Federal Register / Vol. 80, No. 172 / Friday, September 4, 2015 / Rules and Regulations 53469 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart SS—Texas 

■ 2. The second table in § 52.2270(e) 

titled ‘‘EPA Approved Nonregulatory 

Provisions and Quasi-Regulatory 

Measures in the Texas SIP’’ is amended 

by revising the entry for ‘‘Infrastructure 

and Interstate Transport for the 1997 

Ozone and the 1997 and 2006 PM2.5

NAAQS’’. 

The revision reads as follows: 

§ 52.2270 Identification of plan. 

* * * * * 

(e) * * * 

EPA APPROVED NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES IN THE TEXAS SIP 

Name of SIP provision Applicable geographic or 

non-attainment area 

State approval/submittal date 

EPA approval date Comments 

*******

Infrastructure and Interstate 

Transport for the 1997 Ozone 

and the 1997 and 2006 PM2.5

NAAQS.

Statewide ..................................... 12/12/2007, 3/

11/2008, 4/4/

2008, 11/23/

2009 

12/28/2011, 76 FR 81371 Approval for CAA elements 110(a)(2)(A), (B), 

(E), (F), (G), (H), (K), 

(L), and (M). Full approval for CAA elements 

110(a)(2)(C), (D)(i)(II), 

(D)(ii) and (J) with approval of the GHG PSD 

revision (11/10/2014, 79 

FR 66626). 

* * * * * * * 

[FR Doc. 2015–22035 Filed 9–3–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0114; FRL–9931–18] 

Oxathiapiprolin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

oxathiapiprolin in or on multiple 

commodities that are identified and 

discussed later in this document. E.I. du 

Pont de Nemours and Company 

(‘‘Dupont’’) requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 4, 2015. Objections and 

requests for hearings must be received 

on or before November 3, 2015, 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–2014–0114, 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), West William 

Jefferson Clinton 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: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@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://www.ecfr.gov/cgi-bin/textidx?&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–2014–0114 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 3, 2015. 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 


rmajette on DSK2VPTVN1PROD with RULES
53470 Federal Register / Vol. 80, No. 172 / Friday, September 4, 2015 / Rules and Regulations 

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– 

2014–0114, 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.html. 

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 May 23, 

2014 (79 FR 29729) (FRL–9910–29), 

EPA issued a document pursuant to 

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

346a(d)(3), announcing the filing of a 

pesticide petition (PP 3F8220) by 

Dupont, 1007 Market Street, 

Wilmington, DE 19898. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the fungicide 

oxathiapiprolin, 1-(4-{4-[(5RS)-5-(2,6- 

difluorophenyl)-4,5-dihydro-1,2-oxazol3-yl]-1,3-thiazol-2-yl}-1-piperidyl)-2-[5- 

methyl-3-(trifluoromethyl)-1H-pyrazol1-yl] ethanone, in or on the following 

commodities: Brassica (cole) leafy 

vegetables, head and stem brassica crop 

subgroup 5A at 1.5 ppm; bulb 

vegetables, onion, bulb, crop subgroup 

3–07A at 0.04 ppm; bulb vegetables, 

onion, green crop subgroup 3–07B at 2 

ppm; cucurbit vegetables, crop group 9 

at 0.2 ppm; fruiting vegetables crop 

group 8–10 at 0.2 ppm; grape (import 

tolerance) at 0.9 ppm; ginseng root at 0.4 

ppm; leafy greens crop subgroup 4A at 

15 ppm; peas, edible podded at 1 ppm; 

peas, succulent, shelled at 0.05 ppm; 

and vegetable, root and tuber vegetables, 

tuberous corm vegetable crop subgroup 

1C at 0.01 ppm. One comment was 

received on the notice of filing. EPA’s 

response to this comment is discussed 

in Unit IV.C. 

