Federal Register / Vol. 75, No. 81 / Wednesday, April 28, 2010 / Rules and Regulations 22245 

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: April 15, 2010. 

G. Jeffery Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.532, in paragraph (a), 

alphabetically add the following 

commoditiy to the table to read as 

follows: 

§ 180.532 Cyprodinil; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million 

* * * * * 

Canola, seed1 ................. 0.03 

* * * * * 

1 Import only 

* * * * * 

[FR Doc. 2010–9835 Filed 4–27–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0772; FRL–8818–5] 

Imidacloprid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

imidacloprid in or on vegetables, bulb, 

group 3; cereal grains, group 15 and 

cereal grains, forage, fodder and straw, 

group 16. This regulation also deletes 

tolerances for various commodities and 

tolerances from direct/inadvertent 

residues on cereal grains, group 15 and 

cereal grains, forage, fodder and straw, 

group 16, as they will be superseded by 

group tolerances. Bayer CropScience 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective April 

28, 2010. Objections and requests for 

hearings must be received on or before 

June 28, 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–2008–0772. 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: 

Kable Bo Davis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 306–0415; e-mail address: 

davis.kable@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 Access Electronic Copies 

of this Document? 

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. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0772 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before June 28, 2010. 

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–2008–0772, 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 


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Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of December 3, 

2008 (73 FR 73640) (FRL–8390–4), 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 8F7414, 8F7415) 

by Bayer CropScience, 2 T.W. 

Alexander Drive, Research Triangle 

Park, NC 27709. The petitions requested 

that 40 CFR 180.472 be amended by 

establishing tolerances for combined 

residues of the insecticide imidacloprid, 

1-[(6-chloro-3-pyridinyl)methyl]-Nnitro-2-imidazolidinimine, in or on 

vegetable, bulb, group 3 at 2.5 parts per 

million (ppm) (PP 8F7414) and cereal, 

grains, group 15 at 0.05 ppm (PP 

8F7415). That notice referenced a 

summary of the petitions prepared by 

Bayer CropScience, the registrant, 

which is available to the public in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

determined that the available 

toxicology, occupational/residential, 

and residue chemistry databases 

support the establishment of permanent 

tolerances of imidacloprid in or on 

onion, green, subgroup 3-07B at 2.5 

ppm, onion, dry bulb, subgroup 3-07A 

at 0.15 ppm and grain, cereal, except 

rice, group 15 at 0.05 ppm. The reasons 

for these changes are explained in Unit 

IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for combined residues of 

imidacloprid in or on onion, green, 

subgroup 3-07B at 2.5 ppm, onion, dry 

bulb, subgroup 3-07A at 0.15 ppm and 

grain, cereal, except rice, group 15 at 

0.05 ppm. EPA’s assessment of 

exposures and risks associated with 

establishing tolerances follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by imidacloprid as well as the noobserved-adverse-effect-level (NOAEL) 

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

can be found at http:// 

www.regulations.gov in document 

‘‘Imidacloprid: Human-Health Risk 

Assessment,’’ pages 43 - 46 in docket ID 

number EPA–HQ–OPP–2008–0772. 

Imidacloprid has low acute toxicity 

via the dermal and inhalation routes 

and moderate acute toxicity via the oral 

route. It is not an eye or dermal irritant 

and is not a dermal sensitizer. The 

nervous system is the primary target 

organ of imidacloprid. Nervous system 

effects evidenced as changes in clinical 

signs and functional observation battery 

(FOB) assessments were seen in rat 

acute and subchronic neurotoxicity 

studies. Also, in the rat developmental 

neurotoxicity study, a decrease in the 

caudate/putamen width was noted in 

female pups. Retinal atrophy was seen 

in high-dose females in the rat 

combined chronic toxicity/ 

carcinogenicity study. No nervous 

system effects were noted in the mouse 

carcinogenicity or the reproduction and 

developmental studies or in the rabbit 

dermal or rat inhalation studies. The 

dog was less sensitive than rodents to 

the effects of imidacloprid. The rabbit 

appeared to be very sensitive as there 

was increased mortality in the oral 

developmental study at the highest dose 

tested. Increased incidence of 

mineralized particles in the thyroid 

colloid was noted in the rat combined 

chronic toxicity/carcinogenicity study. 

