Federal Register / Vol. 78, No. 80 / Thursday, April 25, 2013 / Rules and Regulations 24349 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

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

Subpart MM—Oregon 

■ 2. Section 52.1970 is amended by 

adding paragraphs (c)(116)(i)(D) and (c) 

(156) to read as follows: 

§ 52.1970 Identification of plan. 

* * * * * 

(c) * * * 

(116) * * * 

(i) * * * 

(D) Based on a SIP revision submitted 

by Oregon on February 16, 2001, Oregon 

Administrative Rules Chapter 340, 

Division 23 ‘‘Rules for Open Burning,’’ 

as effective March 10, 1993, is removed 

from the SIP. 

* * * * * 

(156) On February 16, 2001, May 13, 

2005, March 29, 2006, and March 20, 

2008, the Oregon Department of 

Environmental Quality submitted 

revisions to the Oregon Administrative 

Rules (OAR) Chapter 340 as revisions to 

the Oregon State Implementation Plan 

(SIP). The submissions relate to 

Oregon’s open burning rules, 

enforcement procedures, civil penalties, 

and procedures in contested cases 

(appeals). 

(i) Incorporation by reference. 

(A) The following sections of the OAR 

Chapter 340, Division 264, effective 

December 15, 2000: Division 264, Rules 

For Open Burning: Rule 0010 How to 

Use These Open Burning Rules; Rule 

0020 Policy; Rule 0030 Definitions; Rule 

0040 Exemptions, Statewide; Rule 0050 

General Requirements Statewide; Rule 

0060 General Prohibitions Statewide; 

Rule 0070 Open Burning Conditions; 

Rule 0075 Delegation of Authority; Rule 

0078 Open Burning Control Areas; Rule 

0080 County Listing of Specific Open 

Burning Rules; Rule 0100 Open Burning 

Requirements, Baker, Clatsop, Crook, 

Curry, Deschutes, Gilliam, Grant, 

Harney, Hood River, Jefferson, Klamath, 

Lake, Lincoln, Malheur, Morrow, 

Sherman, Tillamook, Umatilla, Union, 

Wallowa, Wasco and Wheeler Counties; 

Rule 0110 Open Burning Requirements, 

Benton, Linn, Marion, Polk, and 

Yamhill Counties; Rule 0120, Open 

Burning Requirements, Clackmas 

County; Rule 0130, Open Burning 

Requirements, Multnomah County; Rule 

0140 Open Burning Requirements, 

Washington County; Rule 0150 Open 

Burning Requirements, Columbia 

County; Rule 0160 Open Burning 

Requirements, Lane County; Rule 0170 

Open Burning Requirements, Coos, 

Douglas, Jackson and Josephine 

Counties; Rule 0180 Open Burning 

Requirements, Letter Permits, Rule 0190 

Open Burning Requirements, Forced-Air 

Pit Incinerators. 

(B) [Reserved.] 

(ii) Additional Material: 

(A) The following revised sections of 

Oregon Administrative Rules Chapter 

340 effective May 13, 2005: Division 12 

Enforcement Procedures and Civil 

Penalties: Rule 0026 Policy, Rule 0028 

Scope of Applicability, Rule 0030 

Definitions, Rule 0038 Warning Letters, 

Pre-Enforcement Notices and Notices of 

Permit Violation, Rule 0041 Formal 

Enforcement Action, Rule 0042 

Determination of Base Penalty, Rule 

0045 Civil Penalty Determination 

Procedure, Rule 0145 Determination of 

Aggravating or Mitigating Factors, Rule 

0150 Determination of Economic 

Benefit, Rule 0160 Department 

Discretion Regarding Penalty 

Assessment, Rule 0162 Inability to Pay 

the Penalty, Rule 0165 Stipulated 

Penalties, Rule 0170 Compromise or 

Settlement of Civil Penalty by 

Department. 