Additionally, in the Federal Register 

of July 17, 2015 (80 FR 42462) (FRL– 

9923–13), EPA issued a document 

pursuant to FFDCA section 408(d)(3), 21 

U.S.C. 346a(d)(3), announcing a 

correction to the filing of a pesticide 

petition (PP 3F8220) by Dupont. This 

document corrects the petition 

announced in the May 23, 2014 Federal 

Register by adding the omitted entry for 

dried fruit vegetable at 0.9 ppm. No 

FFDCA-related comments were received 

on this notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the tolerance levels of some 

commodities and corrected several 

commodity definitions. The reasons for 

these changes are explained in Unit 

IV.D. 

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 FFDCA section 

408(b)(2)(D), and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for oxathiapiprolin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with oxathiapiprolin 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. 

In the toxicity studies for 

oxathiapiprolin, no treatment-related 

effects were seen at doses up to the limit 

dose. No treatment-related effects were 

seen in subchronic or chronic oral 

toxicity (rats, mice, or dogs), dermal 

toxicity, neurotoxicity, or 

immunotoxicity studies. Additionally, 

there was no evidence of 

carcinogenicity in cancer studies with 

rats or mice. No treatment-related effects 

were seen in maternal or fetal animals 

in rat or rabbit developmental toxicity 

studies. Treatment-related effects were 

observed in offspring animals in rat 

reproduction studies (decreased body 

weight and delayed preputial 

separation); however, the effects were 

only observed at doses above the limit 

dose (1,227 milligram/kilogram/day 

(mg/kg/day)). Such high doses are not 

relevant for human health risk. No other 

treatment-related effects were observed 

in oral or dermal studies with 

oxathiapiprolin. The lack of observed 

toxicity is consistent with the low to 

moderate oral absorption and lack of 

bioaccumulation reported in the rat 

metabolism studies. In acute lethality 

studies, exposure to oxathiapiprolin 

resulted in low toxicity via the oral, 

dermal, and inhalation routes of 

exposure. Oxathiapiprolin was not a 

dermal or eye irritant, or a skin 

sensitizer. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by oxathiapiprolin as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document, 

‘‘Oxathiapiprolin—New Active 

Ingredient Human Health Risk 

Assessment of Uses on Turf, 

Ornamentals, and a Number of Crops’’ 

in docket ID number EPA–HQ–OPP– 

2014–0114. 

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 


rmajette on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 80, No. 172 / Friday, September 4, 2015 / Rules and Regulations 53471 

dose at which the NOAEL and the 

LOAEL are identified. 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. 

The majority of the toxicity studies for 

oxathiapiprolin did not demonstrate 

treatment-related effects, with the 

exception of the reproduction study. 

The effects in the reproduction study 

were minimal and seen at doses (above 

the limit dose) not relevant for human 

exposure. There were no adverse acute 

or chronic effects identified for any 

population groups (including infants 

and children). Therefore, due to the 

limited toxicity in the oxathiapiprolin 

toxicological database, toxicity 

endpoints and points of departure were 

not selected for oxathiapiprolin 

exposure scenarios and a quantitative 

risk assessment was not conducted. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to oxathiapiprolin, EPA 

considered exposure under the 

petitioned-for tolerances. There is likely 

to be dietary exposure to 

oxathiapiprolin from its use as a 

pesticide on food. Should exposure 

occur, however, minimal to no risk is 

expected for the general population, 

including infants and children, due to 

the low toxicity of oxathiapiprolin. 

2. Dietary exposure from drinking 

water. Exposure to oxathiapiprolin via 

drinking water from the proposed uses 

is expected to be minimal due to rapid 

foliar uptake and limited quantities 

available in spray drift. No adverse 

effects were observed in the submitted 

toxicological studies for oxathiapiprolin 

regardless of the route of exposure. 

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). 

Oxathiapiprolin is not proposed or 

registered for any specific use pattern 

that would result in residential handler 

exposure. However, some of the uses 

could involve commercial application 

in areas where residential postapplication activities could occur (i.e., 

individuals playing on treated golf 

courses, commercial landscapes or 

treated ornamentals purchased at a 

retail location). Since no adverse effects 

were observed for oxathiapiprolin in the 

submitted toxicological studies 

(regardless of the route of exposure), 

quantitative residential handler or postapplication exposure assessments are 

not needed. 

