56128 Federal Register / Vol. 77, No. 177 / Wednesday, September 12, 2012 / Rules and Regulations 

EPA-APPROVED REGULATIONS IN THE WEST VIRGINIA SIP 

State citation 

[Chapter 16–20 or 45 CSR] Title/subject 

State 

effective 

date 

EPA approval date Additional explanation/ 

citation at 40 CFR 52.2565 

*******

[45 CSR] Series 8 Ambient Air Quality Standards 

Section 45–8–1 ........................ General ................................... 6/16/11 9/12/12 ....................................

[Insert page number where 

the document begins].

Incorporation by reference of 

the National Ambient Air 

Quality Standards. 

Section 45–8–2 ........................ Definitions ............................... 6/16/11 9/12/12 ....................................

[Insert page number where 

the document begins].

Revised section moved from 

45–8–3 to 45–8–2. 

Section 45–8–3 ........................ Adoption of Standards ............ 6/16/11 9/12/12 ....................................

[Insert page number where 

the document begins].

Section was revised to read 

new title and content. 

Section 45–8–4 ........................ Inconsistency Between Rules 6/16/11 9/12/12 ....................................

[Insert page number where 

the document begins].

Revised section moved from 

45–8–7 to 45–8–4. 

* * * * * * * 

* * * * * 

[FR Doc. 2012–22338 Filed 9–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–1028; FRL–9360–6] 

RIN 2070 

Polyoxin D Zinc Salt; Amendment to an 

Exemption From the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

existing exemption from the 

requirement of a tolerance for residues 

of polyoxin D zinc salt when used as a 

fungicide on almonds, cucurbit 

vegetables, fruiting vegetables, ginseng, 

grapes, pistachios, pome fruits, potatoes, 

and strawberries by expanding the 

current exemption to include all food 

commodities. This regulation 

establishes an exemption from the 

requirement of a tolerance for residues 

of polyoxin D zinc salt in or on all food 

commodities when applied as a 

fungicide and used in accordance with 

good agricultural practices. On behalf of 

Kaken Pharmaceutical Co., Ltd., Conn & 

Smith, Inc. submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting that 

EPA amend the existing exemption from 

the requirement of a tolerance for 

polyoxin D zinc salt. This regulation 

eliminates the need to establish a 

maximum permissible level for residues 

of polyoxin D zinc salt under the 

FFDCA. 

DATES: This regulation is effective 

September 12, 2012. Objections and 

requests for hearings must be received 

on or before November 13, 2012, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–1028, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Colin G. Walsh, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–0298; email address: 

walsh.colin@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

To access the OCSPP test guidelines 

referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines. ’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, 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 


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Federal Register / Vol. 77, No. 177 / Wednesday, September 12, 2012 / Rules and Regulations 56129 

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–2011–1028 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 November 13, 2012. Addresses 

for mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2011–1028, by one of the following 

methods: 

• Federal eRulemaking Portal : http:// 

www.regulations.gov . Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be (CBI) or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Background and Statutory Findings 

In the Federal Register of March 14, 

2012 (77 FR 15012) (FRL–9335–9), EPA 

issued a notice pursuant to FFDCA 

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

announcing the filing of a pesticide 

tolerance petition (PP 1F7940) by Conn 

& Smith, Inc., Agent, 6713 Catskill 

Road, Lorton, VA 22079, on behalf of 

Kaken Pharmaceutical Co., Ltd. The 

petition requested that 40 CFR 180.1285 

be amended by expanding the current 

exemption to include all food 

commodities, thus establishing an 

exemption from the requirement of a 

tolerance for residues of polyoxin D zinc 

salt in or on all food commodities. This 

notice referenced a summary of the 

petition prepared by the petitioner Conn 

& Smith, Inc., on behalf of Kaken 

Pharmaceutical Co., Ltd., which is 

available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Pursuant to 

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

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

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

special consideration to exposure of 

infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * * ’’ Additionally, 

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

that the Agency consider’’ available 

information concerning the cumulative 

effects of such residues and other 

substances that have a common 

mechanism of toxicity.’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

Consistent with FFDCA section 

408(b)(2)(D), EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability, and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. 

