Federal Register / Vol. 79, No. 138 / Friday, July 18, 2014 / Rules and Regulations 41911 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0644; FRL–9913–35] 

Zoxamide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of zoxamide in or 

on onion, bulb, subgroup 3–07A. Gowan 

Company requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective July 

18, 2014. Objections and requests for 

hearings must be received on or before 

September 16, 2014, 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–2013–0644, 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: Lois 

Rossi, 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–2013–0644 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 September 16, 2014. 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– 

2013–0644, 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 29731) (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 3F8164) by 

Gowan Company, P.O. Box 5569, Yuma, 

AZ 85366. The petition requested that 

40 CFR 180.567 be amended by 

establishing tolerances for residues of 

the fungicide zoxamide, 3, 5-dichloro-N- 

(3-chloro-1-ethyl-1-methyl-2- 

oxopropyl)-4-methylbenzamide, and its 

metabolites 3,5-dichloro-1,4- 

benzenedicarboxylic acid (RH–1455 and 

RH–141455) and 3,5-dichloro-4- 

hydroxymethylbenzoic acid (RH–1452 

and RH–141452) calculated as the 

stoichiometric equivalent of zoxamide, 

in or on onion, bulb, subgroup 3–07A at 

0.7 parts per million (ppm). That 

document referenced a summary of the 

petition prepared by Gowan Company, 

the registrant, which is available in the 

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

Comments were received on the notice 

of filing. EPA’s response to these 

comments is discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA is 

establishing the tolerance as requested 

but revising the tolerance expressions 

for zoxamide. The reason 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 

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41912 Federal Register / Vol. 79, No. 138 / Friday, July 18, 2014 / Rules and Regulations 

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 zoxamide 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with zoxamide 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. 

The toxicity data of zoxamide indicate 

that the primary target organ is the liver. 

Liver and thyroid weights increased 

along with liver histopathological 

change and increases in alkaline 

phosphatase. Systemic toxicity was not 

observed in the 28-day rat dermal 

toxicity study up to the limit dose 

(1,000 milligram/kilogram/day (mg/kg/

day)). There are no concerns for 

neurotoxicity, immunotoxicity, 

developmental toxicity, or reproductive 

toxicity. There was no evidence of 

increased susceptibility (quantitative or 

qualitative) for the offspring in the 

reproduction studies or for fetuses 

following in utero exposure in the 

developmental studies. Zoxamide is 

classified as ‘‘not likely to be 

carcinogenic to humans’’ based on the 

lack of treatment-related tumors in 

acceptable/guideline carcinogenicity 

studies in rats and mice. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by zoxamide 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 

Zoxamide. Health Risk Assessment for 

the Proposed New Use on Bulb Onions 

(Crop Subgroup 3–07A) in docket ID 

number EPA–HQ–OPP–2013–0644. 

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 zoxamide used for human 

risk assessment is shown in the Table of 

this unit. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ZOXAMIDE 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 (all populations) .. There is no indication of an adverse effect attributable to a single dose. Additionally, developmental, 

neurotoxicity, and reproductive effects were not observed in the database. An aRfD was not established. 

Chronic dietary (all populations) NOAEL= 48 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.48 

mg/kg/day.

cPAD = 0.48 mg/kg/

day 

Chronic Toxicity—Dog. 

LOAEL = 255 mg/kg/day based on body weight changes, increases in liver and thyroid weights, and increases in alkaline 

phosphatase. 

Dermal short-term (1 to 30 

days).

There were no systemic or dermal toxicity findings in a 28-day dermal toxicity study in the rat up to the limit 

dose (1000 mg/kg/day) and there were no developmental, reproductive, or neurotoxicity concerns observed in 

the database. 

Inhalation short-term (1 to 30 

days) and Inhalation Intermediate-term (1 to 6 months).

Inhalation (or oral) 

study NOAEL= 48 

mg/kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Chronic Toxicity—Dog. 

