74634 Federal Register / Vol. 75, No. 230 / Wednesday, December 1, 2010 / Rules and Regulations 

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: November 18, 2010. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.910, add alphabetically the 

following inert ingredient to the table to 

read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Poly(oxy-1,2-ethanediyl), a-[tris(1-phenylethyl)phenyl]-w-hydroxy-, (CAS Reg. No. 99734–09–5).For use in post-harvest applications; Not to exceed 15% by 

weight in pesticide formulations.

Surfactants. 

* * * * * * * 

[FR Doc. 2010–29992 Filed 11–30–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0136; FRL–8850–9] 

Spiroxamine; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of spiroxamine, 

[(8-(1,1-dimethylethyl)-N-ethyl-Npropyl-1, 4-dioxaspiro[4,5]decane-2- 

methanamine)], including its 

metabolites and degradates in or on 

artichoke, globe, import at 0.7 parts per 

million (ppm) asparagus, import at 0.05 

ppm; and vegetables, fruiting, crop 

group 8, import at 1.2 ppm. Bayer 

CropScience requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 1, 2010. Objections and 

requests for hearings must be received 

on or before January 31, 2011, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0136. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Tamue L. Gibson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–9096; e-mail address: 

gibson.tamue@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 those engaged in the 

following activities: 

• 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 to provide a guide 

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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 EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.gpoaccess.gov/ecfr. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0136 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 January 31, 2011. 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–2010–0136, 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. Summary of Petitioned-For 

Tolerance 

In the Federal Register of March 24, 

2010 (75 FR 14154) (FRL–8815–6), 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 petition (PP 9E7564) by Bayer 

CropScience, 2 T.W. Alexander Drive, 

P.O. Box 12014, Research Triangle Park, 

North Carolina 27709. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the fungicide spiroxamine, 

(8-(1,1-dimethylethyl)-N-ethyl-Npropyl-1,4-dioxaspiro[4,5]decane-2- 

methanamine) and its metabolites 

containing the N-ethyl-N-propyl-1,2- 

dihydroxy-3-aminopropane moiety, 

calculated as parent equivalent, in or on 

artichoke, globe at 0.7 parts per million 

(ppm); asparagus at 0.05 ppm and 

vegetable, fruiting, group 8 at 1.2 ppm. 

That notice referenced a summary of the 

petition prepared by Bayer CropScience, 

the registrant, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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. * * *’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 for spiroxamine 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with spiroxamine follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by spiroxamine as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http:// 

www.regulations.gov in document 

‘‘Spiroxamine: Human Health Risk 

Assessment for Spiroxamine on 

Imported Artichoke, Asparagus and 

Fruiting Vegetables (Corp Group 8),’’ pp. 

33–36 in docket ID number EPA–HQ– 

OPP–2010–0136. 

Spiroxamine has low acute oral and 

inhalation toxicity and is not irritating 

to the eye. However, spiroxamine is a 

skin sensitizer when tested in guinea 

pigs and is a severe dermal irritant. 

Spiroxamine subchronic studies show 

the target organ of toxicity is the liver. 

These studies were characterized by 

slight to mild hepatotoxicity, with 

associated elevation in liver enzymes. 

Mucous membranes of the esophagus 

and forestomach were keratinized and 

hyperplastic as a result of the strong 

irritant properties of spiroxamine. 

Administration of spiroxamine in longterm studies in the dog resulted in 

hepatocytomegaly, cataracts, and liver 

discoloration. In the rat, it resulted in an 

increased mortality in females, 

decreased body weights and body 

weight gains in both sexes, and 

increased esophageal hyperkeratosis in 

both sexes, while in the mouse, chronic 

administration resulted in uterine 

nodules, hyperplasia in the adrenal 

gland of males, hyperkeratosis in the 

esophagus, forestomach, and tongue of 

females, and acanthosis in the pinnae 

and tails of females. Developmental 

effects in rats entailed delayed 

ossification which may be considered 

secondary to decreased body weight. 

Treatment-related developmental effects 

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were not seen in rabbits. There was no 

evidence of increased susceptibility of 

the young animals following exposure 

to spiroxamine in any developmental 

toxicity studies in the data base. There 

was evidence of mild spiroxamineinduced neurotoxicity characterized by 

piloerection and slight to moderate gait 

incoordination, and functional 

observational battery (FOB) effects of 

decreased forelimb grip strength and 

foot splay in males in the acute 

neurotoxicity study. No neuropathology 

was seen in either the acute or 

subchronic toxicity studies in rats and 

no neurotoxicity was detected in the 

subchronic study. Spiroxamine has no 

carcinogenic potential, as indicated in 

both the rat and the mouse 

carcinogenicity studies. In addition, 

spiroxamine has no mutagenicity 

potential, based on several in vivo and 

in vitro studies. 