EPA established a tolerance 

exemption for polyoxin D zinc salt in a 

final rule published in the Federal 

Register on November 19, 2008, (73 FR 

69559) (FRL–8389–5), which supported 

the uses as a fungicide on almonds, 

cucurbit vegetables, fruiting vegetables, 

ginseng, grapes, pistachios, pome fruits, 

potatoes, and strawberries. The 

toxicological data submitted to support 

the previous tolerance exemption 

included the following: Acute (six-pack) 

toxicity, mutagenicity, subchronic (90- 

day oral), developmental, and chronic/ 

oncogenicity studies. All of the studies/ 

information submitted to support the 

previous tolerance exemption indicated 

a lack of toxicity hazards for mammals, 

and EPA concluded that there is a 

reasonable certainty of no harm to 

humans, including infants and children, 

from the proposed food uses of polyoxin 

D zinc salt. This amendment proposes 

to expand the tolerance exemption to 

include all food commodities when 

applied as a fungicide and used in 

accordance with good agricultural 

practices. In support of this expansion 

of the tolerance exemption, new data 

have been generated by the petitioner 

and reviewed by EPA to further address 

the developmental toxicity (OCSPP 

Guideline No. 870.3700) and 

mutagenicity (OCSPP Guideline Nos. 

870.5100 and 870.5375) data 

requirements. The data are required 

when the use of the substance under 

widespread and commonly recognized 

practices may reasonably be expected to 

result in significant exposure to 

humans, specifically females of childbearing age for the developmental 

toxicity data requirement. The rest of 

the toxicological profile as stated in the 

Federal Register of November 19, 2008, 

and referenced herein, has not changed. 

A copy of the November 19, 2008 final 

rule document (73 FR 69559) is located 

under docket ID number EPA–HQ– 

OPP–2008–0417. A copy of the risk 

assessment cited herein (See Ref.) is 

located under docket ID number EPA– 

HQ–OPP–2011–1028. 

As discussed in the Federal Register 

of November 19, 2008 polyoxin D zinc 

salt is a brown musty smelling powder 

derived through the fermentation of the 

microbe Streptomyces cacaoi var. 

asoensis , which was isolated from a soil 

sample collected from Japan. This 

biochemical active ingredient has a nontoxic mode of action, which acts against 

fungi by inhibiting chitin growth in the 

cell walls, thus precluding the 

development of fungal colonies. Its 

effects are considered fungi-exclusive in 

that it has no mode of action relative to 

mammals and passes through 

mammalian digestive systems. Polyoxin 

D zinc salt does not persist in the 


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56130 Federal Register / Vol. 77, No. 177 / Wednesday, September 12, 2012 / Rules and Regulations 

environment and has a well understood 

low toxicity profile. 

As stated previously in this Unit (III), 

new toxicity data have been submitted 

in support of the request by the 

petitioner to expand the current 

tolerance exemption to cover all food 

commodities. These data include: 

1. A prenatal developmental toxicity 

study; and 

2. Two mutagenicity studies. 

All new data, coupled with the data 

submitted to support the previous 

tolerance exemption (73 FR 69561), 

confirm a lack of human health hazard, 

as noted and reported in the original 

assessment of the tolerance exemption, 

associated with dietary exposures of 

polyoxin D zinc salt and fully 

demonstrate the lack of acute, 

subchronic, and chronic toxicity. 

Summaries of the new toxicological data 

submitted in support of the expansion 

of the tolerance exemption follow. 

A. Mutagenicity 

Two new mutagenicity studies were 

performed for polyoxin D zinc salt to 

support the expansion of the tolerance 

exemption. The mutagenicity studies as 

described herein, along with the 

mutagenicity studies submitted to 

support the previous tolerance 

exemption (73 FR 69561), confirm that 

polyoxin D zinc salt is not a mutagen 

and that consumption of food 

commodities that have been treated 

with this substance when used as a 

pesticide is safe and will not result in 

any harm to human health from dietary 

exposure. 

1. A reverse gene mutation assay in 

bacteria Master Record Identification 

Number ((MRID) 48653313) using the 

technical grade of polyoxin D zinc salt, 

dissolved in dimethyl sulfoxide 

(DMSO), with and without metabolic S9 

activation, showed no mutagenic effects 

or evidence of cytotoxicity or 

insolubility even at the limiting dose of 

5,000 ug/plate (See Ref.). Therefore, 

polyoxin D zinc salt is considered to be 

non-mutagenic under the conditions of 

this assay. 

