63686 Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Rules and Regulations 

Polymer CAS No. 

* * * * * 

Poly[oxy(methyl-1,2- 

ethanediyl)], a-[(9Z)-1-oxo-9- 

octadecen-1-yl]-w-[[(9Z)-1- 

oxo-9-octadecen-1yl]oxy]-, 

minimum number average 

molecular weight (in amu) 

2,300 ..................................... 26571–49–3 

* * * * * 

[FR Doc. 2015–26617 Filed 10–20–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0012; FRL–9935–11] 

Pyrimethanil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyrimethanil 

in or on multiple commodities which 

are identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) requested the 

tolerances associated with pesticide 

petition number (PP 4E8302), and Bayer 

CropScience requested the tolerances 

associated with PP 4F8291, under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

October 21, 2015, except for the 

amendment to § 180.661 in amendatory 

instruction number 3, which is effective 

April 21, 2016. Objections and requests 

for hearings must be received on or 

before December 21, 2015, and must be 

filed in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2015–0012, 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–2015–0012 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before December 21, 2015. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2015–0012, 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 December 

17, 2014 (79 FR 75107) (FRL–9918–90), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of (PP 

4E8302) by IR–4, 500 College Road East, 

Suite 201 W, Princeton, NJ 08540. The 

petition requested that 40 CFR part 180 

be amended by establishing tolerances 

for residues of the fungicide 

pyrimethanil, (4,6-dimethyl-N-phenyl-2- 

pyrimidinamine), in or on cucumber at 

1.5 parts per million (ppm); fruit, pome, 

group 11–10 at 14 ppm; fruit, stone, 

group 12–12 at 10 ppm; grapefruit 

subgroup 10–10C at 10 ppm; lemon 

subgroup 10–10B at 11 ppm; orange 

subgroup 10–10A at 10 ppm; and 

tomato subgroup 8–10A at 0.5 ppm. 

Upon approval of the tolerances in this 

petition, the petition requested that the 

tolerances for fruit, citrus, group 10 

except lemon, postharvest; fruit, pome, 

group 11 (preharvest and post-harvest); 

fruit, stone, group 12; lemon (preharvest 

and postharvest); and tomato be 

removed as they are superseded. This 

petition additionally requested that 40 

CFR 180.518 be amended by revising 

the existing tolerance for onion, bulb, 

subgroup 3–07A from 2.0 ppm to 0.20 

ppm. That document referenced a 

summary of the petition prepared on 

behalf of IR–4 by Bayer CropScience, 


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Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Rules and Regulations 63687 

the registrant, which is available in the 

docket EPA–HQ–OPP–2014–0590 at 

http://www.regulations.gov. There were 

no comments received in response to 

this notice of filing. 

In the Federal Register of May 20, 

2015 (80 FR 28925) (FRL–9927–39), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of PP 

4F8291 by Bayer CropScience, 2 T.W. 

Alexander Drive, P.O. Box 12014, 

Research Triangle Park, NC 27709. The 

petition requested that 40 CFR part 180 

be amended by establishing tolerances 

for residues of the fungicide 

pyrimethanil, in or on in or on 

caneberry (subgroup 13–07A) at 15.0 

ppm and bushberry (subgroup 13–07B) 

at 8.0 ppm. That document referenced a 

summary of the petition prepared by 

Bayer CropScience, the registrant, 

which is available in the docket, 

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

was received on the notice of filing. 

EPA’s response to the comment is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petitions, EPA has 

revised the petitioned-for tolerance in or 

on fruit, pome, group 11–10. The 

Agency has also determined that the 

separate subgroup tolerances proposed 

in or on orange subgroup 10–10A, 

lemon subgroup 10–10B, and grapefruit 

subgroup 10–10C should be established 

in or on fruit, citrus, group 10–10. The 

reasons for these changes are explained 

in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

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 pyrimethanil 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with pyrimethanil 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 repeated 

oral exposure to pyrimethanil were the 

liver, kidney and thyroid. By the oral 

route of exposure, the rat was the most 

sensitive species to pyrimethanil 

toxicity, followed by the dog and then 

the mouse. Effects observed including 

clinical signs (for example, vomiting, 

diarrhea and salivation in the dog), 

changes in clinical chemical parameters 

(liver enzymes), changes in organ 

weights (mostly relative), and 

macroscopic and microscopic organ 

changes. These effects were 

accompanied by decreased body weight. 

Clinical signs of neurotoxicity including 

ataxia and dilated pupils, and decreases 

in motor activity, hind limb grip 

strength and body temperature were 

observed in an acute neurotoxicity 

study in rats (females only) at the 

highest dose tested (HDT). However, 

there was no evidence of neurotoxicity 

with repeated dosing in a subchronic 

neurotoxicity study in rats. 

