7466 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 

1See 40 CFR 97.411(c), 97.611(c), and 97.711(c). 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 97 

[FRL–9942–27–OAR] 

Allocations of Cross-State Air 

Pollution Rule Allowances From New 

Unit Set-Asides for the 2015 

Compliance Year 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; notice of data 

availability (NODA). 

SUMMARY: The Environmental Protection 

Agency (EPA) is providing notice of 

emission allowance allocations to 

certain units under the new unit setaside (NUSA) provisions of the CrossState Air Pollution Rule (CSAPR) 

federal implementation plans (FIPs). 

EPA has completed final calculations 

for the second round of NUSA 

allowance allocations for the 2015 

compliance year of the CSAPR NOX

Annual, SO2 Group 1, and SO2 Group 2 

Trading Programs. EPA has posted 

spreadsheets showing the second-round 

2015 NUSA allocations of CSAPR NOX

Annual, SO2 Group 1, and SO2 Group 2 

allowances to new units as well as the 

allocations to existing units of the 

remaining CSAPR NOX Annual, SO2

Group 1, and SO2 Group 2 allowances 

not allocated to new units in either 

round of the 2015 NUSA allocation 

process. EPA will record the allocated 

CSAPR NOX Annual, SO2 Group 1, and 

SO2 Group 2 allowances in sources’ 

Allowance Management System (AMS) 

accounts by February 15, 2016. 

DATES: February 12, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Questions concerning this action should 

be addressed to Robert Miller at (202) 

343–9077 or miller.robertl@epa.gov or to 

Kenon Smith at (202) 343–9164 or 

smith.kenon@epa.gov. 

SUPPLEMENTARY INFORMATION: Under the 

CSAPR FIPs, a portion of each state 

budget for each of the four CSAPR 

trading programs is reserved as a NUSA 

from which allowances are allocated to 

eligible units through an annual one- or 

two-round process. EPA has described 

the CSAPR NUSA allocation process in 

five NODAs previously published in the 

Federal Register (80 FR 30988, June 1, 

2015; 80 FR 44882, July 28, 2015; 80 FR 

55061, September 14, 2015; 80 FR 

69883, November 12, 2015; 80 FR 

77591, December 15, 2015). In the most 

recent of these previous NODAs, EPA 

provided notice of preliminary lists of 

new units eligible for second-round 

2015 NUSA allocations of CSAPR NOX

Annual, SO2 Group 1, and SO2 Group 2 

allowances and provided an 

opportunity for the public to submit 

objections. 

EPA received no objections to the 

preliminary lists of new units eligible 

for second-round 2015 NUSA 

allocations of CSAPR NOX Annual, SO2

Group 1, or SO2 Group 2 allowances 

whose availability was announced in 

the December 15 NODA. EPA is 

therefore making second-round 2015 

NUSA allocations of CSAPR NOX

Annual, SO2 Group 1, and SO2 Group 2 

allowances to the new units identified 

on these lists in accordance with the 

procedures set forth in 40 CFR 

97.412(a)(9) and (12), 97.612(a)(9) and 

(12), and 97.712(a)(9) and (12). 

As described in the December 15 

NODA, any allowances remaining in the 

CSAPR NOX Annual, SO2 Group 1, and 

SO2 Group 2 NUSAs for a given state 

and control period after the second 

round of NUSA allocations to new units 

is completed are to be allocated to the 

existing units in the state according to 

the procedures set forth in 40 CFR 

97.412(a)(10) and (12), 97.612(a)(10) and 

(12), and 97.712(a)(10) and (12). EPA 

has determined that CSAPR NOX

Annual, SO2 Group 1, and SO2 Group 2 

allowances do remain in the NUSAs for 

a number of states following completion 

of second-round 2015 NUSA 

allocations; accordingly, EPA is 

allocating these allowances to existing 

units. The NUSA allowances are 

generally allocated to the existing units 

in proportion to the allocations 

previously made to the existing units 

under 40 CFR 97.411(a)(1), 97.611(a)(1), 

and 97.711(a)(1), adjusted for rounding. 