B. 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 spiroxamine used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SPIROXAMINE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure scenario Point of departure Uncertainty/FQPA 

safety factors 

RfD, PAD, level of 

concern for risk 

assessment 

Study and toxicological effects 

Acute Dietary (General population, 

including infants and children.

NOAEL = 10 mg/kg/ 

day.

UFA = 10X ...............

UFH = 10X 

FQPA = 1X 

aRfD = 0.1 mg/kg/ 

day.

aPAD = 0.1 mg/kg/ 

day 

Acute Neurotoxicity in Rats. 

LOAEL = 30 mg/kg based on 

clinical signs (piloerection and 

slight to moderate gait in coordination) and FOB effects (decreased forelimb grip strength 

and foot splay) in males on Day 

0–1. 

Acute Dietary (females 13–49 years 

old).

No hazard identified. 

Chronic Dietary—general population, 

including infants and children.

NOAEL = 2.5 mg/kg/ 

day.

UFA = 10X ...............

UFH = 10X 

FQPA = 1X 

cRfD = 0.025 mg/kg/ 

day.

cPAD = 0.025 mg/ 

kg/day 

Chronic Oral Toxicity Study in 

Dogs. LOAEL = 28.03/25.84 mg/ 

kg/day M/F based on 

hepatocytomegaly, cataracts and 

decreased albumin in males and 

females; liver discoloration and 

decreased triglycerides in females; and increased alanine 

aminotransferase in males. 

Short-term (1–30 days) Incidental 

Oral.

No residential uses are proposed. 

Intermediate Term (1–6 months) Incidental Oral.No residential uses are proposed. 

Short-term (1–30 days) Dermal ........ NOAEL 5 mg/kg/day UFA = 10X ...............

UFH = 10X 

FQPA = 1X 

LOC = ......................

MOE ≤ 100 

Prenatal Toxicity study in Rats 

(Dermal). 

The maternal LOAEL (systemic) is 

20 mg/kg/day based on decreased body weight gains. 

Intermediate term (1–6 months) Dermal.NOAEL 5 mg/kg/day UFA = 10X ...............

UFH = 10X 

FQPA = 1X 

LOC = ......................

MOE ≤ 100 

Prenatal Toxicity study in Rats 

(Dermal). 

The maternal LOAEL (systemic) is 

20 mg/kg/day based on decreased body weight gains. 

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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SPIROXAMINE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure scenario Point of departure Uncertainty/FQPA 

safety factors 

RfD, PAD, level of 

concern for risk 

assessment 

Study and toxicological effects 

Short term (1–30 days) Inhalation .... NOAEL = 23.6 mg/ 

kg/day.

UFA = 10X ...............

UFH = 10X 

FQPA = 1X 

LOC = ......................

MOE ≤ 100 

28-day Inhalation Toxicity Study in 

Rats. 

LOAEL = 0.518 mg/L = 140.5 mg/ 

kg/day based on decreased 

body weights and body weight 

gains, increased incidences of 

clinical signs of toxicity and dermal irritation, thymic atrophy and 

toxicity to the skin, respiratory 

system and liver. 

Intermediate term (1–6 months) Inhalation.NOAEL = 23.6 mg/ 

kg/day.

UFA = 10X ...............

UFH = 10X 

FQPA = 1X 

LOC = ......................

MOE ≤ 100 

28-day Inhalation Toxicity Study in 

Rats. 

LOAEL = 0.518 mg/L = 140.5 mg/ 

kg/day based on decreased 

body weights and body weight 

gains, increased incidences of 

clinical signs of toxicity and dermal irritation, thymic atrophy and 

toxicity to the skin, respiratory 

system and liver. 

Cancer (oral, dermal, inhalation) ...... Classification: Not likely to be carcinogenic to humans based on negative genotoxicity and carcinogenicity 

in long term cancer studies in rats and mice. 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect 

level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = 

potential variation in sensitivity among members of the human population (intraspecies). FQPA = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to spiroxamine, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing spiroxamine tolerances in 40 

CFR 180.602. EPA assessed dietary 

exposures from spiroxamine 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 spiroxamine. 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 

tolerance levels residues and 100 

percent crop-treated (PCT) for the 

requested uses for spiroxamine. 