Body weight decrements were noted in 

the rat and/or mouse chronic and 

carcinogenicity studies, the rat 

subchronic neurotoxicity study, and the 

developmental, developmental 

neurotoxicity and reproduction studies. 

No effects were observed in the rabbit 

dermal or rat inhalation studies. There 

was no evidence of carcinogenic 

potential in either the rat chronic 

toxicity/carcinogenicity or mouse 

carcinogenicity studies, and there is no 

concern for mutagenicity. There was no 

evidence of increased qualitative or 

quantitative susceptibility of rats or 

rabbits to in utero exposure to 

imidacloprid and no evidence of 

qualitative or quantitative increased 

susceptibility of rat offspring in the 

reproduction study. There was evidence 

of an increased qualitative susceptibility 

in the rat developmental neurotoxicity 

study. At the highest dose tested, 

maternal effects consisted largely of 

slight decreases in food consumption 

and body-weight gain during early 

lactation, while pup effects included 

decreased body weight, decreased motor 

activity, and decreased caudate/ 

putamen width in females. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 


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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 imidacloprid used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

‘‘Imidacloprid: Human-Health Risk 

Assessment,’’ pages 16 - 17 in docket ID 

number EPA–HQ–OPP–2008–0772. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to imidacloprid, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing imidacloprid tolerances in (40 

CFR 180.472). EPA assessed dietary 

exposures from imidacloprid in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA conducted an unrefined, 

acute dietary exposure assessment using 

tolerance-level residues and assuming 

100% crop treated (CT) for all registered 

and proposed commodities for the 

general U.S. population and various 

population subgroups. 

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 

conducted a partially refined, chronic 

dietary exposure assessment using 

tolerance-level residues for all registered 

and proposed commodities and percent 

crop treated (PCT) for some registered 

commodities. 

iii. Cancer. A cancer exposure 

assessment was not performed because 

imidacloprid is not carcinogenic. On 

November 11, 1993, the Agency 

classified imidacloprid as a Group E 

chemical, ‘‘Evidence of noncarcinogenicity for humans,’’ by all 

routes of exposure based upon lack of 

evidence of carcinogenicity in rats and 

mice. 

iv. Percent crop treated (PCT) 

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

FFDCA states that the Agency may use 

data on the actual percent of food 

treated for assessing chronic dietary risk 

only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

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

EPA may require registrants to submit 

data on PCT. 

The Agency used PCT information as 

follows: 

Commodity Average percent Crop 

Treated Data 

Almonds ............ <1 

Apples ............... 25 

Artichokes ......... 5 

Avocados .......... <1 

Blueberries ........ 10 

Broccoli ............. 50 

Cabbage ........... 20 

Cantaloupe ....... 40 

Cauliflower ........ 50 

Celery ............... 10 

Cherries ............ 10 

Cotton ............... 10 

Cucumbers ....... 5 

Eggplant ............ 35 

Field corn .......... <2.5 

Filberts (hazelnuts) .............. <1 

Grapefruit .......... 10 

Grapes .............. 30 

Honeydew ......... 30 

Lemons ............. 5 

Lettuce .............. 65 

Oranges ............ 10 

Peaches ............ 5 

Pears ................ 5 

Pecans .............. 10 

Peppers ............ 30 

Potatoes ............ 35 

Prunes .............. <1 

Pumpkin ............ 10 

Soybeans .......... <1 

Spinach ............. 20 

Squash .............. 10 

Commodity Average percent Crop 

Treated Data 

Strawberries ...... 10 

Sugar beets ...... <1 

Sweet corn ........ <1 

Tangerines ........ 5 

Tobacco ............ 20 

Tomatoes .......... 15 

Walnuts ............. <1 

Watermelon ...... 15 

In most cases, EPA uses available data 

from the United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6 years. EPA uses an average PCT 

for chronic dietary risk analysis. The 

average PCT figure for each existing use 

is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

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

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

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

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which imidacloprid may be applied in 

a particular area. 