Special short-term exposure studies 

conducted for pyrimethanil 

demonstrated increased liver uridine 

diphosphate glucuronosyl transferase 

activity, leading to decreases in thyroid 

hormones (T3, T4) and compensatory 

increases in thyroid-stimulating 

hormone (TSH) in adult rats. Although 

the effects on the thyroid raise a 

potential concern for thyroid toxicity in 

the young, EPA concluded there is no 

concern for thyroid toxicity in the 

young based on the following: (1) The 

effects are not severe in nature and; (2) 

the wide dose spread (i.e., more than 10- 

fold difference between the no observed 

adverse effect levels (NOAELs) and the 

lowest-observed-adverse-effect-levels 

(LOAELs) in each of the studies 

showing effects on thyroid hormone 

levels (as well as the studies the Agency 

is using for its points of departure) 

provides a measure of protection for any 

potential effects linked to decreased 

thyroid hormone levels in offspring. 

Moreover, reproductive toxicity was not 

observed following pyrimethanil 

administration, and developmental 

effects (e.g., decreased fetal weight, 

retarded ossification, extra ribs) were 

observed only at doses that caused 

maternally toxic effects (e.g., death, 

decreased body weight and body-weight 

gain); therefore, pyrimethanil is not 

expected to result in increased 

quantitative or qualitative susceptibility 

for infants and children. 

Thyroid adenomas were seen in rats 

following long-term exposure, and it 

was concluded that they were mediated 

via disruption of the thyroid/pituitary 

axis. There were no concerns for 

mutagenicity. The EPA has classified 

pyrimethanil as ‘‘not likely to be 

carcinogenic to humans at doses that do 

not alter rat thyroid hormone 

homeostasis.’’ This decision was based 

on the following: 

1. There were treatment-related 

increases in thyroid follicular cell 

tumors in male and female SpragueDawley rats at doses which were 

considered adequate to assess 

carcinogenicity; however, rats are 

substantially more sensitive than 

humans to the development of thyroid 

follicular cell tumors in response to 

thyroid hormone imbalance. 

2. There were no treatment-related 

tumors seen in male or female CD–1 

mice at doses which were considered 

adequate to assess carcinogenicity. 

3. There is no mutagenicity concern 

and there is no evidence for thyroid 

carcinogenesis mediated through a 

mutagenic mode of action. 

4. The non-neoplastic toxicological 

evidence (i.e., thyroid growth, thyroid 

hormonal changes) indicated that 

pyrimethanil was inducing a disruption 

in the thyroid-pituitary hormonal status. 

The overall weight-of-evidence was 

considered sufficient to indicate that 

pyrimethanil induced thyroid follicular 

tumors through a non-linear, antithyroid 

mode of action. 

For these reasons, EPA determined 

that quantification of carcinogenic risk 

is not required and that the NOAEL 

established for deriving the chronic 

reference dose (cRfD) would be 

protective of cancer effects. Due to the 

non-linear mode of action of 

pyrimethanil, exposure at the NOAEL is 

not expected to alter thyroid hormone 

homeostasis nor result in thyroid tumor 

formation. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by pyrimethanil as well 


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as the NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in document, 

‘‘Pyrimethanil. Human Health Risk 

Assessment for Proposed Uses on 

Greenhouse-Grown Cucumbers, Tomato 

Subgroup 8–10A, Lemon Subgroup 10– 

10B, Orange Subgroup 10–10A, 

Grapefruit Subgroup 10–10C, Pome 

Fruit Group 11–10, Stone Fruit Group 

12–12 Caneberry Subgroup 13–07A, and 

Bushberry Subgroup 13–07B,’’ in pp. 

29–31 in docket ID number EPA–HQ– 

OPP–2015–0012. 

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://

www.epa.gov/pesticides/factsheets/

riskassess.htm. A summary of the 

toxicological endpoints for pyrimethanil 

used for human risk assessment is 

discussed in Table 1 in Unit III.B. of the 

final rule published in the Federal 

Register of August 1, 2012 (77 FR 

45499) (FRL–9354–7). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pyrimethanil, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing pyrimethanil tolerances in 40 

