Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Rules and Regulations 35291 

■ 3. Amend § 52.2452 by adding 

paragraph (d) to read as follows: 

§ 52.2452 Visibility protection. 

* * * * * 

(d) Limited approval of the Regional 

Haze Plan submitted by the 

Commonwealth of Virginia on July 17, 

2008, March 6, 2009, January 14, 2010, 

October 4, 2010, November 19, 2010, 

and May 6, 2011. 

[FR Doc. 2012–14270 Filed 6–12–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0078; FRL–9348–7] 

Killed, Nonviable Streptomyces 

acidiscabies Strain RL–110T; 

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 killed, 

nonviable Streptomyces acidiscabies 

strain RL–110T in or on all food 

commodities when applied as a pre- or 

post-emergent herbicide and used in 

accordance with good agricultural 

practices. Marrone Bio Innovations, Inc. 

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 killed, nonviable 

Streptomyces acidiscabies strain RL– 

110T under the FFDCA. 

DATES: This regulation is effective June 

13, 2012. Objections and requests for 

hearings must be received on or before 

August 13, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2010–0078, is at 

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

OPP Docket in the Environmental 

Protection Agency Docket Center (EPA/ 

DC), located in EPA West, 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. 

Some documents cited in this final 

rule are located in a different docket 

associated with a notice of receipt 

(NOR) of an application for a new 

pesticide, Streptomyces acidiscabies 

strain RL–110T, under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA). That docket number is 

EPA–HQ–OPP–2010–0079. Such 

documents include the Biopesticides 

Registration Action Document (BRAD) 

provided as a reference in Unit IX. (Ref. 

1) of this final rule, and other 

documents listed Unit IX. of this final 

rule. 

FOR FURTHER INFORMATION CONTACT: Ann 

Sibold, Biopesticides and Pollution 

Prevention Division (7511P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (703) 305–6502; 

email address: sibold.ann@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(g), any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0078 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 August 13, 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– 

2010–0078, 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), Mail Code: 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.htm. 

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 0F7681) 


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35292 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Rules and Regulations 

by Marrone Bio Innovations, Inc., 2121 

Second St., Suite B–107, Davis, CA 

95618. The petition requested that 40 

CFR part 180 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of Streptomyces acidiscabies strain RL– 

110T. This notice referenced a summary 

of the petition prepared by the 

petitioner, Marrone Bio Innovations, 

Inc., which is available in the docket via 

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 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 exemption 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 EPA 

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 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 also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. 

A. Overview of Streptomyces 

acidiscabies Strain RL–110T

Streptomyces species are commonly 

found in agricultural settings (i.e., soils 

and decaying plant material) and are 

present on fresh produce of all kinds 

with no known adverse effects. Indeed, 

the Manual of Clinical Microbiology 

(9th edition) (Ref. 2) states that the 

primary ecological niche for aerobic 

actinomycetes, such as Streptomyces 

acidiscabies strain RL–110T, is likely 

decaying plant material. The Manual of 

Clinical Microbiology (9th edition) (Ref. 

2) further states that infections caused 

by Streptomyces species are infrequent 

and limited to species unrelated to 

acidiscabies and does not identify 

Streptomyces acidiscabies as clinically 

significant. No food borne disease 

outbreaks associated with Streptomyces 

species or mammalian active toxin 

production from Streptomyces species, 

including Streptomyces acidiscabies, 

have been reported. Streptomyces 

species have been used in pesticide 

products to control various pests of 

agricultural products. In conjunction 

with the registration of some of these 

pesticide products, EPA established the 

following exemptions from the 

requirement of a tolerance: 

1. Streptomyces sp. (now 

griseoviridis) strain K61 (40 CFR 

180.1120)—See the Federal Register of 

April 21, 1993 (58 FR 21402) (FRL– 

4577–9). 

2. Streptomyces lydicus WYEC 108 

(40 CFR 180.1253)—See the Federal 

Register of June 3, 2004 (69 FR 31297) 

(FRL–7361–3). 