LOAEL = 255 mg/kg/day based on body weight changes, increases in liver and thyroid weights, and increases in alkaline 

phosphatase. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to zoxamide, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

zoxamide tolerances in 40 CFR 180.567. 

EPA assessed dietary exposures from 

zoxamide in food as follows: 

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Federal Register / Vol. 79, No. 138 / Friday, July 18, 2014 / Rules and Regulations 41913 

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 zoxamide; 

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 2003–2008 National 

Health and Nutrition Examination 

Survey, What We Eat in America 

(NHANES/WWEIA). As to residue levels 

in food, EPA assumed tolerance-level 

residues, 100% crop treated (CT), and 

default processing factors from the 

Dietary Exposure Evaluation Model 

software with the Food Commodity 

Intake Database (DEEM–FCID) Version 

7.81 (except for grape, raisin and potato 

granules/flakes). 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that zoxamide does not pose 

a cancer risk to humans. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for zoxamide in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of zoxamide. 

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 Pesticide 

Root Zone Model Ground Water (PRZM 

GW), the estimated drinking water 

concentrations (EDWCs) of zoxamide for 

chronic exposures (non-cancer) are 

estimated to be 0.81 parts per billion 

(ppb) for surface water and 65.8 ppb for 

ground water, respectively. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 65.8 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). 

Zoxamide is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found zoxamide to share 

a common mechanism of toxicity with 

any other substances, and zoxamide 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that zoxamide 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 prenatal and postnatal toxicity 

studies include rat and rabbit prenatal 

developmental studies in addition to a 

reproduction and fertility effects study 

in rats; and the highest doses used in 

these studies are at or above the limit 

dose. In the developmental studies, 

maternal and fetal toxicity was not 

observed up to the limit dose (1,000 mg/ 

kg/day). In the rat reproduction and 

fertility effects study, decreased body 

weights and body weight gains was 

observed in only the parental females at 

the highest dose tested. Therefore, EPA 

has concluded that there was no 

evidence of increased susceptibility 

(quantitative or qualitative) for the 

offspring in the reproduction studies or 

for fetuses following in utero exposure 

in the developmental studies. 

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 zoxamide 

is complete. 

ii. There is no indication that 

zoxamide is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no evidence that 

zoxamide results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100% CT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to zoxamide in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by zoxamide. 

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, zoxamide 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 zoxamide from 

food and water will utilize 4.8% of the 

cPAD for children 1 to 2 years old, the 

population group receiving the greatest 

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41914 Federal Register / Vol. 79, No. 138 / Friday, July 18, 2014 / Rules and Regulations 

exposure. There are no residential uses 

for zoxamide. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate risk takes into account shortterm and intermediate-term residential 

exposure, respectively, plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Zoxamide is currently not registered 

for any use patterns that could result in 

short-term or intermediate-term 

residential exposure. Because short- or 

intermediate-term residential exposure 

and chronic dietary exposure have 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess short-term risk), further 

assessment of short- and intermediateterm risk is not necessary. EPA relies on 

the chronic dietary risk assessment for 

evaluating short- and intermediate-term 

risk for zoxamide. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

zoxamide is not expected to pose a 

cancer risk to humans. 

5. 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 zoxamide 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography with electron 

capture detection (GC/ECD) and GC 

with mass selective detection (GC/

MSD)) 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. 

Neither Codex, Canada, nor Mexico 

has not established a MRL for zoxamide 

in/on bulb onions, so there will be no 

need to harmonize the international 

standards. 

C. Response to Comments 

One comment was received in 

response to the notice of filing of Gowan 

Company’s application. The commenter 

objected to the increase of chemical 

residues generally and expressed 

concerns about the carcinogenic effects 

of chemicals in general on humans. The 

Agency understands the commenter’s 

concerns regarding toxic chemicals and 

their potential effects on humans. 

