Federal Register / Vol. 77, No. 131 / Monday, July 9, 2012 / Rules and Regulations 40271 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0805; FRL–9353–5] 

Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3; 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 Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 in or on all food commodities when 

applied as a nematicide and used in 

accordance with label directions and 

good agricultural practices. Pasteuria 

Bioscience, 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 

Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3 under the 

FFDCA. 

DATES: This regulation is effective July 

9, 2012. Objections and requests for 

hearings must be received on or before 

September 7, 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–2010–0805, is 

available 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 

(docket ID number: EPA–HQ–OPP– 

2010–0808) associated with notices of 

receipt of applications for pesticide 

products containing a new active 

ingredient, Pasteuria reniformis—Pr3 

(now recognized as Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 instead), under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act. Such documents include the draft 

Biopesticides Registration Action 

Document (BRAD) and environmental 

risk assessment listed in Unit IX. of this 

final rule. 

FOR FURTHER INFORMATION CONTACT: 

Jeannine Kausch, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8920; email address: 

kausch.jeannine@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 OCSPP test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a(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–2010–0805 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 September 7, 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–2010–0805, 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 statue. 

• 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. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

http://www.epa.gov/dockets. 

II. Background and Statutory Findings 

In the Federal Register of February 4, 

2011 (76 FR 6465) (FRL–8858–7), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

tolerance petition (PP 0F7745) by 

Pasteuria Bioscience, Inc., 12085 

Research Dr., Suite 185, Alachua, FL 

32615. The petition requested that 40 

CFR part 180 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of Pasteuria reniformis—Pr3 [SD–5834]. 

This notice referenced a summary of the 

petition prepared by the petitioner, 


tkelley on DSK3SPTVN1PROD with RULES
40272 Federal Register / Vol. 77, No. 131 / Monday, July 9, 2012 / Rules and Regulations 

Pasteuria Bioscience, Inc., which is 

available in the docket via http:// 

www.regulations.gov. Comments were 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit VII.C. 

Based upon review of data and other 

information supporting the petition, 

EPA modified the active ingredient 

name. In addition, EPA also changed the 

commodity to be reflected in the 

tolerance expression from ‘‘in or on all 

raw agricultural crops’’ to ‘‘in or on all 

food commodities.’’ The reasons for 

these changes are explained in Unit 

VII.D. 

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 

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

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), which require EPA to give 

special consideration to exposure of 

infants and children to the pesticide 

chemical residue in establishing a 

tolerance 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, 

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

pesticide. 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 FFDCA section 

408(b)(2)(D), 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 Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 

Pasteuria, a genus of bacteria, 

includes several species that have 

shown potential in controlling plantparasitic nematodes that attack and 

cause significant damage to many 

agricultural crops (see, e.g., the Federal 

Register of December 28, 1994 (59 FR 

66740) (FRL–4923–4), June 30, 2010 (75 

FR 37734) (FRL–8831–9), and February 

15, 2012 (77 FR 8736) (FRL–9337–2) for 

final rules that established tolerance 

exemptions for residues of the 

nematicides, Pasteuria penetrans (40 

CFR 180.1135), Pasteuria usgae (40 CFR 

180.1290), and Pasteuria nishizawae— 

Pn1 (40 CFR 180.1311), respectively). 

These gram-positive, mycelial, 

endospore-forming bacteria are mostly 

obligate parasites (i.e., organisms that 

depend on particular hosts to complete 

their own life cycle) of plant-parasitic 

nematodes, although one Pasteuria 

species—Pasteuria ramosa—is known 

to parasitize Daphnia species, which are 

tiny crustaceans often called ‘‘water 

fleas’’ due to their flea-like size and 

appearance (Refs. 1 and 2). Pasteuria 

species are ubiquitous in most 

environments and are found in 

nematodes in at least 80 countries on 5 

continents, as well as on islands in the 

Atlantic, Pacific, and Indian Oceans 

(Refs. 1 and 2). Higher population 

densities often occur in areas where 

there is an ample supply of nematode 

hosts (e.g., where crops susceptible to 

nematodes are cultivated) (Refs. 1, 3, 4, 

and 5). Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3 was 

specifically isolated from soil samples 

collected in the southeastern United 

States (Ref. 1). 

