45498 Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Rules and Regulations 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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: July 18, 2012. 

G. Jeffery Herndon, 

Acting 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 § 180.940(a), the table is 

amended by adding alphabetically the 

following inert ingredient after the entry 

for ‘‘Magnesium oxide’’ to read as 

follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Pesticide chemical CAS Reg. No. Limits 

*******

2-Methyl-1,3-propanediol ...................................................................................... 2163–42–0 None. 

* * * * * * * 

* * * * * 

[FR Doc. 2012–18506 Filed 7–31–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0477; FRL–9354–7] 

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 these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 1, 2012. Objections and requests 

for hearings must be received on or 

before October 1, 2012, 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–2011–0477, is 

available at http://www.regulations.gov 

or at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, 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: 

Andrew Ertman, Registration Division 

(7509P) Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; email address: 

ertman.andrew@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. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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://ecfr.gpoaccess.gov/cgi/t/ 

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

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2011–0477 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 October 1, 2012. 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 that does not 

contain any 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 a copy of 


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Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Rules and Regulations 45499 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0477, 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 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 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.htm. 

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 July 20, 

2011 (76 FR 43231) (FRL–8880–1), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 1E7861) by IR–4,500 

College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.518 be 

amended by establishing tolerances for 

residues of the fungicide pyrimethanil 

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

pyrimidinamine) in or on the raw 

agricultural commodities onion, bulb, 

subgroup 03–07A at 0.1 parts per 

million (ppm), onion, green, subgroup 

03–07B at 2.0 ppm, berry and small 

fruit, small fruit vine climbing 

subgroup, except fuzzy kiwifruit 13–07F 

at 5.0 ppm, berry and small fruit, low 

growing berry subgroup 13–07G at 3.0 

ppm and ginseng at 2.5 ppm. That 

notice referenced a summary of the 

petition prepared by Bayer CropScience, 

the registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the levels at which tolerances 

are being established for some of the 

commodities. The reason for this change 

is explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * *’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 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. 

Pyrimethanil is of low acute lethality 

by the oral, dermal, and inhalation 

routes. It is a slight eye irritant, is not 

irritating to the skin, and it is not a 

dermal sensitizer. A single oral dose of 

1,000 milligrams/kilogram (mg/kg) 

produced a number of acute signs of 

neurotoxicity, including ataxia, dilated 

pupils, and decreases in motor activity, 

hind limb grip strength, and body 

temperature. However, there was no 

evidence of neurotoxicity with repeated 

dosing in a subchronic neurotoxicity 

study in rats. Exposure to pyrimethanil 

in oral toxicity studies primarily 

resulted in decreased body weights and 

body-weight gain, often accompanied by 

decreases in food consumption. The 

major target organs of repeated oral 

exposure were the liver and the thyroid. 

No reproductive toxicity was observed, 

and developmental effects (e.g., 

decreased fetal weight, retarded 

ossification, extra ribs) were observed 

only at maternally toxic doses. Special 

short-term exposure studies 

demonstrated increased liver uridine 

diphosphate glucuronosyl transferase 

(UDPGT) activity leading to decreases in 

thyroid hormones (T3, T4) and 

compensatory increases in thyroid 

stimulating hormone (TSH) in adult 

rats. 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. 

2. There were no treatment-related 

tumors were 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 an antithyroid mode of 

action. 

5. Rats are substantially more 

sensitive than humans to the 

development of thyroid follicular cell 

tumors in response to thyroid hormone 

imbalance. EPA determined that 

quantification of carcinogenic risk is not 

required since the thyroid tumors arise 

through a non-linear mode of action and 

the no observed adverse effect level 

(NOAEL) (17 mg/kg/day) established for 

deriving the chronic reference dose 

(cRfD) 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 

as the NOAEL and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

titled ‘‘Pyrimethanil Human-Health Risk 

Assessment for Proposed Uses on 


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Ginseng, Bulb Onion Subgroups 3–07A 

and B, and Small Berry Subgroups 13– 

07F and G,’’ pp. 32–34 in docket ID 

number EPA–HQ–OPP–2011–0477. 

