33736 Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) 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 FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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. This action 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: May 28, 2013. 

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. In § 180.499, revise the section 

heading, paragraph (a) introductory text, 

and paragraph (c) to read as follows: 

§ 180.499 Propamocarb; tolerances for 

residues. 

(a) General. Tolerances are 

established for the residues of 

propamocarb, including its metabolites 

and degradates, in or on the 

commodities specified in the following 

table resulting from the application of 

the hydrochloride salt of propamocarb. 

Compliance with the following 

tolerance levels is to be determined by 

measuring only propamocarb (propyl N- 

[3-(dimethylamino)propyl]carbamate): 

* * * * * 

(c) Tolerance with regional 

registrations. Tolerances with regional 

registrations are established for the 

residues of propamocarb, including its 

metabolites and degradates, in or on the 

commodities specified in the following 

table resulting from the application of 

the hydrochloride salt of propamocarb. 

Compliance with the following 

tolerance levels is to be determined by 

measuring only propamocarb (propyl N- 

[3-(dimethylamino)propyl]carbamate): 

Commodity Parts per 

million 

Bean, lima, succulent ........... 2.0 

* * * * * 

[FR Doc. 2013–13190 Filed 6–4–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0204; FRL–9387–9] 

Imidacloprid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of imidacloprid in 

or on fish and fish-shellfish, mollusc 

requested by the Interregional Research 

Project Number 4 (IR–4) under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). In addition, this regulation 

establishes time-limited tolerances for 

residues of imidacloprid in or on 

sugarcane, cane and sugarcane, 

molasses. This action is associated with 

the use of the pesticide on sugarcane 

under a crisis exemption granted by 

EPA under section 18 of the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA). The time-limited 

tolerances expire on December 31, 2015. 

DATES: This regulation is effective June 

5, 2013. Objections and requests for 

hearings must be received on or before 

August 5, 2013, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0204, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 


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information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; email address: 

jackson.sidney@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

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–2012–0204 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 August 5, 2013. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0204, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of May 23, 

2012 (77 FR 30481) (FRL–9347–8), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 2E7988) by IR–4, IR–4 

Headquarters, 500 College Road East, 

Suite 201W, Princeton, NJ 08540. The 

petition requested that 40 CFR 180.472 

be amended by establishing tolerances 

for residues of the insecticide 

imidacloprid, (1-[6-chloro-3-pyridinyl) 

methyl]-N-nitro-2-imidazolidinimine) 

and its metabolites containing the 6- 

chloropyridinyl moiety, in or on fish at 

0.05 parts per million (ppm), and fishshellfish, mollusc at 0.05 ppm. That 

document referenced a summary of the 

petition prepared by the Willapa-Grays 

Harbor Oyster Growers Association, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

III. Time-Limited Tolerance for 

Sugarcane 

Also in this action, EPA, on its own 

initiative, in accordance with FFDCA 

sections 408(e) and 408(l)(6) of, 21 

U.S.C. 346a(e) and 346a(l)(6), is 

establishing time-limited tolerances for 

residues of imidacloprid in or on 

sugarcane, cane at 6.0 ppm and 

sugarcane, molasses at 50 ppm. These 

time-limited tolerances expire on 

December 31, 2015. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under FIFRA section 18. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on FIFRA section 18 related 

time-limited tolerances to set binding 

precedents for the application of FFDCA 

section 408 and the safety standard to 

other tolerances and exemptions. 

Section 408(e) of FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party. Section 18 of FIFRA authorizes 

EPA to exempt any Federal or State 

agency from any provision of FIFRA, if 

EPA determines that ‘‘emergency 

conditions exist which require such 

exemption.’’ EPA has established 

regulations governing such emergency 

exemptions in 40 CFR part 166. 

The Agency is establishing these timelimited tolerances in response to a crisis 

exemption request under FIFRA section 

18 on behalf of the Louisiana 

Department of Agriculture and Forestry, 

for the emergency use of imidacloprid 

on sugarcane to control West Indian 

cane fly (Saccharosydne saccharivora). 

This was the first emergency exemption 

request for the use of imidacloprid on 

sugarcane. 