Endospores of Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 attach to Rotylenchulus species 

nematodes at all life stages, except eggs 

(Ref. 1). After an endospore attaches to 

the cuticle of a nematode host, a germ 

tube penetrates the cuticle, and growth 

and sporogenesis begin in the 

pseudocoelom of the nematode (Ref. 1). 

The nematode is eventually filled with 

cells, mycelial hyphae, and sporangia, 

which leads to its death (Ref. 1). In light 

of the demonstrated nematicidal 

capabilities and host specificity of 

Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3, Pasteuria 

Bioscience, Inc. proposed to register 

pesticide products intended for use on 

several food and nonfood crops, 

primarily as seed or soil treatments, to 

control the reniform nematode 

(Rotylenchulus reniformis). 

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 Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3 in or on all 

food commodities have been fulfilled 

with data submitted by the petitioner. 

The results of the acute dermal toxicity 

and primary dermal irritation tests 

revealed no toxicity or irritation 

attributed to Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3, and these studies received a 

Toxicity Category IV or III classification 

(see 40 CFR 156.62). Although 

infectivity and clearance of Pasteuria 

spp. (Rotylenchulus reniformis 

nematode)—Pr3 were not evaluated in 

the acute oral, pulmonary, and injection 

toxicity/pathogenicity studies, the 

results indicated that Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 was not toxic and/or pathogenic via 

the tested routes of exposure. Finally, 

the petitioner has reported that no 

hypersensitivity incidents occurred 

during development and testing of this 

bacterium. 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 draft BRAD provided as 

a reference in Unit IX. (Ref. 1). 

1. Acute oral toxicity/pathogenicity— 

rat (Harmonized Guideline 885.3050; 

Master Record Identification Number 

(MRID No.) 481460–09). A supplemental 

acute oral toxicity/pathogenicity study 

demonstrated that Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 was not toxic and/or pathogenic to 

laboratory rats when administered by 

oral gavage in a single dose of 1.5 × 109

spores per animal. 

2. Acute pulmonary toxicity/ 

pathogenicity—rat (Harmonized 

Guideline 885.3150; MRID No. 481460– 

10). A supplemental acute pulmonary 

toxicity/pathogenicity study 

demonstrated that Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 was not toxic and/or pathogenic to 

laboratory rats when administered by 

intratracheal instillation in a single dose 

of 1.5 × 108 spores per animal. 

3. Acute injection toxicity/ 

pathogenicity (intravenous)—rat 

(Harmonized Guideline 885.3200; MRID 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 131 / Monday, July 9, 2012 / Rules and Regulations 40273 

No. 481460–11). A supplemental acute 

injection toxicity/pathogenicity study 

demonstrated that Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 was not toxic and/or pathogenic to 

laboratory rats when administered 

intravenously in a single dose of 1 × 107

spores per animal. 

4. Hypersensitivity incidents 

(Harmonized Guideline 885.3400; MRID 

No. 481460–12). The petitioner reported 

that no hypersensitivity incidents, 

including immediate-type or delayedtype reactions of humans and domestic 

animals, occurred during research, 

development, or testing of Pasteuria 

spp. (Rotylenchulus reniformis 

nematode)—Pr3. 

5. Acute dermal toxicity—rabbit 

(Harmonized Guideline 870.1200; MRID 

No. 481460–14). An acceptable acute 

dermal toxicity study demonstrated that 

a test substance containing Pasteuria 

spp. (Rotylenchulus reniformis 

nematode)—Pr3 was not toxic to rabbits 

when dosed at 2,000 milligrams per 

kilogram (mg/kg) for 24 hours. The 

dermal median lethal dose, which is a 

statistically derived single dose that can 

be expected to cause death in 50% of 

test animals, was greater than 2,000 mg/ 

kg for male and female rats combined 

(Toxicity Category III). 