2. An in vitro mammalian 

chromosome aberration test (MRID 

48653314) using the technical grade of 

polyoxin D zinc salt, dissolved in 

DMSO, with and without metabolic S9 

activation, showed clastogenic potential 

in Chinese hamster lung cells (CHL/IU) 

with and without activation (See Ref.). 

In Experiment I, polyoxin D zinc salt 

was tested up to dose levels that caused 

>50% cell lethality without activation 

(260 mg/mL) and with activation (1,600 

mg/mL). Without activation, the 

frequencies of the metaphases with 

structural chromosome aberrations 

(excluding gaps) were 14.5% and 7.5% 

at test article concentrations of 186 and 

260mg/mL, respectively. With activation, 

the frequency of metaphase cells with 

structural chromosome aberrations 

(excluding gaps) was 9.5% at a test 

article concentration of 1,600 mg/mL. 

The frequency of polyploid metaphase 

cells showed no increases either 

without or with activation. In 

Experiment II, a 24-hour continuous 

treatment without activation resulted in 

a 8.0% frequency of metaphases with 

structural chromosome aberrations 

(excluding gaps) at the concentration of 

133 mg/mL. There were no increases in 

the frequency of polyploid metaphases. 

Although the submitted in vitro 

mammalian chromosome aberration test 

showed clastogenic potential, the results 

were not reproducible at the dose levels 

reported in the experiment. In addition, 

the mutagenicity data submitted to 

support the previous tolerance 

exemption (73 FR 69562), which 

included three complimentary Tier I 

mutagenicity tests and a Tier II 

mammalian erythrocyte micronucleus 

in vivo test, showed no mutagenic 

effects, including no clastogenic 

potential (no chromosomal aberrations). 

Furthermore, the lack of systemic 

toxicity noted in the following 

developmental toxicity section (Unit 

III.B) and the fact that no effects were 

reported in the Tier III 2-generation 

reproduction study submitted for the 

previous tolerance exemption (73 FR 

69562), indicate that polyoxin D zinc 

salt is not mutagenic or clastogenic. 

Therefore, based on the weight of 

evidence of the mutagenicity data 

submitted to support this expansion of 

the tolerance exemption and the 

previous tolerance exemption (73 FR 

69561), the mutagenicity data and 

information are sufficient to confirm 

that polyoxin D zinc salt is not a 

mutagen, and that consumption of food 

commodities that have been treated 

with this substance when used as a 

pesticide is safe and will not result in 

any harm to human health from dietary 

exposure. 

B. Developmental Toxicity 

A new developmental study (MRID 

48653315) was performed for polyoxin 

D zinc salt to support the expansion of 

the tolerance exemption. No treatmentrelated effects were observed in general 

appearance, body weight, adjusted for 

gravid uterine weight, weight gain, or 

food consumption in maternal rats at 

the doses tested (0, 100, 300, and 1,000 

milligrams/kilograms bodyweight/day 

(mg/kg bw/day) (See Ref.). Necropsy 

observations showed that almost all rats 

(20/24) in the 1,000 mg/kg/day group 

highest dose tested (HDT) had 

thickening of the limiting ridge. 

Therefore, the lowest observed adverse 

effect level (LOAEL) for maternal 

toxicity of polyoxin D zinc salt in rats 

is 1,000 mg/kg bw/day based on gross 

lesions in the stomach (thickening of the 

limiting ridge). The no observed adverse 

effect level (NOAEL) for maternal 

toxicity is 300 mg/kg bw/day based on 

no effects observed at this dose. 

Although an effect of gross lesions in 

the stomach was found in maternal rats 

at the limit dose tested (1,000 mg/kg 

bw/day), there were no reported 

systemic effects in maternal rats at this 

dose. The effect in the stomach lining 

was limited to a localized gastric 

irritation due to the route of entry (oral 

gavage) at the limit dose tested (1,000 

mg/kg bw/day), which is typical of the 

nature of the test substance. 

