42324 Federal Register / Vol. 75, No. 139 / Wednesday, July 21, 2010 / Rules and Regulations 

Inert ingredients Limits Uses 

*******

Poly(oxy-1,2-ethanediyl), a-isotridecyl-w-methoxy (CAS Reg. 

No. 345642-79-7) 

At a maximum of 10% in formulation Surfactant 

* * * * * * * 

[FR Doc. 2010–17402 Filed 7–21–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0528; FRL–8834–8] 

Pyraclostrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyraclostrobin 

in or on alfalfa and poultry, and 

increases tolerances for residues in or 

on soybean. BASF Corporation 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective July 

21, 2010. Objections and requests for 

hearings must be received on or before 

September 20, 2010, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0528. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Shaunta Hill, Registration Division 

(7504P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8961; e-mail address: 

hill.shaunta@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://www.gpoaccess.gov/ecfr. 

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–2010–0528 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 September 20, 2010. 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 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0528, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of February 4, 

2010 (75 FR 5792) (FRL–9110–5) and 

June 8, 2010 (75 FR 32465) (FRL–8827– 

5), EPA issued notices pursuant to 

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

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

pesticide petitions PP 9F7590 and PP 

9F7528, respectively, by BASF 

Corporation, P.O. Box 13528, Research 


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Federal Register / Vol. 75, No. 139 / Wednesday, July 21, 2010 / Rules and Regulations 42325 

Triangle Park, NC 27709. The petitions 

requested that 40 CFR 180.582 be 

amended by increasing tolerances for 

residues of the fungicide pyraclostrobin, 

carbamic acid, [2-[[[1-(4-chlorophenyl)- 

1H-pyrazol-3- 

yl]oxy]methyl]phenyl]methoxy-, methyl 

ester, in or on soybean, forage at 11.0 

parts per million (ppm) (PP 9F7590), 

and soybean, hay at 14.0 ppm (PP 

9F7590), and by establishing tolerances 

for residues for alfalfa, forage at 10 ppm 

(PP 9F7528), alfalfa, hay at 30 ppm (PP 

9F7528), poultry, fat at 0.1 ppm (PP 

9F7528); poultry, meat byproducts at 0.1 

ppm (PP 9F7528); poultry, meat at 0.1 

ppm (PP 9F7528); and poultry, eggs at 

0.1 ppm (PP 9F7528). These notices 

referenced a summary of the petition 

prepared by BASF Corporation, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

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 section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 pyraclostrobin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with pyraclostrobin 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. 

Pyraclostrobin has a low to moderate 

acute toxicity via the oral, dermal, and 

inhalation routes of exposure. 

Pyraclostrobin produces moderate eye 

irritation, is a moderate dermal irritant, 

and is not a dermal sensitizer. The main 

target organs for pyraclostrobin are the 

upper gastrointestinal tract (mainly the 

duodenum and stomach), the spleen/ 

hematopoiesis, and the liver. In the 90– 

day mouse oral toxicity study, thymus 

atrophy was seen at doses of 30 

milligrams/kilogram (mg/kg) or above, 

but similar effect was not found in the 

mouse carcinogenicity study at doses as 

high as 33 mg/kg. In reproductive and 

developmental studies, there was 

evidence of increased qualitative 

susceptibility following in utero 

exposure in the rabbit, but not in rats. 

In both the acute and subchronic 

neurotoxicity studies, there were no 

indications of treatment-related 

neurotoxicity. EPA classified 

pyraclostrobin as ‘‘Not Likely to be 

Carcinogenic to Humans’’ based on no 

treatment-related increase in tumors in 

both sexes of rats and mice, which were 

tested at doses that were adequate to 

assess carcinogenicity, and the lack of 

evidence of mutagenicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by pyraclostrobin as well 

as the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Revised Pyraclostrobin: Human Health 

Risk Assessment for Proposed Uses on 

Cotton and Belgian Endive’’ at page 15 

in docket ID number EPA–HQ–OPP– 

2006–0522. 

