51490 Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / 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: September 25, 2009. 

Lois Rossi, 

Acting Director, 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 180.463 is amended by 

revising paragraph (b) to read as follows: 

§ 180.463 Quinclorac; tolerances for 

residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

residues of quinclorac, 3,7-dichloro-8- 

quinolinecarboxylic acid in or on the 

specified agricultural commodities, 

resulting from use of the pesticide 

pursuant to FIFRA section 18 

emergency exemptions. The tolerances 

expire and are revoked on the date 

specified in the table. 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Cranberry .......... 15.0 12/31/12 

* * * * * 

[FR Doc. E9–24188 Filed 10–06–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0713; FRL–8793–2] 

Pyraclostrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

pyraclostrobin and its desmethoxy 

metabolite, expressed as parent 

compound, in or on coffee, bean, green 

at 0.3 parts per million (ppm; this is a 

new import tolerance); fruit, stone, 

group 12 at 2.5 ppm (this is an increase 

in the existing domestic tolerance); 

sorghum, grain, forage at 5.0 ppm; 

sorghum, grain, grain at 0.60 ppm; and 

sorghum, grain, stover at 0.80 ppm (the 

sorghum tolerances are new domestic 

tolerances). BASF Corporation 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

October 7, 2009. Objections and 

requests for hearings must be received 

on or before December 7, 2009, 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–2008–0713. 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: John 

Bazuin, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7381; e-mail address: 

bazuin.john@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may potentially be 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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also 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. 

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gov/opptsfrs/home/ 

guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2008–0713 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before December 7, 2009. 

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 


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Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 51491 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0713, 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. Petition for Tolerance 

In the Federal Register of December 3, 

2008 (73 FR 73644) (FRL–8386–9), EPA 

issued a notice pursuant to section 

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

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

pesticide petitions (PP 8F7385, 8F7390, 

and 8E7394) by BASF Corporation, 26 

Davis Drive, Research Triangle Park, NC 

27709. The petition requested that 40 

CFR 180.582 be amended by 

establishing tolerances for combined 

residues of the fungicide pyraclostrobin, 

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

1H- pyrazol-3- 

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

ester) and its desmethoxy metabolite 

(methyl N-[[[1-(4-chlorophenyl)-1Hpyrazol-3-yl]oxy]methyl]phenyl 

carbamate, expressed as parent 

compound, in or on coffee, bean, green 

at 0.5 ppm (PP#8E7394; a new import 

tolerance); fruit, stone, group 12 at 2.5 

ppm (8F7390; an increase in the existing 

domestic tolerance); sorghum, grain at 

0.5 ppm (PP#8F7385; a new domestic 

tolerance); sorghum, forage at 5.0 ppm 

(PP#8F7385; a new domestic tolerance); 

and sorghum, stover at 0.8 ppm 

(PP#8F7385; a new domestic tolerance). 

That notice referenced a summary of the 

petition prepared by BASF Corporation, 

the registrant, which is available to the 

public 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 

reduced the proposed pyraclostrobin 

tolerance for coffee, bean, green from 0.5 

ppm to 0.3 ppm and has increased the 

proposed tolerance for sorghum, grain, 

grain (termed sorghum, grain in 

PP#8F7385) from 0.5 ppm to 0.60 ppm. 

The reasons for these changes are 

explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’ 

Consistent with 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 to the petitioned-for 

tolerances for combined residues of 

pyraclostrobin (carbamic acid, [2-[[[1-(4- 

chlorophenyl)-1H- pyrazol-3- 

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

ester) and its desmethoxy metabolite 

(methyl N-[[[1-(4-chlorophenyl)-1Hpyrazol-3-yl]oxy]methyl]phenyl 

carbamate), expressed as parent 

compound, in or on coffee, bean, green 

at 0.3 ppm; fruit, stone, group 12 at 2.5 

ppm; sorghum, grain, forage at 5.0 ppm; 

sorghum, grain, grain at 0.60 ppm; and 

sorghum, grain, stover at 0.80 ppm. 

