity, which cleared by 

24 hours. Chemosis exhibited by one 

animal at 1 and 24 hours post-treatment 

cleared at 48 hours. The study resulted 

in a classification of Toxicity Category 

III. 

• An acceptable primary dermal 

irritation study in rabbits (MRID 

478203–04) resulted in an observation 

of slight erythema in a single animal at 

24 hours, which resolved by 48 hours. 

The study resulted in a classification of 

Toxicity Category IV. 

Consistent with test note five, 40 CFR 

158.2140, waiver of the acute oral, acute 

dermal, and acute inhalation toxicity 

tests, which provide data on the end-use 

pesticide product, was requested by the 

petitioner. The justification supporting a 

waiver of these tests (MRID 478203–06) 

was adequate as the petitioner 

demonstrated that the combination of 

inert ingredients is not likely to pose 

any significant human health risks. 

Furthermore, the Agency has assigned 

Toxicity Category IV for all three routes 

of exposure: Acute oral toxicity (based 

upon the results of the cited acute oral 

toxicity/pathogenicity study (MRID 

419074–02)); acute dermal toxicity 

(based upon the low toxicity of the inert 

ingredients and observed slight dermal 

irritation (MRID 478203–04)); and acute 

inhalation toxicity (based upon the 

results of the cited acute pulmonary 

toxicity/pathogenicity study (MRID 

419074–04)). 

There have been no reports of 

hypersensitivity in over 15 years of 

registered uses of the progenitor strain, 

nor have incidents associated with the 

testing or production of Bacillus subtilis 

strain CX–9060 been reported. Any 

future hypersensitivity incidents must 

be reported per OCSPP Guideline 

885.3400. 

Consistent with test note four, 40 CFR 

158.2140, no cell culture OCSPP 

Guideline 885.3500) data submission is 

required because Bacillus subtilis strain 

CX–9060 is not a virus. 

IV. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of FFDCA 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 

In examining aggregate exposure, 

section 408 of FFDCA 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). 

1. Food. Bacillus subtilis is ubiquitous 

in the environment (Ref. 1), especially 

in soils (Ref. 3) and agricultural 

environments (Ref. 4). Strain CX–9060 

of Bacillus subtilis is derived from a 

naturally occurring isolate of the genus 

Bacillus, which was originally isolated 

from faba bean plants grown at the 

Nottingham University School of 

Agriculture in the United Kingdom. As 

a result, human dietary exposure to 

background levels of the microbe is 

likely occurring and will likely 

continue. Due to the ubiquitous 

presence of Bacillus subtilis in the 

environment, the Agency expects 

human exposure to Bacillus subtilis 

strain CX–9060 resulting from the 

proposed pesticidal uses will be no 

greater than existing human exposure to 

background levels of Bacillus subtilis. 

Similar Bacillus subtilis strains are 

used internationally in the production 

of food grade products and in fermented 

foods in Japan and Thailand. Reports in 

the literature, implicating Bacillus 

subtilis (as distinguished from the 

specific strain, Bacillus subtilis strain 

CX–9060, at issue in this action) in 

food-borne illness, do not describe any 

pathogen or toxin production, only 

simple food spoilage from Bacillus 

subtilis growth in dough. This, in 

combination with test results (stated 

above) showing a lack of acute oral 

toxicity/pathogenicity, indicates the risk 

posed to adults, infants, and children 

from food-related exposures to Bacillus 

subtilis strain CX–9060 is expected to be 

minimal. Based on the Agency’s 

evaluation of the submitted and cited 

data, there are no dietary risks that 

exceed the Agency’s Level of Concern 

(LOC). 

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. The 

proposed use sites do not include direct 

application to aquatic environments: the 

intended use of Bacillus subtilis strain 

CX–9060 is to treat growing crops 

(including roots and cuttings) for the 

control of plant disease. If the uses 

resulted in pesticide residues in spray 

drift or runoff that were to reach surface 

or ground waters, there is the potential 

for human exposure to Bacillus subtilis 

strain CX–9060 residues in drinking 

water, albeit likely greatly diluted. 