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 pyraclostrobin used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

‘‘Pyraclostrobin: Human Health Risk 

Assessment for Proposed Uses on Grain 

Sorghum (PP#8F7385); Increase of 

Tolerance for the Stone Fruit Crop 

Group 12 to Satisfy European Union 

(EU) Import Requirement (PP#8F7390); 

and Establishment of a Permanent 

Import Tolerance for Coffee 

(PP#8E7394)’’ at page 17 in docket ID 

number EPA–HQ–OPP–2008–0713. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pyraclostrobin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing pyraclostrobin tolerances in 40 

CFR 180.582. EPA assessed dietary 

exposures from pyraclostrobin 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. 

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 performed a slightly 

refined acute dietary exposure 

assessment for pyraclostrobin. EPA 

assumed that 100% of crops covered by 

existing or proposed tolerances were 

treated with pyraclostrobin and that 

these crops either had tolerance-level 

residues or residues at the highest level 

found in field trials. Experimentally 


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derived processing factors were used for 

fruit juices, tomato, and wheat 

commodities but for all other processed 

commodities Dietary Exposure 

Evaluation Model (DEEMTM) default 

processing factors were assumed. 

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 performed a refined 

chronic dietary exposure assessment for 

pyraclostrobin. EPA used data on 

average percent crop treated (PCT) 

(when available) and either tolerancelevel residues or average field trial 

residues. Experimentally derived 

processing factors were used for fruit 

juices, tomato, and wheat commodities, 

but for all other processed commodities 

DEEMTM default processing factors were 

assumed. 

iii. Cancer. EPA classified 

pyraclostrobin as ‘‘Not Likely to be 

Carcinogenic to Humans’’ based on no 

treatment-related increase in tumors in 

both sexes of rats and mice, which were 

tested at doses that were adequate to 

assess carcinogenicity, and the lack of 

evidence of mutagenicity. Accordingly, 

an exposure assessment to evaluate 

cancer risk is unnecessary. 

iv. Anticipated residue and PCT 

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

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require pursuant to FFDCA 

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

years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such Data CallIns as are required by FFDCA section 

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

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

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

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

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

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

EPA may require registrants to submit 

data on PCT. 

The Agency estimated the PCT for 

existing uses as follows: 