Under 40 CFR 97.412(b)(10), 

97.612(b)(10), and 97.712(b)(10), any 

allowances remaining in the CSAPR 

NOX Annual, SO2 Group 1, and SO2

Group 2 Indian country NUSAs for a 

given state and control period after the 

second round of Indian country NUSA 

allocations to new units are added to the 

NUSA for that state or are made 

available for allocation by the state 

pursuant to an approved SIP revision. 

No new units eligible for allocations of 

CSAPR NOX Annual, SO2 Group 1, and 

SO2 Group 2 allowances from any 2015 

Indian country NUSA have been 

identified, and no state has an approved 

SIP revision governing allocation of 

2015 CSAPR allowances. The Indian 

country NUSA allowances are therefore 

being added to the NUSAs for the 

respective states and are included in the 

pools of allowances that are being 

allocated to existing units under 40 CFR 

97.412(b)(10) and (12), 97.612(b)(10) 

and (12), and 97.712(b)(10) and (12). 

The final unit-by-unit data and 

allowance allocation calculations are set 

forth in Excel spreadsheets titled 

‘‘CSAPR_NUSA_2015_NOx_Annual_

2nd_Round_Final_Data_New_Units’’, 

‘‘CSAPR_NUSA_2015_SO2_2nd_

Round_Final_Data_New_Units’’, 

‘‘CSAPR_NUSA_2015_NOx_Annual_

2nd_Round_Final_Data_Existing_

Units’’, and ‘‘CSAPR_NUSA_2015_SO2_

2nd_Round_Final_Data_Existing_

Units’’, available on EPA’s Web site at 

http://www.epa.gov/crossstaterule/

actions.html. 

Pursuant to CSAPR’s allowance 

recordation timing requirements, the 

allocated NUSA allowances will be 

recorded in sources’ AMS accounts by 

February 15, 2016. EPA notes that an 

allocation or lack of allocation of 

allowances to a given unit does not 

constitute a determination that CSAPR 

does or does not apply to the unit. EPA 

also notes that NUSA allocations of 

CSAPR NOX Annual, SO2 Group 1, and 

SO2 Group 2 allowances are subject to 

potential correction if a unit to which 

NUSA allowances have been allocated 

for a given compliance year is not 

actually an affected unit as of January 1 

of the compliance year.1

(Authority: 40 CFR 97.411(b), 

97.611(b), and 97.711(b).) 

Dated: February 1, 2016. 

Reid P. Harvey, 

Director, Clean Air Markets Division, Office 

of Atmospheric Programs, Office of Air and 

Radiation. 

[FR Doc. 2016–02955 Filed 2–11–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0672; FRL–9939–59] 

Diflubenzuron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of diflubenzuron 

in or on multiple commodities which 

are identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 12, 2016. Objections and 

requests for hearings must be received 

on or before April 12, 2016, and must 

be filed in accordance with the 


srobinson on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 7467 

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–2014–0672, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

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

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2014–0672 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 April 12, 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– 

2014–0672, 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 February 

11, 2015 (80 FR 7559) (FRL–9921–94), 

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 4E8306) by IR–4, 

IR–4 Project Headquarters, Rutgers, The 

State University of New Jersey, 500 

College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.377 be 

amended by: (1) Establishing tolerances 

in for the combined residues of the 

insecticide diflubenzuron N-[[(4- 

chlorophenyl)amino]carbonyl]-2,6- 

difluorobenzamide) and its metabolites 

4-chlorophenlyurea and 4-chloroaniline, 

in or on the raw agricultural 

commodities carrot, roots at 0.2 ppm; 

peach subgroup 12–12B at 0.5 ppm; 

plum subgroup 12–12C at 0.5 ppm; 

plum, prune, dried at 0.5 ppm; nut, tree 

group 14–12 at 0.2 ppm; pepper/

eggplant subgroup 8–10 B at 1.0 ppm, 

and cottonseed subgroup 20C at 0.2 

ppm; (2) upon the approval of these 

tolerances, removing established 

tolerances in or on fruit, stone, group 

12, except cherry at 0.07 ppm; nut, tree, 

group 14 at 0.06 ppm; pistachio at 0.06 

ppm; pepper at 1.0 ppm; and cotton, 

undelinted seed at 0.2 ppm; (3) 