Municipal drinking water treatment 

processes and deep water wells, 

however, should further reduce any 

such residues. More importantly, even if 

oral exposure to this ubiquitous microbe 

should occur through drinking water, 

due to its expected lack of acute oral 

toxicity/pathogenicity, the Agency 

concludes that there is a reasonable 

certainty that no harm will result from 

such exposure. 

B. Other Non-Occupational Exposure 

The pesticide uses of Bacillus subtilis 

strain CX–9060 are limited to 

commercial agricultural and 

horticultural settings. There are no 

residential uses; it is not intended to be 

used in and around the home, or in 

schools, day care facilities or other such 

settings. Nonetheless, residential and 

other non-occupational exposure may 


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1636 Federal Register / Vol. 77, No. 7 / Wednesday, January 11, 2012 / Rules and Regulations 

occur since Bacillus subtilis is 

ubiquitous in the environment. The 

potential for non-dietary, nonoccupational exposure to Bacillus 

subtilis strain CX–9060 residues for the 

general population, including infants 

and children, is likely since populations 

have probably been previously exposed 

(and likely will continue to be exposed) 

to background levels of Bacillus subtilis. 

Neither such common human exposures 

to similar Bacillus subtilis strains 

naturally present in soils, waters and 

plants, nor exposures associated with 

those Bacillus subtilis strains used 

internationally in producing food-grade 

products and fermented foods, have 

resulted in reports of disease or other 

effects. Finally, while the literature 

includes accounts of Bacillus subtilis 

infections in humans (which 

consistently are bacteremias associated 

with immunosuppression, surgical 

intervention, neoplastic disease, and 

trauma), those reports are most notable 

for their rare and exceptional nature. 

EPA’s evaluation of the required highdose Tier I acute toxicity and 

pathogenicity tests, which were cited in 

support of this petition, resulted in the 

assignment of Toxicity Category IV 

(least toxic), as well as determinations 

of not infective and not pathogenic, for 

all exposure routes. No toxicological 

end points of concern were identified. 

There are no dietary endpoints that 

exceed the Agency’s LOC. Therefore, the 

Agency has determined that any 

additional exposure to the microbe 

resulting from residues attributable to 

Bacillus subtilis strain CX–9060 

pesticide use will not result in 

additional aggregate non-occupational 

risk from dermal and inhalation 

exposures. Because even regular 

occupational exposures associated with 

this active ingredient pose negligible 

risk, no risk is expected from nonoccupation exposures. 

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.’’ 

EPA has not found Bacillus subtilis 

strain CX–9060 to share a common 

mechanism of toxicity with any other 

substances, and Bacillus subtilis strain 

CX–9060 does not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that Bacillus subtilis strain 

CX–9060 does not have a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

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

amended by the Food Quality Protection 

Act (FQPA) of 1996, provides that 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 

(b)(2)(C) also provides that EPA shall 

apply an additional tenfold margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database, unless 

EPA determines that a different margin 

of safety will be safe for infants and 

children. 

Based on the acute toxicity 

information discussed in Unit III., 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 CX– 

9060. This includes all anticipated 

dietary exposures and all other 

exposures for which there is reliable 

information. The Agency has arrived at 

this conclusion because the data 

available on Bacillus subtilis strain CX– 

9060 demonstrate a lack of toxicity/ 

pathogenicity potential. Thus, there are 

no threshold effects of concern and, as 

a result, the Agency has concluded that 

the additional tenfold margin of safety 

for infants and children is unnecessary 

in this instance. Further, the need to 

consider consumption patterns, special 

susceptibility, and cumulative effects 

does not arise when dealing with 

pesticides with no demonstrated 

significant adverse effects. 

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, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. 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 U.N. 

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. 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 CX–9060. 

VIII. Conclusions 

Therefore, an exemption is 

established for residues of Bacillus 

subtilis strain CX–9060 in or on all food 

commodities. 

