Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Rules and Regulations 66805 

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 § 180.478, revise paragraph (a) 

and add alphabetically the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.478 Rimsulfuron; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

rimsulfuron, including its metabolites 

and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 

rimsulfuron, N-[[(4,6-dimethoxy-2- 

pyrimidinyl)amino] carbonyl]-3- 

(ethylsulfonyl)-2-pyridinesulfonamide. 

Commodity Parts per 

million 

* * * * * 

Sorghum, grain, forage ............... 0.01 

Sorghum, grain, grain ................. 0.01 

Sorghum, grain, stover ............... 0.01 

* * * * * 

* * * * * 

[FR Doc. 2015–27790 Filed 10–29–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0600; FRL–9933–25] 

Teflubenzuron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of teflubenzuron 

[N-[[(3,5-dichloro-2,4- 

difluorophenyl)amino]carbonyl]-2,6- 

difluorobenzamide] in or on multiple 

commodities which are identified and 

discussed later in this document. BASF 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

October 30, 2015. Objections and 

requests for hearings must be received 

on or before December 29, 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–2014–0600, 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 Publishing Office’s eCFR site at http://www.ecfr.gov/cgi-bin/ 

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

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2014–0600 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 December 29, 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 

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– 

2014–0600, 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 January 28, 

2015 (80 FR 4525) (FRL–9921–55), 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 4E8230) by BASF 

Corporation, 26 Davis Dr., Research 

Triangle Park, NC 27709. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the insecticide 

teflubenzuron, in or on apple at 0.5 

parts per million (ppm); apple, wet 

pomace at 0.8 ppm; broccoli at 0.2 ppm; 

cattle, meat byproducts at 0.01 ppm; 

cattle, muscle at 0.01 ppm; cauliflower 

at 0.01 ppm; citrus, oil at 90 ppm; 

coffee, bean, green at 0.6 ppm; corn, 


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field, grain at 0.01 ppm; corn, field, 

refined oil at 0.02 ppm; egg at 0.01 ppm; 

goat, meat byproducts at 0.01 ppm; goat, 

muscle at 0.01 ppm; horse, meat 

byproducts at 0.01 ppm; horse, muscle 

at 0.01 ppm; lemon at 0.9 ppm; mango 

at 1.5 ppm; melon, at 0.3 ppm; milk at 

0.01 ppm; orange at 0.6 ppm; papaya at 

0.4 ppm; pineapple at 0.8 ppm; pork, 

muscle at 0.01 ppm; pork, meat 

byproducts at 0.01 ppm; poultry, meat 

byproducts at 0.01 ppm; poultry, muscle 

at 0.01 ppm; sheep, meat byproducts at 

0.01 ppm; sheep, muscle at 0.01 ppm; 

soybean, hulls at 0.4 ppm; soybean, seed 

at 0.05 ppm; sugarcane, cane at 0.01 

ppm; sunflower, seed at 0.3 ppm; 

tomato at 1.5 ppm; and tomato, paste at 

5 ppm. That document referenced a 

summary of the petition prepared by 

BASF Corporation, the registrant, which 

is available in the docket, http://

www.regulations.gov. No tolerancerelated comments were submitted. 

Based upon review of the data 

supporting the petition, EPA has edited 

tolerance levels for some food 

commodities, and declined to grant 

tolerances for others. The reasons for 

these changes are explained in Unit 

IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with 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 teflubenzuron 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with teflubenzuron 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. Exposure of 

animals to teflubenzuron has shown no 

evidence of neurotoxicity, 

immunotoxicity, or genotoxicity. It is 

categorized as having low acute lethality 

by oral, dermal and inhalation routes of 

exposure. It is not a dermal sensitizer or 

eye irritant. In all species tested, 

hepatotoxicity was indicated. The liver 

is the primary target organ for 

teflubenzuron. In the mouse, which is 

the most sensitive species compared to 

the rat and the dog, liver adenomas were 

observed following chronic exposure. 

Increased enzyme release and numerous 

microscopic indicators of liver injury 

(diffuse hypertrophy, disseminated 

single-cell necrosis, patchy glycogen 

storage, Kupffer cell proliferation, 

phagocytic foci, lipofuscin 

accumulation and centrilobular fatty 

change) were observed in all species 

exposed to teflubenzuron. 

The 2-generation reproductive study 

shows evidence of increased 

quantitative offspring susceptibility. 

There were no effects of teflubenzuron 

exposure on the parental generation, but 

effects on offspring consisted of 

decreased F2 litter weights and 

increased incidence of unilateral 

dilatation of the renal pelvis in F1

offspring. There is no evidence of 

increased fetal susceptibility in either 

the rat or rabbit developmental studies. 

