22914 Federal Register / Vol. 81, No. 75 / Tuesday, April 19, 2016 / Rules and Regulations 

Sector Columbia River at 503–861–6211 

or via VHF-Channel 16. 

Dated: April 6, 2016. 

D.L. Cottrell, 

Captain, U.S. Coast Guard, Acting 

Commander, Thirteenth Coast Guard District. 

[FR Doc. 2016–09027 Filed 4–18–16; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0180; FRL–9943–85] 

Cyprodinil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of cyprodinil in 

or on Nut, Tree, Crop Group 14–12; 

except almond and pistachio. Syngenta 

Crop Protection, LLC requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

19, 2016. Objections and requests for 

hearings must be received on or before 

June 20, 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–2015–0180, 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–2015–0180 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 June 20, 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– 

2015–0180, 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 22, 

2015 (80 FR 22466) (FRL–9925–79), 

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 4F8333) by 

Syngenta Crop Protection, LLC, P.O. 

Box 18300, Greensboro, NC 27419– 

8300. The petition requested that 40 

CFR 180.532 be amended by 

establishing tolerances for residues of 

the fungicide cyprodinil, 4-cyclopropyl6-methyl-N-phenyl-2-pyrimidinamine, 

in or on Nut, Tree, Crop Group 14–12; 

except almond and pistachio at 0.04 

parts per million (ppm). That document 

referenced a summary of the petition 

prepared by Syngenta Crop Group, LLC, 

the registrant, which is available in the 

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

Comments were received on the notice 

of filing. EPA’s response to these 

comments is discussed in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 


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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 cyprodinil 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with cyprodinil follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The major target organs of cyprodinil 

are the liver and the kidney. Liver 

effects were consistent among male and 

female rats and mice in both subchronic and chronic studies and 

typically included increased liver 

weights along with increases in serum 

clinical chemistry parameters associated 

with adverse effects on liver function 

(i.e., increased cholesterol and 

phospholipid levels). Microscopic 

lesions in rats and mice included 

hepatocyte hypertrophy and 

hepatocellular necrosis. In the kidneys, 

adverse effects were seen as chronic 

tubular lesions and chronic kidney 

inflammation following sub-chronic 

exposure of male rats. Chronically, 

cyprodinil caused increased kidney 

weights and progressive nephropathy in 

male rats. Chronic effects in dogs were 

limited to decreased body-weight gain, 

decreased food consumption and 

decreased food efficiency; liver toxicity 

was not seen in the dog. The 

hematopoietic system also appeared to 

be a target of cyprodinil as mild anemia 

was seen in rats exposed subchronically (reductions in hematocrit 

and hemoglobin and microcytosis). 

Although increases in thyroid weight 

and/or hypertrophy of thyroid follicular 

cells were observed at higher doses in 

the rat 28-day oral-toxicity studies and 

in the 90-day oral-toxicity study in rats, 

treatment related changes in thyroid 

weights or gross/microscopic 

observations were not observed in the 

chronic rat study or in other studies. 

A 28-day dietary immunotoxicity 

study in mice resulted in no apparent 

suppression of the humoral component 

of the immune system. The only effect 

attributed to cyprodinil treatment was 

higher mean absolute, relative (to body 

weight), and adjusted liver weights for 

the 5000 ppm group. There were no 

treatment-related effects on absolute, 

adjusted, or relative spleen or thymus 

weights; no effects on specific activity 

or total activity of splenic 

Immunoglobulin M antibody-forming 

cells to the T cell-dependent red blood 

cell antigens. No dermal or systemic 

toxicity was seen following repeated 

dermal application at the highest dose 

in a 21-day dermal toxicity study in 

rabbits. 

An acute neurotoxicity study 

indicated systemic toxicity with signs of 

induced hunched posture, piloerection, 

and reduced responsiveness to sensory 

stimuli and reduced motor activity. 

Females were slightly more affected 

than males per daily clinical 

observations, which disappeared by day 

3 to 4. A dose-related reduction in body 

temperature was seen in all treated 

animals, thus hypothermia is 

considered a compound-related effect in 

the highest dose tested and was found 

to be statistically significant, whereas 

the lower dosed animals was not or only 

marginally significant and was fully 

reversible in all groups. Clinical signs, 

hypothermia, and changes in motor 

activity were found to all be reversible 

by day 8 and 15 investigations. There 

were no histopathological findings to 

support evidence of damage to the 

central nervous system, eyes, optic 

nerves, or skeletal muscles. A subchronic neurotoxicity study showed no 

treatment related effects on mortality, 

clinical signs, or gross or histological 

neuropathology. Functional 

observational battery and motor activity 

testing revealed no treatment related 

effects up to the highest dose tested. 