6. Primary dermal irritation—rabbit 

(Harmonized Guideline 870.2500; MRID 

No. 481460–16). An acceptable primary 

dermal irritation study demonstrated 

that a test substance containing 

Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3 was 

essentially non-irritating to the skin of 

rabbits (Toxicity Category IV). 

IV. Aggregate Exposure 

In examining aggregate exposure, 

FFDCA section 408 directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

A. Dietary Exposure 

1. Food exposure. Dietary exposure to 

Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3, a naturally 

occurring soil bacterium (Ref. 1), is 

anticipated to be negligible. For optimal 

control of the target pest (reniform 

nematode), Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 is applied in a manner that 

facilitates spore movement into or spore 

placement near the root zone of 

potentially affected plants. This requires 

that end users take certain actions, 

depending on the treatment type, that 

would inevitably minimize the amount 

of Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3 residues on 

above-ground commodities. That is, 

although Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3 can be 

applied to soil, plants, or seeds, some 

seeds are incorporated into the soil 

immediately after treatment (at-planting, 

hopper box, planter box, or slurry box 

seed treatments), and pesticide 

applications made to plants or the soil 

are always followed by irrigation to 

incorporate Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 into the soil. In instances where 

food commodities develop underground 

or where treated seed is diverted for 

food or feed purposes or to process into 

oil, exposure to Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 is a more likely scenario. Regardless 

of the situation, however, should 

residues of Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 result in or on food when used as 

a pesticide in accordance with label 

directions and good agricultural 

practices, its lack of toxicity and 

pathogenicity (as demonstrated in the 

available data) indicate that no adverse 

effects are likely to occur with respect 

to any exposures to such residues (see 

additional discussion in Unit III.). 

2. Drinking water exposure. Exposure 

to residues of Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 in consumed drinking water is 

possible but not likely. The proposed 

use patterns for Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 are soil directed, soil incorporated, 

and/or seed directed, thereby limiting 

contact with surface water by drift and 

runoff. Furthermore, ground water is not 

expected to have significant exposure to 

Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3, given that 

this microbial pesticide would likely be 

filtered out by the particulate nature of 

many soil types as are other 

microorganisms (Refs. 6, 7, and 8). If 

Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3 were to be 

transferred to surface or ground waters 

(e.g., through spray drift or runoff) that 

are intended for eventual human 

consumption and directed to 

wastewater treatment systems or 

drinking water facilities, it may not 

survive some of the conditions water is 

subjected to in such systems or 

facilities, including chlorination, pH 

adjustments, and filtration (Refs. 9 and 

10). In the remote likelihood that 

Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3 is present in 

drinking water (e.g., water not subject to 

certain conditions in treatment systems 

and facilities), its lack of toxicity and 

pathogenicity demonstrated by the 

available data indicate that no toxicity, 

pathogenicity, and/or infectivity is 

likely to occur with respect to any 

exposures to residues of Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 in drinking water that might result 

from pesticide applications made in 

accordance with label directions and 

good agricultural practices (see 

additional discussion in Unit III.). 

B. Other Non-Occupational Exposure 

Given Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3’s natural 

presence in soil (Ref. 1), nonoccupational exposure to the bacterium 

almost certainly is already occurring. 

Additional non-occupational exposure 

to Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3 due to 

pesticidal applications is not expected 

because all proposed pesticide end-use 

products are labeled for use in distinct 

agricultural settings. Even if additional 

non-occupational exposures were to 

occur (e.g., eventual expansion of use 

sites), the lack of toxicity, pathogenicity, 

and irritation demonstrated in the 

available data indicate that no adverse 

effects are likely to occur with respect 

to any exposures to such residues that 

might result from pesticide applications 

made in accordance with label 

directions and good agricultural 

practices (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 

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.’’ 