Streptomyces acidiscabies strain RL– 

110T was isolated from scab-infected 

potatoes in Maine and New York. The 

pesticide active ingredient consists of 

killed, nonviable Streptomyces 

acidiscabies strain RL–110T cells and 

spent fermentation media. Thaxtomin 

A, a phytotoxin produced by 

Streptomyces acidiscabies strain RL– 

110T, provides the herbicide mode of 

action. 

B. Microbial Pesticide Toxicology Data 

Requirements 

All applicable mammalian toxicology 

data requirements supporting the 

request for an exemption from the 

requirement of a tolerance for residues 

of killed, nonviable Streptomyces 

acidiscabies strain RL–110T in or on all 

food commodities have been fulfilled 

with data submitted by the petitioner or 

data waiver requests that have been 

granted by EPA. Results of acceptable 

(i.e., data that are scientifically sound 

and useful for risk assessment) toxicity 

tests (acute oral, dermal, and inhalation 

toxicity), primary eye and dermal 

irritation tests, and a skin sensitization 

test, all of which addressed potential 

routes of exposure to the active 

ingredient, revealed little to no toxicity, 

irritation, or sensitization attributed to 

killed, nonviable Streptomyces 

acidiscabies strain RL–110T. Moreover, 

the acute toxicity and primary irritation 

tests received a Toxicity Category IV 

classification (see 40 CFR 156.62). 

Finally, the results of an acute 

intravenous injection toxicity/ 

pathogenicity test demonstrated that 

live Streptomyces acidiscabies strain 

RL–110T were not toxic, infective and/ 

or pathogenic to the test animals. 

The overall conclusions from all 

toxicological information submitted by 

the petitioner are briefly described in 

this unit, while more in-depth synopses 

of some study results can be found in 

the associated Biopesticides Registration 

Action Document (BRAD) provided as a 

reference in Unit IX. (Ref. 1). 

1. Acute oral toxicity/pathogenicity 

(Harmonized Guideline 885.3050) and 

acute pulmonary toxicity/pathogenicity 

(Harmonized Guideline 885.3150) 

(Master Record Identification Number 

(MRID No.) 479468–17). EPA waived the 

acute oral toxicity/pathogenicity and 

acute pulmonary toxicity/pathogenicity 

data requirements for the killed 

microorganism, but required the 

intravenous injection acute toxicity/ 

pathogenicity study to verify the 

product, under a ‘‘worst case’’ scenario, 

would not be toxic and/or pathogenic to 

the test animals. 

The toxicity component of the acute 

oral toxicity/pathogenicity and acute 

pulmonary toxicity/pathogenicity data 

requirements was fulfilled by MRID No. 

479468–02 (acute oral toxicity, 

described in this unit) and MRID No. 

479468–04 (acute inhalation toxicity, 

described in this unit), respectively. 

2. Acute injection toxicity/ 

pathogenicity (intravenous)—rat 

(Harmonized Guideline 885.3200; MRID 

No. 479468–08). An acceptable acute 

injection toxicity/pathogenicity study 

demonstrated that live Streptomyces 

acidiscabies strain RL–110T was not 

toxic, infective, and/or pathogenic to 

rats when administered intravenously in 

a single dose of 9.0 × 106 colony-forming 

units (CFU) per rat. 

3. Acute oral toxicity—rat 

(Harmonized Guideline 870.1100; MRID 

No. 479468–02). An acceptable acute 

oral toxicity study with a test substance 


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containing killed, nonviable 

Streptomyces acidiscabies strain RL– 

110T demonstrated that the oral median 

lethal dose (LD50) (i.e., a statistically 

derived single dose that can be expected 

to cause death in 50% of test animals) 

was greater than 5,000 mg/kg for female 

rats. This is the limit dose, and no 

further acute oral testing is required. 

(Toxicity Category IV). 