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 

assumed tolerance level residues and 

100 PCT for the requested and currently 

registered uses of spiroxamine. 

iii. Cancer. The Agency classified 

spiroxamine as ‘‘Not Likely to be 

Carcinogenic to Humans’’ based on the 

results of the carcinogenicity studies in 

rats and mice. Spiroxamine was 

determined to be non-mutagenic in 

bacteria, negative in an in vivo 

mammalian cytogenetics assay, and did 

not cause unscheduled DNA synthesis 

in mammalian cells in vitro. 

Accordingly, an exposure assessment to 

evaluate 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 spiroxamine. Tolerance level 

residues and/or 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 spiroxamine in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

spiroxamine. 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 Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and SCI– 

GROW model, the estimated drinking 

water concentrations (EDWCs) of 

spiroxamine for acute exposures are 

estimated to be 19 parts per billion 

(ppb) for surface water and 0.035 ppb 

for ground water. For chronic exposures 

for non-cancer assessments are 

estimated to be 15 ppb for surface water 

and 0.035 ppb for ground water. 

3. From 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). 

Spiroxamine 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 

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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 spiroxamine to 

share a common mechanism of toxicity 

with any other substances, and 

spiroxamine does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that spiroxamine 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. 

D. 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 safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no concern for pre- or postnatal 

toxicity due to spiroxamine exposure. 

Delays in ossification, balanopreputial 

separation and vaginal patency were 

observed in the rat and may be 

secondary to decreased body weight. 

The latter two delays were resolved 

within the appropriate age range of 

puberty and no effects on reproductive 

function were observed in the 

multigeneration study in rats. Delayed 

balanopreputial separation was seen 

only in the presence of maternal toxicity 

and is not more severe than the 

maternal effects of decreased body 

weight and esophageal hyperkeratosis 

(due to irritation) seen at the common 

LOAEL of the multigeneration study. 

Delayed balanopreputial separation or 

vaginal patency does not cause concern 

for increased sensitivity to the young. 

There were no other treatment-related 

effects on fertility, viability or lactation 

indices or other reproductive 

parameters in either generation of the 

2-generation reproductive toxicity 

study. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. Except for an immunotoxicity 

study, the toxicity database for 

spiroxamine is complete. In accordance 

with the revised part 158 an 

immunotoxicity study is required. 

Although a test-article related structural 

effect on the immune system was 

observed in the 90-day rat inhalation 

study in the form of thymic atrophy 

accompanied by decreased platelets and 

consequent increased clotting time, 

decreased lymphocytes and increased 

neutrophils, these lesions were seen 

only when inhalation was the route of 

administration and at the highest dose 

tested of 3,000 mg/m3 (equivalent to 141 

mg/kg/day) which exceeds the limit 

dose of 1 mg/L (1,000 mg/m3). These 

route-specific lesions are likely 

secondary to local (respiratory system) 

irritation, inflammation and injury and 

not attributable to frank 

immunotoxicity. The Agency does not 

believe that conducting the 

immunotoxicity study will result in a 

dose less than the POD used in this risk 

assessment: NOAEL = 2.5 mg/kg/day 

based on liver toxicity at approximately 

25 mg/kg/day. Hepatotoxicity was 

accompanied by decreased body weight 

and food consumption which were also 

considered secondary to local (digestive 

system) irritation resulting in test-article 

related hyperkeratosis of the tongue, 

esophagus and stomach. 

ii. There is no concern for 

neurotoxicity with spiroxamine. Signs 

of neurotoxicity were reported in the 

acute neurotoxicity study only. Minimal 

clinical signs of neurotoxicity was 

observed only in males at the lower 

dose level. However, no evidence of 

neurotoxicity were observed at the 

highest dose level in the subchronic 

neurotoxicity study. Therefore, there is 

no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no evidence that 

spiroxamine results in increased 

susceptibility in utero rats or rabbits in 

the prenatal developmental studies or in 

young rats in the 2-generation 

reproduction study. 

iv. Although storage and stability 

sampling and analysis dates have been 

requested for hops, there are no residual 

uncertainties identified in the exposure 

database because there is no indication 

of residue degradation during frozen 

storage. The acute and chronic dietary 

exposure assessments were performed 

based on 100 PCT and tolerance-level 

residues. Conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to spiroxamine in drinking water. 