No mechanism of toxicity in 

mammals has been identified for 

Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3, and 

Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3 does not 

appear to produce a toxic metabolite 

against the target pest. For the purposes 

of this tolerance action, therefore, EPA 

has assumed that Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 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 


tkelley on DSK3SPTVN1PROD with RULES
40274 Federal Register / Vol. 77, No. 131 / Monday, July 9, 2012 / Rules and Regulations 

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 Safety Factor. In 

applying this provision, EPA either 

retains the default value of 10X, or uses 

a different additional or no safety factor 

when reliable data are available to 

support a different additional or no 

safety factor. 

Based on the acute toxicity and 

pathogenicity data discussed in Unit 

III.B., as well as Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3’s host specificity for Rotylenchulus 

species nematodes, EPA concludes that 

there are no threshold effects of concern 

to infants, children, or adults when 

Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3 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 analysis 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 

Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3 when it is 

used as labeled and in accordance with 

good agricultural practices as a 

nematicide. 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 Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 do not demonstrate toxic, 

pathogenic, and/or infective 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 Unit VI. 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 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. 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 Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3. 

C. Response to Comments 

Two comments were submitted. An 

anonymous commenter (EPA–HQ–OPP– 

2010–0012–0019) generally expressed 

opposition to EPA granting tolerance 

exemptions to several petitioners, 

including Pasteuria Bioscience, Inc. 

Specifically, this commenter mentioned 

concern with the prevalence of many 

toxic chemicals in the environment and 

lack of information regarding how such 

chemicals combine. Another commenter 

(EPA–HQ–OPP–2010–0905–0003) also 

expressed opposition to granting 

tolerances and tolerance exemptions for 

several chemicals, including Pasteuria 

reniformis—Pr3 (now recognized as 

Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3 instead), that 

were described in the Federal Register 

of February 4, 2011 (76 FR 6465) (FRL– 

8858–7). This commenter stated that the 

food supply must be rigorously tested, 

that studies submitted by the chemical 

industry must be subjected to 

independent peer review, and that only 

long-term studies can provide data on 

the health impact of exposure to the 

chemicals in the February 4, 2011 

Notice of Filing. 

Data provided by the petitioner 

demonstrated that Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 is not toxic and/or pathogenic at the 

doses administered orally, 

intratracheally, intravenously, and 

dermally to rats or rabbits (see Unit 

III.B.). Moreover, since no mechanism of 

toxicity in mammals has been identified 

for Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3, and 

Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3 does not 

appear to produce a toxic metabolite 

against the target pest, EPA has assumed 

that Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3 does not 

have a common mechanism of toxicity 

with other substances. After conducting 

a comprehensive assessment of the data 

and information submitted by the 

petitioner, EPA has concluded 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 Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3. Thus, under the standard in FFDCA 

section 408(c)(2), a tolerance exemption 

is appropriate. 

D. Revisions to Requested Tolerance 

Exemption 

Two modifications have been made to 

the requested tolerance exemption. 

First, after Pasteuria Bioscience, Inc. 

petitioned EPA to establish a tolerance 

exemption for Pasteuria reniformis—Pr3 

[SD–5834], EPA reviewed the submitted 

product identification data and made 

the following determinations: 

1. The active ingredient name was not 

included in any acceptable taxonomic 

scheme and 

2. Insufficient information was 

provided to show how this taxonomic 

position was established as a new 

species (i.e., reniformis). 

