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. 


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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–2009–0866 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–2008–0866, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of April 13, 

2009 (74 FR 16866) (FRL–8396–6), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 8E7470) by 

Interregional Research Project Number 4 

(IR-4), 500 College Road East, Suite 201 

W, Princeton, NJ 08540. The petition 

requested that 40 CFR 180.414 be 

amended by establishing tolerances for 

residues of the insecticide cyromazine, 

(N-cyclopropyl-1,3,5-triazine-2,4,6- 

triamine) in or on bean, succulent at 2.0 

parts per million (ppm). That notice 

referenced a summary of the petition 

prepared by Syngenta, the registrant, on 

behalf of IR-4 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. 

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 residues of cyromazine on 

bean, succulent at 2.0 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. Cyromazine is not 

an eye irritant or a dermal sensitizer but 

is a mild skin irritant. The liver and 

bone marrow (hematological system) are 

the primary targets for oral toxicity for 

cyromazine based on a chronic dog 

study. Decrease in body weight and food 

consumption are also common effects of 

cyromazine as observed in chronic dog, 

rat, mouse, and rabbit studies. No 

dermal or systemic toxicity was seen at 

the highest dose tested in two 21–day 

dermal toxicity studies in rabbits. No 

neurotoxicity studies with cyromazine 

are available. However, the cyromazine 

chemical class (triazine) does not 

generally target the central or peripheral 

nervous system and available data show 

no evidence of neurotoxic potential for 

cyromazine. There is no evidence that 

cyromazine is teratogenic or that 

offspring are more susceptible than 

adults based on developmental toxicity 

studies in rats and rabbits. In the 2– 

generation reproduction study in rats no 

reproductive effects were observed. 

Cyromazine was shown not to be 

carcinogenic in mice or rats following 

long-term dietary administration and is 

classified as ‘‘not likely to be 

carcinogenic to humans.’’ The available 

mutagenicity data suggest that 

cyromazine does not have genotoxic 

activity. Specific information on the 

studies received and the nature of the 

adverse effects caused by cyromazine as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in docket ID 

number EPA–HQ–OPP–2009–0866, 

pages 25–27 of the document titled 

‘‘Cyromazine Human Health Risk 

Assessment for Proposed New Use of 

Cyromazine on Succulent Beans.’’ 

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 


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aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for cyromazine used for 

human risk assessment can be found at 

http://www.regulations.gov in docket ID 

number EPA–HQ–OPP–2009–0866, 

page 15 of the document titled 

‘‘Cyromazine. Human Health Risk 

Assessment for Proposed New Use of 

Cyromazine on Succulent Beans.’’ 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to cyromazine, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing cyromazine tolerances in 40 

CFR 180.414. EPA assessed dietary 

exposures from cyromazine in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

No such effects were identified in the 

toxicological studies for cyromazine; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. A chronic 

dietary risk assessments was conducted 

for cyromazine using the Dietary 

Exposure Evaluation Model (DEEMFCID, Version 2.03), which uses food 

consumption data from the USDA’s 

Continuing Surveys of Food Intakes by 

Individuals (CSFII) from 1994–1996 and 

1998. As to residue levels in food, 

tolerance level residues and 100% crop 

treated assumptions were used. DEEM 

default and empirical processing factors 

were used to modify the tolerance 

values. 

iii. Cancer. Based on the absence of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

EPA has classified cyromazine as ‘‘not 

likely to be carcinogenic to humans.’’ 

Therefore, a quantitative exposure 

assessment to evaluate cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for cyromazine. Tolerance level residues 

and/or 100% crop treated were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for cyromazine in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of cyromazine. 

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 cyromazine for chronic 

exposures for non-cancer assessments 

are estimated to be 15.8 parts per billion 

(ppb) for surface water and 1.1 ppb for 

ground water. Modeled estimates of 

drinking water concentrations were 

directly entered into the dietary 

exposure model. For chronic dietary 

risk assessment, the water concentration 

of value 15.8 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). 

Cyromazine is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

Cyromazine contains a symmetrical 

triazine substructure like the herbicides 

simazine and atrazine, but atrazine and 

simazine are chlorotriazines, and the 

toxicity of these chemicals is associated 

with the presence of a chlorine 

substituent on the triazine ring. 

Cyromazine is not a chlorotriazine. The 

chlorotriazines have a much different 

toxicological profile than does 

cyromazine which does not have a 

chlorine substituent on the triazine ring. 

EPA has not found cyromazine to share 

a common mechanism of toxicity with 

any other substances, and cyromazine 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that cyromazine 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. 

Based on the available data, there is no 

quantitative and qualitative evidence of 

increased susceptibility observed 

following in utero cyromazine exposure 

to rats and rabbits or following prenatal/ 

postnatal exposure in the 2–generation 

reproduction study. The database is 

considered adequate for selection of 

study endpoints and determination of a 

dose/response to characterize the 

potential prenatal or postnatal toxicity 

of cyromazine to infants and children. 