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2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for imidacloprid in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

imidacloprid. 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 

imidacloprid for acute exposures are 

estimated to be 36.0 parts per billion 

(ppb) for surface water and 2.09 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 36.0 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 17.2 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). 

Imidacloprid is currently registered 

for the following uses that could result 

in residential exposures: Indoor and 

outdoor ornamental plantings, 

ornamental lawns and turf, pre- and 

post-construction termiticide 

applications, spot-on treatments for 

dogs and cats, and crack and crevice 

treatments. Additionally, it is registered 

for use on mattresses for bed bug 

control. EPA assessed residential 

exposure using the assumption that 

residential pesticide handlers (i.e., 

persons who might mix, load and, or 

apply a pesticide material) could be 

exposed to several formulations that 

contain imidacloprid. The Agency also 

assessed post-application exposure for 

adults and children contacting surfaces, 

foliage, or pets that were treated with 

imidacloprid. Residential exposures are 

expected to be short-term (i.e., 1 to 30 

days) or intermediate-term (1 to 6 

months) based upon the pest spectra, 

sites of application, methods of 

application, formulations and the 

retreatment intervals. Since the indoor 

crack and crevice and mattress scenarios 

resulted in the highest potential 

exposures, these assessments are 

protective of all residential exposures 

from imidacloprid. 

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 imidacloprid to 

share a common mechanism of toxicity 

with any other substances, and 

imidacloprid does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that imidacloprid does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

There was no quantitative or qualitative 

evidence of increased susceptibility of 

rat and rabbit fetuses to in utero 

exposure in developmental studies. 

There was no quantitative or qualitative 

evidence of increased susceptibility of 

rat offspring in the multi-generation 

reproduction study. There was evidence 

of increased qualitative susceptibility in 

the rat developmental neurotoxicity 

study; however, the concern is low for 

the following reasons: 

i. The effects in pups are wellcharacterized with a clear NOAEL; 

ii. The pup effects occur in the 

presence of maternal toxicity with the 

same NOAEL for effects in both pups 

and dams; and 

iii. The doses and endpoints selected 

for regulatory purposes are protective of 

the pup effects noted at higher doses in 

the developmental neurotoxicity study. 

Therefore, there are no residual 

uncertainties for prenatal/postnatal 

toxicity in this 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 for all exposure 

scenarios, except acute dietary (all 

populations). That decision is based on 

the following findings: 

i. The toxicological database for 

imidacloprid is complete, with the 

exception of an immunotoxicity study. 

ii. The toxicology database for 

imidacloprid does not show any 

evidence of treatment-related effects on 

the immune system. The overall weight 

of evidence suggests that this chemical 

does not directly target the immune 

system. An immunotoxicity study is 

required as a part of new data 

requirements in 40 CFR part 158 for 

conventional pesticide registration; 

however, the Agency does not believe 

that conducting a functional 

immunotoxicity study will result in a 

lower POD than that currently used for 

overall risk assessment. Therefore, a 

database uncertainty factor (UFDB) is not 

needed to account for lack of this study. 

iii. There is no evidence that 

imidacloprid results in increased 

susceptibility in utero to rats or rabbits 

in the prenatal developmental studies or 

in offspring in the 2–generation 

reproduction study. 

iv. A developmental neurotoxicity 

study was performed with imidacloprid 

and well-defined NOAELs were 

achieved in the study. 

v. There was evidence of increased 

qualitative susceptibility in the rat 

developmental neurotoxicity study; 

however, the concern is low for reasons 

stated above. 

vi. There are no residual uncertainties 

for prenatal/postnatal toxicity. 

vii. The acute dietary food exposure 

assessment utilizes existing and 

proposed tolerance-level residues and 

100% CT information for all 

commodities. By using these screeninglevel assessments, actual exposures/ 

risks will not be underestimated. 

viii. The chronic food exposure 

assessment utilizes and proposed 

tolerance-level residues and %CT data 

for several existing uses. For all 

proposed uses, 100% CT is assumed. 

