25904 Federal Register / Vol. 77, No. 85 / Wednesday, May 2, 2012 / Rules and Regulations 

was a typographical error because the 

document in no place mentions, or 

suggests, an intention of removing those 

tolerances. Public comment is 

unnecessary on an action to correct such 

a clear inadvertent error. EPA finds that 

this constitutes good cause under 5 

U.S.C. 553(b)(3)(B). 

IV. Do any of the statutory and 

executive order reviews apply to this 

action? 

This final rule corrects a technical 

error and does not otherwise change the 

requirements in the final rule. As a 

technical correction, this action is not 

subject to the statutory and Executive 

Order review requirements. For 

information about the statutory and 

Executive Order review requirements as 

they related to the final rule, see Unit 

IV. in the Federal Register of March 2, 

2012. 

V. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

Agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 18, 2012. 

Lois Rossi, 

Registration Division, Office of Pesticide 

Programs. 

Therefore, 40 CFR 180.565 is 

corrected 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 180.565 is corrected by 

alphabetically adding: Caneberry 

subgroup 13–07A; mustard, seed; onion, 

dry bulb; papaya; safflower, seed; and 

nut, tree, group 14 to the table in 

paragraph (a) to read as follows: 

§ 180.565 Thiamethoxam; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Caneberry subgroup 13–07A ....... 0 .35 

* * * * * 

Mustard, seed ............................... 0 .02 

Nut, tree, group 14 ....................... 0 .02 

* * * * * 

Onion, dry bulb ............................. 0 .03 

* * * * * 

Papaya .......................................... 0 .40 

* * * * * 

Safflower, seed ............................. 0 .02 

* * * * * 

* * * * * 

[FR Doc. 2012–10343 Filed 5–1–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0449; FRL–9346–4] 

Acequinocyl; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of acequinocyl in 

or on multiple commodities which are 

identified and discussed later in this 

document. This regulation additionally 

removes several established individual 

tolerances, as they will be superseded 

by inclusion in crop subgroup 

tolerances or by updated commodity 

terminology. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

2, 2012. Objections and requests for 

hearings must be received on or before 

July 2, 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–2011–0449. 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: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; email address: 

nollen.laura@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 

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 


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site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

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–2011–0449 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 July 2, 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–2011–0449, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

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 

Tolerances 

In the Federal Register of July 20, 

2011 (76 FR 43231) (FRL–8880–1), 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 1E7864) by IR–4, 

500 College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.599 be 

amended by establishing tolerances for 

residues of the miticide acequinocyl, [2- 

(acetyloxy)-3-dodecyl-1,4- 

naphthalenedione] and its metabolite, 2- 

dodecyl-3-hydroxy-1,4-naphthoquinone, 

expressed as acequinocyl equivalents, in 

or on bean, succulent shelled at 0.15 

parts per million (ppm); caneberry 

subgroup 13–07A at 4.5 ppm; cherry at 

0.8 ppm; cowpea, forage at 9.0 ppm; 

cucumber at 0.15 ppm; melon subgroup 

9A at 0.06 ppm; soybean, vegetable, 

succulent at 0.25 ppm; fruit, small vine 

climbing, except fuzzy kiwifruit, 

subgroup 13–07F at 1.6 ppm; and berry, 

low growing, subgroup 13–07G at 0.4 

ppm. The petition additionally 

requested that 40 CFR 180.599 be 

amended by removing the established 

tolerances for residues of acequinocyl in 

or on grape at 1.6 ppm and strawberry 

at 0.4 ppm, as they will be superseded 

by inclusion in subgroup 13–07F and 

13–07G, respectively. That notice 

referenced a summary of the petition 

prepared on behalf of IR–4 by Arysta 

LifeScience North America LLC, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerance levels for several 

commodities. Additionally, the Agency 

has determined that tolerances should 

be established on the meat byproducts 

of livestock commodities and the 

previously established tolerances on the 

liver of livestock commodities should be 

removed. The Agency also determined 

that a tolerance is necessary on cowpea, 

hay. Finally, EPA determined that the 

proposed tolerance on cherry should be 

established as two tolerances on sweet 

and tart cherry. The reasons for these 

changes are explained in Unit IV.C. 