establishing regional tolerances for the 

combined residues of diflubenzuron and 

its metabolites 4-chlorophenlyurea and 

4-chloroaniline in or on the raw 

agricultural commodities alfalfa, forage 

at 6 ppm; alfalfa, hay at 20 ppm; and 

alfalfa, seed at 0.9 ppm; and (4) 

modifying the existing tolerances in or 

on the following raw agricultural 

commodities: Egg from 0.05 to 0.15 

ppm; poultry, fat from 0.05 to 0.15 ppm; 

and poultry, meat byproducts from 0.05 

to 0.06 ppm. That document referenced 

a summary of the petition prepared by 

Chemtura Corporation, the registrant, 

which is available in the docket, 

http://www.regulations.gov. A second 

notice of filing for the same petition (PP 

4E8306) and same uses was 

inadvertently published in the Federal 

Register on December 2, 2015 (80 FR 

75449) (FRL–9939–55). This notice of 

filing contained the same information as 

the previously published notice of 

filing. Comments were received in 

response to both notices of filing. EPA’s 

response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

modified the levels at which some of the 

tolerances are being established. 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 


srobinson on DSK5SPTVN1PROD with RULES
7468 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 

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 diflubenzuron 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with diflubenzuron 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. 

For diflubenzuron, the hemopoietic 

system is the target site with effects 

including increased sulfhemoglobin 

and/or methemoglobin levels in rat and 

dog studies. In subchronic and chronic 

feeding studies, the primary endpoint of 

concern was methemoglobinemia and/

or sulfhemoglobinemia. These effects 

were evident in both sexes of mice, rats, 

and dogs and were produced by more 

than one route of administration in rats 

(i.e., oral, dermal and inhalation). The 

general consequence of 

methemoglobinemia and/or 

sulfhemoglobinemia is the impairment 

of the oxygen transportation capacity of 

the blood, which is generally known to 

be caused by aromatic amines in both 

humans and animals. Degradates of 

diflubenzuron with aromatic amines, 

CPU (4-chlorophenylurea) and PCA (4- 

chloroaniline), are also included in the 

diflubenzuron non-cancer risk 

assessment. Monuron, an analog of CPU, 

does not affect methemoglobin 

formation but does produce tumors in 

the liver and kidneys of male rats. The 

non-cancer toxicities of CPU and PCA 

are understood. PCA is similar in 

potency to diflubenzuron on 

methemoglobin formation, while CPU is 

less toxic than PCA. Therefore, the noncancer assessment will include 

diflubenzuron, CPU and PCA, and 

additional toxicity studies are not 

required on CPU and PCA. 

The toxicity data provide no 

indication of an increased susceptibility 

to rats or to rabbits from in utero or 

postnatal exposure to diflubenzuron. 

Developmental and reproduction 

studies in rats and rabbits indicate a 

very low hazard potential for adverse 

effects. Developmental studies were 

tested at the limit dose of 1,000 

milligrams/kilogram/day (mg/kg/day) 

without apparent effects in both dams 

and the fetuses. The reproduction study 

indicated that effects in offspring 

occurred at doses that were higher than 

the doses producing effects in parents. 

The requirements for acute and 

subchronic neurotoxicity studies were 

waived because there are no clear signs 

of neurotoxicity following subchronic or 

chronic dosing in multiple species in 

the diflubenzuron database. The toxicity 

profile of diflubenzuron shows that the 

principal toxic effects are the formation 

of methemoglobinemia and/or 

sulfhemoglobinemia in the blood. An 

immunotoxicity study has been 

reviewed and immunotoxicity was not 

observed above the limit dose. 

The Agency concluded that 

diflubenzuron is not carcinogenic in 

humans based on lack of evidence of 

carcinogenicity in rats and mice. PCA, 

a plant metabolite of diflubenzuron, 

tested positive for splenic tumors in 

male rats and hepatocellular adenomas/ 

carcinomas in male mice in a National 

Toxicology Program (NTP) study. 

