Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations 8741 

a mycelial and endospore-forming 

bacterium parasitic on cyst nematode of 

genera Heterodera and Globodera. 

Research in Microbiology 14:551–564. 

10. 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. 

11. 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. 

12. DeFelice K, Wollenhaupt N, Buchholz D. 

1993. Aquifers and Soil Filter Effect. 

Available from http:// 

extension.missouri.edu/p/WQ24. 

13. Centers for Disease Control and 

Prevention. 2009. Drinking Water— 

Water Treatment. Available from http:// 

www.cdc.gov/healthywater/drinking/ 

public/water_treatment.html. 

14. 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 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: February 1, 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 180.1311 is added to 

subpart D to read as follows: 

§ 180.1311 Pasteuria nishizawae—Pn1; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Pasteuria nishizawae—Pn1 in or on 

all food commodities when applied as a 

nematicide and used in accordance with 

good agricultural practices. 

[FR Doc. 2012–3586 Filed 2–14–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0783; FRL–9332–9] 

Spirotetramat; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

spirotetramat in or on onion, dry bulb 

under section 408(l)(6) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

21 U.S.C. 346a(l)(6). 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 dry 

bulb onions. This regulation establishes 

a maximum permissible level for 

residues of spirotetramat in or on these 

commodities. The time-limited 

tolerances expire on December 31, 2014. 

DATES: This regulation is effective 

February 15, 2012. Objections and 

requests for hearings must be received 

on or before April 16, 2012, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2011–0783. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 


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8742 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Libby Pemberton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9364; email address: 

pemberton.libby@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. 

C. How can I file an objection or hearing 

request? 

Under section 408(g) of the FFDCA, 

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–2011–0783 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 April 16, 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–2011–0783, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 

408(l)(6) of FFDCA, 21 U.S.C. 346a(e) 

and 346a(1)(6), is establishing timelimited tolerances for combined 

residues of spirotetramat, including its 

metabolites and degradates, in or on 

onion, dry bulb at 0.3 parts per million 

(ppm). This time-limited tolerance 

expires on December 31, 2014. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for 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 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 to set binding 

precedents for the application of section 

408 of FFDCA 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 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. Section 

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

III. Emergency Exemptions for 

Spirotetramat on Dry Bulb Onions and 

FFDCA Tolerances 

Thrips rasp the onion tissue and drain 

the exuding sap, causing stunted and 

deformed plants. High thrip populations 

during bulbing can reduce yield. In 

addition, high thrip populations and the 

associated damage can shift the onion 

bulb size distribution downward and 

reduce onion quality. Of even more 

concern, thrips can infect plants with 

iris yellow spot virus. The virus in 

conjunction with thrips feeding activity 

can result in an average 25–35% 


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Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations 8743 

decrease in yield with yield losses 

observed as high as 53% in some fields. 

Onion thrips thrive under hot, dry 

conditions, and can increase and spread 

very quickly. In addition to their ability 

to rapidly increase in population, thrips 

also migrate into onion fields from 

adjacent crops. For example, as nearby 

cereal crops dry down in the early 

summer and alfalfa fields are harvested, 

large populations of thrips can migrate 

to onions. There are a number of 

products registered for thrips control on 

onions. Many were never effective or 

have become ineffective due to 

development of resistance. Due to the 

label restrictions on the available 

effective insecticides, it is currently 

infeasible for producers to control thrips 

for the entire production season with 

the available insecticides in most areas 

of onion production. 

After having reviewed the 

submissions, EPA determined that an 

emergency condition exists for eleven 

states (Colorado, Idaho, Michigan, 

Minnesota, Nevada, New York, Oregon, 

Texas, Utah, Washington, and 

Wisconsin), and that the criteria for 

approval of emergency exemptions are 

met. EPA has authorized specific 

exemptions under FIFRA section 18 for 

the use of spirotetramat on dry bulb 

onion for control of onion thrips (Thrips 

tabaci) in the 11 states listed in this 

unit. 

As part of its evaluation of the 

emergency exemption applications, EPA 

assessed the potential risks presented by 

residues of spirotetramat in or on onion, 

dry bulb. In doing so, EPA considered 

the safety standard in section 408(b)(2) 

of FFDCA, and EPA decided that the 

necessary tolerance under section 

408(l)(6) of FFDCA 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 tolerance without 

notice and opportunity for public 

comment as provided in section 

408(l)(6) of FFDCA. Although this timelimited tolerance expires on December 

31, 2014, under section 408(l)(5) of 

FFDCA, residues of the pesticide not in 

excess of the amounts specified in the 

tolerance remaining in or on onion, dry 

bulb after that date will not be unlawful, 

provided the pesticide was applied in a 

manner that was lawful under FIFRA, 

and the residues do not exceed a level 

that was authorized by this time-limited 

tolerance at the time of that application. 