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 acequinocyl 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with acequinocyl 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. 

Acequinocyl exhibits low acute 

toxicity via the oral, dermal and 

inhalation routes of exposure, as well as 

in primary eye and primary skin 

irritation studies. It is not a dermal 

sensitizer. Acequinocyl is a known 

Vitamin K antagonist; therefore, it is 

thought to produce adverse effects by 

disrupting the blood coagulation 

system, as indicated by increased 

prothrombin time, increased activated 

partial thromboplastin time, and 

internal hemorrhages. 

In rat studies, including a subchronic 

oral toxicity study, a 28-day dermal 

toxicity study, and a chronic feeding/ 

oncogenicity study, acequinocyl 

increased prothrombin and activated 

partial thromboplastin. Internal 

hemorrhages were observed in both a rat 

and rabbit developmental toxicity study, 

a mouse subchronic/chronic toxicity 

study, and in a 2-generation 

reproduction rat study. In a combined 

chronic toxicity/oncogenicity study in 

rats, enlarged eyeballs were observed. 

Hepatotoxicity in the mouse was 

evidenced by histopathology and 

increased liver enzymes. 

In both rat and rabbit developmental 

toxicity studies, acequinocyl increased 

the number of resorptions noted. 

Developmental effects (i.e., resorptions) 

occurred at a dose that was higher than 

or the same as the dose that caused 

maternal toxicity. In the 2-generation 


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reproduction toxicity study in the rat, 

there was no evidence of reproductive 

toxicity, though there were notable toxic 

effects observed in offspring that were 

not observed in adults including 

swollen body parts, protruding eyes, 

clinical signs, delays in pupil 

development and increased mortality 

occurring mainly after weaning. 

There was no evidence of 

carcinogenic potential in either the rat 

or mouse carcinogenicity studies. There 

was also no concern for mutagenic 

activity as indicated by several 

mutagenicity studies. Therefore, 

acequinocyl is classified as ‘‘not likely 

to be carcinogenic to humans.’’ 

Specific information on the studies 

received and the nature of the adverse 

effects caused by acequinocyl as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document: 

‘‘Acequinocyl; Human-Health Risk 

Assessment for Proposed Section 3 Uses 

on Succulent Soybean Vegetable; 

Succulent Shelled Beans; Cowpea 

Forage; Caneberry Subgroup 13–07A; 

Melon Subgroup 9A; Cucumber, Cherry; 

Low-Growing Berry Subgroup 13–07G; 

and Small Fruit Vine Climbing, Except 

Fuzzy Kiwifruit, Subgroup 13–07F,’’ pp. 

31–33 in docket ID number EPA–HQ– 

OPP–2011–0449. 

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 acequinocyl 

used for human risk assessment is 

shown in the Table of this unit. 

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

ASSESSMENT

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (General population including infants 

and children).

N/A ..................................... N/A ..................................... An endpoint attributable to a single dose was not identified in the database. 

Chronic dietary (All populations).NOAEL = 2.7 mg/kg/day ...

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.027 mg/ 

kg/day.

cPAD = 0.027 mg/kg/day 

Carcinogenicity study in mice (18 month); LOAEL = 

7.0 mg/kg/day based on the clinical chemistry and 

microscopic non-neoplastic lesions (brown pigmented cells and perivascular inflammatory cells in 

liver). 

Dermal, short-term ...............

(1 to 30 days) ......................

Dermal study NOAEL = 

200 mg/kg/day.

LOC (occupational/residential) for MOE = 100.28-day dermal study in rats; 

LOAEL = 1,000 mg/kg/day based on increased clotting factor times. 