(B) The following revised sections of 

Oregon Administrative Rules Chapter 

340 effective March 29, 2006: Division 

12 Enforcement Procedures and Civil 

Penalties: Rule 0027 Rule Effective Date, 

Rule 0053 Violations that Apply to all 

Programs, Rule 0054 Air Quality 

Classification of Violations, Rule 0073 

Environmental Cleanup Classification of 

Violation, Rule 0082 Contingency 

Planning Classification of Violations, 

Rule 0130 Determination of Violation 

Magnitude, Rule 0135 Selected 

Magnitude Categories, Rule 0140 

Determination of Base Penalty, Rule 

0155 Additional or Alternate Civil 

Penalties. 

(C) The following revised sections of 

Oregon Administrative Rules Chapter 

340 effective March 20, 2008: Division 

11, Rules of General Applicability and 

Organization, Rule 0005 Definitions, 

Rule 0009 Incorporation of Attorney 

General’s Uniform and Model Rules, 

Rule 0510 Agency Representation by 

Environmental Law Specialist, Rule 

0515 Authorized Representative of 

Respondent other than a Natural Person 

in a Contested Case Hearing, Rule 0573 

Proposed Orders in Contested Cases, 

Rule 0575 Review of Proposed Orders in 

Contested Cases. 

[FR Doc. 2013–09695 Filed 4–24–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0397; FRL–9383–1] 

Bacillus mycoides Isolate J; TimeLimited 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 

requirement of a tolerance for residues 

of Bacillus mycoides isolate J in or on 

potato, when used in accordance with 

the terms of the section 18 emergency 

exemption. This action is in response to 

EPA’s granting of an emergency 

exemption under section 18 of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) authorizing 

use of the pesticide on potato. The timelimited exemption from the requirement 

of a tolerance expires on December 31, 

2015. 

DATES: This regulation is effective April 

25, 2013. Objections and requests for 

hearings must be received on or before 

June 24, 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 section. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0397, 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: 

Debra Rate, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 306–0309; email address: 

rate.debra@epa.gov. 

SUPPLEMENTARY INFORMATION: 


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24350 Federal Register / Vol. 78, No. 80 / Thursday, April 25, 2013 / Rules and Regulations 

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 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–2012–0397 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 June 24, 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 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– 

2012–0397, 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) of, 21 U.S.C. 346a(e) and 

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

exemption from the requirement of a 

tolerance for Bacillus mycoides isolate J, 

in or on potato. This time-limited 

exemption from the requirement of a 

tolerance expires on December 31, 2015. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement of 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 section 18 of FIFRA. Such 

tolerances and exemptions from the 

requirement of a tolerance 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 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(b)(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 tolerance is ‘‘safe.’’ 

Section 408(b)(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 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.* * *’’ 

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. 

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. Emergency Exemption for Bacillus 

mycoides isolate J on Potato and 

Exemption From the Requirement of a 

Tolerance 

The Montana Department of 

Agriculture requested a specific 

emergency exemption, for the use of the 

unregistered active ingredient (ai), 

Bacillus mycoides isolate J (BmJ), to 

control tuber infections caused by 

potato virus Y (PVY), on generation 1 

(G1) and generation 2 (G2) potatoes 

grown for certified seed potato stock. 

There are no registered alternatives to 

control PVY infections, only registered 

alternatives that inadequately control 

the aphids which vector the virus. The 

Montana Department of Agriculture, 

requested use for 2,675 acres of seed 

potato. 

After having reviewed the 

submission, EPA determined that an 

emergency condition existed for this 

State, and that the criteria for approval 

of an emergency exemption were met. 

Accordingly, EPA authorized a specific 

exemption under FIFRA section 18 for 

the use of Bacillus mycoides isolate J on 

potato for control of PVY in Montana. 