There was no evidence of increased 

susceptibility in the developmental rat 

or rabbit study following in utero 

exposure or in the two-generation 

reproduction study following pre- and 

post-natal exposure. Fetal toxicity, 

manifested as significantly lower fetal 

weights and an increased incidence of 

delayed ossification in the rat and a 

slight increase in litters showing extra 

ribs (13th) in the rabbit, was reported in 

developmental toxicity studies. In a rat 

two-generation reproduction study, 

significantly lower pup weights for F1

and F2 offspring were observed. 

However, each of these fetal/neonatal 

effects occurred at the same dose levels 

at which maternal toxicity (decreased 

body weight gain) was observed and 

were considered to be secondary to 

maternal toxicity. 

Based on the lack of evidence of 

carcinogenicity in mice and rats at doses 

that were judged to be adequate to the 

carcinogenic potential, cyprodinil was 

classified as ‘‘not likely to be 

carcinogenic to humans.’’ 

Specific information on the studies 

received and the nature of the adverse 

effects caused by cyprodinil 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, 

‘‘Human Health Risk Assessment for the 

Petition Proposing a New Tolerance for 

the Use of cyprodinil in/on Nut, Tree, 

Crop Group 14–12; except almond and 

pistachio’’ in docket ID number EPA– 

HQ–OPP–2015–0180. 

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 

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 cyprodinil used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of October 16, 2012 

(77 FR 49732) (FRL–9359–7). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to cyprodinil, EPA considered 

exposure under the petitioned-for 


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tolerances as well as all existing 

cyprodinil tolerances in 40 CFR 

180.532. EPA assessed dietary 

exposures from cyprodinil 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. Such effects were identified 

for cyprodinil. EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). This 

dietary survey was conducted from 2003 

to 2008. As to residue levels in food, 

EPA utilized the Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

DEEM–FCID, Version 3.16 default 

processing factors and tolerance-level 

residues and 100 percent crop treated 

(PCT) for all commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used food consumption 

information from the USDA NHANES/ 

WWEIA dietary survey conducted from 

2003 to 2008. As to residue levels in 

food, EPA utilized residue data from 

field trials to obtain average residues 

and assumed 100 PCT. Empirically 

derived processing factors were used in 

these assessments when available; all 

other processing factors used the 

DEEM–FCID Version 7.81 default 

processing factors. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that cyprodinil does not pose 

a cancer risk to humans. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk was not 

conducted. 

iv. Anticipated residue 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. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for cyprodinil and CGA 249287 in 

drinking water. These simulation 

models take into account data on the 

physical, chemical, and fate/transport 

characteristics of cyprodinil and CGA 

249287. Further information regarding 

EPA drinking water models used in 

pesticide exposure assessment can be 

found at http://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/ 

about-water-exposure-models-usedpesticide. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS), Screening 

Concentration in Ground Water (SCI– 

GROW) models and Pesticide Root Zone 

Model Ground Water (PRZM GW), the 

estimated drinking water concentrations 

(EDWCs) of cyprodinil and CGA 249287 

for acute exposures are estimated to be 

34.8 parts per billion (ppb) for surface 

water and 2.05 ppb for ground water. 

EDWCs for chronic exposures for noncancer assessments are estimated to be 

24.7 ppb for surface water and 1.80 ppb 

for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 34.8 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration 

value of 24.7 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). 

Cyprodinil is currently registered for 

the following uses that could result in 

residential exposures: Ornamental 

plants. EPA assessed residential 

exposure using the following 

assumptions: Only short-term inhalation 

exposures to adult residential handlers 

from application to ornamental plants. 

Though there may be short-term dermal 

exposures to handlers, this was not 

assessed since no dermal endpoint was 

identified. Post-application exposures to 

adults and children are not expected. 

Intermediate or chronic exposures are 

not expected. Further information 

regarding EPA standard assumptions 

and generic inputs for residential 

exposures may be found at http:// 

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/standardoperating-procedures-residentialpesticide. 

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 cyprodinil to share 

a common mechanism of toxicity with 

any other substances, and cyprodinil 

does not appear to produce a toxic 

metabolite engendered by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that cyprodinil 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. 

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. 

In a rat developmental toxicity study, 

there were significantly lower mean 

fetal weights in the high-dose group 

compared to controls as well as a 

significant increase in skeletal 

anomalies in the high-dose group due to 

abnormal ossification. The skeletal 

anomalies/variations were considered to 

be a transient developmental delay that 

occurs secondary to the maternal 

toxicity noted in the high-dose group. In 

the rabbit study, the only treatment 

related developmental effect was 

indication of an increased incidence of 

a 13th rib at maternally toxic doses. 


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Signs of fetal effects in the reproductive 

toxicity study included significantly 

lower F1 and F2 pup weights in the 

high-dose group during lactation, which 

continued to be lower than controls 

post-weaning and after the pre-mating 

period in the F1 generation only. 

Reproductive effects were seen only at 

doses that also caused parental toxicity. 