4. Acute dermal toxicity—rat 

(Harmonized Guideline 870.1200; MRID 

No. 479468–03). An acceptable acute 

dermal toxicity study with a test 

substance containing killed, nonviable 

Streptomyces acidiscabies strain RL– 

110T demonstrated that the dermal LD50

was greater than 5,050 mg/kg for male 

and female rats combined. This is the 

limit dose, and no further acute dermal 

testing is required. (Toxicity Category 

IV). 

5. Acute inhalation toxicity—rat 

(Harmonized Guideline 870.1300; MRID 

No. 479468–04). An acceptable acute 

inhalation study with a test substance 

containing killed, nonviable 

Streptomyces acidiscabies strain RL– 

110T demonstrated that the inhalation 

median lethal concentration (LC50) was 

greater than 2.21 mg/L (the limit or 

maximum dose required to be tested) for 

male and female rats combined. 

(Toxicity Category IV). 

6. Primary dermal irritation—rabbit 

(Harmonized Guideline 870.2500; MRID 

No. 479468–06). An acceptable primary 

dermal irritation study demonstrated 

that a test substance containing killed, 

nonviable Streptomyces acidiscabies 

strain RL–110T was not irritating to the 

skin of rabbits (Toxicity Category IV). 

7. Skin sensitization—guinea pig 

(Harmonized Guideline 870.2600; MRID 

No. 479468–07). An acceptable dermal 

sensitization study demonstrated that a 

test substance containing killed, 

nonviable Streptomyces acidiscabies 

strain RL–110T was not a dermal 

sensitizer to guinea pigs. 

IV. Aggregate 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). 

A. Dietary Exposure 

1. Food exposure. Killed, nonviable 

Streptomyces acidiscabies strain RL– 

110T will be applied as a herbicide to 

agricultural crops pre-plant, at-plant 

and post-plant and may be applied up 

to the day of harvest. Exposure to this 

active ingredient through food is 

possible but is expected to be minimal 

for the following reasons: 

i. The proposed pesticide product will 

be diluted prior to application. 

ii. Pre-plant applications will occur 

1–45 days or more before planting. 

iii. At-plant applications will be 

broadcast and incorporated into the soil 

mechanically or by rainfall or sprinkler 

application. 

iv. Post-plant applications for trees 

will be made as a broadcast or banded 

application to soil surface below 

established trees or between tree rows 

and incorporated into the soil by 

rainfall, irrigation or mechanical 

incorporation. 

v. Post-plant lay-by and split 

application will be made between rows 

and incorporated into the soil. 

vi. Application to rice fields is 

followed by flooding or partially 

draining and re-flooding the fields. and 

vii. Rainfall and sprinkler irrigation 

will further wash residues of the 

pesticide from treated crops. 

Following all applications, killed, 

nonviable Streptomyces acidiscabies 

strain RL–110T will naturally degrade 

due to consumption by other biological 

organisms, including bacteria and fungi 

(Ref. 3). 

In the unlikely event that any residues 

of the pesticide remain in or on 

consumed food, no adverse effects 

would be expected, based on the lack of 

toxicity, infectivity, and/or 

pathogenicity demonstrated in the 

submitted studies. 

2. Drinking water exposure. Exposure 

to residues of killed, nonviable 

Streptomyces acidiscabies strain RL– 

110T in consumed drinking water is 

unlikely, since the majority of the 

proposed use patterns (ground and 

aerial) include measures to incorporate 

the herbicide into the soil; however, 

residues may appear at low levels in 

ground and surface water from these 

uses due to runoff or drainage from 

treated fields, or by spray drift. These 

residues will be minimized by natural 

degradation of the active ingredient by 

microbial activity (Ref. 3). Furthermore, 

since application of the product is 

concentrated in upper soil strata, 

movement through the soils would 

likely filter out any remaining product. 

The proposed directions for 

applications to established turf in 

landscapes provide for dilution of the 

product prior to application, but do not 

include measures to incorporate the 

product. Since established turf 

constitutes significant ground cover, 

this, in itself, would be expected to 

reduce the potential runoff of the 

pesticide into surface water and 

percolation to ground water. The 

proposed directions for applications to 

ornamentals in landscapes specify 

dilution prior to application and 

incorporation by irrigation or raking 

into the soil. These measures, along 

with natural degradation and 

incorporation of the product into upper 

soil strata, will reduce the potential for 

runoff into surface or ground water. 