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Federal Register / Vol. 78, No. 80 / Thursday, April 25, 2013 / Rules and Regulations 24351 

As part of its evaluation of the 

emergency exemption application, EPA 

assessed the potential risks presented by 

residues of Bacillus mycoides isolate J in 

or on potato. In doing so, EPA 

considered the safety standard in 

FFDCA section 408(b)(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 

emergency 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, 2015. EPA will take action 

to revoke the time-limited exemption 

from the requirement of a tolerance 

earlier if any experience with, scientific 

data on, 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 Bacillus 

mycoides isolate J meets FIFRA’s 

registration requirements for use on 

potato 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 Bacillus mycoides isolate 

J by a State for special local needs under 

FIFRA section 24(c). Nor does this 

tolerance by itself serve as the authority 

for persons in any State other than 

Montana to use this pesticide on the 

applicable crops under FIFRA section 

18 absent the issuance of an emergency 

exemption applicable within that State. 

For additional information regarding the 

emergency exemption for Bacillus 

mycoides isolate J, consult the person 

listed under FOR FURTHER INFORMATION

CONTACT. 

IV. Toxicological Profile 

Consistent with FFDCA section 

408(b)(2)(D), 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. The 

nature of the toxic effects caused by 

Bacillus mycoides isolate J, are 

discussed in this unit. Refer to risk 

assessments in docket number EPA– 

HQ–OPP–2005–0303 with the titles: (1) 

BPPD Review of Product Chemistry and 

Toxicity/Pathogenicity Data Submitted 

by Montana Microbial Products, for EUP 

of BmjJ WP, which contains Bacillus 

mycoides isolate J and (2) Ecological 

Risk Assessment for Bacillus mycoides 

Isolate J, for additional information. 

The stomach is a hostile environment 

for most microbes, as most oral 

exposure to microbes, leads to 

inactivation by stomach acids, 

proteases, and subsequently bile salts 

(Ref. 1). In contrast, a pulmonary 

exposure study provides those microbes 

that are capable of infecting mammals 

with the greatest opportunity to express 

infectivity by directing them into the 

lungs, from where they may enter the 

bloodstream and other organs. 

Therefore, a microbe that does not show 

significant infectivity in a pulmonary 

exposure study, presents negligible risk 

via oral exposure. 

An Acute Pulmonary Toxicity/ 

Pathogenicity study (OPPTS 885.3150) 

in rats which were dosed intratracheally 

with Bacillus mycoides isolate J at 1.1 × 

108 cfu/animal, did not show complete 

clearance from all organs during the 

study’s 35-day length. The test 

substance, however, did show a pattern 

of clearance in most organs. This is 

similar to what has been observed with 

other spore forming bacteria. 

Differential heat treatment of tissue 

samples showed that most of the 

recovered organisms were spores which 

are quiescent forms of this bacterium. 

Spores routinely take long periods to be 

cleared from pulmonary exposures (Ref. 

2). Bacteria form spores when 

conditions do not support growth, so 

the predominance of spores among the 

Bacillus mycoides isolate J recovered 

from animal tissue, therefore indicates 

little infectivity. No treated animals 

died and there were no signs in the 

animals of toxicity or pathogenicity. 

Associated with the manufacture of 

Bacillus mycoides isolate J, as well as all 

exposures during the previous 

experimental use permits, more than 20 

people have worked with Bacillus 

mycoides isolate J for over 8 years, and 

no adverse effects or incidents of 

hypersensitivity reaction have been 

reported associated with Bacillus 

mycoides isolate J in the routine use of 

the experimental product. 

Given the ubiquitous nature of this 

bacterium on plants, in soil, water, air, 

and decomposing plant tissue (Ref. 3), 

the lack of reported human 

pathogenicity, along with the lack of 

mortality of the test animals, and the 

absence of overt signs of toxicity or 

pathogenicity in the animals during the 

course of this pulmonary study, there is 

not expected to be an increase in dietary 

exposure or threshold effects of concern 

to infants and children when Bacillus 

mycoides isolate J is used as a foliar 

treatment on seed potatoes. 