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 for non-inhalation 

routes of exposure and retained at 10X 

for inhalation exposure scenarios for all 

population groups. That decision is 

based on the following findings: 

i. The toxicity database for cyprodinil 

is complete, except for a 90-day 

inhalation toxicity study required to 

reduce uncertainty associated with the 

use of an oral POD for assessing risk via 

the inhalation route. In the absence of 

a route-specific inhalation study, a 10x 

FQPA SF factor for residential scenarios 

will be retained for risk assessments 

involving inhalation exposure. 

ii. As indicated by an acute 

neurotoxicity study in mice, clinical 

signs, hypothermia, and changes in 

motor activity were all found to be 

reversible and no longer seen at day 8 

and 15 investigations. There were no 

treatment related effects on mortality, 

gross or histological neuropathology. 

Reduced motor activity, induced 

hunched posture, piloerection and 

reduced responsiveness to sensory 

stimuli were observed and disappeared 

in all animals by day 3 to 4. In a subchronic neurotoxicity study in rats, 

there were no treatment related effects 

on mortality, clinical signs, or gross or 

histological neuropathology. No clinical 

signs suggestive of neurobehavioral 

alterations or evidence of 

neuropathological effects were observed 

in the available oral-toxicity studies. 

Based on this evidence, there is no need 

for a developmental neurotoxicity study 

or additional uncertainty factors (UFs) 

to account for neurotoxicity. 

iii. In the prenatal developmental rat 

and rabbit studies and in the 2- 

generation reproduction rat study, 

toxicity to the fetuses/offspring, when 

observed, occurred at the same doses at 

which effects were observed in 

maternal/parental animals. All of these 

fetal effects were considered to be 

secondary to maternal toxicity. There is 

no evidence that cyprodinil 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 acute dietary assessment was 

conservative and based on 100 PCT and 

tolerance level residues as well as 

DEEM default and empirical processing 

factors. The chronic dietary assessment 

was partially refined with average field 

trial residues for some commodities and 

tolerance-level residues for the 

remaining commodities. DEEM default 

and empirical processing factors were 

also incorporated into the chronic 

dietary assessment. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to cyprodinil in 

drinking water. Based on the discussion 

in Unit III.C.3, post-application 

exposure to children as well as 

incidental oral exposure to toddlers is 

not expected. These assessments will 

not underestimate the exposure and 

risks posed by cyprodinil. 

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 population 

adjusted dose (aPAD) and chronic 

population adjusted dose (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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

cyprodinil will occupy 8.6% of the 

aPAD for children one to two years old, 

the population group receiving the 

greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to cyprodinil 

from food and water will utilize 85% of 

the cPAD for children one to two years 

old, the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

cyprodinil is not expected. 

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). Cyprodinil is currently 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

cyprodinil. Using the exposure 

assumptions described in this unit for 

short term exposures, EPA has 

estimated short-term food, water and 

residential exposures. For adults, oral 

dietary and inhalation estimates were 

combined using the total aggregate risk 

index (ARI) methodology since the 

levels of concern (LOC) for oral and 

dietary exposure (LOC=100) and 

inhalation (LOC 1,000) are different. 

The short-term ARI for adults is 70 

which is greater than 1 and is therefore, 

not of concern. 

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). An 

intermediate-term adverse effect was 

identified; however, cyprodinil is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

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 intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

cyprodinil. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

cyprodinil is not expected to pose a 

cancer risk to humans. 

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 cyprodinil 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate HPLC/UV methods (AG– 

631 and AG–631B) are available for 

enforcing tolerances of cyprodinil on 

plant commodities. 

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; 


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email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established an 

MRL for cyprodinil in/on tree nut 

commodities other than pistachio and 

almond. 

V. Conclusion 

Therefore, tolerances are established 

for residues of cyprodinil, in or on Nut, 

Tree Crop Group 14–12; except almond 

and pistachio at 0.04 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: April 7, 2016. 

Daniel J. Rosenblatt, 

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 § 180.532, add alphabetically the 

commodity ‘‘Nut, tree, group 14–12; 

except almond and pistachio’’ to the 

table in paragraph (a), to read as follows: 

§ 180.532 Cyprodinil; tolerances for 

residues. 

(a) * * * (1) * * * 

Commodity Parts per 

million 

*******

Nut, tree, group 14–12; except almond and pistachio ........................................................................................................................ 0.04 

* * * * * * * 


jstallworth on DSK7TPTVN1PROD with RULES
Federal Register / Vol. 81, No. 75 / Tuesday, April 19, 2016 / Rules and Regulations 22919 

* * * * * 

[FR Doc. 2016–09028 Filed 4–18–16; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

[Docket No. 150105004–5355–01] 

RIN 0648–XE569 

Fisheries of the Northeastern United 

States; Northeast Multispecies 

Fishery; Trip Limit Adjustment for the 

Common Pool Fishery 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; inseason 

adjustment. 