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 oxathiapiprolin to share a 

common mechanism of toxicity with 

any other substances, and 

oxathiapiprolin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that oxathiapiprolin 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 

Food Quality Protection Act Safety 

Factor (FQPA 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. 

No evidence of increased quantitative or 

qualitative susceptibility was seen in 

developmental toxicity studies in rats 

and rabbits. No treatment related effects 

were seen in maternal or fetal animals 

in the studies. However, there was 

evidence of increased quantitative 

susceptibility in reproduction studies in 

rats at doses above the limit dose. 

Decreased pup weight and delayed 

sexual maturation (preputial separation) 

were seen in the studies in the absence 

of maternal toxicity. 

3. Conclusion. As part of its 

qualitative assessment, EPA evaluated 

the available toxicity and exposure data 

on oxathiapiprolin and considered its 

validity, completeness, and reliability, 

as well as the relationship of this 

information to human risk. EPA 

considers the toxicity database to be 

complete and has identified no residual 

uncertainty with regard to prenatal and 

postnatal toxicity or exposure. No 

hazard was identified based on the 

available studies; therefore, EPA 

concludes that there are no threshold 

effects of concern to infants, children, or 

adults from oxathiapiprolin. As a result, 

EPA concludes that no additional 

margin of exposure (safety) is necessary. 

E. Aggregate Risks and Determination of 

Safety 

Taking into account the available data 

for oxathiapiprolin, EPA has concluded 

that given the lack of toxicity of this 

substance, no risks of concern are 

expected. Therefore, 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 

oxathiapiprolin. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Method 30422 (Supplement No. 1) 

was developed for plant commodities, 

and Method 31138 was developed for 

livestock commodities. Residues of 

oxathiapiprolin and associated 

metabolites are extracted from crop or 

livestock commodity samples using a 

solution of formic acid, water and 

acetonitrile, and diluted with 

acetonitrile and water. Both methods 

use liquid chromotography with tandem 

mass spectrometry (LC/MS/MS), 

specifically reverse-phase liquid 

chromatography (LC), and detection by 

electrospray tandem mass spectrometry 

(MS/MS). 

The FDA multi-residue methods are 

not suitable for detection and 

enforcement of oxathiapiprolin residues 

or associated metabolites. However, the 

European Multiresidue Method (DFG 

Method S19) and the QuEChERS 

Multiresidue Method have shown 

success in some matrices. 


rmajette on DSK2VPTVN1PROD with RULES
53472 Federal Register / Vol. 80, No. 172 / Friday, September 4, 2015 / Rules and Regulations 

Adequate enforcement methodology 

(LC/MS/MS) is available to enforce the 

tolerance expression. The method may 

be requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

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 oxathiapiprolin. 

C. Response to Comments 

One comment was received in 

response to the notice of filing of 

Dupont’s application. The commenter 

objected to the increase of chemical 

residues generally and expressed 

concerns about the carcinogenic effects 

of chemicals on humans, particularly 

children. The Agency understands the 

commenter’s concerns regarding toxic 

chemicals, their potential effects on 

humans, and population subgroups 

such as children. Pursuant to its 

authority under the FFDCA, and as 

discussed further in this preamble, EPA 

conducted a comprehensive assessment 

of oxathiapiprolin, including its 

potential for carcinogenicity. Based on 

its assessment of the available data, the 

Agency has concluded that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to 

residues of oxathiapiprolin. 

D. Revisions to Petitioned-for 

Tolerances 

For grape, green onion, cucurbit 

vegetables, and edible podded pea, EPA 

has added an additional significant 

figure (such as 1.0 ppm rather than 1 

ppm) to conform to EPA’s convention 

for establishing enforceable tolerances. 

Thus, the tolerance for grape was 

revised to 0.70, for green onion to 2.0, 

for cucurbit vegetables to 0.20, and for 

edible-podded pea to 1.0. This is in 

order to avoid the situation where 

rounding of a residue result to the level 

of precision of the tolerance expression 

would be considered non-violative 

(such as 1.4 ppm being rounded to 1 

ppm). 

