Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Rules and Regulations 29901 

available and applicable voluntary 

consensus standards. 

The requirements of section 12(d) of 

the NTTAA do not apply because this 

rule does not involve technical 

standards. Therefore, EPA did not 

consider the use of any voluntary 

consensus standards. 

J. Executive Order 12898 (Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations) 

Executive Order (EO) 12898 (59 FR 

7629 (Feb. 16, 1994)) establishes Federal 

executive policy on environmental 

justice. Its main provision directs 

Federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority 

populations and low-income 

populations in the United States. 

EPA has determined that this final 

rule will not have disproportionately 

high and adverse human health or 

environmental effects on minority or 

low-income populations because it does 

not affect the level of protection 

provided to human health or the 

environment. As explained above, EPA 

has approved Pennsylvania’s 

antidegradation policy because it is 

consistent with 40 CFR 131.12. This 

rule withdraws a redundant 

antidegradation policy. 

K. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, 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 the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). This rule 

will be effective on June 28, 2010. 

List of Subjects in 40 CFR Part 131 

Environmental protection, 

Antidegradation, Water quality 

standards. 

Dated: May 21, 2010. 

Lisa P. Jackson, 

Administrator. 

■ For the reasons set out in the 

preamble, title 40, chapter I of the Code 

of Federal Regulations is amended as 

follows: 

PART 131—WATER QUALITY 

STANDARDS 

■ 1. The authority citation for part 131 

continues to read as follows: 

Authority: 33 U.S.C. 1251 et seq. 

§ 131.32 [Removed and Reserved] 

■ 2. Section 131.32 is removed and 

reserved. 

[FR Doc. 2010–12933 Filed 5–27–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0268; FRL–8826–4] 

Boscalid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of boscalid in or 

on multiple commodities which are 

identified and discussed later in this 

document. This regulation additionally 

revises established tolerances in or on 

fruit, stone, group 12; hog, fat; poultry, 

fat; and poultry, meat byproducts. 

Finally, this regulation deletes the timelimited tolerance on tangerine as it 

expired on December 31, 2008. BASF 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

28, 2010. Objections and requests for 

hearings must be received on or before 

July 27, 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–2009–0268. 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: 

Shaja Joyner, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–3194; e-mail address: 

joyner.shaja@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 www.gpoaccess.gov/ecfr. 

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29902 Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Rules and Regulations 

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–2009–0268 on 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 July 27, 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–2009–0268, 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 August 19, 

2009 (74 FR 41898) (FRL–8426–7), 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 9F7527 and PP 

9F7529 by BASF Corporation, Research 

Triangle Park, NC 27709. PP 9F7527, 

which was incorrectly written as PP 

9F7529 in the notice, requested that 40 

CFR 180.589 be amended by 

establishing tolerances for residues of 

the fungicide boscalid, 3- 

pyridinecarboxamide, 2-chloro-N-(4’- 

chloro[1,1′-biphenyl]-2-yl), in or on 

alfalfa, forage at 35 part per million 

(ppm); alfalfa, hay at 85 ppm; and 

citrus, crop group 10 at 2 ppm. PP 

9F7529 requested to increase the 

existing tolerance in or on fruit, stone, 

group 12 from 1.7 ppm to 5 ppm. That 

notice referenced a summary of the 

petition prepared by BASF Corporation, 

the registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

several proposed tolerances and has 

determined that separate tolerances are 

necessary for citrus, dried pulp and 

citrus, oil. The Agency has also revised 

several established livestock 

commodities. Finally, EPA has revised 

the tolerance expression for all 

established commodities to be 

consistent with current Agency policy. 

The reasons for these changes are 

explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . . ’’ 

Consistent with 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 boscalid 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with boscalid 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. 