This finding is consistent with a 

previously granted food-use 

experimental use permit (82761–EUP– 

2), where the Agency granted requests 

for waivers for Acute Oral Toxicity and 

Pathogenicity (OPPTS 885.3050); Acute 

Injection Toxicity and Pathogenicity 

(OPPTS 885.3200); Acute Oral Toxicity 

(OPPTS 870.1100); Acute Inhalation 

Toxicity (OPPTS 870.1300) mammalian 

studies for Bacillus mycoides isolate J, 

based on the following: 

1. Bacillus mycoides is not reported as 

a human pathogen, or as a cause of 

foodborne illness, food spoilage, or 

plant diseases, and does not persist on 

plant surfaces. Due to the ubiquitous 

level of Bacillus mycoides present in 

agricultural soils, there has been long 

term human exposure to Bacillus 

mycoides in crops and to residual 

Bacillus mycoides cells or spores in 

food crops (Ref. 3). No toxicity, 

infectivity, or pathogenicity of Bacillus 

mycoides in humans was reported in 

numerous searched citations. 

2. Bacillus mycoides is readily 

differentiable from other Bacillus cereus 

group organisms in production batches 

(including Bacillus thuringiensis, 

Bacillus pseudomycoides, Bacillus 

anthracis, Bacillus cereus, and Bacillus 

weihenstephanensis) and well defined 

quality control procedures are 

established to keep contaminants from 

fermentation batches during the 

production of Bacillus mycoides 

isolate J. 

3. In connection with the manufacture 

of Bacillus mycoides isolate J, no 

adverse effects or incidents of 

hypersensitivity reaction have been 

reported associated with Bacillus 

mycoides isolate J in the routine use of 

the experimental product in a laboratory 

setting. Any such effects would be 

subject to the reporting requirements of 

40 CFR 166.32(a) and guidelines for 

reporting Hypersensitivity Incidents 

(OPPTS 885.3400). 

V. 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 nonVerDate Mar<15>2010 14:12 Apr 24, 2013 Jkt 229001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\FR\FM\25APR1.SGM 25APR1

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24352 Federal Register / Vol. 78, No. 80 / Thursday, April 25, 2013 / Rules and Regulations 

occupational 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 

The authorized section 18 emergency 

exemption is not expected to result in 

increased dietary exposures of Bacillus 

mycoides isolate J to the general 

population based on the following: 

1. Food. The section 18 emergency 

exemption is for foliar application on 

plants, grown from first and second 

generation seed potatoes grown for seed 

stock. Only a small fraction of seed 

potatoes collected from treated plants 

may enter the food chain as livestock 

feed. The quantity of Bacillus mycoides 

isolate J applied to plant foliage, 7.5 × 

1011 spores/acre per application, is 

small compared to the natural 

background levels of Bacillus mycoides. 

In agricultural soils, Bacillus 

mycoides typically occurs at about 105

spores per gram. In persistence studies, 

performed on a variety of crops 

(including peppers, potatoes, and sugar 

beets), the titer of Bacillus mycoides 

isolate J applied to the foliage typically 

declines from 106 spores/cm2 to 

between 100 and 1,000 spores/cm2 over 

a 2-week period. Specifically in 

potatoes, spores applied to foliage will 

not directly contact tubers. Tubers are 

exposed to natural soil concentrations of 

Bacillus mycoides that exceed the 

quantity of Bacillus mycoides isolate J 

spores applied to potato foliage (Ref. 3). 

2. Drinking water exposure. 

According to the World Health 

Organization, Bacillus species are often 

detected in drinking water even after 

going through acceptable water 

treatment processes, largely because the 

spores are resistant to these disinfection 

processes (Ref. 4). Should this microbial 

pesticide be present, no adverse effects 

are expected from exposure to Bacillus 

mycoides through drinking water, based 

on the results of toxicity studies 

described in Unit IV. 

