Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations 12011 

§ 1275.58 Requests for declassification. 

Challenges to the classification and 

requests for the declassification of 

national security classified materials are 

governed by the provisions of 36 CFR 

part 1256, subpart E, as that may be 

amended from time to time. 

§ 1275.60 Freedom of Information Act 

(FOIA) requests. 

(a) The Archivist will process 

Freedom of Information Act (FOIA) 

requests for access to only those 

materials within the Presidential 

historical materials that are identifiable 

by an archivist as records of an agency 

as defined in § 1275.16(f). The Archivist 

will process these requests in 

accordance with the FOIA regulations 

set forth in 36 CFR part 1250, NARA 

Records Subject to FOIA. 

(b) In order to allow NARA archivists 

to devote as much time and effort as 

possible to the processing of materials 

for general public access, the Archivist 

will not process those FOIA requests 

where the requester can reasonably 

obtain the same materials through a 

request directed to an agency (as 

defined in § 1275.16(f)), unless the 

requester demonstrates that he or she 

has unsuccessfully sought access from 

that agency or its successor in law or 

function. 

Dated: March 2, 2016. 

David S. Ferriero, 

Archivist of the United States. 

[FR Doc. 2016–05149 Filed 3–7–16; 8:45 am] 

BILLING CODE 7515–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0194; FRL–9942–24] 

Amitraz, Carfentrazone-ethyl, 

Ethephon, Malathion, Mancozeb, et al.; 

Tolerance Actions; Correction 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; correction. 

SUMMARY: EPA issued a document in the 

Federal Register of November 20, 2015, 

concerning the removal of the entry 

‘‘Rice, straw’’ from the table in 40 CFR 

180.361(a). EPA subsequently issued a 

document in the Federal Register of 

December 21, 2015, which redesignated 

40 CFR 180.361(a) as 40 CFR 

180.361(a)(1). This document corrects 

the document published on November 

20, 2015, to remove the entry ‘‘Rice, 

straw’’ from the table in paragraph 

(a)(1). 

DATES: This final rule correction is 

effective May 18, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

The Agency included in the 

November 20, 2015 document a list of 

those who may be potentially affected 

by this action. 

B. How can I get copies of this document 

and other related information? 

The dockets for this action, identified 

by docket identification (ID) number 

EPA–HQ–OPP–2014–0194 are 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 dockets available 

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

II. What does this correction do? 

The final rule in the Federal Register 

of November 20, 2015, amended 40 CFR 

180.361 to remove the entry ‘‘Rice, 

straw’’ from the table in paragraph (a). 

In the final rule in the Federal Register 

of December 21, 2015 (80 FR 79267) 

(FRL–9937–18), paragraph (a) was 

redesignated as paragraph (a)(1) so we 

are amending 40 CFR 180.361 to remove 

the entry ‘‘Rice, straw’’ from the table in 

paragraph (a)(1). 

FR Doc. 2015–28491 published in the 

Federal Register of November 20, 2015 

(80 FR 72593) (FRL–9935–01) is 

corrected as follows: 

§ 180.361 [Amended] 

■ 1. On page 72598, second column, 

under the heading § 180.361 

[Amended], instruction 16, line 3, 

correct paragraph (a) to read paragraph 

(a)(1). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 25, 2016. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

[FR Doc. 2016–04765 Filed 3–7–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0922; FRL–9942–18] 

Zoxamide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of zoxamide in or 

on the tomato subgroup 8–10A, the 

small, vine climbing fruit, except fuzzy 

kiwifruit, subgroup 13–07F, the 

tuberous and corm vegetable subgroup 

1C and ginseng. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 8, 2016. Objections and requests 

for hearings must be received on or 

before May 9, 2016, 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–2014–0922, 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, 


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12012 Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations 

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–2014–0922 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 May 9, 2016. 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– 

2014–0922, 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 April 6, 

2015 (80 FR 18327) (FRL–9924–00), 

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 4E8335) by IR–4, 

500 College Road East, Suite 201 W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of residues of 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 in or on the raw 

agricultural commodity ginseng at 0.30 

parts per million (ppm) and vegetable, 

tuberous and corm, subgroup 1C at 

0.060 ppm. In addition, IR–4 requested 

to establish tolerances for residues, 

determined by measuring only 

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

ethyl-1-methyl-2-oxypropyl)-4- 

methylbenzamide, in or on the raw 

agricultural commodity tomato 

subgroup 8–10A at 2.0 ppm and fruit, 

small, vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F at 5.0 ppm. 

IR–4 also proposed, upon the approval 

of the aforementioned tolerances, to 

remove established tolerances for grape 

at 3.0 ppm; tomato at 2.0 ppm; and 

potato at 0.060 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. 

There were no comments received in 

response to the notice of filing. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with 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. 

In repeat dose oral and dermal 

toxicity studies in rats, there were no 

indications of systemic toxicity up to 

the highest dose tested (HDT); most of 

the highest doses were at or above the 

limit dose (1,000 milligrams/kilogram/

day (mg/kg/day)). In the repeat dose oral 

toxicity studies in dogs, effects included 

increased liver and thyroid weights, 

liver histopathology (i.e., hepatocellular 

hypertrophy), and increased alkaline 

phosphatase. 


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In the rat and rabbit prenatal 

developmental toxicity studies, there 

were no indications of susceptibility, as 

there was neither maternal nor 

developmental toxicity up to the HDT. 

In the rat reproduction study, there were 

no indications of susceptibility, since 

parental effects (i.e., decreased maternal 

body weight) occurred in the absence of 

reproductive or offspring toxicity. 