For developmental toxicity, no 

treatment-related effects were observed 

on developmental parameters including 

gravid uterine weight, placental weight, 

mean numbers of corpora lutea and 

implantation sites, numbers of early and 

later resorptions (dead or resorbed 

embryos or fetuses), number of live 

fetuses per dam, implantation index, 

viability index, sex ratio, and male and 

female body weight. The incidence of 

external, visceral, and skeletal 

variations and anomalies were not 

affected by treatment of polyoxin D zinc 

salt. Based on no effects observed for 

developmental toxicity at any doses 

tested, the NOAEL for developmental 

toxicity is greater than 1,000 mg/kg bw/ 

day HDT. The LOAEL was not 

identified for developmental toxicity, 

suggesting that the test animals could 

have tolerated a higher dose. 

Based on the developmental toxicity 

data submitted for this expansion to the 

tolerance exemption, and the Tier III 2- 

generation reproduction study 

submitted for the previous tolerance 

exemption (73 FR 69562), which 

showed no reproductive effects at the 

limit dose tested, there are sufficient 

data and information to confirm that 

polyoxin D zinc salt is not a 

developmental toxicant, and that 

consumption of food commodities that 

have been treated with this substance 

when used as a pesticide is safe and will 

not result in any harm to human health 

from dietary exposure. 

IV. Aggregate Exposures 

In examining aggregate exposure, 

FFDCA section 408 directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 


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Federal Register / Vol. 77, No. 177 / Wednesday, September 12, 2012 / Rules and Regulations 56131 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

A. Dietary Exposure 

Dietary risks to humans are 

considered negligible based on the lack 

of dietary toxicological endpoints for 

polyoxin D zinc salt and its non-toxic 

mode of action as a fungi-specific chitin 

synthetase inhibitor that passes through 

mammalian digestive systems. No 

significant acute, subchronic, 

mutagenic, immunotoxic, 

developmental, or chronic dietary 

toxicity hazards were identified in the 

studies submitted to support this 

expansion of the tolerance exemption or 

the previous tolerance exemption (73 FR 

69562). Based on polyoxin D zinc salt’s 

lack of dietary toxicity hazards for 

mammals, no aggregate dietary exposure 

concerns are expected. 

1. Food . The petitioner submitted 

three nature of residue studies (MRIDs 

486533–09 through –11) in plants 

(grapes, tomatoes, and lettuce) to 

support this expansion of the tolerance 

exemption. The three nature of residue 

studies represent EPA Crop Groups 13 

(grapes), 08 (tomatoes), and 04 (lettuce). 

The total radioactive residue (TRR) 

levels measured were 0.520 parts per 

million (ppm) at day 1; 0.538 ppm at 

day 14; and 0.495 ppm at day 30 after 

the final application for the grape plant 

(See Ref.). For tomato plants, 0.073 ppm 

of polyoxin D was found 14 days after 

the last treatment on the tomato fruit. 

For lettuce, 0.025 ppm at day 7 and 

0.107 ppm at day 14 were detected in 

the head of lettuce after final 

application. 

In addition, a terrestrial exposure 

model (T-Rex) was performed for the 

previous tolerance exemption (73 FR 

69562), which indicated that it is highly 

unlikely that there will be adverse 

effects resulting from the use of 

polyoxin D zinc salt via the oral route 

of exposure. EPA’s T-Rex calculations 

delimit aggregate dietary consumption 

of residues to no more than 40 ppm, a 

level that is far below the HDT in any 

of the toxicity testing. 

Based on the residue data submitted 

for this expansion of the tolerance 

exemption, and the T-Rex residue 

modeling data from the previous 

tolerance exemption (73 FR 69562), any 

residues found are far below any 

toxicological endpoints identified in 

this expansion of the tolerance 

exemption (developmental toxicity 

NOAEL greater than 1,000 mg/kg bw/ 

day; maternal toxicity NOAEL of 300 

mg/kg/day) or in the previous tolerance 

exemption (73 FR 69561). The previous 

tolerance exemption showed an acute 

oral toxicity median lethal dose (LD50) 

greater than 10,000 mg/kg; a subchronic 

oral toxicity NOAEL of greater than 

1,333 mg/kg/day and 119 mg/kg/day in 

female and male rats, respectively; a 

subchronic oral toxicity LOAEL of 1,166 

mg/kg/day in male rats based on 

decreased body weight gain, food 

consumption, and food efficiency; and a 

chronic oral toxicity NOAEL 2,058.7 

mg/kg bw/day in male rats and 2,469.8 

mg/kg bw/day in female rats. 