Boscalid has low acute toxicity via the 

oral, dermal, and inhalation routes of 

exposure, and it is not an eye or skin 

irritant. Following subchronic and 

chronic exposure to boscalid, the liver 

and thyroid appeared to be the target 

organs in several species. In mice, 

subchronic exposure to boscalid 

resulted in increased liver weights and 

an increased incidence of marked fatty 

changes in the liver. Subchronic and 

chronic studies in dogs resulted in 

increases in alkaline phosphatase levels 

as well as hepatic weights. In 

subchronic and chronic studies in rats, 

thyroid changes (including increases in 

weights and incidences of follicular cell 

hyperplasia and hypertrophy) were 

considered to have been the result of 

liver adaptive responses. Additionally, 

in three mechanistic rat studies, 

increases in liver microsomal activity, 

induction of total cytochrome P450 

activity, and disruption of thyroid 

homeostasis (by decreasing circulating 

T3 and T4 and increasing TSH resulting 

from hepatic microsomal 

glucuronyltransferase) were noted. The 

liver and thyroid effects were reversed 

with the cessation of test article 

administration. 

In the rabbit developmental toxicity 

study, abortions and early deliveries 

were observed in at the highest dose 

tested. Decreased pup body weights 

and/or body weight gains were noted in 

both the 2-generation reproductive 

toxicity study in rats and in the rat 

developmental neurotoxicity (DNT) 

study at a level that did not induce 

parental toxicity. 

In two chronic/carcinogenicity 

studies in rats that were assessed 

together, statistically significant 

increases in thyroid follicular cell 

adenomas and significant differences in 

a pair-wise comparison with the 

controls were noted in males; thyroid 

hypertrophy and hyperplasia of 

follicular cells, as well as increased 

thyroid weights and mechanistic data 

were also noted. Female rats exhibited 

a slightly significant increase in thyroid 

follicular cell adenomas in these 

studies. A carcinogenicity study in mice 

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showed no evidence of tumor formation 

in either sex, and no evidence of 

malignancies or mutagenicity was found 

in the toxicity database for boscalid. 

Based on the overall weak evidence of 

carcinogenic effects, EPA has classified 

boscalid as having suggestive evidence 

of carcinogenicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by boscalid 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: 

‘‘Boscalid. Human Health Risk 

Assessment for Proposed Use on Alfalfa 

and Citrus (Crop Group 10), and for 

Proposed Increase in Tolerance on 

Stone Fruits (Crop Group 12).’’ Pages 

41–44 in docket ID number EPA–HQ– 

OPP–2009–0268. 

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 boscalid used for human 

risk assessment is shown in Table 1 of 

this unit. 

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

ASSESSMENT

Exposure/Scenario Point of Departure and Uncertainty/Safety Factors 

RfD, PAD, LOC for Risk 

Assessment Study and Toxicological Effects 

Acute dietary (Females 13–50 

years of age; and general population including infants and children) 

No appropriate endpoint attributable to a single dose was available in the current database, including 

the developmental toxicity studies. Therefore, an aRfD and aPAD were not established for any population. 

Chronic dietary 

(All populations) 

NOAEL = 21.8 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.218 mg/ 

kg/day 

cPAD = 0.218 mg/kg/day 

Combined results of chronic rat, carcinogenicity rat, and 1–year dog studies 

LOAEL = 57 mg/kg/day based on liver and 

thyroid effects 

Dermal short-term 

(1 to 30 days) 

Dermal (or oral) study 

NOAEL = 21.8 mg/kg/ 

day (dermal absorption 

rate = 15%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Combined results of chronic rat, carcinogenicity rat, and 1–year dog studies 

LOAEL = 57 mg/kg/day based on liver and 

thyroid effect. 

Cancer (Oral, dermal, inhalation) Classification: Suggestive evidence of carcinogenicity. The cRfD is protective of cancer effects. Quantification of human cancer risk is not necessary. 

UFA = extrapolation from animal to human (interspecies). 

UFH = potential variation in sensitivity among members of the human population (intraspecies). 

FQPA SF = Food Quality Protection Act Safety Factor. 

PAD = population adjusted dose (a = acute, c = chronic). 

RfD = reference dose. 

MOE = margin of exposure. 

LOC = level of concern. 

Additional information regarding the 

toxicological endpoints for boscalid 

used for human risk assessment can be 

found at http://www.regulations.gov in 

docket ID numbers EPA–HQ–OPP– 

2009–0268 and EPA–HQ–OPP–2005– 

0145. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to boscalid, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

boscalid tolerances in 40 CFR 180.589. 