Because rare liver tumors were 

observed only in male mice and there 

was no evidence of carcinogenicity from 

teflubenzuron in female mice or in male 

or female rats, the Agency is using a 

non-linear approach (i.e. reference dose 

(RfD)) to account for the observed 

carcinogenicity that could result from 

exposure to teflubenzuron. Moreover, 

there is no concern for mutagenicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by teflubenzuron 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, 

‘‘Teflubenzuron: Human Health Risk 

Assessment’’ at pp. 4, 13, 21, and 22 in 

docket ID number EPA–HQ–OPP–2014– 

0600. 

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 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 

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 teflubenzuron used for 

human risk assessment is shown in 

Table 1 of this unit. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TEFLUBENZURON FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (General population including infants and 

children).

An endpoint of concern attributable to a single dose was not identified. An acute RfD was not established. 

Chronic dietary (All populations) NOAEL = 2.1 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.021 

mg/kg/day.

cPAD = 0.021 mg/

kg/day 

Carcinogenicity (mouse) LOAEL = 10.5 mg/kg/day based on increased microscopic lesions in the liver (diffuse hypertrophy, 

centrilobular single-cell necrosis, patchy glycogen storage, 

Kupffer cell proliferation, phagocytic foci, and centrilobular 

fatty change) associated with increased relative liver weight. 

Cancer (Oral, dermal, inhalation).The Agency is using a non-linear approach (i.e., RfD) that will adequately account for all chronic toxicity, including carcinogenicity that could result from exposure to teflubenzuron. 

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

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 teflubenzuron, EPA 

considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from teflubenzuron 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 teflubenzuron; 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 teflubenzuron 

residues are present in all commodities 

at tolerance levels and that 100% of all 

crops are treated. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a non-linear RfD 

approach is appropriate for assessing 

cancer risk to teflubenzuron. Cancer risk 

was assessed using the same exposure 

estimates as discussed in Unit III.C.1.ii. 

chronic exposure. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for teflubenzuron. Tolerance-level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. Because there are no domestic 

agricultural or residential uses 

registered or proposed for 

teflubenzuron, there will be no exposure 

in drinking water; therefore, a drinking 

water assessment is not necessary. 

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). 

Teflubenzuron 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 teflubenzuron to 

share a common mechanism of toxicity 

with any other substances, and 

teflubenzuron does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that teflubenzuron 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. 

The rat 2-generation reproductive study 

showed evidence of increased 

quantitative offspring susceptibility to 

teflubenzuron. While there were no 

parental effects, adverse offspring effects 

were observed and consisted of 

decreased F2 litter weights and 

increased incidence of unilateral 

dilatation of the renal pelvis in F1

offspring. There were no effects of 

teflubenzuron in the developmental rat 

study up to the highest dose tested. In 

the developmental rabbit study, 

maternal effects were observed at the 

limit dose and were consistent with 

liver toxicity; no fetal effects were 

observed. 

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: 


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i. The toxicity database for 

teflubenzuron is complete for assessing 

the safety of tolerances for which there 

is no associated U.S. pesticide 

registration. 

ii. There is no indication that 

teflubenzuron is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors (UFs) to 

account for neurotoxicity. 

iii. As discussed in Unit III.D.2., there 

is evidence of quantitative susceptibility 

in the rat in the 2-generation 

reproductive study. There is no residual 

concern or uncertainty regarding these 

effects as the study established a clear 

NOAEL and LOAEL. Moreover, the 

Agency is using a lower POD in its 

assessment, which will be protective of 

these effects. 

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. There are no 

drinking water or residential exposures 

as there are no U.S. registrations of 

pesticides containing teflubenzuron. 

These assessments will not 

underestimate the exposure and risks 

posed by teflubenzuron. 

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, teflubenzuron 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 teflubenzuron 

from food and water will utilize 50% of 

the cPAD for children 1–2 years old the 

population group receiving the greatest 

exposure. There are no residential uses 

for teflubenzuron. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Teflubenzuron is for 

use on imported commodities only, no 

residential exposure or chronic 

exposure from water is expected. 

Because no short-term adverse effect 

was identified, teflubenzuron is not 

expected to pose a short-term risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Because no intermediate-term adverse 

effect was identified, teflubenzuron is 

not expected to pose an intermediateterm risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the results of the 

chronic assessment, EPA concludes that 

teflubenzuron will not pose a cancer 

risk for the U.S. population. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

teflubenzuron residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The petitioner submitted a highperformance liquid chromatography 

method with tandem mass-spectrometry 

detection (LC/MS/MS) analytical 

method, BASF Method L0160/01, for 

analysis of residues of teflubenzuron 

in/on dry and oily crop commodities. 

The method has been adequately 

validated by the petitioner as well as by 

an independent laboratory, and was also 

adequately radio validated using 

weathered samples obtained from 

metabolism studies. In addition, the 

Quechers multi residue method (MRM) 

is considered suitable for the analysis of 

teflubenzuron in fruits and vegetables. 

Adequate enforcement methodology 

(high-performance liquid 

chromatography with tandem mass 

spectrometry) is available to enforce the 

tolerance expression. 