As part of its assessment of the 

emergency exemption request, EPA 

assessed the potential risks presented by 

the residues of imidacloprid in or on 

sugarcane, cane and sugarcane, 

molasses. In doing so, EPA considered 

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

of the FFDCA, and EPA decided that the 

necessary time-limited tolerances under 

section 408(l)(6) of the FFDCA would be 

consistent with the safety standard. 

Consistent with the need to move 

quickly on the emergency exemption in 

order to address the urgent non-routine 

situation and to ensure that the resulting 

food is safe and lawful, EPA is issuing 

these time-limited tolerances without 

notice and opportunity for public 

comment, as provided for in section 

408(l)(6). Although, these time-limited 

tolerances expire and are revoked on 

December 31, 2015, under section 

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

pesticide not in excess of the amount 

specified in the tolerance remaining in 

or on sugarcane, cane and sugarcane, 

molasses after that date will not be 


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33738 Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations 

unlawful, provided the pesticide is 

applied in a manner that was lawful 

under FIFRA, and the residues do not 

exceed a level that was authorized by 

these time-limited tolerances at the time 

of application. EPA will take action to 

revoke these time-limited tolerances 

earlier if any experience with, scientific 

data, or other relevant information on 

this pesticide indicates that the residues 

are not safe. 

Because these time-limited tolerances 

are being approved under emergency 

conditions, EPA has not made any 

decisions about whether imidacloprid 

meets EPA’s registration requirements 

for use on sugarcane or whether 

permanent tolerances for this use would 

be appropriate. Under this 

circumstance, EPA does not believe that 

the time-limited tolerances provide a 

basis for registration of sugarcane by a 

State for special local needs under 

FIFRA section 24(c). Nor do the timelimited tolerances serve as the basis for 

any State other than Louisiana to use 

this pesticide on this crop under section 

18 of FIFRA without following all 

provisions of EPA’s regulations 

implementing FIFRA section 18 as 

identified in 40 CFR part 166. For 

additional information regarding the 

emergency exemption for imidacloprid, 

contact the Agency’s Registration 

Division at the address provided under 

FOR FURTHER INFORMATION CONTACT. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for imidacloprid 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with imidacloprid follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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. 

The main targets of toxicity following 

oral administration of imidacloprid in 

mammalian systems were the nervous 

system and the thyroid. The most 

sensitive species tested was the rat. 

Evidence of neurotoxicity was reported 

in the rat acute neurotoxicity (ACN) 

study as changes in clinical signs and 

functional-observation battery (FOB) 

measurements, including decreased 

motor and locomotor activities, tremors, 

gait abnormalities, increased righting 

reflex impairments and body 

temperature, decreased number of rears 

and response to stimuli, and decreases 

in forelimb and hindlimb grip strength. 

Also, in a rat developmental 

neurotoxicity (DNT) study where 

imidacloprid was administered to 

pregnant/lactating dams in the diet, 

there were decreases in offspring motor 

activity measurements and a small but 

statistically significant decrease in the 

caudate/putamen width in the brain of 

female pups. No neurotoxic effects were 

reported in any other toxicity study 

including the rat subchronic 

neurotoxicity study. Long-term dietary 

exposure to imidacloprid in chronic 

toxicity studies resulted in an increased 

incidence of mineralized particles in the 

thyroid colloid in rats, decreased body 

weights in mice, and no toxic effects in 

dogs. No toxic effects were reported via 

the dermal route in rabbits or via the 

inhalation route in rats at the highest 

dose or concentration tested. No 

evidence of increased qualitative or 

quantitative susceptibility was found in 

either rats or rabbits in prenatal 

developmental toxicity studies or in rats 

in a two-generation reproductive 

toxicity study. Increased qualitative 

susceptibility was indicated in the rat 

DNT study, however; the neurotoxic 

offspring effects noted above occurred 

in the presence of maternal decreased 

food consumption and body weight 

gain, and a clear maternal no-observedadverse-effect level (NOAEL) was 

established. There was no evidence of 

carcinogenic potential in either the rat 

chronic toxicity/carcinogenicity or 

mouse carcinogenicity studies, and 

imidacloprid was not genotoxic in a 

variety of assays. 