EPA assessed dietary exposures from 

boscalid 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. No such effects were 

identified in the toxicological studies 

for boscalid; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the food 

consumption data 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 utilized 

tolerance-level residues and assumed 

100 percent crop treated (PCT) data for 

all commodities. 

iii. Cancer. As discussed in Unit 

III.A., EPA has classified boscalid as 

having suggestive evidence of 

carcinogenicity due to some evidence of 

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29904 Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Rules and Regulations 

thyroid follicular cell adenomas in male 

and female rats. Nonetheless, EPA 

concluded that the cPAD would be 

protective of these effects based on the 

following: 

The adenomas occurred at dose levels 

above the level used to establish the 

cPAD, statistically significant increases 

were only seen for benign tumors 

(adenomas) and not for malignant ones 

(carcinomas), the increase in adenomas 

in females was slight, and there was no 

concern for mutagenicity. EPA’s 

estimate of chronic exposure as 

described above is relied upon to 

evaluate whether any exposure could 

exceed the cPAD and thus pose a cancer 

risk. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for boscalid. 

Tolerance level residues or 100 PCT 

were assumed for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for boscalid in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of boscalid. 

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 First Index Reservoir 

Screening Tool (FIRST) and Screening 

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

water concentrations (EDWCs) of 

boscalid for chronic exposures for noncancer assessments are estimated to be 

29.6 parts per billion (ppb) for surface 

water and 0.63 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 29.6 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). 

Boscalid is currently registered for use 

on turf at golf courses and for use on 

several fruit commodities at ‘‘pick-yourown’’ (PYO) farms and orchards; 

therefore, post-application exposure to 

golfers and people harvesting fruit at 

PYO farms and orchards is possible. 

EPA assessed residential exposure using 

the following assumptions: For adult 

and adolescent (12 years of age or older) 

golfers, short-term post-application 

dermal exposure to turf treated with 

boscalid was assessed. PYO activities 

may result in potential acute postapplication exposure to boscalid; 

however, because no adverse effects 

were noted in the boscalid toxicity 

database resulting from a single 

exposure to the chemical, a postapplication exposure and risk 

assessment is not necessary for this 

scenario. Further information regarding 

EPA standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

EPA also notes that while adolescents 

are likely to represent the vast majority 

of youth who play golf on a routine 

basis, it is possible for younger children 

(less than 12 years old) to be exposed to 

golf course turf that has been treated 

with boscalid. However, assessing risk 

for younger golfers is difficult because 

of the uncertainties associated with the 

extrapolation of adult dermal exposure 

data and because of the increased 

likelihood of other behaviors that might 

contribute to exposure, such as 

incidental oral exposure resulting from 

contact with treated turf. Therefore, 

younger golfers were assessed 

qualitatively for this exposure scenario 

after selecting an appropriate target age 

of 5 years old to assess risk. The surface 

area to body weight ratio (SA/BW) for 

male children, when calculated and 

compared to that of the average adult, 

was found to be approximately 70% 

greater. Based on this parameter alone, 

the exposure to children could be 

almost twice that of the adult golfer; 

however, younger golfers are not 

expected to use the golf course for the 

same length of time as an adult. The 

shorter duration on the golf course for 

younger golfers offsets the higher SA/ 

BW; therefore, risks from short-term 

post-application exposures to young 

golfers are likely to be similar to risks 

for adult golfers. 

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 boscalid to share 

a common mechanism of toxicity with 

any other substances, and boscalid does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

boscalid 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 Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicology 

database for boscalid includes rat and 

rabbit prenatal developmental toxicity 

studies, a 2-generation reproductive 

toxicity study in rats, and a DNT study 

in rats. No qualitative or quantitative 

evidence of increased susceptibility was 

noted in the developmental toxicity 

study in rats. However, in the 2- 

generation reproduction study in rats, 

body weight effects were seen in the 

mid and high doses in the second 

generation male pups. However, the 

degree of concern is low for the 

quantitative evidence of susceptibility 

seen in this study, since the body 

weight effects were seen in only one sex 

and only after dosing for two 

generations. Also, there is a clear 

NOAEL for the body weight effects seen 

in the rat 2-generation reproduction 

study, and EPA is regulating based on 

a POD below where these effects were 

seen. 