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 pyrimethanil used for 

human risk assessment is shown in the 

Table of this unit. 

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

ASSESSMENT

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (Females 13– 

49 years of age).

NOAEL = 45 mg/kg/day ....

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Acute RfD = 0.45 mg/kg/ 

day.

aPAD = 0.45 mg/kg/day 

Developmental Toxicity—Rabbit: 

LOAEL = 300 mg/kg/day based on increases in 

fetuses with 13 thoracic vertebrae and 13 pairs of 

ribs. 

Acute dietary (General population including infants 

and children).

NOAEL = 100 mg/kg/day ..

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Acute RfD = 1 mg/kg/day ..

aPAD = 1 mg/kg/day 

Acute Neurotoxicity—Rat: 

LOAEL = 1,000 mg/kg/day based on decreased motor 

activity, ataxia, decreased body temperature, hind 

limb grip strength, and dilated pupils. 

Chronic dietar (All populations).NOAEL= 17 mg/kg/day .....

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Chronic RfD = 0.17 mg/kg/ 

day.

cPAD = 0.17 mg/kg/day 

Chronic Toxicity—Rat: 

LOAEL = 221 mg/kg/day based on decreased bodyweight gains; increased serum cholesterol and 

GGT, increased relative liver/body weight ratios, necropsy and histopathological findings in the liver and 

thyroid. 

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

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population-adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to 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) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA assumed 

default processing factors (as necessary), 

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 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

assumed default processing factors (as 

necessary), empirical processing factors 

for orange and apple juice, tolerance 

level residues and 100 PCT for all 

commodities. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or nonlinear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or nonlinear approach is 

used and a cancer RfD is calculated 

based on an earlier noncancer key event. 

If carcinogenic mode of action data are 

not available, or if the mode of action 

data determines a mutagenic mode of 

action, a default linear cancer slope 

factor approach is utilized. Based on the 

data summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to pyrimethanil. Cancer risk 

was assessed using the same exposure 

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

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for pyrimethanil. Tolerance-level 

residues and 100 PCT were assumed for 

all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for pyrimethanil in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

pyrimethanil. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 


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Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Rules and Regulations 45501 

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 Screening 

Concentration in Ground Water (SCI– 

GROW) models the estimated drinking 

water concentrations (EDWCs) of 

pyrimethanil for acute exposures are 

estimated to be 86.5 parts per billion 

(ppb) for surface water and 4.8 ppb for 

ground water. For chronic exposures for 

non-cancer assessments, they are 

estimated to be 29.4 ppb for surface 

water and 4.8 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 86.5 ppb 

was used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 29.4 

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 

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. 

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 to 1X. That decision is 

based on the following findings: 

i. The toxicology database for 

pyrimethanil is complete. 

ii A guideline immunotoxicity study 

has been submitted, and there is no 

evidence for immunotoxicity due to 

pyrimethanil treatment. Evidence of 

neurotoxicity was observed at a very 

high dose (the limit dose) in the acute 

neurotoxicity study in rats. However, 

the study has a clear NOAEL, which is 

being utilized as the POD for the acute 

dietary exposure scenario, and there 

was no evidence of neurotoxicity 

observed in the subchronic 

neurotoxicity study in rats up to the 

highest dose tested in that study (430 

mg/k/day). A developmental 

neurotoxicity (DNT) study is not 

required. 

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. Thyroid has been shown to be one 

of the target organs in adult animals for 

pyrimethanil-induced toxicity thus 

raising a potential concern for thyroid 

toxicity in the young. EPA, however, 

concluded that there is no concern for 

thyroid toxicity in the young based on 

the following weight of evidence 

considerations: the effects seen on the 

thyroid and the liver in the database, 

while treatment-related, are not severe 

in nature; and in each of the studies that 

show an effect on thyroid hormone 

levels, as well as in all studies chosen 

for PODs selection, there is a wide dose 

spread (∼10-fold difference between 

NOAELs and LOAELs) which provides 

a measure of protection for any potential 

effects linked to decreased thyroid 

hormone levels in offspring. 