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 established a MRL for 

teflubenzuron in or on pome fruit at 1.0 

ppm. The U.S. tolerance being 

established for residues of 

teflubenzuron on apples is harmonized 

with this value. 

C. Revisions to Petitioned-For 

Tolerances 

The petition requested tolerances for 

several livestock commodities (cattle, 

meat byproducts; cattle, muscle; egg; 

goat, meat byproducts; goat, muscle; 

horse, meat byproducts; horse, muscle; 

milk; pork, meat byproducts; pork, 

muscle; poultry, meat byproducts; 

poultry, muscle; sheep, meat 

byproducts; and sheep, muscle.) Based 

on the results of livestock feeding 

studies, EPA is not establishing 

tolerances for these commodities 

because there is no expectation of finite 

residues in livestock commodities. The 

tolerance proposal for apple, wet 

pomace is not being established because 

the commodity is not likely to be 

imported. The petitioned-for tolerance 

for tomato, paste is not being 

established because concentration of 

residues is not expected above the 

tolerance established for tomato (1.5 

ppm); the tolerance for tomato will be 

adequate to cover any residues in 

tomato paste. 

In the case of apple, EPA is 

establishing a higher tolerance (from 0.5 

ppm to 1.0 ppm) to harmonize with the 

established Codex MRL. Based on EPA’s 

methods for calculating residue levels 

on processed commodities, EPA is 

establishing a higher tolerance for 

citrus, oil (90 ppm to 100 ppm) and a 

lower tolerance for soybean, hulls (0.4 

ppm to 0.15 ppm) than what was 

requested. Using the Organization for 

Economic Cooperation and 

Development (OECD) calculation 

procedures, EPA is establishing a higher 

tolerance for papaya tolerance (0.4 ppm 

to 0.5 ppm) and a lower tolerance for 

the lemon (0.90 ppm to 0.80 ppm) than 

was requested. 

In addition, EPA is adding significant 

figures to tolerance levels in accordance 

with EPA policy for the following 

commodities: Broccoli; coffee, bean, 


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green; melon, subgroup 9A; orange; 

pineapple; and sunflower, seed. EPA is 

also revising the commodity term ‘‘corn, 

field’’ to ‘‘corn, field, grain’’ to be 

consistent with the food and feed 

commodity vocabulary used for 

tolerances. Finally, EPA is establishing 

a tolerance for ‘‘melon, subgroup 9A’’ 

instead of ‘‘melon’’ as requested because 

the regulatory definition of ‘‘melon’’ 

includes all commodities listed under 

‘‘melon, subgroup 9A.’’ 

V. Conclusion 

Therefore, tolerances are established 

for residues of teflubenzuron, in or on 

apple at 1.0 ppm; broccoli at 0.20 ppm; 

cauliflower at 0.01 ppm; citrus, oil at 

100 ppm; coffee, bean, green at 0.60 

ppm; corn, field, grain at 0.01 ppm; 

corn, field, refined oil at 0.02 ppm; 

lemon at 0.80 ppm; mango at 1.5 ppm; 

melon, subgroup 9A at 0.30 ppm; orange 

at 0.60 ppm; papaya at 0.50 ppm; 

pineapple at 0.80 ppm; soybean, seed at 

0.05 ppm; soybean, hulls at 0.15 ppm; 

sugarcane, cane at 0.01 ppm; sunflower, 

seed at 0.30 ppm; and tomato at 1.5 

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 

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: October 20, 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 § 180.687 to subpart C to read 

as follows: 

§ 180.687 Teflubenzuron; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the 

insecticide teflubenzuron, 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 teflubenzuron (N-[[(3,5- 

dichloro-2,4- 

difluorophenyl)amino]carbonyl]-2,6- 

difluorobenzamide). 

Commodity Parts per 

million 

Apple 1 ........................................ 1.0 

Broccoli 1 ..................................... 0.20 

Cauliflower 1 ................................ 0.01 

Citrus, oil 1 .................................. 100 

Coffee, bean, green 1 ................. 0.60 

Corn, field, grain 1 ....................... 0.01 

Corn, field, refined oil 1 ............... 0.02 

Lemon 1 ....................................... 0.80 

Mango 1 ....................................... 1.5 

Melon, subgroup 9A1 ................. 0.30 

Orange 1 ...................................... 0.60 

Papaya 1 ..................................... 0.50 

Pineapple 1 .................................. 0.80 

Soybean, seed 1 ......................... 0.05 

Soybean, hulls 1 .......................... 0.15 

Sugarcane, cane 1 ...................... 0.01 

Sunflower, seed 1 ........................ 0.30 

Tomato 1 ..................................... 1.5 

1There are no U.S. registrations as of October 30, 2015. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2015–27593 Filed 10–29–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2015–0001; Internal 

Agency Docket No. FEMA–8407] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities where the sale of flood 

insurance has been authorized under 


Lhorne on DSK5TPTVN1PROD with RULES