Inhalation, short-term (1 to 

30 days).

Oral NOAEL = 60 mg/kg/ 

day (inhalation absorption rate = 100%).

UFA = 10x 

UFH = 10x 

LOC (occupational/residential) = MOE <100.Developmental toxicity study in rabbits; Maternal 

LOAEL = 120 mg/kg/day based on clinical signs 

(hematuria, reduced fecal output, body weight loss, 

and reduced food consumption) and gross necropsy 

findings (pale lungs and liver, hemorrhaging uterus, 

fluid in the cecum, fur in the stomach, blood stained 

vaginal opening, blood-stained urinary bladder contents/urine). 

Cancer (Oral, dermal, inhalation).Classification: ‘‘Not likely to be Carcinogenic to Humans.’’ 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. MOE = margin of exposure. LOC = level of concern. mg/kg/day = milligram/kilogram/day. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to acequinocyl, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing acequinocyl tolerances in 40 

CFR 180.599. EPA assessed dietary 

exposures from acequinocyl 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. No such effects were 

identified in the toxicological studies 

for acequinocyl; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA utilized 

tolerance level residues and 100 percent 

crop treated (PCT) information for all 

registered and proposed uses. The 

assessment also used Dietary Exposure 


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Evaluation Model (DEEM–FCIDTM) ver. 

7.81 default processing factors, with the 

exception of those for grape juice and 

raisins. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that acequinocyl 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 acequinocyl. 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 acequinocyl in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of acequinocyl. 

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 Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

acequinocyl for chronic exposures for 

non-cancer assessments are estimated to 

be 6.69 parts per billion (ppb) for 

surface water and 0.0036 ppb for ground 

water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 6.69 ppb 

was used to assess the contribution to 

drinking 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). 

Acequinocyl is currently registered for 

the following use by commercial 

applicators and homeowners that could 

result in residential exposure: 

Landscape ornamentals in residential 

and public areas. Residential handlers 

are expected to complete all tasks 

associated with the use of acequinocyl 

including mixing and loading (if 

needed), and application of acequinocyl 

with either a low-pressure hand wand 

or with a hose-end sprayer. EPA 

assessed potential short-term dermal 

and inhalation exposures to residential 

handlers from these scenarios. 

Residential handler exposure scenarios 

are considered to be short-term only, 

due to the infrequent use patterns 

associated with homeowner products. 

Postapplication exposure was not 

anticipated for the registered residential 

uses; therefore, a quantitative 

postapplication assessment was not 

conducted. Further information 

regarding EPA standard assumptions 

and generic inputs for residential 

exposures may be found at http:// 

www.epa.gov/pesticides/trac/science/ 

trac6a05.pdf. 

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 acequinocyl to 

share a common mechanism of toxicity 

with any other substances, and 

acequinocyl does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that acequinocyl 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. 

The acequinocyl toxicity database is 

adequate to evaluate potential increased 

susceptibility of infants and children, 

and includes developmental toxicity 

studies in rats and rabbits and a 2- 

generation reproduction study in rats. In 

the rat prenatal developmental toxicity 

study, developmental toxicity was 

indicated by increased resorptions and 

fetal variations. The developmental 

toxicity study in rabbits identified an 

increased number of complete 

resorptions. In the rat 2-generation 

reproductive toxicity study, both the 

maternal and reproductive toxicity 

LOAELs were not observed; however, 

the LOAEL for parental males was 58.9/ 

69.2 mg/kg/day, based on hemorrhagic 

effects. The offspring systemic LOAEL 

was also 58.9 mg/kg/day. Though the 

offspring LOAEL was similar to that of 

parental males, the study noted 

increased qualitative susceptibility of 

pups (swollen body parts, protruding 

eyes, clinical signs, delays in pupil 

development and increased mortality). 

These effects occurred mainly after 

weaning. 