Pursuant to its authority under the 

FFDCA, and as discussed further in this 

preamble, EPA conducted a 

comprehensive assessment of zoxamide, 

which included an assessment on the 

carcinogenic potential of zoxamide. 

Based on its assessment of the available 

data, the Agency has concluded that 

zoxamide is not likely to be a 

carcinogen and that there is a reasonable 

certainty that no harm will result from 

aggregate exposure to residues of 

zoxamide. 

D. Revisions to Petitioned-For 

Tolerances 

EPA is revising the tolerance 

expressions to clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of Zoxamide 

not specifically mentioned; and 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of zoxamide, 3, 5-dichloroN-(3-chloro-1-ethyl-1-methyl-2- 

oxopropyl)-4-methylbenzamide and its 

metabolites 3,5-dichloro-1,4- 

benzenedicarboxylic acid (RH–1455 and 

RH–141455) and 3,5-dichloro-4- 

hydroxymethylbenzoic acid (RH–1452 

and RH–141452) calculated as the 

stoichiometric equivalent of zoxamide, 

in or on onion, bulb, subgroup 3–07A at 

0.7 ppm. 

In addition, EPA is revising the 

tolerance expressions for zoxamide 

contained in paragraphs (a)(1) and 

(a)(2), and in paragraph (b), removing 

the commodity ginseng, and reserving 

paragraph (b). 

VI. 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 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 

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Federal Register / Vol. 79, No. 138 / Friday, July 18, 2014 / Rules and Regulations 41915 

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). 

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: July 10, 2014. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.567 is amended as 

follows: 

■ a. Revise the introductory text of 

paragraph (a)(1); 

■ b. Revise the introductory text of 

paragraph (a)(2); 

■ c. Alphabetically add ‘‘Onion, bulb, 

subgroup 3–07A’’ to the table in 

paragraph (a)(2); and 

■ d. Remove and reserve paragraph (b) 

to read as follows: 

§ 180.567 Zoxamide; tolerance for 

residues. 

(a) General. (1) Tolerances are 

established for residues of zoxamide 

including 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 

zoxamide (3,5-dichloro-N-(3-chloro-1- 

ethyl-1-methyl-2-oxopropyl)-4- 

methylbenzamide). 

* * * * * 

(2) Tolerances are established for 

residues of zoxamide including 

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 the sum of zoxamide 

(3,5-dichloro-N-(3-chloro-1-ethyl-1- 

methyl-2-oxopropyl)-4- 

methylbenzamide) and its metabolites 

3,5-dichloro-1,4-benzenedicarboxylic 

acid (RH–1455 and RH–141455) and 

3,5-dichloro-4-hydroxymethylbenzoic 

acid (RH–1452 and RH–141452) 

calculated as the stoichiometric 

equivalent of zoxamide. 

Commodity Parts per 

million 

Onion, bulb, subgroup 3–07A .. 0.7 

* * * * * 

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

[FR Doc. 2014–16807 Filed 7–17–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0023; FRL–9912–10] 

Polyoxyalkylated Trimethylopropanes; 

Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 

polyoxyalkylated trimethylopropanes 

with 20 to 80 moles of ethylene and/or 

propylene oxide, fatty acid esters with 

C8 through C22 aliphatic alkanoic and/or 

alkenoic fatty acids, branched or linear, 

the resulting polyoxyalkylene 

trimethylopropane esters having a 

minimum molecular weight (MW) of 

3,000 when used as an inert ingredient 

in a pesticide chemical formulation. 

Spring Trading Co., on behalf of Croda, 

Inc., submitted a petition to EPA under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), requesting an exemption 

from the requirement of a tolerance. 

This regulation eliminates the need to 

establish a maximum permissible level 

for residues of polyoxyalkylated 

trimethylopropanes on food or feed 

commodities. 

DATES: This regulation is effective July 

18, 2014. Objections and requests for 

hearings must be received on or before 

September 16, 2014, 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–2013–0023, 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: Lois 

Rossi, 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 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. 

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