EPA will take action to revoke this timelimited tolerance earlier if any 

experience with, scientific data on, or 

other relevant information on this 

pesticide indicate that the residues are 

not safe. 

Because this time-limited tolerance is 

being approved under emergency 

conditions, EPA has not made any 

decisions about whether spirotetramat 

meets FIFRA’s registration requirements 

for domestic use on dry bulb onions or 

whether permanent tolerances for this 

use would be appropriate. Under these 

circumstances, EPA does not believe 

that this time-limited tolerance decision 

serves as a basis for registration of 

spirotetramat 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 the 11 states listed in this unit 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 spirotetramat, 

contact the Agency’s Registration 

Division at the address provided under 

FOR FURTHER INFORMATION CONTACT. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with the factors specified 

in FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure expected as a result 

of this emergency exemption request 

and the time-limited tolerances for 

combined residues of spirotetramat and 

its metabolites and degradates on onion, 

dry bulb at 0.3 ppm. EPA’s assessment 

of exposures and risks associated with 

establishing time-limited tolerances 

follows. 

A. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for spirotetramat used for 

human risk assessment is discussed in 

Unit III. of the final rules published in 

the Federal Register of July 9, 2008 (73 

FR 39251) (FRL–8367–1) and May 18, 

2011 (76 FR 28675) (FRL–8865–8). The 

final rule of July 9, 2008 established a 

number of tolerances for residues of 

spirotetramat, including onion, bulb, 

subgroup 3A–07. Subsequently, in the 

final rule published in the Federal 

Register of May 18, 2011, EPA added a 

footnote to the established tolerance for 

onion, bulb, subgroup 3A–07 to indicate 

that currently there are no U.S. 

registrations for onions. Use on onions 

at that time was assessed for import 

tolerances only. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to spirotetramat, EPA 

considered exposure under the timelimited tolerances established by this 

action as well as all existing 

spirotetramat tolerances in 40 CFR 

180.641. EPA assessed dietary 

exposures from spirotetramat in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. Such effects were identified 

for spirotetramat. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA assumed 100 

percent crop treated (PCT) and 

tolerance-level residues for all foods. 

Empirical and Dietary Exposure 

Evaluation Model (DEEMTM) (ver. 7.81) 

default processing factors were used for 

processed commodities. Residues in 

drinking water were addressed by 


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incorporating directly in the dietary 

assessment the acute concentrations of 

spirotetramat residues in surface water 

estimated by the First Index Reservoir 

Screening Tool (FIRST) model. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

conducted a conservative chronic 

dietary assessment assuming tolerancelevel residues, empirical and DEEMTM

(ver. 7.81) default processing factors, 

and 100 PCT. Drinking water was 

incorporated directly in the dietary 

assessment using the chronic 

concentrations for surface water. 

iii. Cancer. Based on the data 

summarized in Unit IV.A., EPA has 

concluded that spirotetramat does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for spirotetramat. Tolerance level 

residues and 100 PCT were assumed for 

all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for spirotetramat in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

spirotetramat. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/

oppefed1/models/water/index.htm. 

Based on the FIRST and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

spirotetramat for acute exposures are 

estimated to be 0.212 parts per billion 

(ppb) for surface water; and 3.96 × 10¥4

ppb for ground water. 

For chronic exposures for non-cancer 

assessments, the EDWCs are estimated 

to be 1.37 × 10¥3 ppb for surface water 

and 3.96 × 10¥4 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

For acute dietary risk assessment, the 

most conservative water concentration 

value of 0.212 ppb was used to assess 

the contribution to drinking water based 

on the use of spirotetramat on pome 

fruit (0.4 lb ai/A/year). 

For chronic dietary risk assessment, 

the most conservative water 

concentration of value 1.37 × 10¥3 ppb 

was used to assess the contribution to 

drinking water, based on the use of 

spirotetramat on Christmas trees (0.32 lb 

ai/A/year). 

3. Sources of non-dietary exposure. 

The term ‘‘residential exposure’’ is used 

in this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Spirotetramat is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found spirotetramat to 

share a common mechanism of toxicity 

with any other substances, and 

spirotetramat does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that spirotetramat does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/

cumulative. 