The chronic assessment is somewhat 

refined and based on reliable data and 

will not underestimate exposure/risk. 

ix. The dietary drinking water 

assessment utilizes water concentration 


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values generated by model and 

associated modeling parameters which 

are designed to provide conservative, 

health-protective, high-end estimatesof 

water concentrations which will not 

likely be exceeded. 

x. The residential handler assessment 

is based upon the residential standard 

operating procedures (SOPs) in 

conjunction with chemical-specific 

study data in some cases and Pesticide 

Handler Exposure Database (PHED) unit 

exposures in other cases. The majority 

of the residential post-application 

assessment is based upon chemicalspecific Turf Transfer Residue (TTR) 

data or other chemical-specific postapplication exposure study data. The 

chemical-specific study data as well as 

the surrogate study data used are 

reliable and also are not expected to 

underestimate risk to adults as well as 

to children. In a few cases where 

chemical-specific data were not 

available, the SOPs were used alone. 

The residential SOPs are based upon 

reasonable ‘‘worst-case’’ assumptions 

and are not expected to underestimate 

risk. These assessments of exposure are 

not likely to underestimate the resulting 

estimates of risk from exposure to 

imidacloprid. 

A 3X FQPA SF was retained in the 

form of a UFL (uncertainty factor due to 

extrapolation from a LOAEL in the 

absence of a NOAEL) for the acute 

dietary (all populations) exposure 

scenario only, since a NOAEL was not 

observed in the relevant study for that 

exposure scenario (acute neurotoxicity 

study in rats). A 3X uncertainty factor 

was judged to be adequate (as opposed 

to a 10X) for the following reasons: 

1. The LOAEL (42 mg/kg) is 

comparable to the LOAELs seen in 

adults in the developmental rat study 

(30 mg/kg/day) and the 2–generation 

reproduction study [47/52 milligrams/ 

kilograms/day (mg/kg/day) (male/ 

female)] and in the offspring in the DNT 

study (55 mg/kg/day); 

2. The extrapolated NOAEL of 14 mg/ 

kg (42/3 = 14) is comparable to the 

NOAEL of 20 mg/kg/day established in 

the offspring in the DNT; and, 

3. The neurotoxic effects in this study 

showed a good dose response which 

resulted in minimal effects on motor 

activity and locomotor activity at the 

LOAEL. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute 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, imidacloprid is not 

expected to pose an acute risk. Using 

the exposure assumptions discussed in 

this unit for acute exposure, the acute 

dietary exposure from food and water to 

imidacloprid will occupy 70% of the 

aPAD for (children 1 to 2 years old) the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to imidacloprid 

from food and water will utilize 32% of 

the cPAD for (children 1 to 2 years old) 

the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

imidacloprid 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). 

Imidacloprid is currently registered 

for crack and crevice uses and bed bug 

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 imidacloprid. Using the 

exposure assumptions described in Unit 

III.C.3. for short-term exposures, EPA 

has concluded the combined short-term 

food, water, and residential exposures 

aggregated result in aggregate MOEs of 

430 for adults and 170 for children. 

Toddlers’ residential short-term 

aggregate exposure includes dermal and 

inhalation exposure from the crack and 

crevice uses, dermal exposure from the 

bed-bug uses, and incidental oral 

exposure from hand-to-mouth contact 

with treated surfaces. Adult short-term 

aggregate exposure includes dermal and 

inhalation exposure from indoor crack 

and crevice uses, and dermal exposure 

from the bed-bug uses. These exposures 

were higher than those calculated for all 

other residential uses of imidacloprid. 

Therefore, the crack and crevice and bed 

bug treatment exposure estimates were 

aggregated with the chronic dietary to 

provide a worst-case estimate of shortterm aggregate risk for the U.S. 

population and children 1 to 2 years 

old. The combined short-term 

residential MOEs for these scenarios 

were 580 for adults and 240 for 

children. 

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). 