In the case of crop group 8–10, 

Fruiting Vegetables, the petitioned-fortolerance was based on the exclusion of 

a tomato field trial from the tolerance 

calculation. If this trial is excluded, all 

representative commodities (bell 

pepper, non-bell pepper, and tomato) 

support a crop group tolerance of 0.20 

ppm. However, EPA has concluded that 

this trial cannot be excluded from the 

tolerance derivation because there were 

insufficient data to support this trial as 

an outlier. Including those data in the 

tolerance calculation for crop group 8– 

10, EPA is establishing a tolerance for 

crop group 8–10 at 0.50 ppm and a 

tolerance for dried tomatoes at 3.0 ppm. 

EPA is not issuing a crop group 8–10 

tolerance for dried versions of all 

commodities in that crop group, as 

EPA’s current regulations do not permit 

the Agency to establish crop group 

processed commodity tolerances. 

Moreover, the available data do not 

support establishing separate individual 

tolerances for dried versions of the other 

commodities in crop group 8–10. 

In the case of ginseng, Dupont 

submitted four field trials at the good 

agricultural practice (GAP) proposed 

use rate and two field trials at 

approximately two times the GAP. 

Based on a review of the data and 

consultation with the global partners, 

EPA has concluded that using the 1× 

data is more appropriate for setting the 

tolerance, and is establishing a tolerance 

at 0.15 ppm based on that data. 

The Agency also corrected the 

commodity definitions for the following 

commodities: Bulb vegetables, onion, 

bulb, crop subgroup 3–07A, to onion, 

bulb, subgroup 3–07A; bulb vegetables, 

onion, green crop subgroup 3–07B to 

onion, green, subgroup 3–07B; brassica 

(cole) leafy vegetables, head and stem 

brassica crop subgroup 5A to brassica, 

head and stem, subgroup 5A; cucurbit 

vegetables, crop group 9 to vegetable, 

cucurbit, group 9; fruiting vegetables 

crop group 8–10 to vegetable, fruiting, 

group 8–10; ginseng root to ginseng; 

leafy vegetables (except brassica 

vegetables), leafy greens crop subgroup 

4A to leafy greens, subgroup 4A; peas, 

edible podded to pea, edible-podded; 

peas, succulent, shelled to pea, 

succulent shelled; and vegetable, root 

and tuber vegetables, tuberous corm 

vegetable crop subgroup 1C, to 

vegetable, tuberous and corm, subgroup 

1C. 

The registrant did not petition for 

rotational crop tolerances. However, 

EPA has concluded that for future MRL 

harmonization purposes, it is 

appropriate to set a value of 0.10 ppm 

for inadvertent residues in all other food 

commodities/feed commodities (other 

than those covered by a tolerance as a 

result of use on growing crops). 

V. Conclusion 

Therefore, tolerances are established 

for residues of oxathiapiprolin, 1-(4-{4- 

[(5RS)-5-(2,6-difluorophenyl)-4,5- 

dihydro-1,2-oxazol-3-yl]-1,3-thiazol-2- 

yl}-1-piperidyl)-2-[5-methyl-3- 

(trifluoromethyl)-1H-pyrazol-1-yl] 

ethanone, in or on the following 

commodities: Brassica, head and stem, 

subgroup 5A at 1.5 ppm; ginseng at 0.15 

ppm; grape at 0.70 ppm; leafy greens 

subgroup 4A at 15 ppm; onion, bulb, 

crop subgroup 3–07A at 0.04 ppm; 

onion, green, crop subgroup 3–07B at 

2.0 ppm; peas, edible podded at 1.0 

ppm; peas, succulent, shelled at 0.05 

ppm; tomato, dried at 3.0 ppm; 

vegetable, cucurbit, crop group 9 at 0.20 

ppm; vegetables, fruiting, crop group 8– 

10 at 0.50 ppm; and vegetable, tuberous 

and corm, crop subgroup 1C at 0.01 

ppm. 