The proposed use in rice provides the 

greatest potential for residues of killed, 

nonviable Streptomyces acidiscabies 

strain RL–110T to appear in ground and 

surface water, since application to rice 

fields is followed by flooding the treated 

fields. If residues of Streptomyces 

acidiscabies strain RL–110T are 

transferred to surface or ground waters 

that are intended for eventual human 

consumption, and subjected to 

sanitation (e.g., chlorination, pH 

adjustments, filtration, high 

temperatures) in drinking water 

treatment plants, the residues would 

likely be removed from the finished 

drinking water (Ref. 4). In the unlikely 

event that any residues of the pesticide 

occur in drinking water even after being 

processed at a water treatment facility, 

no adverse effects would be expected, 

based on the lack of toxicity and 

pathogenicity demonstrated in the 

submitted studies. 

B. Other Non-Occupational Exposure 

Given the natural occurrence of 

Streptomyces acidiscabies in soil (Refs. 

5 and 6), non-occupational and 

residential exposure may already be 

occurring. Application of killed, 

nonviable Streptomyces acidiscabies 

strain RL–110T to established turf in 

residential and landscape settings will 

result in exposure via the dermal and 

inhalation routes. Any such exposures 

are expected to be minimal, since the 

concentration of killed, nonviable 

Streptomyces acidiscabies strain RL– 

110T is diluted prior to application and 

the active ingredient is not expected to 

persist (see the food and drinking water 

exposure sections in this unit). 

In the unlikely event that the 

proposed uses of the pesticide result in 

residential, non-occupational exposure, 

no adverse effects would be expected, 

based on the lack of toxicity, irritation 

and sensitization demonstrated in 

available data (see additional discussion 

in Unit III.). 

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 


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35294 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Rules and Regulations 

tolerance exemption, EPA 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 killed, nonviable 

Streptomyces acidiscabies strain RL– 

110T to share a common mechanism of 

toxicity with any other substances, and 

killed, nonviable Streptomyces 

acidiscabies strain RL–110T does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, EPA 

has assumed that killed, nonviable 

Streptomyces acidiscabies strain RL– 

110T does not have a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine chemicals 

that 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) 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 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 safety will be 

safe for infants and children. This 

additional margin of safety is commonly 

referred to as the Food Quality 

Protection Act (FQPA) 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 acute toxicity and 

pathogenicity data discussed in Unit 

III.B., EPA concludes that there are no 

threshold effects of concern to infants, 

children or adults when killed, 

nonviable Streptomyces acidiscabies 

strain RL–110T is used as labeled in 

accordance with good agricultural 

practices. As a result, EPA concludes 

that no additional margin of exposure 

(safety) is necessary. 

Moreover, based on the same data and 

EPA analyses as presented in this unit, 

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 

killed, nonviable Streptomyces 

acidiscabies strain RL–110T when it is 

used as labeled and in accordance with 

good agricultural practices as a pre- or 

post-emergent herbicide. Such exposure 

includes all anticipated dietary 

exposures and all other exposures for 

which there is reliable information. EPA 

has arrived at this conclusion because, 

considered collectively, the data and 

information available on killed, 

nonviable Streptomyces acidiscabies 

strain RL–110T do not demonstrate toxic 

potential to mammals, including infants 

and children. 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes for the 

reasons stated in this document and 

because EPA 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. In this context, 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 killed, nonviable Streptomyces 

acidiscabies strain RL–110T. 