B. Other Non-Occupational Exposure 

Natural background levels of Bacillus 

mycoides are reported to typically occur 

at about 105 spores per gram in 

agricultural soils. Use of Bacillus 

mycoides isolate J pursuant to the 

section 18 emergency exemption is not 

likely to result in increased exposure in 

the general population because the 

2,675 treated acres are not accessible to 

the general population. 

VI. Cumulative Effects 

Pursuant to section 408(b)(2)(D)(v) of 

FFDCA, EPA has considered available 

information on the cumulative effects of 

such residues and other substances that 

have a common mechanism of toxicity. 

These considerations included the 

cumulative effects on infants and 

children of such residues and other 

substances with a common method of 

toxicity. Because there is no indication 

of mammalian toxicity or pathogenicity 

resulting from exposure to Bacillus 

mycoides isolate J, we conclude that 

there are no cumulative effects for this 

bacterium. 

VII. Determination of Safety for U.S. 

Population, Infants, and Children 

The Agency has determined that there 

is reasonable certainty that no harm will 

result to the U.S. population from 

exposure to residues of Bacillus 

mycoides isolate J in connection with 

the section 18 emergency exemption. 

This determination includes all 

anticipated dietary exposures and other 

non-occupational exposures for which 

there is reliable information. Oral 

ingestion of the Bacillus mycoides 

isolate J organism on potatoes treated 

under the section 18 emergency 

exemption is unlikely because the 

portion of the potato plant that is treated 

is not intended for human or livestock 

consumption. 

Data submitted in a pulmonary 

toxicity/pathogenicity study performed 

at doses several orders of magnitude 

above expected exposure revealed no 

signs of overt toxicity or pathogenicity 

in the test animals. The pulmonary 

exposure route is more sensitive than an 

oral exposure study which has the 

various inactivation processes discussed 

in Unit IV. The results of an extensive 

literature search, which included 

numerous citations of the test organism, 

yielded no reports of its pathogenicity 

for mammals (Ref. 5). 

Section 408(b)(2)(C) of FFDCA 

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

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 

will be safe for infants and children. In 

the absence of specific studies showing 

that infants and children are not at risk, 

the Agency has retained a 10X safety 

factor to account for gaps in the 

database for Bacillus mycoides isolate J. 

In this instance, however, based on all 

available information, the Agency 

concludes that Bacillus mycoides isolate 

J presents no oral toxicity effects of 

concern. Thus, there are no threshold 

effects of concern to infants and 

children when Bacillus mycoides isolate 

J is used in accordance with the 

authorized section 18 use directions. 

VIII. Other Considerations 

A. Endocrine Disruptors 

The pesticidal active ingredient, 

Bacillus mycoides isolate J is not known 

to exert an influence on the endocrine 

system. 

B. Analytical Method(s) 

Analytical methods for Bacillus 

mycoides isolate J that are sufficient to 

justify the issuance of the section 18 

emergency exemption have been 

submitted to the Agency. An 

enforcement analytical method is not 

required to support an exemption from 

the requirement of a tolerance. 

C. Codex Maximum Residue Level 

No codex maximum residue levels 

exist for the microbial Bacillus 

mycoides isolate J. 

IX. Conclusion 

Therefore, a time-limited exemption 

from the requirement of a tolerance is 

established for residues of Bacillus 

mycoides isolate J, in or on potatoes. 

This time-limited exemption from the 

requirement of a tolerance expires on 

December 31, 2015. 

X. References 

1. Martinsen, T.C., Bergh, K. & Waldrum, 

H.L., (2005) Gastric Juice: A Barrier 

Against Infectious Diseases, Basic and 

Clinical Pharmacology and Toxicology, 

vol. 96: 94–102. 

2. USEPA. Prevention, Pesticides and Toxic 

Substances. Reregistration Eligibility 

Decision (RED) Bacillus thuringiensis. 

EPA738–R–98–004. March 1998. 