Therefore, EPA has classified PCA as 

a probable human carcinogen. CPU is 

the major degradate found in water and 

is a significant metabolite in milk. CPU 

is structurally related to monuron 

(N,Ndimethyl-CPU), a compound 

producing tumors of the kidney and 

liver in male rats. EPA has assumed 

CPU is a probable human carcinogen as 

well. However, based on 

methemoglobinemia observed only at 

high doses of monuron, a compound 

similar to CPU and PCA, the noncarcinogenic risk assessment will 

include diflubenzuron, CPU, and PCA. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by diflubenzuron 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 ‘‘Diflubenzuron: Human Health 

Risk Assessment for an Amended 

Section 3 Registration for Carrot, Peach 

Subgroup 12–12B, Plum Subgroup 12– 

12C, Pepper/Eggplant Subgroup 8–10B, 

Cottonseed Subgroup 20C, Alfalfa 

(Regional Restrictions) and R175 Crop 

Group Conversion for Tree Nut Group 

14–12’’ on page 45 in docket ID number 

EPA–HQ–OPP–2014–0672. 

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 diflubenzuron used for 

human risk assessment is discussed in 

Table 1 in Unit III.B. of the final rule 

published in the Federal Register of 

January 31, 2014 (79 FR 5294) (FRL– 

9904–27). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to diflubenzuron, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing diflubenzuron tolerances in 40 

CFR 180.377. EPA assessed dietary 

exposures from diflubenzuron 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 diflubenzuron; therefore, a 


srobinson on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 7469 

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 (USDA) National Health and 

Nutrition Examination Survey, ‘‘What 

We Eat in America’’ (NHANES/WWEIA) 

from 2003 through 2008. As to residue 

levels in food, EPA used the assumption 

that diflubenzuron residues are present 

in most commodities at tolerance levels 

(including tolerances previously 

established as well as those established 

in this action) and that 100% of all 

crops are treated. Average field trial 

residues were assumed for grapefruit, 

lemon, and orange. Tolerances include 

residues of diflubenzuron, PCA, and 

CPU. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that diflubenzuron does not 

pose a cancer risk to humans. However, 

the metabolites CPU and PCA are 

considered probable carcinogens and 

have Q*s assigned to them. Individual 

cancer dietary exposure analyses were 

conducted for each metabolite. For PCA, 

average percent crop treated (PCT) was 

used for some commodities. One-half 

the Limit of Quantitation (LOQ) was 

used for estimating PCA residues on the 

majority of crops because most crops 

did not contain detectable residues of 

PCA. Average field trial residue was 

used for mushrooms. The CPU cancer 

dietary analysis focused on CPU 

residues in milk because metabolism 

studies indicate that diflubenzuron 

metabolizes to CPU in milk. EPA 

assumed that 100% of milk 

commodities contained CPU at 1⁄2 the 

LOQ. One-half the LOQ was used since 

detectable residues of CPU were not 

found in the feeding study. 

iv. Anticipated residue and PCT 

information. Section 408(b)(2)(E) of 

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require pursuant to FFDCA 

section 408(f)(1) that data be provided 5 

years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

For the cancer dietary exposure 

analysis, the Agency estimated the PCT 

for existing uses as follows: 

Soybeans (1%), peppers (2.5%), 

oranges (10%), tangerines (10%), 

grapefruit (25%), pear (5%), apricot 

(10%), peach (5%), almond, (10%), 

pecan (2.5%), rice (2.5%), wheat (1%), 

cotton (1%), artichoke (45%), peanut 

(10%), lemon (1%), plum (5%), and 

walnut (2.5%). 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6 to 7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which diflubenzuron may be applied in 

a particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for diflubenzuron and CPU in drinking 

water. PCA is only a minor metabolite 

in the environment and residues are not 

expected to be present in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of diflubenzuron. 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. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

Based on the Surface Water 

Concentration Calculator model (SWCC) 

for surface water the Estimated Drinking 

Water Concentration (EDWC) of 1.3 

microgram/Liter (mg/L) (including 

diflubenzuron and CPU) was used to 

assess chronic non-cancer dietary risk. 

Based on the Pesticide Root Zone 

Model-Groundwater (PRZM–GW) model 

for ground water the cancer risk for CPU 

was assessed using the EDWC of 8.02 

mg/L. 

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). 

Diflubenzuron 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 


srobinson on DSK5SPTVN1PROD with RULES
7470 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 

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 diflubenzuron to 

share a common mechanism of toxicity 

with any other substances, and 

diflubenzuron does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that diflubenzuron 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. 