In the rat DNT study, transient body 

weight effects were seen in one sex at 

postnatal days 1–4 with the animals 

recovering by postnatal day 11. Body 

weight effects were also seen in the high 

dose, which was the limit dose. The 

degree of concern for these effects is low 

since the effects were either transient in 

nature or occurred at the limit dose, and 

EPA is regulating based on a POD below 

where these effects were seen. In the 

rabbit developmental study there was 

evidence of qualitative sensitivity; 

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Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Rules and Regulations 29905 

however, fetal effects were seen only at 

the limit dose in the presence of 

maternal toxicity. Further, since EPA is 

regulating based on a POD which is an 

order of magnitude below where these 

effects were seen in the rabbit 

developmental study, EPA concludes 

that there is a low degree of concern for 

the qualitative sensitivity evidenced in 

the fetuses in the rabbit developmental 

study. 

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 boscalid is 

complete, except for immunotoxicity 

testing. Recent changes to 40 CFR part 

158 make immunotoxicity testing 

(OPPTS Guideline 870.7800) required 

for pesticide registration; however, the 

existing data are sufficient for endpoint 

selection for exposure/risk assessment 

scenarios, and for evaluation of the 

requirements under the FQPA. The 

available data for boscalid show no 

evidence of treatment-related effects on 

the immune system, and the Agency 

does not believe that conducting an 

immunotoxicity study will result in a 

lower point of departure than currently 

selected for overall risk assessment. 

Therefore, an additional database 

uncertainty factor to account for 

potential immunotoxicity does not need 

to be applied. 

ii. A rat DNT study is available which 

provides no indication that boscalid is 

a neurotoxic chemical, and there is no 

evidence of reproductive or 

developmental neurotoxicity in the 

toxicity database. 

iii. Data involving the testing of young 

animals did show increased quantitative 

sensitivity in the young with regard to 

body weight effects, and qualitative 

sensitivity was seen in one 

developmental study. However, clear 

NOAELs were identified for all of these 

effects. Moreover, the body weight 

effects at the LOAELs in these studies 

were either transient or inconsistent, 

and qualitative sensitivity occurred at 

the limit dose in the presence of 

maternal toxicity. Additionally, EPA is 

regulating based on a POD below where 

these effects are seen. EPA concludes 

that there are no residual uncertainties 

for prenatal and/or postnatal toxicity. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to boscalid in 

drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of adult golfers, 

which is expected to be similar to 

potential post-application exposure of 

children. These assessments will not 

underestimate the exposure and risks 

posed by boscalid. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing 

the estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, boscalid is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to boscalid from 

food and water will utilize 37% 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 boscalid 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). Boscalid 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 

boscalid. 

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 an 

aggregate MOE of 840 for the general 

U.S. population and an aggregate MOE 

of 1,140 for youth (13–19 years old). As 

described above, the level of risk to 

younger golfers is expected to be 

similar. Because EPA’s level of concern 

for boscalid is a MOE of 100 or below, 

these MOEs are not of 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). An 

intermediate-term adverse effect was 

identified; however, boscalid is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

boscalid. 

5. Aggregate cancer risk for U.S. 

population. Based on the discussion in 

Unit III.A., EPA has concluded that the 

cPAD is protective of possible cancer 

effects. Given the results of the chronic 

risk assessment above, cancer risk 

resulting from exposure to boscalid is 

not of concern. 

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 boscalid 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate gas chromatography with 

mass spectrometric detection (GC/MS) 

and GC with electron capture (EC) 

methods are available to enforce 

boscalid tolerances in or on plant and 

livestock commodities, respectively. 