C. Safety Factor for Infants and Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA 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 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

There was no evidence of increased 

susceptibility of rat or rabbit to prenatal 

or postnatal exposure to spirotetramat. 

In the rat developmental toxicity study, 

toxicity to offspring was observed at the 

same dose as maternal toxicity, which 

was also the limit dose. In the 

developmental toxicity study in the 

rabbit, only maternal toxicity was 

observed. In both reproductive toxicity 

studies, toxicity to offspring (decreased 

body weight) was observed at the same 

dose as parental toxicity. Therefore, no 

evidence of increased susceptibility of 

offspring was found across four relevant 

toxicity studies with spirotetramat. 

3. Conclusion. EPA has determined 

that reliable data show that the safety of 

infants and children are adequately 

protected at the FQPA SF of 1X. That 

decision is based on the following 

findings: 

i. The toxicity database for 

spirotetramat is complete except for an 

immunotoxicity study and a subchronic 

neurotoxicity study which are 

considered to be outstanding due to 

recent amendments to the data 

requirements in 40 CFR part 158. 

Despite the absence of these studies, 

other related studies indicate that the 

immunotoxicity study and subchronic 

neurotoxicity study are unlikely to show 

risks to infants and children that would 

warrant an additional safety factor. The 

only indication of possible 

immunotoxicity in the toxicology 

database for spirotetramat is a 90-day 

oral toxicity study in dogs that shows 

effects in the thymus gland, an organ of 

the immune system. However, the 

endpoint selected for risk assessment is 

protective against these thyroid effects, 

as it was based on accelerated thymus 

involution and decreased thyroid 

hormone levels in the dog. Moreover, 

thymus involution has been 

demonstrated to occur in animals when 

the thyroid is induced to decrease 

hormone levels, so it is reasonable to 

conclude that the thymus involution in 

these dogs was secondary to the thyroid 

effects, rather than a direct effect on the 

immune system. The dose at which 

these effects were observed was chosen 

as a point of departure because there 

was some consistency of dose and effect 

seen across the subchronic and chronic 

toxicity studies. However, the effects 

occurred in relatively few animals and 

thus selection of this endpoint is 

considered a very protective point of 

departure; it is at least tenfold lower 

than any other potential point of 

departure. With respect to 

immunotoxicity, no immunotoxic 

effects were seen in rats or mice, the 

species in which immunotoxicity 

studies are conducted. Thus, the Agency 

does not believe that conducting a 

functional immunotoxicity study in any 

rodent species will result in a lower 

POD than that currently used for overall 

risk assessment. For this reason and 

because the current POD is considered 


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Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations 8745 

extremely protective, an uncertainty 

factor (UFDB) is not needed to account 

for the lack of this study. Data regarding 

neurotoxicity is discussed in Unit 

III.C.3.ii. 

ii. EPA has concluded that 

spirotetramat is not a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. Although a subchronic 

neurotoxicity study is now required as 

part of the revisions to 40 CFR part 158, 

the existing toxicological database 

indicates that spirotetramat is not a 

neurotoxic chemical in mammals. The 

only clinical signs at any dose in the 

acute neurotoxicity study were staining 

of the fur or perianal region with urine 

and decreased motor activity. The urine 

staining that was identified is not 

considered a neurotoxic effect and was 

likely due to a colored metabolite that 

was excreted into the urine or feces or 

to a change in the pH of the urine due 

to an excreted metabolite. The 

decreased motor activity observed is not 

considered evidence of neurotoxicity 

because there were no effects on 

movement or gait and there were no 

confirmatory findings of neurological 

pathology. Thus, both of these effects 

are considered signs of general toxicity 

(malaise). Further, the effects seen in the 

acute neurotoxicity study are not 

corroborated by any other study in the 

database. Although brain dilation was 

found in one dog in the one-year dog 

study, EPA concluded that this effect 

was most likely not caused by 

administration of spirotetramat given 

evidence showing this to be a congenital 

anomaly in the test species, and because 

there is no other evidence of brain 

pathology in the database. Finally, the 

conclusion that spirotetramat is not a 

neurotoxic chemical is supported by the 

fact that the acute, subchronic and 

developmental neurotoxcity studies 

available for structurally-related 

compounds (spirodiclofen and 

spiromesifen) do not show evidence of 

neurotoxicity in adults or young. 