Commodity PCT 

Almond .................................. 35% 

Apple ..................................... 10% 

Apricot ................................... 10% 

Barley .................................... 1% 

Bell pepper ........................... 10% 

Black bean seed ................... 5% 

Blackberry ............................. 20% 

Blueberry .............................. 20% 

Broad bean (succulent) ........ 2.5% 

Broad bean seed .................. 5% 

Broccoli ................................. 5% 

Cabbage ............................... 10% 

Cantaloupe ........................... 15% 

Carrot .................................... 25% 

Celery ................................... 2.5% 

Cherry ................................... 30% 

Chinese mustard cabbage ... 10% 

Cowpea seed ........................ 5% 

Cowpea (succulent) .............. 2.5% 

Cucumber ............................. 5% 

Currant .................................. 5% 

Dry bulb onion ...................... 15% 

Field corn .............................. 5% 

Filbert .................................... 10% 

Garlic .................................... 10% 

Grape .................................... 25% 

Grapefruit .............................. 25% 

Great northern bean seed .... 5% 

Green onion .......................... 15% 

Head lettuce ......................... 5% 

Leaf lettuce ........................... 5% 

Kidney bean seed ................. 5% 

Lima bean seed .................... 5% 

Lima bean (succulent) .......... 2.5% 

Mung bean seed ................... 5% 

Napa cabbage ...................... 10% 

Navy bean seed ................... 5% 

Nectarine .............................. 15% 

Non-bell pepper .................... 10% 

Orange .................................. 5% 

Peach .................................... 15% 

Peanut .................................. 25% 

Pear ...................................... 10% 

Pecan .................................... 2.5% 

Pigeon pea (succulent) ......... 5% 

Pink bean seed ..................... 5% 

Pinto bean seed ................... 5% 

Pistachio ............................... 25% 

Plum ...................................... 5% 

Pop corn ............................... 5% 

Potato ................................... 10% 

Pumpkin ................................ 20% 

Raspberry ............................. 35% 

Snap bean (succulent) ......... 2.5% 

Soybean ................................ 5% 

Spinach ................................. 10% 

Strawberry ............................ 50% 

Succulent pea ....................... 5% 

Sugar beet ............................ 35% 

Summer squash ................... 10% 

Sweet corn ............................ 5% 

Commodity PCT 

Tangerine .............................. 15% 

Tomato .................................. 20% 

Watermelon .......................... 30% 

Wheat ................................... 5% 

Winter squash ....................... 10% 

In most cases, EPA uses available data 

from USDA/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

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

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

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

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which pyraclostrobin may be applied in 

a particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 


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for pyraclostrobin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

pyraclostrobin. 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 Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

pyraclostrobin for acute exposures are 

estimated to be 35.6 parts per billion 

(ppb) for surface water and 0.02 ppb for 

ground water and for chronic exposures 

for non-cancer assessments are 

estimated to be 2.3 ppb for surface water 

and 0.02 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 35.6 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 2.3 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). 

Pyraclostrobin is currently registered 

for the following uses that could result 

in residential exposures: Residential turf 

grass and recreational sites. EPA 

assessed residential exposure using the 

following assumptions: Residential and 

recreational turf applications are 

applied by professional pest control 

operators (PCOs) only and, therefore, 

residential handler exposures do not 

occur. There is, however, a potential for 

short- and intermediate-term postapplication exposure of adults and 

children entering lawn and recreation 

areas previously treated with 

pyraclostrobin. Exposures from treated 

recreational sites are expected to be 

similar to, or in many cases lower than, 

those from treated residential turf sites 

so a separate exposure assessment for 

recreational turf sites was not 

conducted. EPA assessed exposures 

from the following residential turf postapplication scenarios: 

(1) Short-/intermediate-term adult and 

toddler post-application dermal 

exposure from contact with treated 

lawns. 

(2) Short-/intermediate-term toddlers’ 

incidental ingestion of pesticide 

residues on lawns from hand-to-mouth 

transfer. 

(3) Short-/intermediate-term toddlers’ 

object-to-mouth transfer from mouthing 

of pesticide-treated turfgrass. 

(4) Short-/intermediate-term toddlers’ 

incidental ingestion of soil from 

pesticide-treated residential areas. The 

post-application risk assessment was 

conducted in accordance with the 

Residential Standard Operating 

Procedures and recommended 

approaches of the Health Effects 

Division’s Science Advisory Council for 

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 pyraclostrobin to 

share a common mechanism of toxicity 

with any other substances, and 

pyraclostrobin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that pyraclostrobin 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 website 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 

pre-natal and post-natal 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. Pre-natal and post-natal sensitivity. 

The pre-natal and post-natal toxicology 

database for pyraclostrobin includes the 

rat and rabbit developmental toxicity 

studies and the 2–generation 

reproduction toxicity study in rats. In 

reproductive and developmental studies 

there was evidence of increased 

qualitative susceptibility following in 

utero exposure in the rabbit, but not in 

rats. In the 2-generation reproduction 

study, the highest dose tested did not 

cause maternal systemic toxicity, nor 

did it elicit reproductive or offspring 

toxicity. There is low concern for prenatal developmental effects seen in the 

rabbit because there are clear NOAELs 

for maternal and developmental effects, 

this toxicity endpoint is used to 

establish the acute dietary RfD, and the 

developmental effect was seen at the 

same dose level as that produced for the 

maternal effect. 

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 toxicity database for 

pyraclostrobin is considered adequate to 

support toxicity endpoint selection for 

risk assessment and FQPA evaluation. 

However, under the current 40 CFR 

158.500 data requirement guidelines, 

the immunotoxicity data (780.7800) is 

required as a condition of approval. In 

the absence of specific immunotoxicity 

studies, EPA has evaluated the available 

pyraclostrobin toxicity data to 

determine whether an additional 

database uncertainty factor is needed to 

account for potential immunotoxicity. 