EPA’s assessment of exposures and risks 

associated with establishing tolerances 

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\kil0gram (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 noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http:// 

www.regulations.gov in the document 

Revised Pyraclostrobin: Human Health 

Risk Assessment for Proposed Uses on 

Cotton and Belgian Endive, page 15 in 

docket ID number EPA–HQ–OPP–2006– 

0522–004. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 


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with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

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 greater than that 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), 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 percent 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 derived 

processing factors were used for fruit 

juices, tomato, and wheat commodities 

but for all other processed commodities 

Dietary Exposure Evaluation Model 

(DEEM) 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 tolerance-level 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 used PCT information as 

follows: 

Commodity PCT 

Almond 35 

Apple 10 

Apricot 10 

Barley 1 

Black bean seed 5 

Broad bean 

(succulent) 2.5 

Broad bean 

seed 5 

Cowpea (succulent) 2.5 

Cowpea seed 5 

Great northern 

bean seed 5 

Kidney bean 

seed 5 

Lima bean (succulent) 2.5 

Lima bean seed 5 

Mung bean seed 5 

Navy bean seed 5 

Pink bean seed 5 

Pinto bean seed 5 

Snap bean (succulent) 2.5 

Sugar beet 35 


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Commodity PCT 

Blackberry 20 

Blueberry 20 

Broccoli 5 

Cabbage 10 

Napa cabbage 10 

Chinese mustard 

cabbage 10 

Cantaloupe 15 

Carrot 25 

Celery 2.5 

Cherry 30 

Field corn 5 

Pop corn 5 

Sweet corn 5 

Cucumber 5 

Currant 5 

Filbert 10 

Garlic 10 

Grape 25 

Grapefruit 25 

Head lettuce 5 

Leaf lettuce 5 

Nectarine 15 

Dry bulb onion 15 

Green onion 15 

Orange 5 

Succulent pea 5 

Pigeon pea 

(succulent) 5 

Peach 15 

Peanut 25 

Pear 10 

Pecan 2.5 

Bell pepper 10 

Non-bell pepper 10 

Pistachio 25 

Plum 5 

Potato 10 

Pumpkin 20 

Commodity PCT 

Raspberry 35 

Soybean 5 

Spinach 10 

Summer squash 10 

Winter squash 10 

Strawberry 50 

Tangerine 15 

Tomato 20 

Watermelon 30 

Wheat 5 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6 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 pyralostrobin may be applied in 

a particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for 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 


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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: 

i. Short-/intermediate-term adult and 

toddler post-application dermal 

exposure from contact with treated 

lawns, 

ii. Short-/intermediate-term toddlers’ 

incidental ingestion of pesticide 

residues on lawns from hand-to-mouth 

transfer, 

iii. Short-/intermediate-term toddlers’ 

object-to-mouth transfer from mouthing 

of pesticide-treated turfgrass, and 

iv. 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 

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 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 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 rabbits, 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 (OPPTS 

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 and, other than the high-dose 

thymus effects seen in the 90–day 

mouse study, no significant evidence of 

pyraclostrobin-induced immunotoxicity 

was demonstrated in the studies 

conducted either in adult animals or in 

the offspring following prenatal and 

postnatal exposures. Increased spleen 

weights observed in 28–day rat studies 

were accompanied by mild hemolytic 

anemia (a hematopoi-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/day. A 

similar conclusion was reached in an 

earlier action on pyraclostrobin. (See 72 

FR 52108, September 12, 2007). 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 safety factors to account for 

neurotoxicity. 

iii. There is no evidence that 

pyraclostrobin 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. 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 prenatal and/or postnatal 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 PCT. The chronic 

dietary food exposure assessments were 

performed using tolerance-level or 

average field trial residues and 100 PCT 

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. Similarly, residential standard 

operating procedures were used to 

assess post-application dermal exposure 


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Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 51495 

of children as well as incidental oral 

exposure of toddlers. 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 13–49 years old, and 

2.5% 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 1–2 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- and intermediateterm residential exposures to 

pyraclostrobin. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that the 

combined short-term food, water, and 

residential exposures aggregated result 

in aggregate MOEs of 230 for adults and 

120 for children 1–2 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 to pyraclostrobin through food 

and water with intermediate-term 

exposures for 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 

aggregated result in aggregate MOEs of 

230 for adults and 120 for children 1– 

2 years old. The endpoints and points 

of departure (NOAELs) are identical for 

short- and intermediate-term exposures, 

so the aggregate MOEs for intermediateterm exposure are the same as those for 

short-term exposure. 

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 

pyraclostrobin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Two adequate methods were 

proposed for enforcing the tolerances for 

residues of pyraclostrobin and its 

desmethoxy metabolite in/on plant 

commodities: A liquid chromatography/ 

mass spectrometry/mass spectrometry 

(LC/MS/MS) method (BASF Method 

D9908), and a high pressure liquid 

chromatography/ultraviolet (HPLC/UV) 

method (BASF Method D9904). The 

validated method level of quantitation 

(LOQ) for both pyraclostrobin and its 

desmethoxy metabolite is 0.02 ppm in 

all tested plant matrices, for a combined 

LOQ of 0.04 ppm. Adequate 

independent method validation and 

radiovalidation data were submitted for 

both methods. Following the standard 

operating procedure for reviewing 

tolerance methods, EPA has determined 

that Method D9904 is suitable as an 

enforcement method. 