CFR 180.518. EPA assessed dietary 

exposures from pyrimethanil 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 

pyrimethanil. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America, (NHANES/WWEIA). As 

to residue levels in food, EPA assumed 

default processing factors, empirical 

processing factors for orange and apple 

juice, tolerance-level residues, and 100 

percent crop treated (PCT) for all 

commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 NHANES/

WWEIA. As to residue levels in food, 

EPA assumed default processing factors, 

empirical processing factors for orange 

and apple juice, tolerance-level 

residues, and 100 PCT for all 

commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that pyrimethanil is not 

likely to be carcinogenic to humans at 

doses that do not alter rat thyroid 

hormone homeostasis. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk was not 

performed. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for pyrimethanil. Tolerance-level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. In drinking water, residues of 

concern are pyrimethanil and the 

degradate 2-amino-4,6- 

dimethylpyrimidine. The Agency used 

screening-level water exposure models 

in the dietary exposure analysis and risk 

assessment for pyrimethanil and its 

degradate in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of pyrimethanil 

and its degradate. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Surface 

Water Concentration Calculator (SWCC) 

models, the estimated drinking water 

concentrations (EDWCs) of pyrimethanil 

and its degradate for acute exposures are 

estimated to be 156 parts per billion 

(ppb) for surface water and 128 ppb for 

ground water. For chronic exposures for 

non-cancer assessments, they are 

estimated to be 27.9 ppb for surface 

water and 117 ppb for ground water. 

Current EPA policy typically 

recommends the EDWCs for use in 

dietary assessments be derived from the 

water source with the highest EDWCs, 

which for pyrimethanil is surface water 

for acute exposure and groundwater for 

chronic exposure. However, due to 

generally low leaching (EDWCs and 

incomplete breakthrough) identified in 

the 100-year simulation in groundwater, 

the surface water EDWCs are 

recommended for both acute and 

chronic exposure assessments. 

Therefore, for acute dietary risk 

assessment, the water concentration 

value of 156 ppb was used to assess the 

contribution to drinking water. For 

chronic dietary risk assessment, the 

water concentration of value 27.9 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). 

Pyrimethanil is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ EPA has not 

found pyrimethanil to share a common 

mechanism of toxicity with any other 

substances, and pyrimethanil does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

pyrimethanil 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 


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Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Rules and Regulations 63689 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicology 

database for pyrimethanil includes rat 

and rabbit developmental toxicity 

studies and a 2-generation reproduction 

toxicity study in rats. As discussed in 

Unit III.A., there was no evidence of 

increased quantitative or qualitative 

susceptibility of fetuses or offspring 

following exposure to pyrimethanil in 

these studies. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced 1X. That decision is based 

on the following findings: 

i. The toxicity database for 

pyrimethanil is complete. 

ii. Clinical signs of neurotoxicity 

(ataxia, decreased motor activity, 

decreased body temperature, decreased 

hind limb grip strength in males, and 

dilated pupils) were observed only in 

females in the acute neurotoxicity study 

in rats and only at the HDT (1,000 

milligram/kilogram (mg/kg)). Although 

the limit dose was not tested in the 

subchronic neurotoxicity study, no 

clinical signs, behavioral changes, or 

neuropathology were seen at one-half of 

the limit dose (up to 430 milligram/

kilogram/day (mg/kg/day)). In addition, 

no neurotoxic signs were seen in the 

rest of the toxicity database for 

pyrimethanil and the target organ for 

toxicity is the thyroid. The selected 

endpoints for pyrimethanil will be 

protective of any potential signs of 

neurotoxicity. Therefore, the concern for 

neurotoxicity is low, and there is no 

need for a developmental neurotoxicity 

study or additional uncertainty factors 

(UFs) to account for neurotoxicity. 

iii. There is no evidence that 

pyrimethanil results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the surface water modeling used to 

assess exposure to pyrimethanil in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by pyrimethanil. 

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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

pyrimethanil will occupy 40% 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 pyrimethanil 

from food and water will utilize 80% of 

the cPAD for children one to two years 

old, the population group receiving the 

greatest exposure. There are no 

residential uses for pyrimethanil. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposures take 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, pyrimethanil is not 

registered for any use patterns that 

would result in short- or intermediateterm residential exposures. Short- and 

intermediate-term risk is assessed based 

on short- or intermediate-term 

residential exposure plus chronic 

dietary exposure. Because there is no 

short- or intermediate-term residential 

exposures 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 intermediateterm risk is necessary, and EPA relies on 

the chronic dietary risk assessment for 

evaluating short-term risk for 

pyrimethanil. 

4. Aggregate cancer risk for U.S. 

population. EPA has determined that 

the thyroid tumors seen in rat studies 

arise through a non-linear mode of 

action and the NOAEL (17 mg/kg/day) 

established for deriving the cRfD is not 

expected to alter thyroid hormone 

homeostasis nor result in thyroid tumor 

formation. Thus, the chronic risk 

assessment addresses any cancer risk. 