The toxicology database for 

imidacloprid does not show any 

evidence of treatment-related effects on 

the immune system. Results of an 

acceptable immunotoxicity study in rats 

showed no immunotoxic effects at the 

highest dose level tested. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by imidacloprid as well 

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

toxicity studies can be found at http:// 

www.regulations.gov in document: 

‘‘Imidacloprid—Section 3 Request for 

use on Oyster Beds in Washington 

(WA), and Section 18 Emergency 

Exemption Request for use on 

Sugarcane in Louisiana (LA). HumanHealth Risk Assessment,’’ dated March 

7, 2013 at pp. 41–44 in docket ID 

number EPA–HQ–OPP–2012–0204– 

0008. 

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 the NOAEL and the 

LOAEL are identified. 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 imidacloprid used for 


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human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR IMIDACLOPRID 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 (All populations) ............... LOAEL = 42 mg/ 

kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

Acute RfD = 0.14 

mg/kg/day 

aPAD = 0.14 mg/ 

kg/day 

Acute neurotoxicity—rat LOAEL = 42 mg/kg/day based 

upon the decrease in motor and locomotor activities observed in females. 

Chronic dietary (All populations) ............ NOAEL= 5.7 mg/ 

kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 

0.057 mg/kg/day 

cPAD = 0.057 mg/ 

kg/day 

Combined chronic toxicity/carcinogenicity—rat. LOAEL = 

16.9 mg/kg/day, based upon increased incidence of 

mineralized particles in thyroid colloid in males. 

Incidental Oral Short-term (1–30 days) 

Intermediate-term (1 to 6 months).

NOAEL= 10 mg/kg/ 

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 

100.

Prenatal developmental toxicity—rat. LOAEL = 30 mg/kg/ 

day based on decreased maternal body weight gain. 

Incidental Oral Long Term (> 6 months) NOAEL= 5.7 mg/ 

kg/day 

UFA= 10x 

UFH= 10x 

FQPA SF =1x 

LOC for MOE = 

100.

Combined chronic toxicity/carcinogenicity—rat. LOAEL = 

16.9 mg/kg/day, based upon increased incidence of 

mineralized particles in thyroid colloid in males. 

Dermal Short-term (1 to 30 days) Intermediate-term (1 to 6 months).Oral study NOAEL 

= 10 mg/kg/day 

(dermal absorption = 7.2%) 

NOAEL = 10 mg/ 

kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 

100.

Prenatal developmental toxicity—rat. LOAEL = 30 mg/kg/ 

day based on decreased maternal body weight gain. 

Dermal Long-term (> 6 months) ............. Oral study 

NOAEL= 5.7 mg/ 

kg/day (dermal 

absorption = 

7.2%) 

NOAEL= 5.7 mg/ 

kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 

100.

Combined chronic toxicity/carcinogenicity—rat. LOAEL = 

16.9 mg/kg/day, based upon increased incidence of 

mineralized particles in thyroid colloid in males. 

Inhalation Short- (1–30 days) & 

Intermediate- (1–6 months) terms.

Oral study 

NOAEL= 10 mg/ 

kg/day (inhalation absorption = 

100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 

100.

Prenatal developmental toxicity—rat. LOAEL = 30 mg/kg/ 

day based on decreased maternal body weight gain. 

Long-Term Inhalation (> 6 months) ....... Oral study NOAEL 

= 5.7 mg/kg/day 

(inhalation absorption = 100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 

100.

Combined chronic toxicity/carcinogenicity—rat. LOAEL = 

16.9 mg/kg/day, based upon increased incidence of 

mineralized particles in thyroid colloid in males. 


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

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Cancer (Oral, dermal, inhalation) ........... Classification: ‘‘Not likely to be carcinogenic to humans’’ based on no evidence of carcinogenic potential in either the rat chronic toxicity/carcinogenicity or mouse carcinogenicity studies. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

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, the use on 

sugarcane under the FIFRA section 18 

emergency exemption authorized by 

EPA, 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. 

Such effects were identified for 

imidacloprid. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America, (NHANES/WWEIA). As 

to residue levels in food, EPA 

conducted an unrefined, acute dietary 

exposure assessment using tolerancelevel residues and assumed 100 percent 

crop treated (PCT) for all commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the 2003–2008 NHANES/WWEIA. 

