11494 Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Rules and Regulations 

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: February 12, 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 180.361 is amended by 

revising paragraph (b) to read as follows: 

§ 180.361 Pendimethalin; tolerances for 

residues 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

combined residues of the herbicide 

pendimethalin, [N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine], and 

its metabolite 4-[(1-ethylpropyl)amino]- 

2-methyl-3,5-dinitrobenzyl alcohol, 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 

Bermuda grass, forage ................................................................................................................................ 25 12/31/09 

Bermuda grass, hay .................................................................................................................................... 60 12/31/09 

* * * * * 

[FR Doc. E9–5831 Filed 3–17–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0936; FRL–8402–8] 

Pyraclostrobin; Pesticide Tolerances 

for Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for combined 

residues of pyraclostrobin and its 

desmethoxy metabolite in or on 

sugarcane, cane and sugarcane, 

molasses. This action is in response to 

EPA’s granting of an emergency 

exemption under section 18 of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) authorizing 

use of the pesticide on sugarcane. This 

regulation establishes a maximum 

permissible level for residues of 

pyraclostrobin and its desmethoxy 

metabolite in these food. The timelimited tolerances expire and are 

revoked on December 31, 2011. 

DATES: This regulation is effective 

March 18, 2009. Objections and requests 

for hearings must be received on or 

before May 18, 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–2008–0936. All documents in the 

docket are listed in the docket index 

available in 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: 

Libby Pemberton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9364; e-mail address: 

pemberton.libby@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: 

• 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 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 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 40 CFR part 180 

through the Government Printing 

Office’s e-CFR cite at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 


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Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Rules and Regulations 11495 

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. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2008–0936 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 

on or before May 18, 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 

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 your 

copies, identified by docket ID number 

EPA–HQ–OPP–2008–0936, 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. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 

408(l)(6) of FFDCA, 21 U.S.C. 346a(e) 

and 346a(1)(6), is establishing timelimited 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]phenylcarbamate, 

expressed as parent compound, in or on 

sugarcane, cane at 0.02 parts per million 

(ppm) and sugarcane, molasses at 0.4 

ppm. These time-limited tolerances 

expire and are revoked on December 31, 

2011. EPA will publish a document in 

the Federal Register to remove the 

revoked tolerances from the CFR. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on section 18 related timelimited tolerances to set binding 

precedents for the application of section 

408 of FFDCA and the new safety 

standard to other tolerances and 

exemptions. Section 408(e) of FFDCA 

allows EPA to establish a tolerance or an 

exemption from the requirement of a 

tolerance on its own initiative, i.e., 

without having received any petition 

from an outside party. 

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. . . .’’ 

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’ 

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemption for 

Pyraclostrobin on Sugarcane, cane and 

Sugarcane, molasses and FFDCA 

Tolerances 

Florida and Louisiana declared a 

crisis exemption under FIFRA section 

18 for the use of pyraclostrobin on 

sugarcane for control of Orange Rust 

(Puccinia Keuhnii) and/or Brown Rust 

(Puccinia melanocephala). EPA concurs 

that emergency conditions exist for 

these States, and that the criteria for an 

emergency exemption are met. 

As part of its evaluation of the 

emergency exemption application, EPA 

assessed the potential risks presented by 

residues of pyraclostrobin in or on 

sugarcane, cane and sugarcane, 

molasses. In doing so, EPA considered 

the safety standard in section 408(b)(2) 