Based on the results of chronic risk 

assessment, EPA concludes that 

aggregate exposure to pyrimethanil will 

not cause a cancer risk. 

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 pyrimethanil 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

high-performance liquid 

chromatography (HPLC), is available to 

enforce the tolerance expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

There are no Codex MRLs established 

for residues of pyrimethanil in or on 

cucumber or bushberry subgroup 13– 

07B or caneberry subgroup 13–07A 

commodities. A U.S. tolerance in or on 

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tkelley on DSK3SPTVN1PROD with RULES
63690 Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Rules and Regulations 

for at 14 ppm; however, the EPA is 

establishing a tolerance at 15 ppm in 

order to harmonize with Codex MRLs 

established on associated pome fruit 

commodities at 15 ppm. The U.S. 

tolerance in or on bulb onion subgroup 

3–07A at 0.20 ppm is harmonized with 

a Codex MRL on bulb onion. Although 

there is a Codex MRL at 0.7 ppm for 

tomato, EPA is establishing a tolerance 

for the tomato subgroup 8–10A at 0.50 

ppm in order to harmonize with the 

Canadian MRL to facilitate trade with 

Canada. The U.S. tolerances for citrus 

fruit group 10–10 at 10 ppm and stone 

fruit group 12–12 at 10 ppm cannot be 

harmonized with Codex MRLs on the 

same commodities because the residue 

data supporting these uses result in 

tolerance calculations that are higher 

than the Codex MRLs for citrus (7 ppm) 

and the range of MRLs for stone fruit 

commodities (2 ppm to 4 ppm), which 

precludes harmonization. 

C. Response to Comments 

One comment was received to the 

Notice of Filing for PP 4F8291, which 

provided general support for the 

proposed tolerances. There were no 

concerns identified in this public 

comment. 

D. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

supporting the petitions, EPA has 

revised the petitioned-for tolerance in or 

on fruit, pome, group 11–10 from 14 

ppm to 15 ppm, in order to harmonize 

with the Codex MRL on associated 

pome fruit commodities. The Agency 

has also determined that the separate 

subgroup tolerances petitioned-for in or 

on orange subgroup 10–10A at 10 ppm, 

lemon subgroup 10–10B at 11 ppm, and 

grapefruit subgroup 10–10C at 10 ppm 

should be established in or on fruit, 

citrus, group 10–10 at 10 ppm. A citrus 

group 10–10 tolerance at 10 ppm is 

supported by available data and 

harmonizes the U.S. tolerance with the 

Canadian MRL. 

E. International Trade Considerations 

In this rulemaking, EPA is reducing 

the tolerance for the onion, bulb, 

subgroup 3–07A from 2.0 ppm to 0.20 

ppm. The petitioner requested this 

reduction because it was a 

typographical error when the previous 

rule for pyrimethanil was published. 

EPA had assessed the tolerance at 0.20 

ppm, but the rule was printed as 2.0 

ppm. The reduction is appropriate 

based on available data and residue 

levels resulting from registered use 

patterns. In accordance with the World 

Trade Organization’s Sanitary and 

Phytosanitary Measures Agreement, 

EPA is allowing the existing higher 

tolerance to remain in effect for 6 

months following the publication of this 

rule in order to allow a reasonable 

interval for producers in the exporting 

countries to adapt to the requirements of 

these modified tolerances. On April 21, 

2016, the new reduced tolerance for 

subgroup 3–07A will go into effect. At 

that time, residues of pyrimethanil on 

commodities contained in subgroup 3– 

07A will need to comply with the new 

tolerance of 0.20 ppm. This reduction in 

tolerance is not discriminatory; the 

same food safety standard contained in 

the FFDCA applies equally to 

domestically produced and imported 

foods. 

V. Conclusion 

Therefore, tolerances are established 

for residues of pyrimethanil (4,6- 

dimethyl-N-phenyl-2-pyrimidinamine) 

in or on bushberry subgroup 13–07B at 

8.0 ppm; caneberry subgroup 13–07A at 

15 ppm; cucumber at 1.5 ppm; fruit, 

citrus, group 10–10 at 10 ppm; fruit, 

pome, group 11–10 at 15 ppm; fruit, 

stone group 12–12 at 10 ppm; and 

tomato subgroup 8–10A at 0.50 ppm. 

This regulation additionally revises the 

tolerance in or on onion, bulb, subgroup 

3–07A from 2.0 ppm to 0.20 ppm. 