Imidacloprid is currently registered 

for crack and crevice uses and bed bug 

uses that could result in intermediateterm residential exposure and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to imidacloprid. 

Using the exposure assumptions 

described in Unit III.C.3. for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures aggregated result 

in aggregate MOEs of 400 for adults and 

150 for children. Toddlers’ residential 

intermediate-term aggregate exposure 

includes dermal and inhalation 

exposure from the crack and crevice 

uses, dermal exposure from the bed-bug 

uses, and incidental oral exposure from 

hand-to-mouth contact with treated 

surfaces. Adult intermediate-term 

aggregate exposure includes dermal and 

inhalation exposure from indoor crack 

and crevice uses, and dermal exposure 

from the bed-bug uses. These exposures 

were higher than those calculated for all 

other residential uses of imidacloprid. 

Therefore, the crack and crevice and bed 

bug treatment exposure estimates were 

aggregated with the chronic dietary 

exposure to provide a worst-case 

estimate of intermediate-term aggregate 

risk for the U.S. population and 

children 1 to 2 years old. The combined 

intermediate-term residential MOEs for 

these scenarios were 540 for adults and 

260 for children. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in mice and 

rats at doses that were judged to be 

adequate to assess the carcinogenic 

potential, imidacloprid was classified as 

‘‘not likely to be carcinogenic to 

humans,’’ and is not expected to pose a 

cancer risk to humans. Therefore, a 


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quantitative cancer risk assessment is 

not needed. 

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 imidacloprid 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies, 

Bayer Gas Chromatography/Mass 

Spectrometry (GC/MS) Method 00200 

and Bayer GC/MS Method 00191, is 

available to enforce the tolerance 

expression. 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 

There are no established Mexican 

maximum residue limits (MRLs) for the 

proposed new uses. There are 

established Codex MRLs for the sum of 

imidacloprid and its metabolites 

containing the 6-chloropyridinyl moiety 

expressed as imidacloprid, in or on 

cereal grain at 0.05 ppm, leeks at 0.05 

ppm, and bulb onions at 0.1 ppm. There 

are also established Canadian MRLs for 

1-[(6-chloro-3-pyridinyl)methyl]-Nnitro-1H-imidazol-2-amine, including 

metabolites containing the 6- 

chloropicolyl moiety in or on sweet 

corn at 0.05 ppm and field corn at 0.05 

ppm. With the exception of onions, 

there is no harmonization issue for these 

petitions. The Codex MRLs for leeks 

(0.05 ppm) and bulb onions (0.1 ppm) 

can not be harmonized as the U.S. use 

pattern necessitates higher tolerances 

(0.15 ppm for onion, dry bulb, subgroup 

3-07A; and 2.5 ppm for onion, green, 

subgroup 3-07B). 

C. Response to Comments 

There were no comments submitted 

in response to the Notice of Filing 

published in the Federal Register on 

December 3, 2008. 

D. Revisions to Petitioned-For 

Tolerances 

Due to residues on dry bulb onions 

and green onions varying by greater 

than 5X, the establishment of a crop 

group tolerance for crop group 3 was not 

appropriate. The Agency determined 

that the available toxicology, 

occupational/residential, and residue 

chemistry databases support the 

establishment of permanent tolerances 

of imidacloprid in or on onion, green, 

subgroup 3-07B at 2.5 ppm and onion, 

dry bulb, subgroup 3-07A at 0.15 ppm. 

No new field trial data were 

submitted in support of the proposed 

tolerance for cereal grains, however 

there are existing tolerances of 

combined residues of imidacloprid in or 

on barley, grain; corn, field, grain; corn, 

pop, grain; corn, sweet, kernel plus cob 

with husks removed; millet, pearl, grain; 

millet, proso, grain; oats, grain, grain; 

rye, grain; sorghum, grain; and wheat, 

grain at 0.05 ppm. There are no existing 

field trial data on rice, another member 

of the cereal grains crop group. In the 

absence of rice data, the available 

toxicology, occupational/residential, 

and residue chemistry databases 

support the establishment of permanent 

tolerances of imidacloprid in or on 

grain, cereal, except rice, group 15 at 

0.05 ppm. In connection with the 

imidacloprid petition for cereal grain 

group tolerance, EPA has reviewed the 

available cereal grain data on forage, 

fodder, and straw of cereal grains. 