Thus, Pasteuria Bioscience, Inc. 

submitted additional product 

identification data and revised the 

active ingredient name from Pasteuria 

reniformis—Pr3 [SD–5834] to Pasteuria 

spp. (Rotylenchulus reniformis 

nematode)—Pr3 to accurately represent 

what was described in this new data 

(e.g., identification down to this 

isolate’s genus and of its primary target 

pest, the reniform nematode). With this 

modification to the active ingredient 

name, inclusion of the American Type 

Culture Collection accession number 

(i.e., SD–5834) was also dropped 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 131 / Monday, July 9, 2012 / Rules and Regulations 40275 

because Pasteuria Bioscience, Inc. 

already created a unique isolate 

identifier (i.e., Pr3). Use of just 

Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3 throughout 

this document, particularly in the 

tolerance exemption expression, is now 

supported by data, is consistent with the 

representation of this active ingredient 

in other associated regulatory 

documents, and should assist in 

preventing confusion regarding this 

active ingredient’s nomenclature in the 

future. Second, EPA is changing ‘‘in or 

on all raw agricultural crops’’ to ‘‘in or 

on all food commodities’’ to align with 

the terminology the Agency currently 

uses when establishing tolerances or 

tolerance exemptions for residues of 

pesticide chemicals under the FFDCA. 

VIII. Conclusions 

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 Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3. Therefore, an exemption from the 

requirement of a tolerance is established 

for residues of Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 in or on all food commodities when 

applied as labeled as a nematicide and 

used in accordance with good 

agricultural practices. 

IX. References 

1. U.S. EPA. 2011a. Draft Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 Biopesticides Registration Action 

Document dated May 8, 2012 (available 

as ‘‘Supporting & Related Material’’ 

within docket ID number EPA–HQ– 

OPP–2010–0808 at 

www.regulations.gov). 

2. U.S. EPA. 2011b. Environmental Risk 

Assessment of Pasteuria spp. 

(Rotylenchulus reniformis nematode)— 

Pr3 (PC 016456) for a Section 3 

Registration of the Technical Product 

(EPA File Symbol 85004–U) and Two 

End Use Products (EPA File Symbols 

85004–L and 85004–I) for Control of the 

Reniform Nematode. Memorandum from 

S. Borges to J. Kausch dated March 26, 

2012 (available as ‘‘Supporting & Related 

Material’’ within docket ID number 

EPA–HQ–OPP–2010–0808 at 

www.regulations.gov). 

3. Cetintas R, Dickson DW. 2004. Persistence 

and suppressiveness of Pasteuria 

penetrans to Meloidogyne arenaria Race 

1. Journal of Nematology 36:540–549. 

4. Tain B, Yang J, Zhang K–Q. 2007. Bacteria 

used in the biological control of plantparasitic nematodes: populations, 

mechanisms of action, and future 

prospects. FEMS Microbiology Ecology 

61:197–213. 

5. Noel GR. 2008. IPM of soybean cyst 

nematode in the USA. In: Integrated 

Management and Biocontrol of Vegetable 

and Grain Crops Nematodes. Eds. A. 

Cianio and K.G. Mukerji. Springer. Pages 

119–126. 

6. Pang L, McLeod M, Aislabie J, Sˇimu ̊nek J, 

Close M, Hector R. 2008. Modeling 

transport of microbes in ten undisturbed 

soils under effluent irrigation. Vadose 

Zone Journal 7:97–111. 

7. Aislabie J, Smith JJ, Fraser R, McLeod M. 

2001. Leaching of bacterial indicators of 

faecal contamination through four New 

Zealand soils. Australian Journal of Soil 

Research 39:1397–1406. 

8. DeFelice K, Wollenhaupt N, Buchholz D. 

1993. Aquifers and Soil Filter Effect. 

Available from http:// 

extension.missouri.edu/p/WQ24. 

9. Centers for Disease Control and 

Prevention. 2009. Drinking Water— 

Water Treatment. Available from http:// 

www.cdc.gov/healthywater/drinking/ 

public/water_ treatment.html. 

10. U.S. EPA. 2004. Primer for Municipal 

Wastewater Treatment Systems. EPA 

832–R–04–001. Available from http:// 

www.epa.gov/npdes/pubs/primer.pdf. 