As to residue levels in food, EPA 

conducted a partially refined chronic 

dietary exposure assessment using 

tolerance-level residues for all 

commodities and PCT information for 

some registered commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that imadicloprid does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

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 estimated the PCT for 

existing uses as follows: For the chronic 

assessment, the following average 

weighted PCT information was used: 

Almonds 1%; apples: 30%; artichokes: 

5%; avocados: 1%; beans, green: 5%; 

blueberries: 10%; broccoli: 55%; 

cabbage: 25%; caneberries: 10%; 

cantaloupe: 40%; carrots: 1%; 

cauliflower: 50%; celery: 10%; cherries: 

15%; corn (seed treatment): 2.5%; 

cotton: 5%; cotton: 5%; cucumbers: 5%; 

dry beans/peas: 1%; eggplant: 60%; 

filberts (hazelnuts): 2.5%; grapefruit: 

25%; grapes: 30%; honeydew: 30%; 

lemons: 5%; lettuce: 65%; onions: 1%; 

oranges: 20%; peaches: 5%; peanuts: 

1%; pears: 5%; peas, green: 2.5%; 

pecans: 15%; peppers: 15%; pistachios: 

1%; potatoes: 35%; prunes: 1%; 

pumpkin: 10%; sorghum: 15%; 

soybeans: 5%; spinach: 20%; squash: 

15%; strawberries: 10%; sugar beets: 

2.5%; sweet corn: 1%; tangerines: 10%; 

tobacco: 25%; tomatoes: 25%; walnuts: 

5%; watermelon: 20%; wheat: 10%. 

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 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

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

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit IV.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. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 


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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 (SCI– 

GROW) 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. 

For chronic exposures, assessments 

are estimated to be 17.2 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). The 

proposed use of imidacloprid on oyster 

beds is professionally applied and not 

expected to result in residential handler 

exposure, but can result in residential 

post-application exposures via potential 

contact with residues in the oyster bed 

water or sediment during recreational 

swimming, or in the case of subsistence 

fishermen or local Native American 

tribes, collecting oysters. There are no 

residential uses associated with the 

proposed Section 18 Emergency 

Exemption use on sugarcane. 

Imidacloprid is currently registered for 

the following uses that could result in 

residential exposures: Residential lawns 

and gardens, indoor uses for bed bugs 

and crack-and-crevice treatments, pet 

uses in spot-on treatments and collars, 

and pre- and post-construction 

termiticide and wood preservative uses. 

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 as well as the pest spectra, 

sites of application, methods of 

application, formulations and the 

retreatment intervals. 

For the registered imidacloprid 

residential uses, in general, short-term 

dermal, inhalation, and incidental oral 

post-application exposures are 

expected. Intermediate- and long-term 

dermal, incidental oral and inhalation 

exposures are expected from the pet 

collar use, as it presents the potential for 

prolonged exposure via a continuous 

source and frequent contact (i.e., 

playing with pets). Short-term dermal 

and inhalation handler exposures are 

expected. The Agency also assessed 

potential for post-application exposure 

for adults and children as a result of 

both the proposed use on oyster beds 

and from existing residential uses. 

Based on the proposed oyster bed use 

pattern, only short-term postapplication dermal, incidental oral, and 

inhalation exposures to imidacloprid 

residues in affected water and sediment 

are expected. The exposure assessment 

used equations and inputs that are 

generally derived from SWIMODEL 3.0, 

developed by EPA as a screening tool to 

conduct exposure assessments of 

pesticides found in swimming pools 

and spas and EPA’s Risk Assessment 

Guidance for Superfund—Part E, 

Supplemental Guidance for Dermal Risk 

Assessment (‘‘RAGS–E’’). 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

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

science/residential-exposure-sop.html. 

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 Web site 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. 

No evidence of increased quantitative or 

qualitative susceptibility was found in 

rats and rabbits in the prenatal 

developmental toxicity studies or in rats 

in the two-generation reproductive 

toxicity study, where developmental 

effects were observed at the same or 

higher doses than those causing 

maternal effects. Increased qualitative 

susceptibility was found in the rat DNT 

study, but the concern is low based on 

the following observations: 

i. The pup effects (body-weight 

deficits, decreased motor activity, and 

small decrease in female caudate/ 

putamen width) which occurred only in 

the presence of maternal toxicity 

(decreased body weight gain and food 

consumption) are well-characterized 

with a clear maternal NOAEL that is 

protective of both maternal and pup 

effects. 

ii. The doses selected for regulatory 

purposes are lower and thus protective 

of the pup effects noted in the DNT 

study, which occurred at higher doses of 

imidacloprid. 