Individual imidacloprid tolerances now 

exist for many forage, fodder, and straw 

cereal grain commodities. EPA has 

determined that sufficient data are 

available to establish the following 

group tolerances associated with the 

cereal grain group tolerance: Grain, 

cereal, forage, fodder and straw, group 

16, forage at 7.0 ppm; grain, cereal, 

forage, fodder and straw, group 16, hay 

at 6.0 ppm; grain, cereal, forage, fodder 

and straw, group 16, stover at 0.3 ppm 

and grain, cereal, forage, fodder and 

straw, group 16, straw at 3.0 ppm. The 

Crop Group 16 tolerances are being 

limited like the Crop Group 15 tolerance 

to exclude rice. 

The following established tolerances 

are being deleted because they are 

superseded by inclusion in groups 15 

and 16: Barley, grain at 0.05 ppm; 

barley, hay at 0.5 ppm; barley, straw at 

0.5 ppm; corn, field, forage at 0.10 ppm; 

corn, field, grain at 0.05 ppm; corn, 

field, stover at 0.20 ppm; corn, pop, 

grain at 0.05 ppm; corn, pop, stover at 

0.20 ppm; corn, sweet, forage at 0.10 

ppm; corn, sweet, kernel plus cob with 

husks removed at 0.05 ppm; corn, 

sweet, stover at 0.20 ppm; millet, pearl, 

forage at 2.0 ppm; millet, pearl, grain at 

0.05 ppm; millet, pearl, hay at 6.0 ppm; 

millet, pearl, straw at 3,0 ppm; millet, 

proso, forage at 2.0 ppm; millet, proso, 

grain at 0.05 ppm; millet, proso, hay at 

6.0 ppm; millet, proso, straw at 3.0 ppm; 

oat, forage at 2.0 ppm; oat, grain at 0.05 

ppm; oat, hay at 6.0 ppm; oat, straw at 

3.0 ppm; rye, forage at 2.0 ppm; rye, 

grain at 0.05 ppm; rye, hay at 6.0 ppm; 

rye, straw at 3.0 ppm; sorghum, forage 

at 0.10 ppm; sorghum, grain, grain at 

0.05 ppm; sorghum, grain, stover at 0.10 

ppm; wheat, forage at 7.0 ppm; wheat, 

grain at 0.05 ppm; wheat, hay at 0.5 

ppm and wheat, straw at 0.5 ppm. 

Additionally, the following tolerances 

from indirect or inadvertent residues are 

also being deleted: Corn, sweet, kernel 

plus cob with husks removed at 0.05 

ppm; grain, cereal, forage, fodder and 

straw, group 16, forage at 2.0 ppm; 

grain, cereal, forage, fodder and straw, 

group 16, hay at 6.0 ppm; grain, cereal, 

forage, fodder and straw, group 16, 

stover at 0.3 ppm; grain, cereal, forage, 

fodder and straw, group 16, straw at 3.0 

ppm and grain, cereal, group 15 at 0.05 

ppm. The following tolerance from 

indirect or inadvertent residues is being 

added: Rice, grain at 0.05 ppm. 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of imidacloprid, 

1-[(6-chloro-3-pyridinyl)methyl]-Nnitro-2-imidazolidinimine, in or on 

onion, dry bulb, subgroup 3-07A at 0.15 

ppm; onion, green, subgroup 3-07B at 

2.5 ppm; grain, cereal, except rice, 

group 15 at 0.05 ppm; grain, cereal, 

forage, fodder and straw, except rice, 

group 16, forage at 7.0 ppm; grain, 

cereal, forage, fodder and straw, except 

rice, group 16, hay at 6.0 ppm; grain, 

cereal, forage, fodder and straw, except 

rice, group 16, stover at 0.3 ppm and 

grain, cereal, forage, fodder and straw, 

except rice, group 16, straw at 3.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 