Finally, this regulation removes 

tolerances in or on fruit, citrus, group 

10, except lemon, postharvest; fruit, 

pome, group 11 (pre-harvest and postharvest); fruit, stone, group 12; lemon, 

preharvest and postharvest; and tomato. 

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 tolerances 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. 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Rules and Regulations 63691 

Dated: October 13, 2015. 

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 § 180.518, the table in paragraph 

(a)(1): 

■ a. Remove the commodities ‘‘fruit, 

citrus, group 10, except lemon, 

postharvest’’; ‘‘fruit, pome, group 11 

(pre-harvest and post-harvest)’’; ‘‘fruit, 

stone, group 12’’; ‘‘lemon, preharvest 

and postharvest’’; and ‘‘tomato’’; and 

■ b. Add alphabetically the following 

commodities to the table. 

The additions read as follows: 

§ 180.518 Pyrimethanil; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

* * * * * 

Bushberry subgroup 13–07B ...... 8.0 

Caneberry subgroup 13–07A ..... 15 

* * * * * 

Cucumber ................................... 1.5 

Fruit, citrus, group 10–10 ........... 10 

Fruit, pome, group 11–10 ........... 15 

* * * * * 

Fruit, stone, group 12–12 ........... 10 

* * * * * 

Tomato subgroup 8–10A ............ 0.50 

* * * * * 

* * * * * 

■ 3. In § 180.518, in the table in 

paragraph (a)(1), effective April 21, 

2016, revise the existing tolerance 

‘‘Onion, bulb, subgroup 3–07A’’ to read 

as follows: 

§ 180.518 Pyrimethanil; tolerances for 

residues. 

(a) General. 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Onion, bulb, subgroup 3–07A .... 0.2 

* * * * * 

* * * * * 

[FR Doc. 2015–26596 Filed 10–20–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 271 

[EPA–R06–RCRA–2015–0109; FRL–9936– 

00–Region 6] 

Texas: Final Authorization of State 

Hazardous Waste Management 

Program Revision 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: The State of Texas has 

applied to the United States 

Environmental Protection Agency (EPA) 

for final authorization of the changes to 

its hazardous waste program under the 

Resource Conservation and Recovery 

Act (RCRA). EPA has determined that 

these changes satisfy all requirements 

needed to qualify for final authorization, 

and is authorizing the State’s changes 

through this direct final rule. In the 

‘‘Proposed Rules’’ section of today’s 

Federal Register, EPA is also publishing 

a separate document that serves as the 

proposal to authorize these changes. 

EPA believes this action is not 

controversial and does not expect 

comments that oppose it. Unless EPA 

receives written comments which 

oppose this authorization during the 

comment period, the decision to 

authorize Texas’ changes to its 

hazardous waste program will take 

effect. If EPA receives comments that 

oppose this action, EPA will publish a 

document in the Federal Register 

withdrawing today’s direct final rule 

before it takes effect, and the separate 

document in today’s ‘‘Proposed Rules’’ 

section of this Federal Register will 

serve as the proposal to authorize the 

changes. 

DATES: This final authorization is 

effective on December 21, 2015 unless 

the EPA receives adverse written 

comment by November 20, 2015. If the 

EPA receives such comment, EPA will 

publish a timely withdrawal of this 

direct final rule in the Federal Register 

and inform the public that this 

authorization will not take effect. 

ADDRESSES: Submit your comments by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Email: [insert name and email 

address of appropriate Regional 

contact]. 

• Fax: (prior to faxing, please notify 

the EPA contact listed below). 

• Mail: [insert name and address of 

appropriate Regional contact]. 

• Hand Delivery or Courier: Deliver 

your comments to [insert name and 

address of appropriate Regional 

contact]. 

Instructions: EPA must receive your 

comments by November 20, 2015. Direct 

your comments to Docket ID Number 

0109. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI), or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov, or 

email. The Federal regulations.gov Web 

site is an ‘‘anonymous access’’ system, 

which means EPA will not know your 

identity or contact information unless 

you provide it in the body of your 

comment. If you send an email 

comment directly to EPA without going 

through regulations.gov, your email 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. (For additional information 

about EPA’s public docket, visit the EPA 

Docket Center homepage at 

www.epa.gov/epahome/dockets.htm). 

Docket: All documents in the docket 

are listed in the www.regulations.gov 

index. Although listed in the index, 

some information is not publicly 

available, e.g., CBI or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, will be publicly 

available only in hard copy. Publicly 

available docket materials are available 

either electronically in 

www.regulations.gov, or in hard copy. 

You can view and copy Texas’ 

application and associated publicly 

available materials from 8:30 a.m. to 4 

p.m. Monday through Friday at the 

following locations: Texas Commission 


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