In summary, the residue and toxicity 

data demonstrate a lack of aggregate 

dietary risk that is sufficient to support 

this expansion of the tolerance 

exemption. 

2. Drinking water exposure . As stated 

in the previous tolerance exemption (73 

FR 69562), there is a small potential for 

trace amounts of polyoxin D zinc salt to 

enter drinking water sources after a 

significant rainfall, via surface water 

runoff, and/or via incidental spray drift. 

The petitioner submitted a 

photodegradation in water study (MRID 

48653305) to support this tolerance 

exemption. The results of the study 

show that polyoxin D zinc salt has a net 

photolytic half-life of 0.4 days in sterile 

natural water (See Ref.) . Even if 

residues of polyoxin D zinc salt enter 

water sources, residues are expected to 

degrade and be so diluted as to be 

negligible. The data and information 

demonstrate a lack of aggregate dietary 

risk via drinking water and is sufficient 

to support this expansion of the 

tolerance exemption. 

B. Other Non-Occupational Exposure 

No new non-occupational exposure is 

expected to result from the new food 

uses of polyoxin D zinc salt. No health 

risks are expected from any nonoccupational exposure to polyoxin D 

zinc salt based on the data submitted for 

the previous tolerance exemption (73 FR 

69562) and for this expansion of the 

tolerance exemption. 

1. Dermal exposure . No new nonoccupational dermal exposures are 

expected to result from the new food 

uses of polyoxin D zinc salt resulting 

from this expansion of the tolerance 

exemption. Any new dermal exposure 

associated with this expansion of the 

tolerance exemption is expected to be 

occupational in nature. 

2. Inhalation exposure . No new nonoccupational inhalation exposures are 

expected to result from the new food 

uses of polyoxin D zinc salt resulting 

from this expansion of the tolerance 

exemption. Any new inhalation 

exposure associated with this expansion 

of the tolerance exemption is expected 

to be occupational in nature. 

V. Cumulative Effects From Substances 

With a Common Mechanism of Toxicity 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, 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 polyoxin D zinc 

salt to share a common mechanism of 

toxicity with any other substances, and 

polyoxin D zinc salt does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that polyoxin D zinc salt 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. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

FFDCA section 408(b)(2)(C) provides 

that EPA shall assess the available 

information about consumption patterns 

among infants and children, special 

susceptibility of infants and children to 

pesticide chemical residues, and the 

cumulative effects on infants and 

children of the residues and other 

substances with a common mechanism 

of toxicity. In addition, FFDCA section 

408(b)(2)(C) provides that EPA shall 

apply an additional tenfold 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 unless 

EPA determines that a different margin 

of safety will be safe for infants and 

children. Margins of exposure safety, 

which are often referred to as 

uncertainty factors, are incorporated 

into EPA risk assessments either 

directly or through the use of a margin 

of exposure analysis, or by using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk. 

Relevant data and information 

submitted for the previous tolerance 

exemption (73 FR 69560) and for this 

expansion of the tolerance exemption 

indicate that polyoxin D zinc salt has 

negligible acute, subchronic, chronic, 

and developmental toxicity. Moreover, 

polyoxin D zinc salt is defined by its 

fungistatic non-toxic mode of action, 

and demonstrates no significant 

mammalian effect. Therefore, the 


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56132 Federal Register / Vol. 77, No. 177 / Wednesday, September 12, 2012 / Rules and Regulations 

Agency concludes that there is a 

reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to the residues of polyoxin D 

zinc salt. This includes all anticipated 

dietary exposures and all other 

exposures for which there is reliable 

information. EPA has arrived at this 

conclusion because the data and 

information available on polyoxin D 

zinc salt do not demonstrate toxic 

potential to mammals. Thus, there are 

no threshold effects of concern and, as 

a result, an additional margin of safety 

is not necessary. 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes for the 

reasons stated above, and because EPA 

is establishing an exemption from the 

requirement of a tolerance without any 

numerical limitation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for polyoxin D zinc salt. 