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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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: June 13, 2012. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 


tkelley on DSK3SPTVN1PROD with RULES
40276 Federal Register / Vol. 77, No. 131 / Monday, July 9, 2012 / Rules and Regulations 

1Public Law 111–311, 124 Stat. 3294 (2010) 

(codified at 47 U.S.C. 621). The CALM Act was 

enacted on December 15, 2010 (S. 2847, 111th 

Cong.). The relevant legislative history includes the 

Senate and House Committee Reports to bills S. 

2847 and H.R. 1084, respectively, as well as the 

Senate and House Floor Consideration of these 

bills. See Senate Commerce, Science, and 

Transportation Committee Report dated Sept. 29, 

2010, accompanying Senate Bill, S. 2847, 111th 

Cong. (2010), S. REP. 111–340 (‘‘Senate Committee 

Report to S. 2847’’); House Energy and Commerce 

Committee Report dated Dec. 14, 2009, 

accompanying House Bill, H.R. 1084, 111th Cong. 

(2009), H.R. REP. 111–374 (‘‘House Committee 

Report to H.R. 1084’’); Senate Floor Consideration 

of S. 2847, 156 Cong. Rec. S7763 (daily ed. Sept. 

29, 2010) (bill passed) (‘‘Senate Floor Debate’’); 

House Floor Consideration of S. 2847, 156 Cong. 

Rec. H7720 (daily ed. Nov. 30, 2010) (‘‘House Floor 

Debate of S. 2847’’) and H7899 (daily ed. Dec. 2, 

2010) (bill passed); House Floor Consideration of 

H.R. 1084, 155 Cong. Rec. H14907 (daily ed. Dec. 

15, 2009). The Senate and House Committee 

Reports were prepared before the bill was amended 

to add Section 2(c) of the CALM Act (the 

compliance provision). See Senate Floor Debate at 

S7763–S7764 (approving ‘‘amendment No. 4687’’). 

See also House Floor Debate of S. 2847 at H7720 

(Rep. Eshoo stating that ‘‘[w]ith the passage of this 

legislation, we will end the practice of consumers 

being subjected to advertisements that are 

ridiculously loud, and we can protect people from 

needlessly loud noise spikes that can actually harm 

their hearing. This technical fix is long overdue, 

and under the CALM Act, as amended by the 

Senate, consumers will be in the driver’s seat.’’). We 

note that our action herein satisfies the statutory 

mandate that the Commission adopt final rules in 

this proceeding on or before December 15, 2011. 

2See Advanced Television Systems Committee 

(‘‘ATSC’’) A/85: ‘‘ATSC Recommended Practice: 

Techniques for Establishing and Maintaining Audio 

Loudness for Digital Television,’’ (July 25, 2011) 

(‘‘RP’’ or ‘‘the RP’’). To obtain a copy of the RP, visit 

the ATSC Web site: http://www.atsc.org/cms/ 

standards/a_85-2011a.pdf. See also CALM Act sec. 

2(a); Senate Committee Report to S. 2847 at 1; 

House Committee Report to H.R. 1084 at 1. 

3See CALM Act sec. 2(a). 

4See CALM Act sec. 2(b)(1). 

5 ‘‘Locally inserted’’ commercials are commercials 

added to a programming stream by a station or 

MVPD prior to or at the time of transmission to 

viewers. In contrast, commercials that are placed 

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 180.1316 is added to 

subpart D to read as follows: 

§ 180.1316 Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3; exemption from 

the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Pasteuria spp. (Rotylenchulus 

reniformis nematode)—Pr3 in or on all 

food commodities when applied as a 

nematicide and used in accordance with 

label directions and good agricultural 

practices. 

[FR Doc. 2012–16695 Filed 7–6–12; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 73 and 76 

[MB Docket No. 11–93; FCC 11–182] 

Implementation of the Commercial 

Advertisement Loudness Mitigation 

(CALM) Act 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the 

Commission adopts rules to implement 

the Commercial Advertisement 

Loudness Mitigation (‘‘CALM’’) Act. 