In addition, inadvertent tolerances are 

established residues of oxathiapiprolin 

on all other food commodities/feed 

commodities (other than those covered 

by a tolerance as a result of use on 

growing crops) at 0.10 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

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 action 

has been exempted from review under 

Executive Order 12866, this action 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 action 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 


rmajette on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 80, No. 172 / Friday, September 4, 2015 / Rules and Regulations 53473 

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 tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (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 

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

VII. 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 27, 2015. 

Jack E. Housenger, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Add § 180.685 to subpart C to read 

as follows: 

§ 180.685 Oxathiapiprolin; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the fungicide 

oxathiapiprolin, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only oxathiapiprolin, 1-[4-[4- 

[5-(2,6-difluorophenyl)-4,5-dihydro-3- 

isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2- 

[5-methyl-3-(trifluoromethyl)-1Hpyrazol-1-yl]-ethanone, in or on the 

commodity. 

Commodity Parts per 

million 

Brassica, head and stem, subgroup 5A ................................. 1 .5 

Ginseng ...................................... 0 .15 

Grape 1 ........................................ 0 .70 

Leafy greens subgroup 4A ......... 15 

Onion, bulb, subgroup 3–07A .... 0 .04 

Onion, green, subgroup 3–07B .. 2 .0 

Pea, edible-podded .................... 1 .0 

Pea, succulent shelled ............... 0 .05 

Tomato, dried ............................. 3 .0 

Vegetable, cucurbit, group 9 ...... 0 .20 

Vegetable, fruiting, group 8–10 .. 0 .50 

Vegetable, tuberous and corm, 

subgroup 1C ........................... 0 .01 

1There is no associated U.S. registration as 

of September 4, 2015. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

Tolerances are established for residues 

of the fungicide oxathiapiprolin, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

oxathiapiprolin, 1-[4-[4-[5-(2,6- 

difluorophenyl)-4,5-dihydro-3- 

isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2- 

[5-methyl-3-(trifluoromethyl)-1Hpyrazol-1-yl]-ethanone, in or on the 

commodity. 

Commodity Parts per 

million 

All other food commodities/feed 

commodities (other than those 

covered by a tolerance as a result of use on growing crops) ... 0.10 

[FR Doc. 2015–21917 Filed 9–3–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 622 

[Docket No. 130312235–3658–02] 

RIN 0648–XE126 

Fisheries of the Caribbean, Gulf of 

Mexico, and South Atlantic; SnapperGrouper Resources of the South 

Atlantic; Trip Limit Reduction 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; trip limit 

reduction. 

SUMMARY: NMFS reduces the 

commercial trip limit for vermilion 

snapper in or from the exclusive 

economic zone (EEZ) of the South 

Atlantic to 500 lb (227 kg), gutted 

weight. This trip limit reduction is 

necessary to protect the South Atlantic 

vermilion snapper resource. 

DATES: This rule is effective 12:01 a.m., 

local time, September 10, 2015, until 

12:01 a.m., local time, January 1, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Catherine Hayslip, NMFS Southeast 

Regional Office, telephone: 727–824– 

5305, email: catherine.hayslip@

noaa.gov. 

SUPPLEMENTARY INFORMATION: The 

snapper-grouper fishery in the South 

Atlantic includes vermilion snapper and 

is managed under the Fishery 

Management Plan for the SnapperGrouper Fishery of the South Atlantic 

Region (FMP). The FMP was prepared 

by the South Atlantic Fishery 

Management Council and is 

implemented by NMFS under the 

authority of the Magnuson-Stevens 

Fishery Conservation and Management 

Act (Magnuson-Stevens Act) by 

regulations at 50 CFR part 622. 

The commercial ACL (commercial 

quota) for vermilion snapper in the 

South Atlantic is divided into two, 6- 

month periods. The commercial quota is 

394,829 lb (179,091 kg), gutted weight, 


rmajette on DSK2VPTVN1PROD with RULES