of FFDCA, and EPA decided that the 

necessary tolerance under section 

408(l)(6) of FFDCA would be consistent 

with the safety standard and with 

FIFRA section 18. Consistent with the 

need to move quickly on the emergency 

exemption in order to address an urgent 

non-routine situation and to ensure that 

the resulting food is safe and lawful, 

EPA is issuing this tolerance without 

notice and opportunity for public 

comment as provided in section 

408(l)(6) of FFDCA. Although these 

time-limited tolerances expire and are 

revoked on December 31, 2011, under 

section 408(l)(5) of FFDCA, residues of 

the pesticide not in excess of the 

amounts specified in the tolerance 

remaining in or on sugarcane, cane and 

sugarcane, molasses. after that date will 

not be unlawful, provided the pesticide 

was applied in a manner that was lawful 

under FIFRA, and the residues do not 

exceed a level that was authorized by 

these time-limited tolerances at the time 

of that application. EPA will take action 

to revoke these time-limited tolerances 

earlier if any experience with, scientific 

data on, or other relevant information 

on this pesticide indicate that the 

residues are not safe. 

Because these time-limited tolerances 

are being approved under emergency 

conditions, EPA has not made any 

decisions about whether pyraclostrobin 

meets FIFRA’s registration requirements 

for use on sugarcane, cane and 

sugarcane, molasses or whether 

permanent tolerances for this use would 

be appropriate. Under these 

circumstances, EPA does not believe 

that this time-limited tolerance decision 

serves as a basis for registration of 

pyraclostrobin by a State for special 

local needs under FIFRA section 24(c). 

Nor does this tolerance serve as the 

basis for persons in any State other than 

Florida and Louisiana to use this 

pesticide on these crops under FIFRA 

section 18 absent the issuance of an 

emergency exemption applicable within 

that State. For additional information 

regarding the emergency exemption for 

pyraclostrobin, contact the Agency’s 

Registration Division at the address 


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provided under FOR FURTHER

INFORMATION CONTACT. 

IV. 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 the factors specified 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure expected as a result 

of this emergency exemption request 

and the time-limited 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]phenylcarbamate, 

expressed as parent compound, in or on 

sugarcane, cane at 0.02 ppm and 

sugarcane, molasses at 0.4 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing timelimited tolerances follows. 

A. 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 

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-term, intermediate-term, 

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 Oats, 

Oilseed Group (Canola and Flax), Plus 

Seed Treatment on Oats, Canola, and 

Flax; Tropical Fruits (Avocado, Black 

Sapote, Canistel, Mamey Sapote, 

Mango; Papaya, Sapodilla, and Star 

Apple);Increased Tolerance on Barley; 

Adding Aerial Application to Turf and 

Ornamentals; and Adding In-Furrow 

Applications to Corn, Soybean, and 

Sugar Beets pages 21 to 23 in docket ID 

number EPA–HQ–OPP–2007–0906– 

0004. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pyraclostrobin, EPA 

considered exposure under the timelimited tolerances established by this 

action 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. EPA identified such an effect 

for the general population (decreased 

body weight gain seen after a single oral 

dose in the rat acute neurotoxicity 

study) and for females 13 to 49 years old 

(increased resorptions/litter and 

increased total resorptions seen in the 

rabbit developmental toxicity study that 

are presumed to occur after a single 

exposure). The aPAD for the general 

population has been established at 3.0 

milligrams/kilogram/day (mg/kg/day); 

whereas, the aPAD for females 13 to 49 

years old is significantly lower (0.05 

mg/kg/day), due to the more sensitive 

endpoint on which it is based. In 

estimating acute dietary exposure, EPA 

used food consumption information 

from the U.S. Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA assumed 

that residues are present at tolerance 

levels or for some commodities 

(amaranth, leafy; arugula; 

chrysanthemum; cress, garden; cress, 

upland; dandelion, leaves; fennel; 

parsley, leaves; radicchio; rhubarb; 

spinach; swiss chard; beans, dry; celery; 

lettuce, head; lettuce, leaf; and pea, dry) 

at the highest residue level found in 

residue field trials. One hundred 

percent crop treated (PCT) was assumed 

for all commodities in the assessment. 