SUMMARY: This action increases the trip 

limit for Gulf of Maine cod, Gulf of 

Maine haddock, and Southern New 

England/Mid-Atlantic yellowtail 

flounder for Northeast multispecies 

common pool vessels for the remainder 

of the 2015 fishing year. The regulations 

authorize the Regional Administrator to 

adjust the trip limits for common pool 

vessels in order to facilitate harvest of, 

or prevent exceeding, the pertinent 

common pool quotas during the fishing 

year. Increasing these trip limits is 

intended to provide additional fishing 

opportunities and help allow the 

common pool fishery to catch its 

allowable quota for this stock. 

DATES: The trip limit increase is 

effective April 14, 2016, through April 

30, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Sarah Heil, Supervisory Fishery Policy 

Analyst, 978–281–9257. 

SUPPLEMENTARY INFORMATION: The 

regulations at § 648.86(o) authorize the 

Regional Administrator (RA) to adjust 

the possession limits for common pool 

vessels in order to prevent the 

overharvest or underharvest of the 

common pool quotas. As of April 5, 

2016, the common pool had caught 

approximately 61 percent of its annual 

quota of Gulf of Maine (GOM) cod, 11 

percent of its GOM haddock quota, and 

88 percent of its Southern New 

England/Mid-Atlantic (SNE/MA) 

yellowtail flounder quota. To allow the 

common pool fishery to catch more of 

its quota for these stocks, effective April 

14, 2016, the trip limits for GOM cod, 

GOM haddock, and SNE/MA yellowtail 

flounder for all common pool vessels 

are increased as summarized in Table 1. 

These changes are intended to provide 

additional fishing opportunities for 

common pool vessels. 

TABLE 1—FISHING YEAR 2015 COMMON POOL TRIP LIMIT INCREASES

Stock Current possession/trip limit New possession/trip limit 

GOM Cod ...................................... 25 lb (11.3 kg) per trip ................................................ 100 lb (45.4 kg) per trip. 

GOM Haddock .............................. 50 lb (22.7 kg) per DAS up to 200 lb (90.7 kg) per 

trip.

500 lb (226.8 kg) per DAS up to 1,000 lb (453.6 kg) 

per trip. 

SNE/MA Yellowtail Flounder ......... 50 lb (22.7 kg) per trip ................................................ 500 lb (226.8 kg) per DAS up to 1,000 lb (453.6 kg) 

per trip. 

Weekly quota monitoring reports for 

the common pool fishery can be found 

on our Web site at: http:// 

www.greateratlantic.fisheries.noaa.gov/ 

ro/fso/MultiMonReports.htm. We will 

continue to monitor common pool catch 

through vessel trip reports, dealerreported landings, vessel monitoring 

system catch reports, and other 

available information and, if necessary, 

we will make additional adjustments to 

common pool management measures. 

Classification 

This action is required by 50 CFR part 

648 and is exempt from review under 

Executive Order 12866. 

The Assistant Administrator for 

Fisheries, NOAA, finds good cause 

pursuant to 5 U.S.C. 553(b)(B) and 5 

U.S.C. 553(d)(3) to waive prior notice 

and the opportunity for public comment 

and the 30-day delayed effectiveness 

period because it would be 

impracticable and contrary to the public 

interest. 

The regulations at § 648.86(o) 

authorize the RA to adjust the Northeast 

multispecies possession and trip limits 

for common pool vessels in order to 

prevent the overharvest or underharvest 

of the pertinent common pool subACLs. The catch data used to justify 

increasing the possession and trip limit 

for GOM cod, GOM haddock, and SNE/ 

MA yellowtail flounder only recently 

became available. The possession and 

trip limit increase implemented through 

this action allows for increased harvest 

of these stocks, to help ensure that the 

fishery may achieve optimum yield. As 

a result, the time necessary to provide 

for prior notice and comment, and a 30- 

day delay in effectiveness, would 

prevent us from increasing the 

possession and trip limit for these 

stocks before the end of the fishing year 

on April 30, 2016, which would prevent 

the additional fishing opportunities this 

action is intended to provide. This 

would undermine management 

objectives of the Northeast Multispecies 

Fishery Management Plan and cause 

unnecessary negative economic impacts 

to the common pool fishery. There is 

additional good cause to waive the 

delayed effective period because this 

action relieves restrictions on fishing 

vessels by increasing a trip limit. 

Authority: 16 U.S.C. 1801 et seq. 

Dated: April 14, 2016. 

Alan D. Risenhoover, 

Director, Office of Sustainable Fisheries, 

National Marine Fisheries Service. 

[FR Doc. 2016–09016 Filed 4–14–16; 4:15 pm] 

BILLING CODE 3510–22–P 


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