For pyraclostrobin, a complete battery of 

subchronic, chronic, carcinogenicity, 

developmental and reproductive 

studies, and acute and subchronic 

neurotoxicity screening studies are 

available for consideration. The 

immunotoxic potential of pyraclostrobin 

has been well characterized in 

relationship to other adverse effects 

seen in the submitted toxicity studies. 

Under the conditions of the studies, the 

results do not indicate the immune 

system to be the primary target. Other 

than the high-dose thymus effects seen 

in the 90-day mouse study, no 

significant evidence of pyraclostrobininduced immunotoxicity was 

demonstrated in the studies conducted 

either in adult animals or in the 

offspring following pre-natal and postnatal exposures. Increased spleen 

weights observed in 28-day and 90-day 

rat studies were accompanied with mild 

hemolytic anemia (a hematopoieses 

response) indicating these effects are 

unrelated to an immunotoxic response. 

Currently, the point of departure in 

establishing the chronic RfD is 3.4 mg/ 

kg/day. The Agency does not believe 

that conducting a special series 

870.7800 immunotoxicity study will 

result in a NOAEL less than 3.4 mg/kg/ 


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day. A similar conclusion was reached 

in an earlier action on pyraclostrobin. 

(See 72 FR 52108, 52120 (September 12, 

2007)) (FRL–8144–4). In light of these 

conclusions, EPA does not believe an 

additional uncertainty or safety factor is 

needed to address the lack of the 

required immunotoxicity study. 

ii. There is no indication that 

pyraclostrobin is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

pyraclostrobin results in increased 

quantitative susceptibility in in utero 

rats or rabbits in the prenatal 

developmental studies or in young rats 

in the 2-generation reproduction study. 

Although there is qualitative evidence 

of increased susceptibility in the 

prenatal development study in rabbits, 

the Agency did not identify any residual 

uncertainties after establishing toxicity 

endpoints and traditional UFs to be 

used in the risk assessment of 

pyraclostrobin. The degree of concern 

for pre-natal and/or post-natal toxicity is 

low. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute dietary food exposure 

assessments were performed using 

tolerance-level or highest field trial 

residues and 100% crop treated. The 

chronic dietary food exposure 

assessments were performed using 

tolerance-level or average field trial 

residues and 100% CT or average PCT. 

Average PCT is conservatively derived 

from multiple data sources and is 

averaged by year and then across all 

years. The field trials represent 

maximum application rates and 

minimum PHIs. A limited number of 

experimentally derived processing 

factors from pyraclostrobin processing 

studies were also used to refine the 

analysis. The results of the refined 

chronic dietary analysis are based on 

reliable data and will not underestimate 

the exposure and risk. Conservative 

surface water modeling estimates were 

used. EPA used similarly conservative 

assumptions to assess post-application 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by pyraclostrobin. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases 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 POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

pyraclostrobin will occupy 81% of the 

aPAD for females 13 to 49 years old, and 

3% of the aPAD for children 1–2 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 pyraclostrobin 

from food and water will utilize 24% of 

the cPAD for children 1 to 2 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 

pyraclostrobin 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). 

Pyraclostrobin 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 pyraclostrobin. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 230 for adults and 120 for 

children 1 to 2 years old. The aggregate 

MOE for adults is based on the 

residential turf scenario and includes 

combined food, drinking water, and 

post-application dermal exposures. The 

aggregate MOE for children includes 

food, drinking water, and postapplication dermal and incidental oral 

exposures from entering turf areas 

previously treated with pyraclostrobin. 

MOEs above 100 are considered to be of 

no 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). 

Pyraclostrobin is currently registered 

for uses that could result in 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to pyraclostrobin. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in aggregate MOEs of 230 for adults and 

120 for children 1 to 2 years old. The 

endpoints and points of departure 

(NOAELs) are identical for short- and 

intermediate-term exposures, so the 

aggregate MOEs for intermediate-term 

exposure are the same as those for shortterm exposure. MOEs above 100 are 

considered to be of no concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

pyraclostrobin 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 

pyraclostrobin residues. 