Residential exposures are not expected. 

These assessments will not 

underestimate exposures and risks 

posed by spiroxamine. 

E. 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 population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

given the estimated aggregate exposure. 

Short-term, intermediate-term, 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 

spiroxamine will occupy 36% of the 

aPAD for children 1–2 years 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 spiroxamine 

from food and water will utilize 40% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no proposed or 

existing residential uses for 

spiroxamine. Based on the explanation 

in Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of spiroxamine is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Spiroxamine is not registered for any 

use patterns that would result in 

residential exposure. Therefore, there is 

no potential for short-term risk to 

spiroxamine. 

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). 

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Federal Register / Vol. 75, No. 230 / Wednesday, December 1, 2010 / Rules and Regulations 74639 

Spiroxamine is not registered for any 

use patterns that would result in 

intermediate-term residential exposure. 

Therefore, there is no potential for 

intermediate-term risk to spiroxamine. 

5. Aggregate cancer risk for U.S. 

population. For spiroxamine, there were 

no observed evidence of carcinogenicity 

in two adequate rodent carcinogenicity 

studies, spiroxamine was determined to 

be non-mutagenic in bacteria, negative 

in an in vivo mammalian cytogenetics 

assay and did not cause unscheduled 

DNA synthesis in mammalian cells in 

vitro. Therefore, spiroxamine 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 spiroxamine 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography/mass spectrometry 

(GC/MS) Bayer AG Method No. 00407) 

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; e-mail 

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. 

There are no currently established 

Codex, Canadian, or Mexican maximum 

residue limits for spiroxamine on 

artichoke, asparagus and fruiting 

vegetables (crop group 8). 

C. Revisions to Petitioned-for Tolerances 

EPA is revising the tolerance 

expression to spiroxamine to clarify the 

chemical moieties that are covered by 

the tolerances and specify how 

compliance with the tolerances is to be 

measured. The revised tolerance 

expression makes clear that the 

tolerances cover residues of the 

spiroxamine, including its metabolites 

and degradates, but that compliance 

with the specified tolerance levels is to 

be determined by measuring only the 

sum of spiroxamine and its metabolites 

containing the N-ethyl-N-propyl-1,2- 

dihyroxy-3-amino propane moiety, 

calculated as the stoichiometric 

equivalent of spiroxamine, in or on the 

commodity. In addition, although it was 

not noted in the company petition, a 

request for import tolerances (only) was 

petitioned of the Agency for the uses in 

this final rule. 

V. Conclusion 

Therefore, tolerances are established 

for residues of spiroxamine, including 

its metabolites and degradates in or on 

artichoke, globe, import at 0.7 ppm; 

asparagus, import at 0.05 ppm and 

vegetables, fruiting (crop group 8), 

import at 1.2 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 

et seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 

et seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. 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. 

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74640 Federal Register / Vol. 75, No. 230 / Wednesday, December 1, 2010 / Rules and Regulations 

Dated: November 17, 2010. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.602 is amended by 

revising paragraph (a) introductory text 

and alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.602 Spiroxamine; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

spiroxamine, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 

spiroxamine, [(8-(1,1-dimethylethyl)-Nethyl-N-propyl-1,4- 

dioxaspiro[4,5]decane-2-methanamine) 

in or on the commodities. 

Commodity Parts per 

million 

Artichoke, globe, import 1 ........ 0 .7 

Asparagus 1 ............................. 0 .05 

* * * * * 

Vegetable, fruiting , crop 

group 8 1 .............................. 1 .2 

1 No U.S. registration as of December 1, 

2010. 

* * * * * 

[FR Doc. 2010–30114 Filed 11–30–10; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 300 

[Docket No. 100507218–0325–02] 

RIN 0648–AY91 

International Fisheries; South Pacific 

Tuna Fisheries; Procedures To 

Request Licenses and a System To 

Allocate Licenses 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule. 

SUMMARY: Pursuant to its authority 

under the South Pacific Tuna Act of 

1988 (SPTA), NMFS issues regulations 

to modify the procedures that U.S. purse 

seine vessels use to request fishing 

licenses to fish in areas managed under 

the SPTA. This rule also establishes a 

system for allocating licenses in the 

event more applications are received 

than there are licenses available. Such 

an allocation system is needed because 

the number of applications is 

approaching the number of available 

licenses, and may exceed that number. 