Default processing factors were applied 

to all commodities except those for 

which experimentally-derived 

processing factors were available: Apple 

juice, grape juice, citrus juices, 

cottonseed oil, tomato paste, tomato 

puree, wheat flour, and wheat germ. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

assumed that residues are present at 

tolerance levels in all crops except 

apple, broccoli, celery, collard, grape, 

lettuce, citrus, pepper, mustard green 

and tomato. EPA relied on anticipated 

residues (average residues from field 

trials) for these crops. One hundred PCT 

was assumed for all commodities in the 

assessment. Default processing factors 

were applied to all commodities except 

those for which experimentally-derived 

processing factors were available: Apple 

juice, grape juice, citrus juices, tomato 

paste, tomato puree, wheat flour, and 

wheat germ. 


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iii. Cancer. Based on the results of 

carcinogenicity studies in rats and mice, 

EPA has concluded that pyraclostrobin 

is ‘‘not likely to be carcinogenic to 

humans.’’ Consequently, a quantitative 

cancer exposure and risk assessment is 

not appropriate for pyraclostrobin. 

iv. Anticipated residue information. 

Section 408(b)(2)(E) of FFDCA 

authorizes EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide residues 

that have been measured in food. If EPA 

relies on such information, EPA must 

require pursuant to FFDCA section 

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

after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such Data 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. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

pyraclostrobin in drinking water. 

Because the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the environmental fate 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 (SCI/ 

GROW) models, the estimated 

environmental concentrations (EECs) 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. The EECs for chronic 

exposures 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 riskassessment, the 

water concentration value of 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 residential non-dietary 

sites: Residential and recreational turf 

grass. 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-term 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; therefore, a 

separate exposure assessment for 

recreational turf sites was not 

conducted. EPA assessed exposures 

from the following residential turf post 

application scenarios: 

i. Adult and toddler post application 

dermal exposure from contact with 

treated lawns 

ii. Toddlers’ incidental ingestion of 

pesticide residues on lawns from handto-mouth transfer 

iii. Toddlers’ object-to-mouth transfer 

from mouthing of pesticide-treated turf 

grass, and: 

iv. 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 (SOPs) 

and recommended approaches of the 

Health Effects Division’s (HED’s) 

Science Advisory Council for Exposure 

(Expo SAC). 

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 the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

C. Safety Factor for Infants and Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional SF 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. 

There was no evidence of increased 

quantitative or qualitative susceptibility 

of in utero rats or offspring following 

exposure to pyraclostrobin in the rat 

developmental and reproduction 

studies. In the rabbit developmental 

study, there was evidence of increased 

qualitative susceptibility of in utero 

rabbits following exposure to 

pyraclostrobin (increases in resorptions/ 

litter and post-implantation losses). 

However, this qualitative susceptibility 

seen in the rabbit developmental study 

does not indicate a heightened risk for 

infants or children because: The 

developmental effects were seen in the 

presence of maternal toxicity; there are 

clear NOAELs for maternal and 

developmental toxicities; and this 

endpoint is used in the acute dietary 

reference dose (RfD) exposure 

assessment for females, 13 years and 

older, as well as for short-term and 

intermediate-term dermal risk 

assessments. 

3. Conclusion. EPA has determined 

that reliable data show that it would be 

safe for infants and children to reduce 

the FQPA safety factor to 1X. This 


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determination was exhaustively 

discussed in a prior order concerning 

pyraclostrobin, September 12, 2007 (72 

FR 52108) (FRL–8144–4). In summary, 

the safety factor decision is based on the 

following findings: 

i. The toxicity database for 

pyraclostrobin is complete. 

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 

susceptibility in utero rats in the 

prenatal developmental study orin 

young rats in the 2-generation 

reproduction study. Although there is 

qualitative evidence of increased 

susceptibility in the prenatal 

developmental 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 toxicity is low. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues or anticipated 

residues derived from reliable field trial 

data. Conservative ground water and 

surface water modeling estimates were 

used. Similarly, conservative 

assumptions were used to assess postapplication dermal exposure of children 

as well as incidental oral exposure of 

toddlers. These assessments will not 

underestimate the exposure and risks 

posed by pyraclostrobin. 