Based on the available developmental 

toxicity studies in rats and rabbits and 

the reproduction study, there is no 

increased susceptibility to fetuses 

exposed in utero. There was no 

indication of abnormalities in fetal 

development in the developmental 

toxicity studies in either rats or rabbits 

at the maternal limit doses of 1,000 mg/ 

kg/day. In addition, there was no 

evidence of sensitivity following preand/or post-natal exposure in a twogeneration reproduction 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 1X. That decision is 

based on the following findings: 

i. The toxicological database for 

diflubenzuron is adequate for risk 

assessment. The non-cancer toxicity of 

CPU and PCA is well understood. CPU 

is less toxic and does not affect 

methemoglobin. PCA does cause 

methemoglobin formation but is similar 

in potency to diflubenzuron. Therefore, 

assuming equal toxicity of CPU and 

PCA to diflubenzuron is health 

protective, additional toxicity studies 

are not required on the metabolites. 

ii. There are no clear signs of 

neurotoxicity following subchronic or 

chronic dosing in multiple species in 

the diflubenzuron database; therefore, 

there is no need for any neurotoxicity 

studies. 

iii. There is no evidence that 

diflubenzuron 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. The dietary exposure assessment 

uses conservative assumptions which 

will not underestimate dietary exposure 

and EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to diflubenzuron in drinking water. 

These assessments will not 

underestimate the exposure and risks 

posed by diflubenzuron. 

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, diflubenzuron 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 diflubenzuron 

from food and water will utilize 39% of 

the cPAD for children 1 to 2 years old, 

the population group receiving the 

greatest exposure. There are no 

residential uses for diflubenzuron. 

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). 

Short- and intermediate-term adverse 

effects were identified; however, 

diflubenzuron is not registered for any 

use patterns that would result in shortor 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-term risk), 

no further assessment of short- or 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating short- and 

intermediate-term risk for 

diflubenzuron. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

diflubenzuron is not expected to pose a 

cancer risk to humans. However, the 

metabolites CPU and PCA are 

considered probable carcinogens and 

have Q*s assigned to them. Individual 

cancer dietary exposure analyses were 

conducted for each metabolite. The 

cancer assessment for PCA includes 

food only (it is not expected to be 

present in drinking water). The cancer 

assessment for CPU includes milk and 

water only. For PCA, the cancer dietary 

exposure estimate for the U.S. 

population is 1.3 × 10¥6. For CPU, the 

cancer dietary exposure estimate for the 

U.S. population is 2.8 × 10¥6. 

EPA generally considers cancer risks 

in the range of 10¥6 or less to be 

negligible. The precision which can be 

assumed for cancer risk estimates is best 

described by rounding to the nearest 

integral order of magnitude on the log 

scale; for example, risks falling between 

3 × 10¥7 and 3 × 10¥6 are expressed as 

risks in the range of 10¥6. 

Considering the precision with which 

cancer hazard can be estimated, the 

conservativeness of low-dose linear 

extrapolation, and the rounding 

procedure described above, cancer risk 

should generally not be assumed to 

exceed the benchmark level of concern 

of the range of 10¥6 until the calculated 

risk exceeds approximately 3 × 10¥6. 

This is particularly the case where some 

conservatism is maintained in the 

exposure assessment. Although the PCA 

and CPU exposure risk assessment are 

refined, they retain significant 

conservatism in that residues in food 


srobinson on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 7471 

were estimated at 1⁄2 LOQ even though 

no residues were detected in field trials 

and feeding studies, and for some 

commodities EPA assumed 100 PCT. 

Accordingly, EPA has concluded the 

cancer risk for all existing 

diflubenzuron uses, and the uses 

associated with the tolerances 

established in this action fall within the 

range of 1 × 10¥6 and are thus 

negligible. 

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 

diflubenzuron residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement analytical 

methods are available for the 

enforcement of tolerances for residues of 

diflubenzuron and its metabolites in 

crop and livestock commodities. Three 

enforcement methods for diflubenzuron 

are published in PAM, Vol. II as 

Methods I, II, and III. Method I is a GC/ 

ECD method that determines 

diflubenzuron in plants as derivatized 

4-chloroaniline (PCA). Method II is a 

GC/ECD method that can separately 

determine residues of diflubenzuron, 4- 

chlorophenylurea (CPU) and PCA in 

eggs, milk, and livestock tissues, each as 

derivatized PCA. Method III is an HPLC/ 

UV method that determines 

diflubenzuron per se in eggs, milk, and 

livestock tissues. All three methods 

have undergone successful Agency 

validations. 