C. Revisions to Requested Tolerance 

Exemption 

In the Federal Register of March 10, 

2010, EPA announced Marrone Bio 

Innovations, Inc.’s filing of a pesticide 

petition that proposed establishing an 

exemption from the requirement of a 

tolerance for residues of Streptomyces 

acidiscabies strain RL–110T in or on all 

agricultural commodities. Two 

modifications have been made to the 

requested tolerance exemption. First, 

based upon the data and information 

available to the Agency, EPA is adding 

the qualifiers ‘‘killed’’ and ‘‘nonviable’’ 

before the microorganism’s taxonomic 

name and unique identifier. Use of these 

qualifiers is now consistent with the 

representation of this active ingredient 

in other associated regulatory 

documents and should assist in 

preventing confusion regarding its 

nomenclature in the future. Second, 

EPA is changing ‘‘in or on all 

agricultural commodities’’ to ‘‘in or on 

all food commodities’’ to align with the 

terminology the Agency currently uses 

when establishing tolerance exemptions 

for residues of other like active 

ingredients. 

VIII. Conclusions 

EPA concludes that there is 

reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to residues of killed, nonviable 

Streptomyces acidiscabies strain RL– 

110T. Therefore, an exemption from the 

requirement of a tolerance is established 

for residues of killed, nonviable 

Streptomyces acidiscabies strain RL– 

110T in or on all food commodities 

when applied as a pre- or post-emergent 

herbicide and used in accordance with 

good agricultural practices. 

IX. References 

1. U.S. EPA. 2012. Biopesticides 

Registration Action Document Killed, 

Nonviable Streptomyces acidiscabies strain 

RL–110T Revised April 22, 2012 (available as 

‘‘Supporting & Related Material’’ within 

docket ID number EPA–HQ–OPP–2010– 

0079–0019 at http://www.regulations.gov). 

2. Murray PR, EJ Baron, JH Jorgensen, ML 

Landry, MA Pfaller, editors. 2007. Manual of 

Clinical Biology. Vol.1. 9th Ed. Washington 

(DC): ASM Press. 

3. Doumbou CL, Akimov V, Beaulieu C. 

1998. Selection and characterization of 

microorganisms utilizing thaxtomin A, a 

phytotoxin produced by Streptomyces 

scabies. Applied and Environmental 

Microbiology 64:4313–4316. 

4. Centers for Disease Control and 

Prevention. 2009. Drinking Water—Water 

Treatment. Available from http:// 

www.cdc.gov/healthywater/drinking/public/ 

water_treatment.html. 

5. Faucher E, Savard T, Beaulieu C. 1992. 

Characterization of actinomycetes isolated 

from common scab lesions on potato-tubers. 

Canadian Journal of Plant Pathology 14:197– 

202. 


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Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Rules and Regulations 35295 

6. Loria R, Kers J, Joshi M. 2006. Evolution 

of plant pathology in Streptomyces. Annual 

Review of Phytopathology 44:469–487. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

exemption under section 408(d) of 

FFDCA in response to a petition 

submitted to EPA. 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 section 408(d) of FFDCA, 

such as the tolerance exemption in this 

final rule, do not require the issuance of 

a proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

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

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes. 

As a result, this action does not 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, 

EPA 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, EPA 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 

EPA 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: April 25, 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. Section 180.1314 is added to 

subpart D to read as follows: 

§ 180.1314 Killed, nonviable Streptomyces 

acidiscabies strain RL–110T; exemption 

from the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of killed, nonviable Streptomyces 

acidiscabies strain RL–110T in or on all 

food commodities when applied as a 

pre- or post-emergent herbicide and 

used in accordance with good 

agricultural practices. 

[FR Doc. 2012–14243 Filed 6–12–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0245; FRL–9352–4] 

RIN 2070–ZA16 

Methyl Bromide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of methyl bromide 

in or on cotton, undelinted seed under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA) because there is a need for 

imported undelinted cottonseed for use 

as additional feed for dairy cattle in the 

United States. 

DATES: This regulation is effective June 

13, 2012. Objections and requests for 

hearings must be received on or before 

August 13, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0245; 

FRL–9352–4, is available either 

electronically through http:// 

www.regulations.gov or in hard copy at 

the OPP Docket in the Environmental 

Protection Agency Docket Center (EPA/ 

DC), located in EPA West, 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: 

Kimberly Nesci, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8059; email address: 

nesci.kimberly@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 


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