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Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 15, 2010. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.472 is revised to read 

as follows: 

§ 180.472 Imidacloprid; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide imidacloprid, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only the sum of imidacloprid 

(1-[6-chloro-3-pyridinyl) methyl]-Nnitro-2-imidazolidinimine) and its 

metabolites containing the 6- 

chloropyridinyl moiety, calculated as 

the stoichiometric equivalent of 

imidacloprid, in or on the following 

commodities: 

Commodity Parts per million 

Acerola ............................ 1.0 

Almond, hulls .................. 4.0 

Apple ............................... 0.5 

Apple, wet pomace ......... 3.0 

Artichoke, globe .............. 2.5 

Aspirated grain fractions 240 

Atemoya .......................... 0.30 

Avocado .......................... 1.0 

Banana ........................... 0.50 

Beet, sugar, molasses .... 0.30 

Beet, sugar, roots ........... 0.05 

Beet, sugar, tops ............ 0.50 

Biriba ............................... 0.30 

Blueberry ........................ 3.5 

Borage, seed .................. 0.05 

Caneberry, subgroup 13- 

A .................................. 2.5 

Canistel ........................... 1.0 

Canola, seed .................. 0.05 

Cattle, fat ........................ 0.30 

Cattle, meat .................... 0.30 

Cattle, meat byproducts 0.30 

Cherimoya ...................... 0.30 

Citrus, dried pulp ............ 5.0 

Coffee, bean, green ........ 0.80 

Cotton, gin byproducts ... 4.0 

Cotton, meal ................... 8.0 

Cotton, undelinted seed 6.0 

Crambe, seed ................. 0.05 

Cranberry ........................ 0.05 

Currant ............................ 3.5 

Custard apple ................. 0.30 

Egg ................................. 0.02 

Elderberry ....................... 3.5 

Commodity Parts per million 

Feijoa .............................. 1.0 

Flax, seed ....................... 0.05 

Fruit, citrus, group 10 ..... 0.70 

Fruit, pome, group 11 ..... 0.6 

Fruit, stone, group 12 ..... 3.0 

Goat, fat .......................... 0.30 

Goat, meat ...................... 0.30 

Goat, meat byproducts ... 0.30 

Gooseberry ..................... 3.5 

Grain, cereal, forage, 

fodder and straw, 

group 16, forage, except rice ...................... 7.0 

Grain, cereal, forage, 

fodder and straw, 

group 16, hay, except 

rice .............................. 6.0 

Grain, cereal, forage, 

fodder and straw, 

group 16, stover, except rice ...................... 0.30 

Grain, cereal, forage, 

fodder and straw, 

group 16, straw, except rice ...................... 3.0 

Grain, cereal, group 15, 

except rice ................... 0.05 

Grape .............................. 1.0 

Grape, juice .................... 1.5 

Grape, raisin ................... 1.5 

Guava ............................. 1.0 

Herbs subgroup 19A, 

dried herbs .................. 48 

Herbs subgroup 19-A, 

fresh herbs .................. 8.0 

Hog, fat ........................... 0.30 

Hog, meat ....................... 0.30 

Hog, meat byproducts .... 0.30 

Hop, dried cones ............ 6.0 

Horse, fat ........................ 0.30 

Horse, meat .................... 0.30 

Horse, meat byproducts 0.30 

Huckleberry ..................... 3.5 

Ilama ............................... 0.30 

Jaboticaba ...................... 1.0 

Juneberry ........................ 3.5 

Kava, leaves ................... 4.0 

Kava, roots ..................... 0.40 

Leaf petioles subgroup 

4B ................................ 6.0 

Leafy greens subgroup 

4A ................................ 3.5 

Lettuce, head .................. 3.5 

Lettuce, leaf .................... 3.5 

Lingonberry ..................... 3.5 

Longan ............................ 3.0 

Lychee ............................ 3.0 

Mango ............................. 1.0 

Milk ................................. 0.10 

Mustard, black, seed ...... 0.05 

Mustard, field, seed ........ 0.05 

Mustard, Indian, seed ..... 0.05 

Mustard, rapeseed, seed 0.05 

Mustard, seed ................. 0.05 

Nut, tree, group 14 ......... 0.05 