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 for the acute dietary 

assessment. For the acute dietary 

assessment, EPA has determined that 

reliable data show the safety of infants 

and children would be adequately 

protected if the FQPA SF were reduced 

to 3X. Those decisions are based on the 

following findings: 

i. The toxicity database for 

imidacloprid contains all the required 

studies, although the acute 

neurotoxicity study, which was selected 

for determining the acute dietary 

endpoint, lacks a NOAEL. An FQPA SF 

of 3X is retained for the acute dietary 


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endpoint in the form of a database 

uncertainty factor (UF) for lack of a 

NOAEL. EPA has determined that an 

FQPA safety factor of 3X is adequate to 

protect infants and children because the 

effect (decreased motor and locomotor 

activity), which occurred at the LOAEL 

is minimal and not statistically different 

from the control group. Furthermore, 

the LOAEL of 42 mg/kg/day is 

comparable to the LOAEL of 55 mg/kg/ 

day for offspring effects (which includes 

decreased motor activity) in the rat DNT 

study, and the extrapolated NOAEL 

from the acute neurotoxicity study of 14 

mg/kg/day (42/3 = 14) is comparable to 

and more protective than the NOAEL of 

20 mg/kg/day established in the DNT for 

offspring effects. 

ii. There was evidence of 

neurotoxicity in the rat neurotoxicity 

studies. Evidence of neurotoxicity was 

reported in the rat acute neurotoxicity 

study as discussed above in Unit IV.A. 

Also, in a rat DNT study where 

imidacloprid was administered to 

pregnant/lactating dams in the diet, 

there were decreases in offspring motor 

activity measurements and a small but 

statistically significant decrease in the 

caudate/putamen width in the brain of 

female pups. Well-defined NOAELs 

were achieved in the study, therefore 

the concern is low. No adverse 

neurotoxic effects were reported in any 

other toxicity study including the rat 

subchronic neurotoxicity study. 

iii. Although the prenatal 

developmental studies in rats and 

rabbits and the 2-generation 

reproduction study in rats did not show 

evidence that imidacloprid results in 

increased susceptibility in utero or in 

offspring, respectively, the rat DNT 

study showed evidence of increased 

qualitative susceptibility in pups. For 

the reasons discussed in Unit IV.D.2, 

however, the concern for this 

susceptibility is low. Therefore, there 

are no residual uncertainties for 

prenatal/postnatal toxicity in this study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute dietary food exposure 

assessment utilizes tolerance-level 

residues and 100 PCT information for 

all commodities. The chronic food 

exposure assessment utilizes tolerancelevel residues for all commodities and 

PCT data for some existing uses and 100 

PCT for all proposed uses. EPA made 

conservative (protective) assumptions in 

the dietary drinking water assessment 

utilizing water concentration values 

generated by models and associated 

modeling parameters, which are 

designed to provide conservative, 

health-protective, high-end estimates of 

water concentrations which will not 

likely be exceeded. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by imidacloprid. 

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. Short-, 

intermediate-, and chronic-term 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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

imidacloprid will occupy 74% of the 

aPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic dietary exposure, EPA has 

concluded that chronic exposure to 

imidacloprid from food and water will 

utilize 28% of the cPAD for children 

1–2 years old the population group 

receiving the greatest exposure. The 

chronic aggregate risk assessment takes 

into account average exposure estimates 

from dietary consumption of 

imidacloprid (food and drinking water) 

and long-term residential uses. Highend estimates of residential exposure 

are used, and average values are used 

for food and drinking water exposures. 

Based on the proposed and existing use 

patterns, there is potential for long-term 

residential exposure from the pet-collar 

use, as it presents the potential for 

prolonged exposure via a continuous 

source and frequent contact (i.e., 

playing with pets). Using the exposure 

assumptions described in this unit for 

long-term exposures, EPA has 

concluded the combined average food 

and water and long-term residential 

exposures result in aggregate MOEs of 

760 for adults and 230 for children 

1–2 years old, the population subgroup 

receiving the greatest exposure. Because 

EPA’s level of concern for imidacloprid 

is a MOE of 100 or below, these MOEs 

are not of concern. 