v. There are no residual uncertainties 

with respect to exposure data. The 

dietary food exposure assessment 

utilizes tolerance-level residues 

(established or recommended) and 100 

PCT for all proposed/established 

commodities. By using these 

assumptions, the acute and chronic 

exposures/risks will not be 

underestimated. The dietary drinking 

water assessment utilizes water 

concentration values generated by 

models and associated modeling 

parameters that are designed to provide 

conservative, health-protective, highend estimates of water concentrations 

that will not likely be exceeded. 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 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 

pyrimethanil will occupy 35% of the 

aPAD for all infants <1 year 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 64% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for pyrimethanil. 

3. Short-and intermediate-term risk. 

Short-term and intermediate-term 

aggregate exposure takes into account 

short-and intermediate-term residential 

exposure plus chronic exposure to food 


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and water (considered to be a 

background exposure level). A short-and 

intermediate-term adverse effect was 

identified; however, pyrimethanil is not 

registered for any use patterns that 

would result in short- and/or 

intermediate-term residential exposure. 

Short-and intermediate-term risk is 

assessed based on short-and 

intermediate-term residential exposure 

plus chronic dietary exposure. Because 

there is no short-and 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-and 

intermediate-term risk), no further 

assessment of short-and intermediateterm risk is necessary, and EPA relies on 

the chronic dietary risk assessment for 

evaluating short-and intermediate-term 

risk for pyrimethanil. 

4. Aggregate cancer risk for U.S. 

population. The Agency 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. 

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. 

The Codex has established MRLs for 

pyrimethanil in or on strawberry at 3 

ppm, bulb onions at 0.2 ppm, and 

spring onion at 3 ppm. These MRLs are 

the same as the tolerances established 

by this rule for pyrimethanil on the low 

growing berry subgroup 13–07G, the 

bulb onion subgroup 3–07A, and the 

green onion subgroup 3–07B in the 

United States. 

The Codex has established an MRL for 

pyrimethanil in or on grapes at 4 ppm 

which is less than tolerance of 5.0 ppm 

set on the small vine climbing fruit 

subgroup 13–07F of which grape is a 

member. The reason for this is due to 

the fact that the European PHI is 21 days 

and the U.S. PHI is 7 days. Residues are 

thus higher in U.S. residue trials, 

necessitating a higher tolerance. 

C. Revisions to Petitioned-For 

Tolerances 

Using the Organization for Economic 

Co-operation and Development (OECD) 

tolerance calculation procedures for the 

residue data set indicates that the 

requested tolerance of 2.5 ppm for 

residues of pyrimethanil in/on ginseng 

is too high and that a tolerance of 1.5 

ppm is appropriate. Also, the tolerance 

levels for the bulb onion subgroup 3– 

07A and green onion subgroup 3–07B 

were modified to harmonize with 

existing Codex Maximum Residue 

Levels (MRLs). Lastly, EPA has revised 

the tolerance expressions to clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of 

pyrimethanil not specifically 

mentioned; and 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of pyrimethanil (4,6- 

dimethyl-N-phenyl-2-pyrimidinamine) 

in or on onion, bulb, subgroup 03–07A 

at 0.20 ppm; onion, green, subgroup 03– 

07B at 3.0 ppm; fruit, small, vine 

climbing subgroup 13–07F, except fuzzy 

kiwifruit 13–07F at 5.0 ppm; berry, low 

growing, subgroup 13–07G at 3.0 ppm 

and ginseng at 1.5 ppm. 

Also, due to the tolerances established 

in this unit by this document, the 

following existing tolerances are 

removed as unnecessary; strawberry; 

grape; onion, bulb; and onion, green. 

VI. Statutory and Executive Order 

Reviews 

This final rule 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 final rule 

has been exempted from review under 

Executive Order 12866, this final rule 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 final rule 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 final rule 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 


sroberts on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Rules and Regulations 45503 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

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 of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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: July 18, 2012. 