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. The toxicity database for 

acequinocyl is complete except for 

immunotoxicity and acute and 

subchronic neurotoxicity testing. Recent 

changes to 40 CFR part 158 imposed 

new data requirements for 

immunotoxicity testing (OPPTS 

Guideline 870.7800) and acute and 

subchronic neurotoxicity testing 

(OPPTS Guideline 870.6200) for 

pesticide registration. The toxicology 

database for acequinocyl does not show 

any evidence of treatment-related effects 

on the immune system, and the overall 

weight-of-evidence suggests that this 

chemical does not directly target the 

immune system. Therefore, the Agency 

does not believe that conducting a 

functional immunotoxicity study will 

result in a lower POD than that 

currently in use for overall risk 

assessment, and additional UFs are not 

needed to account for a lack of this 

study. 

Previously, EPA concluded that 

exposure to acequinocyl does not pose 

a neurotoxicity concern. Acequinocyl is 

a known Vitamin K antagonist; 

neurotoxic compounds of similar 

structure were not identified. While 

there is potential evidence of 

neurotoxicity or neuropathology in the 

2-generation reproduction study as well 

as the rat subchronic oral toxicity study, 

these toxicities are not considered to be 

primary effects because they were 

observed at very high doses and in the 

presence of more severe systemic effects 


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in both studies. The Agency does not 

believe that conducting the acute and 

subchronic neurotoxicity studies will 

result in a lower POD than that 

currently used for overall risk 

assessment; therefore, additional UFs to 

account for neurotoxicity are not 

necessary. 

ii. There is no evidence of increased 

susceptibility of rat or rabbit fetuses to 

in utero exposure to acequinocyl. In the 

2-generation reproduction study in rats, 

increased qualitative susceptibility was 

observed in offspring. However, EPA 

determined that the degree of concern is 

low for the noted effects because the 

effects were observed at the same doses 

as parental effects, and there is a clear 

NOAEL established which was used in 

endpoint selection. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

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 acequinocyl 

in drinking water. Residential uses are 

not expected to result in postapplication 

exposure to infants and children. These 

assessments will not underestimate the 

exposure and risks posed by 

acequinocyl. 

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 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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, acequinocyl is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to acequinocyl 

from food and water will utilize 55% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of acequinocyl 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). Acequinocyl is 

currently registered for uses that could 

result in short-term residential 

exposure, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to acequinocyl. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 2,500 for the general U.S. 

population, and 2,600 for females 13–49 

years old. Because EPA’s level of 

concern for acequinocyl is a MOE of 100 

or below, these MOEs are not of 

concern. 

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). An 

intermediate-term adverse effect was 

identified; however, acequinocyl is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

acequinocyl. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

acequinocyl 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 acequinocyl 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Morse Methods (Meth-135 and #Meth133, revision #3), two high-performance 

liquid chromatography methods with 

tandem mass-spectroscopy detection 

(HPLC/MS/MS), are adequate 

enforcement methodologies available to 

enforce the tolerance expression. 

The methods 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 Codex has not established MRLs 

for acequinocyl. 

C. Revisions to Petitioned-For 

Tolerances 

Based on analysis of the residue field 

trial data supporting the petitions, EPA 

revised the proposed tolerances on 

berry, low growing, subgroup 13–07G 

from 0.4 ppm to 0.50 ppm; bean, 

succulent shelled from 0.15 ppm to 0.30 

ppm; cowpea, forage from 9.0 ppm to 

6.0 ppm; caneberry subgroup 13–07A 

from 4.5 ppm to 4.0 ppm; and melon 

subgroup 9A from 0.06 ppm to 0.15 

ppm. The Agency revised these 

tolerance levels based on analysis of the 

residue field trial data using the 

Organization for Economic Co-operation 

and Development (OECD) tolerance 

calculation procedures. EPA also 

determined that the proposed tolerance 

on cherry at 0.8 ppm should be 

established as two separate tolerances 

on cherry, tart at 1.0 ppm; and cherry, 

sweet at 0.50 ppm because residues 

were generally higher in tart cherries 

than in sweet cherries. EPA determined 


emcdonald on DSK29S0YB1PROD with RULES
Federal Register / Vol. 77, No. 85 / Wednesday, May 2, 2012 / Rules and Regulations 25909 