Okra ................................ 1.0 

Onion, dry bulbs, subgroup 3-07A ................ 0.15 

Onion, green, subgroup 

3-07B ........................... 2.5 

Papaya ............................ 1.0 

Passionfruit ..................... 1.0 

Peanut ............................ 0.45 

Peanut, hay .................... 35 


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22252 Federal Register / Vol. 75, No. 81 / Wednesday, April 28, 2010 / Rules and Regulations 

Commodity Parts per million 

Peanut, meal .................. 0.75 

Pecan .............................. 0.05 

Persimmon ...................... 3.0 

Pistachio ......................... 0.05 

Pomegranate .................. 0.90 

Potato, chip ..................... 0.40 

Potato, processed potato 

waste ........................... 0.90 

Poultry, fat ...................... 0.05 

Poultry, meat .................. 0.05 

Poultry, meat byproducts 0.05 

Pulasan ........................... 3.0 

Rambutan ....................... 3.0 

Rapeseed, seed ............. 0.05 

Raspberry, wild ............... 2.5 

Safflower, seed ............... 0.05 

Salal ................................ 3.5 

Sapodilla ......................... 1.0 

Sapote, black .................. 1.0 

Sapote, mamey .............. 1.0 

Sheep, fat ....................... 0.30 

Sheep, meat ................... 0.30 

Sheep, meat byproducts 0.30 

Soursop .......................... 0.30 

Soybean, forage ............. 8.0 

Soybean, hay .................. 35 

Soybean, meal ................ 4.0 

Soybean, seed ................ 3.5 

Spanish lime ................... 3.0 

Star apple ....................... 1.0 

Starfruit ........................... 1.0 

Strawberry ...................... 0.50 

Sugar apple .................... 0.30 

Sunflower, seed .............. 0.05 

Tomato, paste ................. 6.0 

Tomato, puree ................ 3.0 

Vegetable, brassica 

leafy, group 5 .............. 3.5 

Vegetable, cucurbit, 

group 9 ........................ 0.5 

Vegetable, fruiting, group 

8 .................................. 1.0 

Vegetable, leaves of root 

and tuber, group 2 ...... 4.0 

Vegetable, legume, 

group 6, except soybean ............................ 4.0 

Vegetable, root and 

tuber, group 1, except 

sugar beet ................... 0.40 

Watercress ...................... 3.5 

Watercress, upland ......... 3.5 

Wax jambu ...................... 1.0 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

Tolerances are established for indirect 

or inadvertent residues of the 

insecticide imidacloprid, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only the sum of imidacloprid 

(1-[6-chloro-3-pyridinyl) methyl]-Nnitro-2-imidazolidinimine) and its 

metabolites containing the 6- 

chloropyridinyl moiety, calculated as 

the stoichiometric equivalent of 

imidacloprid, in or on the following 

commodities, when present therein as a 

result of the application of the pesticide 

to growing crops listed in this section 

and other non-food crops as follows: 

Commodity Parts per million 

Rice, grain ...................... 0.05 

Vegetable, foliage of legume, group 7 ............... 2.5 

Vegetable, legume, 

group 6 ........................ 0.3 

[FR Doc. 2010–9761 Filed 4–27–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0866; FRL–8801–6] 

Cyromazine; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of cyromazine in 

or on succulent beans at 2.0 parts per 

million (ppm). Interregional Research 

Project Number 4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

28, 2010. Objections and requests for 

hearings must be received on or before 

June 28, 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–2008–0866. 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: 

Barbara Madden, Registration Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6463; e-mail address: 

madden.barbara@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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

To access the OPPTS harmonized test 

guidelines referenced in this document 

electronically please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods & Guidelines’’ on the left-side 

navigation menu. 


sroberts on DSKD5P82C1PROD with RULES