Zoxamide has been classified as ‘‘not 

likely to be carcinogenic in humans’’ 

based on the results of carcinogenicity 

studies in rats and mice. In the acute 

and subchronic neurotoxicity studies, 

there were no indications of 

neurotoxicity up to the HDT. 

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 the document 

titled ‘‘Zoxamide. Human Health 

Aggregate Risk Assessment for the 

Proposed New Uses on Ginseng, Tomato 

Subgroup 8–10A; Small Fruit, Vine 

Climbing, Except Fuzzy Kiwifruit, 

Subgroup 13–07F; and Tuberous and 

Corm Vegetable Subgroup 1C’’ on page 

25 in docket ID number EPA–HQ–OPP– 

2014–0922. 

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://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for zoxamide used for human 

risk assessment is discussed in Unit 

III.B. of the final rule published in the 

Federal Register of July 18, 2014 (79 FR 

41911) (FRL–9913–35). 

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: 

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 United States Department of 

Agriculture’s (USDA’s) 2003–2008 

National Health and Nutrition 

Examination Survey, What We Eat in 

America (NHANES/WWEIA) database. 

As to residue levels in food, EPA 

assumed tolerance-level residues and 

100 percent crop treated (PCT) for all 

established and proposed commodities. 

The assessment also utilized default 

processing factors from the Dietary 

Exposure Evaluation Model—Food 

Commodity Intake Database (DEEM– 

FCID) version 7.81 except for raisin and 

potato granules/flakes, where the 

processing factor was set at 1. 

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. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for zoxamide. 

Tolerance level residues and 100 PCT 

were assumed for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for zoxamide and its major metabolites 

in drinking water. These simulation 

models take into account data on the 

physical, chemical, and fate/transport 

characteristics of zoxamide and its 

metabolites. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at 

http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Pesticide 

Root Zone Model Ground Water (PRZM 

GW) model, the estimated drinking 

water concentrations (EDWCs) of 

zoxamide and its major metabolites for 

chronic exposures are estimated to be 

22.84 parts per billion (ppb) for surface 

water and 65.8 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 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:// 

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 


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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. 

There was no evidence for increased 

susceptibility following prenatal 

exposure in prenatal developmental 

toxicity studies in rats and rabbits. 

Additionally, there was no evidence for 

increased susceptibility following preor postnatal exposure in the 

reproduction and fertility effects study 

in rats. 

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 1×. 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 PCT 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 6.3% of the 

cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for zoxamide. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

A short- and intermediate-term 

adverse effect was identified; however, 

zoxamide is not registered for any use 

patterns that would result in either 

short- or intermediate-term residential 

exposure. Short- and intermediate-term 

risk is assessed based on short- and 

intermediate-term residential exposure 

plus chronic dietary exposure. Because 

there is no short- or intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess short- or 

intermediate-term risk), no further 

assessment of short- or intermediateterm risk is necessary, and 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. 

The tolerances being established for 

the tomato subgroup 8–10A and the 

small vine climbing fruit, except fuzzy 

kiwifruit, subgroup 13–07F are 

harmonized with established Codex 

MRLs on tomato and grape, 

respectively. The tolerance being 

established for the tuberous and corm 

vegetable subgroup 1C at 0.06 ppm is 

not harmonized with a Codex MRL on 

potato at 0.02 ppm. The underlying 

residue data and residue definition used 

to support the Subgroup 1C tolerance 

supports a tolerance recommendation 

that is higher than the established 

Codex MRL on potato at 0.02 ppm. 

There is not a Codex MRL for ginseng. 

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 


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Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations 12015 

stoichiometric equivalent of zoxamide 

in or on the raw agricultural commodity 

ginseng at 0.30 ppm and vegetable, 

tuberous and corm, subgroup 1C at 0.06 

ppm. In addition, tolerances are 

established for residues, determined by 

measuring only zoxamide (3,5-dichloroN-(3-chloro-1-ethyl-1-methyl-2- 

oxypropyl)-4-methylbenzamide, in or on 

raw agricultural commodity tomato 

subgroup 8–10A at 2.0 ppm and fruit, 

small vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F at 5.0 ppm. 

Lastly, upon the establishment of the 

aforementioned tolerances, the 

established tolerances for grape at 3.0 

ppm; tomato at 2.0 ppm; and potato at 

0.060 ppm are removed as unnecessary. 

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 

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 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: February 25, 2016. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.567: 

■ a. In the table in paragraph (a)(1): 

■ i. Add alphabetically entries for 

‘‘Fruit, small vine climbing’’ and 

‘‘Tomato subgroup 8–10A’’; and 

■ ii. Remove the entries for ‘‘Grape’’ and 

‘‘Tomato’’; and 

■ b. In the table in paragraph (a)(2): 

■ i. Add alphabetically entries for 

‘‘Ginseng’’ and ‘‘Vegetable, tuberous and 

corm’’; and 

■ ii. Remove the entry ‘‘Potato’’. 

The additions read as follows: 

§ 180.567 Zoxamide; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

Fruit, small vine climbing, except 

fuzzy kiwifruit, subgroup 13– 

07F .......................................... 5.0 

*****

Tomato subgroup 8–10A ............ 2.0 

*****

(2) * * * 

Commodity Parts per 

million 

Ginseng ...................................... 0.30 

*****

Vegetable, tuberous and corm, 

subgroup 1C ........................... 0.06 

* * * * * 

[FR Doc. 2016–04740 Filed 3–7–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0443; FRL–9943–21] 

Fluopyram; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes, 

amends, and deletes tolerances for 

residues of fluopyram in or on multiple 

commodities which are identified and 

discussed later in this document. Bayer 

CropScience requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 8, 2016. Objections and requests 

for hearings must be received on or 

before May 9, 2016, 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) 


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