Adequate enforcement methodology 

is available to enforce the tolerance 

expression. The method (D9904) may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

The Codex Alimentarius Commission 

(CAC) has established maximum residue 

limits (MRLs) for residues of 

pyraclostrobin on stone fruit and coffee 

beans. However, the residue definitions 

for pyraclostrobin differ in the CAC 

MRLs and United States tolerances. The 

CAC definition contains parent only, 

whereas the United States residue 

definition includes a metabolite. EPA is 

unwilling to modify the residue 

definition for the United States 

tolerance because both parent and its 

metabolite are major residues in crop 

matrices and are measured by the 

enforcement method. Additionally, the 

CAC MRL and United States tolerance 

values differ for stone fruit. They are the 

same for coffee beans. The CAC value 

for stone fruits of 1 ppm is based on 

evaluation of United States residue data 

for cherries, where the highest residue 

was 0.63 ppm. This action sets a United 

States tolerance of 2.5 ppm based on 

results from new trials conducted in 

2007 on cherries, peaches, and plums 

using a water dispersible granule 

formulation containing pyraclostrobin 

and boscalid. Use of this particular 

formulation requires an increase in the 

United States tolerance from its present 

value of 0.9 ppm (40 CFR 180.582) 

because measured residues were as high 

as 1.9 ppm. For this reason the United 

States tolerance value cannot be 

harmonized with the CAC MRL. Canada 

has established tolerances for various 

stone fruits at 0.7 ppm. The United 

States and Canadian residue definitions 

are the same; however, the United States 

tolerance for stone fruits being set in 

this action is higher than the Canadian 

tolerances for individual stone fruit 

commodities because of the new 

formulation uses of pyraclostrobin in 

the United States that result in higher 

residues in stone fruits. 

C. Revisions to Petitioned-For 

Tolerances 

EPA reduced the pyraclostrobin 

tolerance for coffee, bean, green from 0.5 

ppm, as proposed by BASF Corporation, 


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51496 Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 

to 0.3 ppm because the Agency’s 

tolerance spreadsheet determined that 

the lower value was more appropriate 

based on the field trial data. EPA 

increased the tolerance for sorghum, 

grain, grain (termed sorghum, grain in 

PP#8F7385) from 0.5 ppm to 0.60 ppm 

because the Agency’s tolerance 

spreadsheet determined that the higher 

value was more appropriate based on 

the field trial data. 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of pyraclostrobin 

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

1H- pyrazol-3- 

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

ester) and its desmethoxy metabolite 

(methyl N-[[[1-(4-chlorophenyl)-1Hpyrazol-3-yl]oxy]methyl]phenyl 

carbamate), expressed as parent 

compound, in or on coffee, bean, green 

at 0.3 ppm; fruit, stone, group 12 at 2.5 

ppm; sorghum, grain, forage at 5.0 ppm; 

sorghum, grain, grain at 0.60 ppm; and 

sorghum, grain, stover at 0.80 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 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 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: September 25, 2009. 

Lois 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 by 

alphabetically adding the following 

commodities to the table and by revising 

fruit, stone, group 12 in the table in 

paragraph (a)(1) read as follows: 

180.582 Pyraclostrobin; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

* * * * * 

Coffee, bean, green .................. 0.31

* * * * * 

Fruit, stone, group 12 ............... 2.5 

* * * * * 

Sorghum, grain, forage ............. 5.0 

Sorghum, grain, grain ............... 0.60 

Sorghum, grain, stover ............. 0.80 

* * * * * 

1There is no U.S. registration on coffee, 

bean, green as of September 30, 2009. 

* * * * * 

[FR Doc. E9–24058 Filed 10–06–09; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 412, 413, 415, 485, and 

489 

[CMS–1406–CN] 

RINs 0938–AP33; 0938–AP39; 0938–AP76 

Medicare Program; Changes to the 

Hospital Inpatient Prospective 

Payment Systems for Acute Care 

Hospitals and Fiscal Year 2010 Rates 

and to the Long-Term Care Hospital 

Prospective Payment System and Rate 

Year 2010 Rates; Corrections 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Correction of final rules and 

interim final rule with comment period. 

SUMMARY: This document corrects 

technical errors and typographical 

errors that appeared in the final rules 

and interim final rule with comment 


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