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 MRLs for 

diflubenzuron in or on peach and 

nectarine at 0.5 ppm which is the same 

as the tolerance in the United States for 

the peach subgroup 12–12B at 0.50 

ppm; a tolerance on plums at 0.5 ppm 

which is the same as the U.S. tolerance 

for the plum subgroup 12–12C at 0.5 

ppm; and a tolerance on tree nuts at 0.2 

ppm which is the same as the U.S. 

tolerance for the tree nut group 14–12 at 

0.20 ppm, and which was raised to 

harmonize with Codex. 

The Codex has established MRLs for 

diflubenzuron on chili peppers at 3 

ppm, dried chili peppers at 20 ppm, and 

sweet peppers at 0.7 ppm which are 

different from the tolerances established 

in the U.S. for diflubenzuron on the 

pepper/eggplant subgroup 8–10B at 1.0 

ppm. The pepper/eggplant subgroup 8– 

10B covers both bell and non-bell 

peppers and the Codex MRLs split them 

out into two separate tolerances which 

the U.S. does not do because the 

petition was for the entire subgroup. 

Based on the residue data submitted and 

reviewed for this action, it would not be 

appropriate for the U.S. tolerance to 

harmonize with either the chili pepper 

MRL of 3 ppm or the sweet pepper MRL 

of 0.7 ppm. Also, in regards to the dried 

chili pepper MRL, this is not expected 

to be an issue since the U.S. does not 

set tolerances on dried fruits and 

vegetables, but instead the processed 

food is considered to be the whole 

processed commodity after 

compensating for or reconstituting the 

commodity’s normal moisture content. 

C. Response to Comments 

One comment was received in 

response to the February 11, 2015 

Notice of Filing, however, it related to 

a different chemical than diflubenzuron 

and therefore is not relevant to this 

action. Two comments were received in 

response to the December 2, 2015 Notice 

of Filing. One commenter opposed 

residues of this pesticide on food and 

argued that EPA should deny the 

petition. The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

pesticides should be banned on 

agricultural crops. However, the existing 

legal framework provided by section 

408 of the Federal Food, Drug and 

Cosmetic Act (FFDCA) states that 

tolerances may be set when persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

that statute. This citizen’s comment 

appears to be directed at the underlying 

statute and not EPA’s implementation of 

it; the citizen has made no contention 

that EPA has acted in violation of the 

statutory framework. The second 

comment stated that ‘‘without long term 

studies of its effects on the environment 

and the toxic effects on aquatic 

invertebrates, then there should be a 

slight reduction in ppm of 

diflubenzuron used on crops.’’ This 

comment is not relevant to the Agency’s 

evaluation of safety of the diflubenzuron 

tolerances; section 408 of the FFDCA 

focuses on potential harms to human 

health and does not permit 

consideration of effects on the 

environment. 

D. Revisions to Petitioned-For 

Tolerances 

Based on an evaluation of the residue 

data, the Agency modified the levels at 

which tolerances were proposed for the 

existing tolerances for egg, poultry fat, 

and poultry meat byproducts. In 

addition, the Agency determined that a 

separate tolerance is not required for the 

commodity ‘‘plum, prune, dried’’ since 

residues are not found to concentrate on 

prunes. Lastly, some of the tolerances 

levels were modified to reflect the 

correct significant figures. 

V. Conclusion 

Therefore, tolerances are established, 

modified and removed for residues of 

diflubenzuron N-[[(4- 

chlorophenyl)amino]carbonyl]-2,6- 

difluorobenzamide) and its metabolites 

4-chlorophenlyurea and 4-chloroaniline, 

as follows: 

Under 180.377(a)(1) a tolerance is 

established for the cottonseed subgroup 

20C at 0.20 ppm; existing tolerances are 

changed for egg to 0.07 ppm; poultry, fat 

to 0.10 ppm; and poultry, meat 

byproducts to 0.08 ppm; and the 

existing tolerance for cotton, undelinted 

seed at 0.2 ppm is removed as 

unnecessary. 