3. Ludwig, W., Schleiffer, Whitman, W.H. 

(2009) Class I: Bacilli, class. nov., in 

‘‘Bergey’s Manual of Systematic 

Bacteriology’’, 2nd Edition, Volume 3, 

The Firmicutes, P. DeVos, G.M. Garrity, 

D. Jones, N.R.Krieg, W. Ludwig, K.H. 

Schleiffer, & W.B. Whitman (eds.) 

Springer Publishing. 

4. World Health Organization, Guidelines for 

Drinking-Water Quality. (2011) Fourth 

Edition. 

5. Logan, N.A. & Turnbull, P.C.B. (2003) 

Bacillus and other Endospore-forming 

Bacteria, Chap 32. in ‘‘Manual of Clinical 


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Federal Register / Vol. 78, No. 80 / Thursday, April 25, 2013 / Rules and Regulations 24353 

Microbiology’’ 8th edition, P.R.Murray, 

E.J. Baron, J.H. Jorgensen, M.A. Pfaller & 

R.H. Yolken (eds), ASM Press. 

XI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

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 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 in accordance with 

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

such as the tolerances 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). 

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: April 12, 2013. 

Daniel J. Rosenblatt, 

Acting 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. Revise § 180.1269 to read as 

follows: 

§ 180.1269 Bacillus mycoides isolate J; 

exemption from the requirement of a 

tolerance. 

Bacillus mycoides isolate J is 

temporarily exempt from the 

requirement of a tolerance when used as 

a fungicide on potatoes in accordance 

with a valid Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) 

section 18 emergency exemption. This 

temporary exemption from the 

requirement of a tolerance expires and 

is revoked on December 31, 2015. 

[FR Doc. 2013–09706 Filed 4–24–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Transportation Security Administration 

49 CFR Part 1572 

[Docket No. TSA–2004–19605; Amendment 

No. 1572–10] 

Provisions for Fees Related to 

Hazardous Materials Endorsements 

and Transportation Worker 

Identification Credentials 

AGENCY: Transportation Security 

Administration, DHS. 

ACTION: Final rule. 

SUMMARY: The Transportation Security 

Administration (TSA) is removing 

specific fee amounts from regulations 

regarding security threat assessments 

(STAs) and credentialing for Hazardous 

Materials Endorsements (HMEs) and 

Transportation Worker Identification 

Credentials (TWICs). These provisions 

include State collection of the HME fee, 

TSA collection of the HME fee, and 

collection of the TWIC fee. Removing 

specific fee references will enable TSA 

to have the necessary flexibility to lower 

or increase fees as necessary to meet the 

statutory obligation to recover its costs. 

Current fee amounts as identified in 

these sections will remain unchanged 

until any future revisions to fee 

schedules are published in the Federal 

Register. 

DATES: Effective May 28, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Carolyn Mitchell, Office of Intelligence 

and Analysis (OIA), TSA–10, 

Transportation Security Administration, 

601 South 12th Street, Arlington, VA 

20598–6010; telephone (571) 227–2372; 

email carolyn.mitchell@dhs.gov. 

For legal questions: Traci Klemm, 

Office of Chief Counsel, TSA–2, 

Transportation Security Administration, 

601 South 12th Street, Arlington, VA 

20598–6002; telephone (571) 227–3596; 

facsimile (571) 227–1378; email 

traci.klemm@dhs.gov. 

SUPPLEMENTARY INFORMATION: 

Availability of Rulemaking Document 

You can get an electronic copy using 

the Internet by— 

(1) Searching the electronic Federal 

Docket Management System (FDMS) 

Web page at http://www.regulations.gov; 

(2) Accessing the Government 

Printing Office’s Web page at http:// 

www.gpo.gov/fdsys/browse/ 

collection.action?collectionCode=FR to 

view the daily published Federal 

Register edition; or accessing the 

‘‘Search the Federal Register by 


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