The license allocation system includes 

objective criteria to be used by NMFS in 

prioritizing among license applicants. 

The license application procedures are 

modified in accordance with the 

allocation system, and are designed to 

provide license holders and prospective 

license applicants with a clear and 

certain regulatory process. The 

regulations for vessels licensed under 

the SPTA are also modified to require 

that the vessel monitoring system units 

(VMS units), also known as mobile 

transmitting units, installed and carried 

on the vessels are a type that is NMFSapproved. 

DATES: This final rule is effective 

January 3, 2011. 

ADDRESSES: Copies of supporting 

documents that were prepared for this 

final rule, including the regulatory 

impact review (RIR), as well as the 

proposed rule, are available via the 

Federal e-Rulemaking portal, at http:// 

www.regulations.gov. Those documents 

are also available from the Regional 

Administrator, NMFS, Pacific Islands 

Regional Office, 1601 Kapiolani Blvd., 

Suite 1110, Honolulu, HI 96814–4700. 

Written comments regarding the 

burden-hour estimates or other aspects 

of the collection-of-information 

requirements contained in this final rule 

may be submitted to NMFS, Pacific 

Islands Regional Office (see contact 

information above), and by e-mail to 

OIRA_Submission@omb.eop.gov or fax 

to 202–395–7285. 

FOR FURTHER INFORMATION CONTACT: Tom 

Graham, NMFS, Pacific Islands Regional 

Office, 808–944–2219. 

SUPPLEMENTARY INFORMATION: 

Electronic Access 

This final rule is also accessible at 

http://www.gpoaccess.gov/fr. 

Background 

On June 28, 2010, NMFS published a 

proposed rule in the Federal Register 

(75 FR 36619) that would modify the 

regulations at 50 CFR part 300, subpart 

D. Those regulations are issued under 

the authority of the South Pacific Tuna 

Act of 1988 (SPTA) (16 U.S.C. 973– 

973r), which was enacted to implement 

the Treaty on Fisheries between the 

Governments of Certain Pacific Island 

States and the Government of the 

United States of America and its 

annexes, schedules, and implementing 

agreements, as amended (‘‘the Treaty’’). 

The SPTA authorizes the Secretary of 

Commerce (Secretary), with the 

concurrence of the Secretary of State 

and after consultation with the 

Secretary of the Department in which 

the United States Coast Guard is 

operating (currently the Department of 

Homeland Security), to issue regulations 

as may be necessary to carry out the 

purposes and objectives of the Treaty 

and the SPTA. The authority to issue 

regulations has been delegated to 

NMFS. 

The Treaty governs the conduct of 

U.S. fishing vessel operations in the 

Treaty Area, as defined at 50 CFR 

300.31, and which encompasses 

approximately 10 million square miles 

(26 million square kilometers) of the 

western and central Pacific Ocean 

(WCPO). The Treaty allows U.S. purse 

seine vessels access to a large portion of 

the WCPO by authorizing, and 

regulating through a licensing system, 

U.S. purse seine vessels operations 

within all or part of the exclusive 

economic zones (EEZs) of the 16 Pacific 

Island Parties (PIPs) to the Treaty. 

Licenses to operate in the Licensing 

Area under the Treaty are issued by the 

Pacific Islands Forum Fisheries Agency 

(FFA), based in Honiara, Solomon 

Islands, which acts as the Treaty 

Administrator on behalf of the PIPs. 

Licenses are issued on an annual basis, 

with the licensing period starting June 

15th of each year. U.S. purse seine 

vessels licensed under the Treaty are 

used to target skipjack tuna and 

yellowfin tuna. 

Currently, the Treaty allows for a 

maximum of 45 licenses to U.S. purse 

seine fishing vessels to fish in the 

Licensing Area of the Treaty. Of the 45 

licenses, 5 are reserved for U.S. vessels 

engaged in ‘‘joint venture’’ arrangements 

designed to maximize the benefits 

generated for the PIPs. The Licensing 

Area comprises the entire Treaty Area, 

with the exception of areas subject to 

the jurisdiction of the United States and 

areas closed to fishing under the Treaty. 

It thus includes all or part of the EEZs 

of the following countries: Australia, 

Cook Islands, Federated States of 

Micronesia, Fiji, Kiribati, Marshall 

Islands, Nauru, New Zealand, Niue, 

Palau, Papua New Guinea, Samoa, 

Solomon Islands, Tonga, Tuvalu, and 

Vanuatu. 

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