IV. Other Considerations 

Analytical Enforcement Methodology 

There are adequate residue analytical 

methods for tolerance enforcement. The 

analytical methods for plant 

commodities are liquid chromatography 

with tandem mass spectroscopy/mass 

spectroscopy detector (LC/MS/MS) and 

high pressure liquid chromatography 

with ultraviolet detector (HPLC/UV), 

which both measure pyraclostrobin and 

its desmethoxy metabolite. The 

analytical methods for live stock 

commodities, gas chromatography with 

mass spectroscopy detector (GC/MS) 

and LC/MS/MS, convert pyraclostrobin 

and related metabolites to 

chlorophenylpyrazolol (BF 500–5) and 

hydroxylated chlorophenylpyrazolol 

(BF 500–8) in goats and 

chlorophenylpyrazolol (BF 500–5) and 

hydroxylated chlorophenylpyrazolol 

(BF 500–9) in poultry. 

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. 


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Federal Register / Vol. 75, No. 139 / Wednesday, July 21, 2010 / Rules and Regulations 42329 

B. International Residue Limits 

There are currently no proposed or 

established Codex, Canadian, or 

Mexican Maximum Residue Limits 

(MRLs) for residues of pyraclostrobin on 

alfalfa and soybeans. However, there are 

Canadian MRLs for various livestock 

commodities, including poultry meat, 

meat byproducts and eggs. The U.S. 

tolerance and Canadian MRL 

expressions are the same for both plant 

and livestock commodities, but several 

of the recommended changes in 

tolerances on livestock commodities 

will result in differences between the 

U.S. tolerances and the respective 

Canadian MRLs, due to increase in 

poultry dietary burden as a result of 

registration of alfalfa. 

V. Conclusion 

Therefore, tolerances are established 

for residues of pyraclostrobin, carbamic 

acid, [2-[[[1-(4-chlorophenyl)-1Hpyrazol-3-yl]oxy]methyl] 

phenyl]methoxy-, methyl ester, in or on 

alfafa, forage at 10 ppm; alfalfa, hay at 

30 ppm; poultry, fat at 0.1 ppm; poultry, 

meat byproducts at 0.1 ppm; poultry, 

meat at 0.1 ppm; poultry, eggs at 0.1 

ppm; and tolerances are increased for 

residues in or on soybean; forage at 11 

ppm; and soybean, hay; at 14 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA 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 section 408(d) of FFDCA, 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 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 section 408(n)(4) of FFDCA. 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 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) (Public Law 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 12, 2010. 

Lois Ann Rossi, 

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 180.582 is amended as 

follows: 

a. Revise the introductory text of 

paragraph (a)(1). 

b. Add alphabetically the 

commodities ‘‘Alfalfa, forage’’ and 

‘‘Alfalfa, hay’’ to the table in paragraph 

(a)(1). 

c. Revise the entries for ‘‘Soybean, 

forage’’ and ‘‘Soybean, hay.’’ in the table 

in paragraph (a)(1). 

d. Add alphabetically four 

commodities to the table in paragraph 

(a)(2). 

§ 180.582 Pyraclostrobin; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the fungicide 

pyradostrobin, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only the sum of 

pyraclostrobin (carbamic acid, [2-[[[ 1- 

(4-chlorophenyl)-1H-pyrazol-3-yl]oxy] 

methyl]phenyl]methoxy-, methyl ester) 

and its desmethoxy metabolite (methylN-[[[1-(4-chlorophenyl)-1H-pyrazol-3- 

yl]oxy]methyl] phenylcarbamate), 

calculated as the stoichiometric 

equivalent of pyraclostrobin, in or on 

the commodity. 