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; email address: residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

There are currently no Codex, 

Canadian, or Mexican MRLs for residues 

of boscalid in or on alfalfa forage, alfalfa 

hay, or citrus fruits. However, there is 

a Codex MRL for stone fruits at 3 ppm 

and a Canadian MRL for stone fruits at 

1.7 ppm. At this time, the revised U.S. 

tolerance on fruit, stone, group 12 at 3.5 

ppm cannot be harmonized because 

residue field trial data support a 

tolerance that is higher than the Codex 

and Canadian MRLs. Codex and 

Canadian MRLs for boscalid also exist 

for various livestock commodities. 

However, because Codex and Canadian 

MRLs on boscalid do not exist for some 

animal feed commodities which have 

U.S. tolerances, the dietary burden of 

boscalid is higher for animals in the 

U.S., and U.S. livestock tolerances 

cannot be harmonized with equivalent 

Codex or Canadian MRLs at this time. 

C. Revisions to Petitioned-For 

Tolerances 

Based on analysis of the data 

supporting the petition, EPA has revised 

the proposed tolerances on alfalfa, 

forage from 35 ppm to 30 ppm; alfalfa, 

hay from 85 ppm to 65 ppm; fruit, 

citrus, group 10 from 2.0 to 1.6 ppm; 

and fruit, stone, group 12 from 5.0 to 3.5 

ppm. The Agency has also determined 

that individual tolerances are necessary 

for citrus, dried pulp at 4.5 ppm; and 

citrus, oil at 85 ppm because boscalid 

residues concentrate in these 

commodities. EPA revised these 

tolerance levels based on analysis of the 

residue field trial data using the 

Agency’s Tolerance Spreadsheet in 

accordance with the Agency’s Guidance 

for Setting Pesticide Tolerances Based 

on Field Trial Data. Because tolerances 

are being established on alfalfa forage 

and alfalfa hay under 40 CFR 

180.589(a)(1), which applies to residues 

resulting from intentional or inadvertent 

use, EPA has also revised current 

inadvertent residue tolerance entries so 

that they exclude alfalfa, as follows: 

animal feed, nongrass, group 18, forage, 

except alfalfa and animal feed, nongrass, 

group 18, hay, except alfalfa. 

Additionally, EPA is modifying 

several tolerances for secondary 

residues in animal commodities. In 

conjunction with assessing potential 

residues in animal commodities from 

the proposed and established uses of 

boscalid, EPA has determined that the 

established tolerances for secondary 

residues in or on poultry and hog 

commodities need to be raised. 

Therefore, the Agency is increasing the 

established tolerances for hog, fat from 

0.10 ppm to 0.20 ppm; poultry, fat from 

0.05 ppm to 0.20 ppm; and poultry, 

meat byproducts from 0.10 to 0.20 ppm. 

Finally, EPA has revised the tolerance 

expression to clarify (1) that, as 

provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of boscalid not specifically 

mentioned; and (2) that compliance 

with the specified tolerance levels is to 

be determined by measuring only the 

specific compounds mentioned in the 

tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of boscalid, 3- 

pyridinecarboxamide, 2-chloro-N-(4′- 

chloro[1,1′-biphenyl]-2-yl), in or on 

alfalfa, forage at 30 ppm; alfalfa, hay at 

65 ppm; fruit, citrus, group 10 at 1.6 

ppm; citrus, dried pulp at 4.5 ppm; and 

citrus, oil at 85 ppm. Additionally, 

previously established tolerances are 

revised for fruit, stone, group 12 at 3.5 

ppm; hog, fat at 0.20 ppm; poultry, fat 

at 0.20 ppm; and poultry, meat 

byproducts at 0.20 ppm. Finally, this 

regulation deletes a time-limited 

tolerance on tangerine at 2.0 ppm, as it 

expired on December 31, 2008. 

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). 