Daniel J. Rosenblatt, 

Acting 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. Section 180.518 is amended as 

follows: 

■ a. Revising the introductory text to 

paragraph (a)(1); 

■ b. Removing the entries for ‘‘Grape’’; 

‘‘Onion, bulb’’; and ‘‘Onion, green; and 

‘‘Strawberry’’ from the table in 

paragraph (a)(1); 

■ c. Alphabetically adding the following 

commodities to the table in paragraph 

(a)(1); and 

■ d. Revising the introductory text for 

paragraphs (a)(2) and (3). 

The amendments read as follows: 

§ 180.518 Pyrimethanil; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the fungicide 

pyrimethanil, including its metabolites 

and degradates, in or on the 

commodities in the following table 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 

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

pyrimidinamine). 

Commodity Parts per 

million 

* * * * * 

Berry, low growing, subgroup 

13–07G ................................... 3.0 

* * * * * 

Fruit, small, vine climbing, subgroup 13–07F, except fuzzy 

kiwifruit .................................... 5.0 

* * * * * 

Ginseng ...................................... 1.5 

* * * * * 

Onion, bulb, subgroup 3–07A .... 2.0 

Onion, green, subgroup 3–07B .. 3.0 

* * * * * 

(2) Tolerances are established for 

residues of the fungicide pyrimethanil, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only the sum of pyrimethanil 

and its metabolite 4-[4,6-dimethyl-2- 

pyrimidinyl)amino]phenol, calculated 

as the stoichiometric equivalent of 

pyrimethanil. 

* * * * * 

(3) Tolerances are established for 

residues of the fungicide pyrimethanil, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only the sum of pyrimethanil 

and its metabolite 4,6-dimethyl-2- 

(phenylamino)-5-pyrimidinol, 

calculated as the stoichiometric 

equivalent of pyrimethanil. 

* * * * * 

[FR Doc. 2012–18388 Filed 7–31–12; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 90 

[WP Docket No. 07–100; PS Docket No. 06– 

229; WT Docket No. 06–150; FCC 12–61] 

4.9 GHz Band 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: The Commission adopts rule 

changes to three aspects of the technical 

provisions of part 90 of the 

Commission’s rules pertaining to public 

safety operations. All of these changes 

are designed to correct typographical or 

other ministerial errors in these 

provisions. First, the Commission 

reinstates a rule provision that 

exempted 4940–4990 MHz (4.9 GHz) 

band applicants from certified 

frequency coordination. Next, the 

Commission corrects the bandwidth of 

Channel 14 in the 4.9 GHz band plan 

from five megahertz to one megahertz, 

and amends the band plan to list the 

center frequencies for each channel 

aggregation permitted in the rules. 

Finally, the Commission corrects minor 

errors in the Public Safety Pool 

Frequency Table and associated list of 

limitations. All of these changes are 

designed to correct typographical or 

other ministerial errors in these 

provisions. These changes affecting the 

4.9 GHz band in particular will improve 

spectrum efficiency and clarify the rules 

so as to encourage greater use of the 4.9 

GHz band. 

DATES: Effective August 31, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Thomas Eng, Policy and Licensing 

Division, Public Safety and Homeland 

Security Bureau, Federal 

Communications Commission, 445 12th 

Street SW., Washington, DC 20554, at 

(202) 418–0019, TTY (202) 418–7233, or 

via email at Thomas.Eng@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Fourth 

Report and Order in WP Docket No. 07– 

100; PS Docket No. 06–229; WT Docket 

No. 06–150; adopted and released on 

June 13, 2012. The complete text of this 

document is available for inspection 

and copying during normal business 

hours in the FCC Reference Information 

Center, Portals II, 445 12th Street SW., 

Room CY–A257, Washington, DC 20554. 

This document may also be purchased 

from the Commission’s duplicating 

contractor, Best Copy and Printing, Inc., 

in person at 445 12th Street SW., Room 

CY–B402, Washington, DC 20554, via 

telephone at (202) 488–5300, via 


sroberts on DSK5SPTVN1PROD with RULES