iii. There is no evidence that 

spirotetramat results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. There was no 

evidence of increased susceptibility of 

offspring following pre- or post-natal 

exposure in any study. In the rat 

developmental toxicity study, toxicity to 

offspring was observed at the same dose 

as maternal toxicity, which was also the 

limit dose. In the developmental 

toxicity study in the rabbit, only 

maternal toxicity was observed. In both 

reproductive toxicity studies, toxicity to 

offspring (decreased body weight) was 

observed at the same dose as parental 

toxicity. Therefore, no evidence of 

increased susceptibility of offspring was 

found across four relevant toxicity 

studies with spirotetramat. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dataset used to establish a tolerance 

for spirotetramat and its metabolites on 

onion, bulb, subgroup 3A–07 consisted 

of field trial data representing 

application rates of ∼0.26 a.i./A 

(Northern EU, 100 OD formulation) with 

a 7-day PHI. As specified by the 

Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data 

SOP, the field trial application rates and 

PHIs are within 25% of the maximum 

label application rate and minimum 

label PHI, respectively. The dietary food 

exposure assessments were performed 

based on 100 PCT and tolerance-level 

residues. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to spirotetramat in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by spirotetramat. 

D. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

spirotetramat will occupy 11% of the 

aPAD for children 1–2 yrs old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to spirotetramat 

from food and water will utilize 93% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for spirotetramat. 

3. Short-term risk. Spirotetramat is 

not registered for any use patterns that 

would result in short-term residential 

exposure. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Spirotetramat is not registered for any 

use patterns that would result in 

intermediate-term residential exposure. 

Therefore, the intermediate-term 

aggregate risk is the sum of the risk from 

exposure to spirotetramat through food 

and water, which has already been 

addressed, and will not be greater than 

the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

spirotetramat is not expected to pose a 

cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children, 

from aggregate exposure to spirotetramat 

residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography with tandem mass 

spectrometry (HPLC–MS/MS)) is 

available to enforce the tolerance 

expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. The 


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8746 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations 

U.S. provided the primary review of the 

available toxicology studies, and Canada 

provided the primary review of the 

residue chemistry data. All of the 

residues of concern for tolerances and 

MRLs have been harmonized among 

Austria, Canada and the U.S. All 

toxicology endpoints have been 

harmonized, with the exception of the 

acute reference dose (aRfd), which has 

been harmonized with Canada. The 

Codex has not established MRLs for 

spirotetramat on onion, dry bulb. This 

time-limited tolerance is harmonized 

with the Canadian MRL for 

spirotetramat on onion, dry bulb. 

VI. Conclusion 

Therefore, time-limited tolerances are 

established for combined residues of 

spirotetramat, including its metabolites 

and degradates in or on onion, dry bulb 

at 0.3 ppm. These tolerances expire on 

December 31, 2014. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under sections 408(e) and 408(l)(6) of 

FFDCA. 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 

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

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 section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L.104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VIII. 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: February 1, 2012. 

Lois Rossi, 

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. Section 180.641 is amended by 

revising paragraph (b) to read as follows: 

§ 180.641 Spirotetramat; tolerances for 

residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

residues of the spirotetramat, including 

its metabolites and degradates, in or on 

the commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only the sum 

of spirotetramat (cis-3-(2,5- 

dimethlyphenyl)-8-methoxy-2-oxo-1- 

azaspiro[4.5]dec-3-en-4-yl-ethyl 

carbonate) and its metabolites cis-3-(2,5- 

dimethylphenyl)-4-hydroxy-8-methoxy1-azaspiro[4.5]dec-3-en-2-one, cis-3- 

(2,5-dimethylphenyl)-3-hydroxy-8- 

methoxy-1-azaspiro[4.5]decane-2,4- 

dione, cis-3-(2,5-dimethylphenyl)-8- 

methoxy-2-oxo-1-azaspiro[4.5]dec-3-en4-yl beta-D-glucopyranoside, and cis-3- 

(2,5-dimethylphenyl)-4-hydroxy-8- 

methoxy-1-azaspiro[4.5]decan-2-one, 

calculated as the stoichiometric 

equivalent of spirotetramat, in or on the 

specified agricultural commodities, 

resulting from use of the pesticide 

pursuant to FIFRA section 18 

emergency exemptions. The tolerances 

expire on the date specified in the table. 

Commodity 

Parts 

per 

million 

Expiration 

date 

Onion, dry bulb 0.3 December 31, 

2014. 

* * * * * 

[FR Doc. 2012–3283 Filed 2–14–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0578; FRL–9336–7] 

Indoxacarb; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of indoxacarb in 

or on egg, poultry fat, poultry meat, and 

poultry meat byproducts. E.I. du Pont de 

Nemours and Company requested these 


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