VIII. Conclusions 

EPA concludes that there is a 

reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to residues of polyoxin D zinc 

salt. Therefore, the existing exemption 

from the requirement of a tolerance for 

residues of polyoxin D zinc salt when 

used as a fungicide on almonds, 

cucurbit vegetables, fruiting vegetables, 

ginseng, grapes, pistachios, pome fruits, 

potatoes, and strawberries is amended 

by establishing an exemption from the 

requirement of a tolerance for residues 

of polyoxin D zinc salt in or on all food 

commodities when applied as a 

fungicide and used in accordance with 

good agricultural practices. 

IX. References 

The reference used in this document 

is in the OPP docket listed under docket 

ID EPA–HQ–OPP–2011–1028 and may 

be seen by accessing the 

www.regulations.gov Web site. A copy 

of the previous final rule published in 

the Federal Register on November 19, 

2008, is in the OPP docket listed under 

docket ID EPA–HQ–OPP–2008–0417. 

U.S. EPA. 2011. Memorandum from 

Manying Xue to Colin Walsh. Polyoxin 

D zinc salt (EPA Reg. #: 68173–1), 

Containing 23.8% of Polyoxin D Zinc 

Salt (Active Ingredient). Science Review 

of Product Chemistry, Residue 

Chemistry, Non-Target Organism and 

Toxicity Data in Support of label 

Amendment. U.S. Environmental 

Protection Agency Office of Pesticide 

Programs. May 11, 2012. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under FFDCA section 408(d) 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 FFDCA section 408(d), such as 

the tolerance exemption in this final 

rule, do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

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

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq .). 

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

XI. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq .), 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 the rule in the Federal 

Register. This action 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: August 29, 2012. 

Keith A. Matthews, 

Director, Biopesticides and Pollution 

Prevention 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: 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 177 / Wednesday, September 12, 2012 / Rules and Regulations 56133 

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

■ 2. Section 180.1285 is revised to read 

as follows: 

§ 180.1285 Polyoxin D zinc salt; exemption 

from the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for the 

residues of polyoxin D zinc salt in or on 

all food commodities when applied as a 

fungicide and used in accordance with 

good agricultural practices. 

[FR Doc. 2012–22315 Filed 9–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0433; FRL–9359–6] 

Dinotefuran; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of dinotefuran in 

or on multiple commodities which are 

identified and discussed later in this 

document. Also, due to the tolerances 

established by this document, the 

Agency is removing the existing 

tolerances for grape and potato as 

unnecessary. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 12, 2012. Objections and 

requests for hearings must be received 

on or before November 13, 2012, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0433, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Andrew Ertman, Registration Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; email address: 

ertman.andrew@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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://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–2011–0433 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 November 13, 2012. Addresses 

for mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2011–0433, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of September 

7, 2011 (76 FR 55329) (FRL–8886–7), 

EPA issued a notice pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 1E7863) by IR–4, 500 

College Rd. East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.603 be 

amended by establishing tolerances for 

residues of the insecticide dinotefuran, 

(RS)-1-methyl-2-nitro-3-((tetrahydro-3- 

furyl)methyl)guanidine, including its 

metabolites and degradates, in or on 

berry, low growing, except strawberry, 

subgroup 13–07H at 0.2 parts per 

million (ppm); watercress at 5.0 ppm; 

onion, green, subgroup 3–07B at 6.0 

ppm; onion, bulb, subgroup 3–07A at 

0.07 ppm; peach at 0.9 ppm; vegetable, 

tuberous and corm, subgroup 1C at 0.05 

ppm; fruit, small, vine climbing, except 

fuzzy kiwifruit, subgroup 13–07F at 0.9 

ppm; and tea, plucked leaves at 25.0 

ppm. That notice referenced a summary 

of the petition prepared by Mitsui 

Chemicals Agro, Inc., the registrant, 

which is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Also, due to the tolerances established 

by this document, the following existing 

tolerances are being removed as 

unnecessary: Grape and potato. 

Based upon review of the data 

supporting the petition, EPA has 


srobinson on DSK4SPTVN1PROD with RULES