that a tolerance is necessary on cowpea, 

hay at 18 ppm. Based on the results of 

the data supporting the cowpea 

tolerance, the appropriate tolerance for 

residues of acequinocyl in or on 

cowpea, forage is 6.0 ppm. Typically, 

forage is harvested before the plant has 

bloomed. Because it was not specified at 

what plant stage the product can be 

applied, EPA deemed it necessary to 

establish a tolerance on cowpea, hay as 

well. There is typically a 3-fold drying 

factor between forage and hay; therefore, 

EPA is establishing a tolerance for 

residues of acequinocyl in or on 

cowpea, hay at 18 ppm. 

Finally, because cowpea forage and 

hay are significant feedstuff 

commodities for livestock, the 

maximum reasonable dietary burdens of 

acequinocyl were recalculated for 

acequinocyl using the Agency’s most 

recent guidance on constructing 

reasonably balanced livestock diets. The 

Agency determined that the currently 

established tolerance level of 0.02 ppm 

for residues of acequinocyl in the fat of 

cattle, goat, horse, and sheep are still 

appropriate. Furthermore, the 

established 0.02 ppm tolerance level in 

the liver of cattle, goat, horse, and sheep 

is appropriate. However, EPA is revising 

the commodity definition to meat 

byproducts rather than liver in order to 

reflect the correct terminology. 

Therefore, EPA determined that 

tolerances should be established at 0.02 

ppm for the meat byproducts of cattle, 

goat, horse, and sheep; and the 

established tolerances in the liver of 

cattle, goat, horse, and sheep should be 

removed. 

V. Conclusion 

Therefore, tolerances are established 

for residues of acequinocyl, including 

its metabolites and degradates, in or on 

the commodities in the table in 

paragraph (a) of § 180.599. Compliance 

with the tolerance levels specified in the 

table of paragraph (a) of § 180.599 is to 

be determined by measuring only the 

sum of acequinocyl [2-(acetyloxy)-3- 

dodecyl-1,4-naphthalenedione] and its 

metabolite, 2-dodecyl-3-hydroxy-1,4- 

naphthoquinone, calculated as the 

stoichiometric equivalent of 

acequinocyl, in or on soybean, 

vegetable, succulent at 0.25 ppm; berry, 

low growing, subgroup 13–07G at 0.50 

ppm; fruit, small vine climbing, except 

fuzzy kiwifruit, subgroup 13–07F at 1.6 

ppm; bean, succulent shelled at 0.30 

ppm; cowpea, forage at 6.0 ppm; 

cowpea, hay at 18 ppm; caneberry 

subgroup 13–07A at 4.0 ppm; melon 

subgroup 9A at 0.15 ppm; cucumber at 

0.15 ppm; cherry, tart at 1.0 ppm; 

cherry, sweet at 0.50; cattle, meat 

byproducts at 0.02 ppm; goat, meat 

byproducts at 0.02 ppm; horse, meat 

byproducts at 0.02 ppm; and sheep, 

meat byproducts at 0.02 ppm. This 

regulation additionally removes 

established tolerances in or on grape at 

1.6 ppm; strawberry at 0.40 ppm; cattle, 

liver at 0.02 ppm; goat, liver at 0.02 

ppm; horse, liver at 0.02 ppm; and 

sheep, liver at 0.02 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. 

Dated: April 20, 2012. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.599, paragraph (a), the 

table is amended by removing the 

entries for ‘‘Cattle, liver’’; ‘‘Goat, liver’’; 

‘‘Grape’’; ‘‘Horse, liver’’; ‘‘Sheep, liver’’; 

and ‘‘Strawberry’’ and by alphabetically 

adding the following commodities to 

read as follows: 

§ 180.599 Acequinocyl; tolerances for 

residues. 