Among other things, the CALM Act 

directs the Commission to incorporate 

into its rules by reference and make 

mandatory a technical standard, 

developed by an industry standards 

development body, that is designed to 

prevent digital television commercial 

advertisements from being transmitted 

at louder volumes than the program 

material they accompany. As mandated 

by the statute, the rules apply to digital 

TV broadcasters, digital cable operators, 

and other digital multichannel video 

programming distributors (‘‘MVPDs’’). 

Also per the statute, the rules will take 

effect one year after adoption, and will 

therefore be effective as of December 13, 

2012. The rules adopted are designed to 

protect viewers from excessively loud 

commercials and, at the same time, 

permit broadcasters and MVPDs to 

implement their obligations in a 

minimally burdensome manner. The 

Commission will require broadcast 

stations and MVPDs to ensure that all 

commercials are transmitted to 

consumers at the appropriate loudness 

level in accordance with the industry 

standard. 

DATES: Effective December 13, 2012. The 

incorporation by reference of certain 

publications listed in the rule is 

approved by the Director of the Federal 

Register as of December 13, 2012. 

FOR FURTHER INFORMATION CONTACT: For 

additional information on this 

proceeding, contact Evan Baranoff, 

Evan.Baranoff@fcc.gov, or Lyle Elder, 

Lyle.Elder@fcc.gov, of the Media 

Bureau, Policy Division, (202) 418–2120 

or Shabnam Javid, 

Shabnam.Javid@fcc.gov, of the 

Engineering Division, Media Bureau at 

(202) 418–7000. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Report 

and Order (R&O), FCC 11–182, adopted 

and released on December 13, 2011. The 

full text of this document is available 

electronically via ECFS at http:// 

fjallfoss.fcc.gov/ecfs/ or may be 

downloaded at http://transition.fcc.gov/ 

Daily_Releases/Daily_Business/2011/ 

db1214/FCC-11-182A1.doc. (Documents 

will be available electronically in ASCII, 

Word 97, and/or Adobe Acrobat.) This 

document is also available for public 

inspection and copying during regular 

business hours in the FCC Reference 

Center, Federal Communications 

Commission, 445 12th Street SW., CY– 

A257, Washington, DC 20554. The 

complete text may be purchased from 

the Commission’s copy contractor, 445 

12th Street SW., Room CY–B402, 

Washington, DC 20554. Alternative 

formats are available for people with 

disabilities (Braille, large print, 

electronic files, audio format), by 

sending an email to fcc504@fcc.gov or 

calling the Commission’s Consumer and 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). 

Document Summary 

I. Introduction 

1. With this Report & Order (R&O), we 

adopt rules to implement the 

Commercial Advertisement Loudness 

Mitigation (‘‘CALM’’) Act.1 Among 

other things, the CALM Act directs the 

Commission to incorporate into its rules 

by reference and make mandatory a 

technical standard, developed by an 

industry standards development body, 

that is designed to prevent digital 

television commercial advertisements 

from being transmitted at louder 

volumes than the program material they 

accompany.2 As mandated by the 

statute, the rules apply to digital TV 

broadcasters, digital cable operators, 

and other digital multichannel video 

programming distributors (‘‘MVPDs’’).3

Also per the statute, the rules will take 

effect one year after adoption, and will 

therefore be effective as of December 13, 

2012.4 The rules we adopt today are 

designed to protect viewers from 

excessively loud commercials and, at 

the same time, permit broadcasters and 

MVPDs to implement their obligations 

in a minimally burdensome manner. As 

described below, we will require 

broadcast stations and MVPDs to ensure 

that all commercials are transmitted to 

consumers at the appropriate loudness 

level in accordance with the industry 

standard. In the event of a pattern or 

trend of complaints, stations and 

MVPDs will be deemed in compliance 

with regard to their locally inserted 

commercials if they demonstrate that 

they use certain equipment in the 

ordinary course of business.5 For the 


tkelley on DSK3SPTVN1PROD with RULES