D. 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. Shortterm, intermediate-term, and chronicterm 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 80% of the 

aPAD for (females 13–49 years) 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 48% of 

the cPAD for (children 1–2 years,) the 

population group receiving the greatest 

exposure. Based on the explanation in 

the unit 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 food and water and 

short-term exposures for pyraclostrobin. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that the 

aggregated food, water, and residential 

exposures result in aggregate MOEs of 

200 for adults and 100 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, post-application dermal and 

incidental oral exposures from entering 

turf are as previously treated with 

pyraclostrobin. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account 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 food and water and 

intermediate-term exposures for 

pyraclostrobin. Since the endpoints and 

points of departure NOAELs are 

identical for short-term and 

intermediate-term exposures, the 

aggregate MOEs for intermediate-term 

exposure are the same as those for shortterm exposure (200 for adults and 100 

for children, 1 to 2 years old). 

5. Aggregate cancer risk for U.S. 

population. EPA has classified 

pyraclostrobin into the category ‘‘Not 

Likely to be Carcinogenic to Humans.’’ 

Pyraclostrobin is not expected to pose a 

cancer risk. 

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. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Two adequate enforcement 

methodologies (a Liquid 

Chromatography/Mass Spectrometry 

(LC/MS/MS) method (BASF Method 

D9808), and a High Performance Liquid 

Chromatography using Untraviolet 

Detection (HPLC/UV) method (BASF 

Method D9904)) are available to enforce 

the tolerance expression in/on plant 

commodities. Two more adequate 

methods have also been proposed for 

enforcing tolerances for livestock 

commodities: HPLC/UV method 439/0 

and method 446 (consisting of CAS 

Chromatography/Mass Spectroscopy 

(GC/MS) method 446/0 and LC/MS/MS 

method 446/1) The methods 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 

No Codex maximum residue levels 

have been established for residues of 

pyraclostrobin in or on these 

commodities. 

VI. Conclusion 

Therefore, time-limited tolerances are 

established for combined residues of the 

fungicide, pyraclostrobin; carbamic 

acid, [2-[[[1-(4-chlorophenyl)-1Hpyrazol-3- 

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

ester and its desmethoxy metabolite; 

(methyl-N-[[[1-(4-chlorophenyl)-1Hpyrazol-3- 

yl]oxy]methyl]phenylcarbamate, 

expressed as parent compound, in or on 

sugarcane, cane at 0.02 ppm and 

sugarcane, molasses at 0.4 ppm. These 

tolerances expire and are revoked on 

December 31, 2011. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under sections 408(e) and 408(l)(6) 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 


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Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Rules and Regulations 11499 

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 in accordance with 

sections 408(e) and 408(l)(6) 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). 

VIII. 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: February 24, 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 commodities to 

the table in paragraph (b) to read as 

follows: 

§ 180.582 Pyraclostrobin; tolerances for 

residues. 

* * * * * 

(b) *** 

Commodity Parts per million Expiration/revocation date 

*****

Sugarcane, cane .................................................................................................. 0.02 December 31, 2011 

Sugarcane, molasses .......................................................................................... 0.4 December 31, 2011 

* * * * * 

[FR Doc. E9–5834 Filed 3–17–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0794; FRL–8399–5] 

Formaldehyde, Polymer with 2- 

Methyloxirane and 4-Nonylphenol; 

Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of formaldehyde, 

polymer with 2-methyloxirane and 4- 

nonylphenol (CAS Reg. No. 37523–33– 

4); when used as an inert ingredient in 

a pesticide chemical formulation. Akzo 

Nobel Surface Chemistry, LLC, 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of formaldehyde, polymer 

with 2-methyloxirane and 4- 

nonylphenol on food or feed 

commodities. 

DATES: This regulation is effective 

March 18, 2009. Objections and requests 

for hearings must be received on or 

before May 18, 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–2008–0794. 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 


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