Commodity Parts per 

million 

Alfalfa, forage ........................... 10 

Alfalfa, hay ................................ 30 

* * * * * 

Soybean, forage ....................... 11 

Soybean, hay ............................ 14 

* * * * * 

* * * * * 

(2) * * * 

Commodity Parts per 

million 

* * * * * 

Poultry, eggs ............................. 0.10 


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42330 Federal Register / Vol. 75, No. 139 / Wednesday, July 21, 2010 / Rules and Regulations 

Commodity Parts per 

million 

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

Poultry, meat ............................ 0.10 

Poultry, meat by-products ........ 0.10 

* * * * * 

* * * * * 

[FR Doc. 2010–17793 Filed 7–20–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2008–0483; FRL–8832–2] 

RIN 2070–AJ36 

Elemental Mercury Used in Flow 

Meters, Natural Gas Manometers, and 

Pyrometers; Significant New Use Rule 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is promulgating a 

significant new use rule (SNUR) under 

section 5(a)(2) of the Toxic Substances 

Control Act (TSCA) for elemental 

mercury (CAS No. 7439–97–6) for use in 

flow meters, natural gas manometers, 

and pyrometers, except for use in these 

articles when they are in service as of 

September 11, 2009. This action will 

require persons who intend to 

manufacture (including import) or 

process elemental mercury for an 

activity that is designated as a 

significant new use by this rule to notify 

EPA at least 90 days before commencing 

that activity. Persons subject to the 

provisions of this rule will not be 

exempt from significant new use 

reporting if they import into the United 

States or process elemental mercury as 

part of an article. The required 

notification will provide EPA with the 

opportunity to evaluate the intended 

use and, if necessary, to prohibit or limit 

that activity before it occurs. 

DATES: This final rule is effective August 

20, 2010. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPPT–2008–0483. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

the EPA Docket Center (EPA/DC) at Rm. 

3334, EPA West Bldg., 1301 

Constitution Ave., NW., Washington, 

DC. The EPA/DC Public Reading Room 

hours of operation are 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

legal holidays. The telephone number of 

the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Peter 

Gimlin, National Program Chemicals 

Division (7404T), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (202) 566– 

0515; e-mail address: 

gimlin.peter@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; e-mail address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you manufacture (defined 

by statute to include import) or process 

elemental mercury used in flow meters, 

natural gas manometers, or pyrometers. 

Potentially affected entities may 

include, but are not limited to, 

manufacturers of instruments and 

related products for measuring, 

displaying, and controlling industrial 

process variables (North American 

Industrial Classification System 

(NAICS) code 334513). This listing is 

not intended to be exhaustive, but rather 

provides 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 

NAICS codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

40 CFR 721.5 for SNUR-related 

obligations. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. Persons who import 

any chemical substance governed by a 

final SNUR are subject to the TSCA 

section 13 (15 U.S.C. 2612) import 

certification requirements and the 

corresponding regulations at 19 CFR 

12.118 through 12.127 and 19 CFR 

127.28. Those persons must certify that 

the shipment of the chemical substance 

complies with all applicable rules and 

orders under TSCA, including any 

SNUR requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. In 

addition, TSCA section 12(b) (15 U.S.C. 

2611(b)) export notification 

requirements are triggered by 

publication of a proposed SNUR. 

Therefore, on or after October 11, 2009, 

any persons who export or intend to 

export elemental mercury are subject to 

the export notification provisions of 

TSCA section 12(b) (see 40 CFR 721.20) 

and must comply with the export 

notification requirements in 40 CFR part 

707, subpart D. EPA also notes that, 

pursuant to the Mercury Export Ban Act 

of 2008 (Pub. L. 110–414), the export of 

elemental mercury from the United 

States will be prohibited as of January 

1, 2013, unless an exemption is 

obtained under TSCA section 12(c)(4). 

II. Background 

A. What Action is the Agency Taking? 

EPA proposed this SNUR for 

elemental mercury used in flow meters, 

natural gas manometers, and pyrometers 

on September 11, 2009 (74 FR 46707) 

(FRL–8432–3). EPA’s response to public 

comments received on the proposed 

rule appear in Unit III.C. Please consult 

the September 11, 2009, Federal 

Register document for further 

background information for this final 

rule. 

This final SNUR will require persons 

to notify EPA at least 90 days before 

commencing the manufacture, import, 

or processing of elemental mercury for 

any of the following significant new 

uses: Flow meters, natural gas 

manometers, or pyrometers. This rule 

does not affect the manufacturing and 

processing of elemental mercury for use 

in these articles when they are in 

service as of September 11, 2009. EPA 


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