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Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Rules and Regulations 29907 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 18, 2010 

Daniel J. Rosenblatt 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.589 is amended by: 

i. Revising the introductory text for 

paragraphs (a)(1) and (a)(2); 

ii. Revising the entry for ‘‘Fruit, stone, 

group 12’’ and alphabetically adding 

‘‘Alfalfa, forage’’; ‘‘Alfalfa, hay’’; ‘‘Citrus, 

dried pulp’’; ‘‘Citrus, oil’’; and ‘‘Fruit, 

citrus, group 10’’; to the table in 

paragraph (a)(1); 

iii. Revising the entries for ‘‘Hog, fat’’; 

‘‘Poultry, fat’’; and ‘‘Poultry, meat 

byproducts’’ in the table in paragraph 

(a)(2); 

iv. Revising paragraph (b); 

v. Revising paragraph (d) introductory 

text and revising the entries for ‘‘Animal 

feed, nongrass, group 18, forage’’ and 

‘‘Animal feed, nongrass, group 18, hay’’ 

in the table in paragraph (d) to read as 

follows: 

§ 180.589 Boscalid; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the fungicide 

boscalid, including its metabolites and 

degradates, in or on the commodities 

listed below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only boscalid, 

3-pyridinecarboxamide, 2-chloro-N-(4′- 

chloro[1,1’-biphenyl]-2-yl), in or on the 

following raw agricultural commodities: 

Commodity Parts per million 

Alfalfa, forage 30.0 

Alfalfa, hay 65.0 

*****

Citrus, dried pulp 4.5 

Citrus, oil 85.0 

*****

Fruit, citrus, group 10 1.6 

*****

Fruit, stone, group 12 3.5 

*****

(2) Tolerances are established for 

residues of the fungicide boscalid, 

including its metabolites and 

degradates, in or on the commodities 

listed below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only the sum 

of boscalid, 3-pyridinecarboxamide, 2- 

chloro-N-(4’-chloro[1,1’-biphenyl]-2-yl), 

and metabolites 2-chloro-N-(4’-chloro-5- 

hydroxy-biphenyl-2-yl) nicotinamide 

and glucuronic acid conjugate of 2- 

chloro-N-(4′-chloro-5-hydroxy-biphenyl2-yl) nicotinamide, calculated as the 

stoichiometric equivalent of boscalid in 

or on the following food commodities: 

Commodity Parts per million 

*****

Hog, fat 0.20 

*****

Poultry, fat 0.20 

*****

Poultry, meat byproducts 0.20 

*****

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for residues of the fungicide boscalid, 

including its metabolites and 

degradates, in connection with use of 

the pesticide under section 18 

emergency exemptions granted by EPA. 

Compliance with the tolerance level 

specified below is to be determined by 

measuring only boscalid, 3- 

pyridinecarboxamide, 2-chloro-N-(4′- 

chloro[1,1’-biphenyl]-2-yl). This 

tolerance will expire and is revoked on 

the date specified in the following table: 

Commodity Parts per million Expiration/revocation date 

Endive, Belgian 16 12/31/10 

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29908 Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Rules and Regulations 

* * * * * 

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

indirect or inadvertent residues of the 

fungicide boscalid, including its 

metabolites and degradates, in or on the 

commodities listed below. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only boscalid, 3-pyridinecarboxamide, 

2-chloro-N-(4′-chloro[1,1’-biphenyl]-2- 

yl), in or on the following commodities: 

Commodity Parts per million 

Animal feed, nongrass, group 18, forage, except alfalfa 1.0 

Animal feed, nongrass, group 18, hay, except alfalfa 2.0 

*****

[FR Doc. 2010–12921 Filed 5–27–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0279; FRL–8828-–6] 

Prothioconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

prothioconazole and prothioconazoledesthio, calculated as parent in or on 

grain, cereal, group 15 (except sweet 

corn, sorghum, and rice), and grain, 

cereal, forage, fodder and straw, group 

16 (except sweet corn, sorghum, and 

rice) and sweet corn. Bayer CropScience 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective May 

28, 2010. Objections and requests for 

hearings must be received on or before 

July 27, 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–2009–0279. 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: 

Tawanda Maignan, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8050; e-mail address: 

maignan.tawanda@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 

cite at http://www.gpoaccess.gov/ecfr. 

To access the harmonized test 

guidelines referenced in this document 

electronically, please go http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. 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–2009–0279 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 July 27, 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 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–2009–0279, 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 

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