Under 180.377(a)(2), tolerances are 

established in or on the raw agricultural 

commodities carrot, roots at 0.20 ppm; 

peach subgroup 12–12B at 0.50 ppm; 

plum subgroup 12–12C at 0.50 ppm; 

nut, tree group 14–12 at 0.20 ppm; the 

pepper/eggplant subgroup 8–10 B at 1.0 

ppm; and the following existing 

tolerances are removed as unnecessary: 

Fruit, stone, group 12, except cherry at 

0.07 ppm; nut, tree, group 14 at 0.06 

ppm; pistachio at 0.06 ppm; and pepper 

at 1.0 ppm. 

Under 180.377(c) regional tolerances 

are established for the combined 

residues of diflubenzuron and its 

metabolites 4-chlorophenlyurea and 4- 

chloroaniline in or on the raw 

agricultural commodities alfalfa, forage 

at 6 ppm; alfalfa, hay at 20 ppm; and 

alfalfa, seed at 0.9 ppm. 


srobinson on DSK5SPTVN1PROD with RULES
7472 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 

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 3, 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 § 180.377: 

■ a. Remove the entries in the table in 

paragraph (a)(1) for ‘‘Cotton, undelinted 

seed,’’ ‘‘Egg,’’ ‘‘Poultry, fat,’’ and 

‘‘Poultry, meat byproducts.’’ 

■ b. Add alphabetically the entries for 

‘‘Cottonseed subgroup 20C,’’ ‘‘Egg,’’ 

‘‘Poultry, fat,’’ and ‘‘Poultry, meat 

byproducts’’ to the table in paragraph 

(a)(1). 

■ c. Remove the entries in the table in 

paragraph (a)(2) for ‘‘Fruit, stone, group 

12, except cherry,’’ ‘‘Nut, tree, group 

14,’’ ‘‘Pepper,’’ and ‘‘Pistachio.’’ 

■ d. Add alphabetically the entries for 

‘‘Carrot, roots,’’ ‘‘Peach subgroup 12– 

12B,’’ ‘‘Pepper/Eggplant subgroup 8– 

10B,’’ ‘‘Plum subgroup 12–12C,’’ and 

‘‘Nut, tree, group 14–12’’ to the table in 

paragraph (a)(2). 

■ e. Revise paragraph (c). 

The additions and revision read as 

follows: 

§ 180.377 Diflubenzuron; tolerances for 

residues. 

(a) General (1) * * * 

Commodity Parts per 

million 

* * * * * 

Cottonseed subgroup 20C ....... 0.20 

Egg ........................................... 0.07 

* * * * * 

Poultry, fat ................................ 0.10 

Poultry, meat byproducts .......... 0.08 

* * * * * 

(2) * * * 

Commodity Parts per 

million 

* * * * * 

Carrot, roots .............................. 0.20 

* * * * * 

Peach subgroup 12–12B .......... 0.50 

* * * * * 

Pepper/Eggplant subgroup 8– 

10B ........................................ 1.0 

* * * * * 

Plum Subgroup 12–12C ........... 0.50 

Nut, tree, group 14–12 ............. 0.20 

* * * * * 

* * * * * 

(c) Tolerances with regional 

registrations. Tolerances with regional 

registration are established for residues 

of the insecticide diflubenzuron (N-[[(4- 

chlorophenyl)amino]carbonyl]-2,6- 

difluorobenzamide), 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 

diflubenzuron (N-[[(4- 

chlorophenyl)amino]carbonyl]-2,6- 

difluorobenzamide), 4- 

chlorophenylyurea and 4-chloroaniline, 

calculated as the stoichiometric 

equivalent of diflubenzuron, in or on 

the commodity. 

Commodity Parts per 

million 

Alfalfa, forage ........................... 6.0 

Alfalfa, hay ................................ 20 

Alfalfa, seed .............................. 0.90 

* * * * * 

[FR Doc. 2016–02816 Filed 2–11–16; 8:45 am] 

BILLING CODE 6560–50–P 


srobinson on DSK5SPTVN1PROD with RULES