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. Available from http:// 

www.epa.gov/oppt/biotech/pubs/fra/ 

fra009.htm. 

3. Bergey. 2009. Bergey’s Manual of 

Systematic Bacteriology, Volume 3; 2nd 

Ed. Springer. New York. 

4. U.S. EPA. 2008. Memorandum (J. V. 

Gagliardi to D. Greenway). December 23, 

2008. Bacillus subtilis MBI 600. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA 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 


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Federal Register / Vol. 77, No. 7 / Wednesday, January 11, 2012 / Rules and Regulations 1637 

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 section 408(d) of FFDCA, 

such as the 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104–4). 

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), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

XI. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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 15, 2011. 

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. Section 180.1309 is added to 

subpart D to read as follows: 

§ 180.1309 Bacillus subtilis strain CX– 

9060; exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of the microbial pesticide Bacillus 

subtilis strain CX–9060, in or on all food 

commodities, when applied or used in 

accordance with good agricultural 

practices. 

[FR Doc. 2012–228 Filed 1–10–12; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 20 and 54 

[WC Docket Nos. 10–90, 07–135, 05–337, 

03–109; GN Docket No. 09–51; CC Docket 

Nos. 01–92, 96–45; WT Docket No. 10–208; 

FCC 11–189] 

Connect America Fund; Developing an 

Unified Intercarrier Compensation 

Regime; Lifeline and Link Up 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the 

Commission amends rules regarding the 

attributes of ‘‘voice telephony service’’ 

to be supported by the Federal universal 

service support mechanisms. This 

action is necessary to reflect the 

evolution of the marketplace and to 

limit supported services. The 

Commission also waives certain 

effective dates so that intercarrier 

compensation for non-access traffic 

exchanged between Local Exchange 

Carriers (LEC) and Commercial Mobile 

Radio Service (CMRS) providers 

pursuant to an interconnection 

agreement in effect as of December 23, 

2011, will be subject to a default billand-keep methodology on July 1, 2012, 

rather than on December 29, 2011. This 

action is necessary to limit marketplace 

disruption by delaying bill-and-keep 

until carriers are eligible to receive 

recovery as part of the transitional 

revenue recovery mechanism for this 

type of traffic. 

DATES: Effective January 11, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Amy Bender, Wireline Competition 

Bureau, (202) 418–1469, or Victoria 

Goldberg, Wireline Competition Bureau, 

(202) 418–7353, or TTY: (202) 418– 

0484. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Order on 

Reconsideration (Order) in WC Docket 

Nos. 10–90, 07–135, 05–337, 03–109, 

GN Docket No. 09–51, CC Docket Nos. 

01–92, 96–45, WT Docket No. 10–208, 

FCC 11–189, released on December 23, 

2011. The full text of this document is 

available for public inspection during 

regular business hours in the FCC 

Reference Center, Room CY–A257, 445 

12th Street SW., Washington, DC 20554. 

1. In this Order, the Commission 

modifies on its own motion two aspects 

of the USF/ICC Transformation Order, 

76 FR 73830, November 18, 2011. 

2. In the USF/ICC Transformation 

Order, the Commission eliminated its 

former list of nine supported services 

and amended § 54.101 of the 

Commission’s rules to specify that 

‘‘voice telephony service’’ is supported 

by federal universal service support 

mechanisms. The Commission found 

this to be a more technologically neutral 

approach that focuses on the 

functionality offered instead of the 

technologies used, while allowing 

services to be provided over any 

platform. This approach also recognizes 

that many of the services enumerated in 

the previous rule are universal today 

and that the importance of operator 

services and directory assistance, in 

particular, has declined with changes in 

the marketplace. A number of parties 

have raised questions about how the 

amended rule should be understood to 

affect Lifeline-only ETCs and their 

compliance with section 214(e)(1)(A) of 

the Act, which requires a carrier to 

provide supported services using its 

own facilities, in whole or in part, in 

order to be eligible to receive support. 

Several parties have urged the 

Commission to take action to ensure 

that there is no disruption to the 

services currently being provided to 


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