(a) General. * * * 


emcdonald on DSK29S0YB1PROD with RULES
25910 Federal Register / Vol. 77, No. 85 / Wednesday, May 2, 2012 / Rules and Regulations 

1The notice of proposed rulemaking was 

published at 76 FR 8992–95. 

2The Board’s predecessor, the Interstate 

Commerce Commission (ICC), promulgated final 

rules implementing the Trails Act in Rail Abans.— 

Use of Rights-of-Way as Trails (49 CFR parts 1105 

& 1152), 2 I.C.C. 2d 591 (1986) (Rail 

Abandonments). The agency has modified or 

clarified its Trails Act rules since that time. See, 

e.g., Aban. & Discontinuance of Rail Lines & Rail 

Transp. Under 49 U.S.C. 10903, 1 S.T.B. 894 (1996); 

Policy Statement on Rails to Trails Conversions, EP 

272 (Sub-No. 13B) (ICC served Jan. 29, 1990); Rail 

Abans.—Use of Rights-of-Way as Trails— 

Supplemental Trails Act Procedures, 4 I.C.C. 2d 152 

(1987). 

Commodity Parts per 

million 

* * * * * 

Bean, succulent shelled ............... 0 .30 

Berry, low growing, subgroup 13– 

07G ........................................... 0 .50 

Caneberry subgroup 13–07A ....... 4 .0 

* * * * * 

Cattle, meat byproducts ............... 0 .02 

Cherry, sweet ............................... 0 .50 

Cherry, tart .................................... 1 .0 

* * * * * 

Cowpea, forage ............................ 6 .0 

Cowpea, hay ................................. 18 

Cucumber ..................................... 0 .15 

* * * * * 

Fruit, small vine climbing, except 

fuzzy kiwifruit, subgroup 13– 

07F ............................................ 1 .6 

* * * * * 

Goat, meat byproducts ................. 0 .02 

* * * * * 

Horse, meat byproducts ............... 0 .02 

Melon subgroup 9A ...................... 0 .15 

* * * * * 

Sheep, meat byproducts .............. 0 .02 

Soybean, vegetable, succulent .... 0 .25 

* * * * * 

* * * * * 

[FR Doc. 2012–10346 Filed 5–1–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Surface Transportation Board 

49 CFR Part 1152 

[Docket No. EP 702] 

National Trails System Act and 

Railroad Rights-of-Way 

AGENCY: Surface Transportation Board, 

DOT. 

ACTION: Final rule. 

SUMMARY: The Surface Transportation 

Board (Board or STB) is changing, 

clarifying, and updating some of its 

existing regulations and procedures 

regarding the use of railroad rights-ofway (ROW) for rail banking and interim 

trail use under the National Trails 

System Act (Trails Act). New rules are 

adopted that require the parties jointly 

to notify the Board when an interim trail 

use/rail banking agreement has been 

reached. The new rules also require 

parties to ask the Board to vacate a trail 

condition and issue a replacement trail 

condition covering the portion of rightof-way subject to the trail use agreement 

if their trail use agreement covers only 

part of the right-of-way. In addition, the 

final rules clarify that a new party who 

assumes responsibility for a recreational 

trail must acknowledge that the interim 

trail use is subject to future reactivation 

of the railroad line. 

DATES: This rule is effective on May 30, 

2012. 

ADDRESSES: Information or questions 

regarding this final rule should 

reference Docket No. EP 702 and be in 

writing addressed to: Chief, Section of 

Administration, Office of Proceedings, 

Surface Transportation Board, 395 E 

Street SW., Washington, DC 20423– 

0001. 