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 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 this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in an 

aggregate MOE of 240 for adults from 

the combined dermal post-application 

exposures from contacting treated lawns 

and gardens which resulted in the 

highest short-term exposure and an 

aggregate MOE of 120 for children from 

the combined dermal and hand-tomouth exposure from contacting treated 

wood surfaces which resulted in the 

highest short-term exposure. Because 

EPA’s level of concern for imidacloprid 

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). 

Although there is potential for 

intermediate-term residential exposure 

from the registered pet collar use, an 

intermediate-term aggregate assessment 

was not conducted. The short- and 

intermediate-term toxicological 

endpoints are the same; therefore, the 

exposures assessed in the short-term 

aggregate (adults—combined dermal 

post-application exposures from 

contacting treated lawns and gardens; 

and children—combined dermal and 

hand-to-mouth from contacting treated 

wood surfaces) are protective of those 

for intermediate-term duration 

exposures. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

imidacloprid is not expected to pose a 

cancer risk to humans. Therefore, a 

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. 


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V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methods are 

available for determination of 

imidacloprid residues of concern in 

plant Bayer gas chromatography/mass 

spectrometry (GC/MS) Method 00200 

and livestock commodities (Bayer GC/ 

MS Method 00191). These methods 

have undergone successful EPA petition 

method validations (PMVs), and the 

registrant has fulfilled the remaining 

requirements for additional raw data, 

method validation, independent 

laboratory validation (ILV), and an 

acceptable confirmatory method highperformance liquid chromatography/ 

ultraviolet (HPLC/UV) Method 00357. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

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 

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

The Codex Alimentarius is a joint 

United Nations 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 established 

Codex, MRLs for imidacloprid on fish; 

fish-shellfish, mollusc; or sugarcane. 

VI. Conclusion 

Therefore, tolerances are established 

for residues of imidacloprid (1-[6- 

chloro-3-pyridinyl)methyl]-N-nitro-2- 

imidazolidinimine) and its metabolites 

containing the 6-chloropyridinyl 

moiety, in or on fish at 0.05 ppm, and 

fish-shellfish, mollusc at 0.05 ppm. 

In addition, this regulation establishes 

time-limited tolerances for residues of 

imidacloprid in or on sugarcane, cane at 

6.0 ppm and sugarcane, molasses at 50 

ppm. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) 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 FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 

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

VIII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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. This action 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: May 23, 2013. 

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 amended by 

adding alphabetically the following 

commodities to the table in paragraph 

(a) and adding paragraph (b) to read as 

follows: 

§ 180.472 Imidacloprid; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Fish ............................................. 0.05 

Fish-shellfish, mollusc ................. 0.05 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for residues of the insecticide 

imidacloprid, including its metabolites 

and degradates in connection with use 

of the pesticide under a Section 18 

emergency exemption granted by EPA. 

Compliance with the tolerance levels 


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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. These tolerances will 

expire and are revoked on the dates 

specified in the following table: 

Commodity Parts per million Expiration/revocation date 

Sugarcane, cane ................................................................................................ 6 .0 12/31/15 

Sugarcane, molasses ........................................................................................ 50 12/31/15 

* * * * * 

[FR Doc. 2013–13203 Filed 6–4–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0704; FRL–9386–9] 

Sedaxane; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of sedaxane in or 

on multiple commodities which are 

identified and discussed later in this 

document. Syngenta Crop Protection, 

LLC requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective June 

5, 2013. Objections and requests for 

hearings must be received on or before 

August 5, 2013, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0704, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Heather Garvie, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–0034; email address: 

garvie.heather@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

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–2012–0704 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 August 5, 2013. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0704, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of September 

28, 2012 (77 FR 59578) (FRL–9364–6), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 2F8071) by 

Syngenta Crop Protection, Inc., 

Regulatory Affairs, P.O. Box 18300, 

Greensboro, NC 27419–8300. The 

petition requested that 40 CFR 180.665 

be amended by establishing tolerances 

for residues of the fungicide sedaxane, 

in or on corn (grain, forage, stover), 

popcorn (grain, stover), and corn ears at 

0.01 parts per million (ppm); sorghum 

(grain, forage, stover) at 0.01 ppm; pea 

and bean, dried, shelled, subgroup 6C 

(grain, forage, hay) at 0.01 ppm; and 

rapeseed, subgroup 20A (grain) at 0.01 

ppm. That document referenced a 


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