FOR FURTHER INFORMATION CONTACT: Julia 

Farr at (202) 245–0359. Assistance for 

the hearing impaired is available 

through the Federal Information Relay 

Service (FIRS) at 1–800–877–8339. 

SUPPLEMENTARY INFORMATION: On 

February 16, 2011, the Board served a 

notice of proposed rulemaking (NPRM), 

in which it proposed to change, clarify, 

and update some of its existing 

regulations at 49 CFR 1152.29 regarding 

the use of railroad rights-of-way for rail 

banking and interim trail use under the 

Trails Act, 16 U.S.C. 1247(d).1 The 

Board asked for comments on a 

proposed rule requiring the railroad and 

the trail sponsor jointly to notify the 

Board when a trail use agreement has 

been reached and to notify the Board of 

the exact location of the right-of-way 

subject to the interim trail use 

agreement by including a map and 

milepost marker information. We also 

proposed a rule to require parties to ask 

the Board to vacate the Certificate of 

Interim Trail Use (CITU) or Notice of 

Interim Trail Use (NITU) when an 

interim trail use agreement covers only 

a portion of the right-of-way and request 

a replacement CITU/NITU to cover the 

portion of the right-of-way subject to the 

trail use agreement. Finally, we 

proposed a rule to clarify that a 

substitute trail sponsor must 

acknowledge that interim trail use is 

subject to reactivation at any time and 

suggested other minor modifications to 

clarify and update the existing 

regulations at 49 CFR 1152.29. In 

addition to these specific proposals, we 

invited comments on what, if any, 

changes to the Trails Act rules would 

address concerns about the Board’s 

regulations specifying what a state must 

do to satisfy the Trails Act’s 

assumption-of-liability requirement, and 

whether the current methods of 

providing notice to adjoining 

landowners could be augmented by 

additional methods of indirect notice 

that take advantage of advances in 

technology without creating an undue 

burden on rail carriers. 

Background. The Trails Act was 

enacted in 1968 to establish a 

nationwide system of recreation and 

scenic trails. National Trails System 

Act, Public Law. 90–543, § 2(b), 82 Stat. 

919 (1968) (codified, as amended, at 16 

U.S.C. 1241–1251). As originally 

enacted, it did not contain any special 

provisions for railroad rights-of-way. In 

1983, however, Congress added a rail 

section, codified at 16 U.S.C. 1247(d), to 

advance two declared policies: 

preserving unused railroad rights-ofway for possible future rail use and 

promoting nature trails. See Preseault v. 

ICC, 494 U.S. 1, 17–18 (1990). 

The enactment of the ‘‘Rails-to-Trails’’ 

provision followed a history of 

Congressional concern about the loss of 

rail corridors as a national 

transportation resource. See id. at 5; Birt 

v. STB, 90 F.3d 580, 582–83 (DC Cir. 

1996). Under 16 U.S.C. 1247(d), the STB 

must ‘‘preserve established railroad 

rights-of-way for future reactivation of 

rail service’’ by prohibiting 

abandonment where a trail sponsor 

offers to assume managerial, tax, and 

legal responsibility for a right-of-way for 

use in the interim as a trail. Nat’l 

Wildlife Fed’n v. ICC, 850 F.2d 694, 

699–702 (DC Cir. 1988). The statute 

provides that, if such interim use is 

subject to restoration or reconstruction 

for railroad purposes, the ‘‘interim use 

shall not be treated, for purposes of any 

law or rule of law, as an abandonment. 

* * *’’ 16 U.S.C. 1247(d). Instead, the 

right-of-way is ‘‘rail banked,’’ which 

means that the railroad (or any other 

approved rail service provider) may 

reassert control at any time in order to 

restore service on the line. 49 CFR 

1152.29(c)(2), (d)(2); Birt, 90 F.3d at 

583.2 If a line is rail banked and 

designated for trail use, any reversion to 

adjoining landowners that might 

otherwise occur under state law upon 


emcdonald on DSK29S0YB1PROD with RULES