No increase in susceptibility was seen 

in developmental toxicity studies in rat 

and rabbit or reproductive toxicity 

studies in the rat. Toxicity to offspring 

was observed at dose levels the same or 

greater than those causing maternal or 

parental toxicity. Based on the results of 

developmental and reproductive 

toxicity studies, there is not a concern 

for increased qualitative and/or 

quantitative susceptibility following in 

utero exposure to cyromazine. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 


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infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

cyromazine is complete except for acute 

and subchronic neurotoxicity studies 

and immunotoxicity testing. Recent 

changes to 40 CFR part 158 make these 

studies (OPPTS Guideline 870.7800) 

required for pesticide registration; 

however, the available data for 

cyromazine do not show potential for 

neurotoxicity or immunotoxicity. 

Although specific neurotoxicity studies 

have not yet been submitted, there is no 

evidence of neurotoxicity in any study 

in the toxicity database for cyromazine. 

In the absence of specific 

immunotoxicity studies, EPA has 

evaluated the available cyromazine 

toxicity database to determine whether 

an additional database uncertainty 

factor is needed to account for potential 

immunotoxicity. No evidence of 

immunotoxicity was found. Due to the 

lack of evidence of immunotoxicity for 

cyromazine, EPA does not believe that 

conducting immunotoxicity testing will 

result in a NOAEL less than the cRfD 

NOAEL of 1.5 mg/kg bw/day already 

established for cyromazine. 

Consequently, the EPA believes the 

existing data are sufficient for endpoint 

selection for exposure/risk assessment 

scenarios and for evaluation of the 

requirements under the FQPA, and an 

additional database uncertainty factor 

does not need to be applied. 

ii. There is no indication that 

cyromazine is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

cyromazine results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2–generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to cyromazine 

in drinking water. 

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, cyromazine is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to cyromazine 

from food and water will utilize 85% of 

the cPAD for children 1 to 2 years old, 

the population group receiving the 

greatest exposure. There are no 

residential uses for cyromazine. 

3. Short- and intermediate term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short-term 

and intermediate-term residential 

exposure plus chronic exposure to food 

and water (considered to be a 

background exposure level). 

Cyromazine is not registered for any use 

patterns that would result in residential 

exposure. Therefore, the short-term and 

intermediate-term aggregate risk is the 

sum of the risk from exposure to 

cyromazine through food and water and 

will not be greater than the chronic 

aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. Cyromazine is classified as 

a ‘‘Group E’’ chemical (negative for 

carcinogenicity in humans). This 

classification is based on the lack of 

evidence of carcinogenicity in mice and 

rats. EPA does not expect cyromazine to 

pose a cancer risk. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to cyromazine 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Methods AG-408 [high-performance 

liquid chromatography/ultraviolet 

(HPLC/UV)] and AG-417A [gas-liquid 

chromatography/nitrogen-phosphorus 

detector (GLC/NPD)] are the tolerance 

enforcement methods for cyromazine as 

published in the Pesticide Analytical 

Manual (PAM), Vol. II. These methods 

combined and with minor modifications 

comprise Method AG-621. The residue 

data submitted in support of this 

petition were generated using Methods 

AG-408 and AG-621. Method AG-621 

has been adequately validated for use 

for the determination of residues of 

cyromazine in/on bulb vegetables, leafy 

Brassica vegetables, and turnip greens. 

Method AG-408 is adequate for 

enforcement of the proposed tolerance 

for residues of cyromazine. 

B. International Residue Limits 

There are currently no established 

Codex maximum residue limits (MRLs) 

for residues of cyromazine on succulent 

beans. 

V. Conclusion 

Therefore, tolerances are established 

for residues of cyromazine, Ncyclopropyl-1,3,5-triazine-2,4,6- 

triamine, in or on bean, succulent at 2.0 

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). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 


sroberts on DSKD5P82C1PROD with RULES
22256 Federal Register / Vol. 75, No. 81 / Wednesday, April 28, 2010 / Rules and Regulations 

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: March 26, 2010. 

Lois Rossi, 

Director, Registration DivisionOffice 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 180.414 is amended by 

alphabetically adding the following 

commodity to the table in paragraph 

(a)(1) to read as follows: 

§180.414 Cyromazine; tolerances for 

residues 

(a)* * * (1)* * * 

Commodity Parts per million 

* * * * * 

Bean, succulent .... 2.0 

* * * * * 

* * * * * 

[FR Doc. 2010–9741 Filed 4–27–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0162; FRL–8817–3] 

Difenoconazole Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of the fungicide 

difenoconazole in or on: Almond, hulls; 

brassica, head and stem, subgroup 5A; 

brassica, leafy green, subgroup 5B; 

citrus, dried pulp; citrus, oil; fruit, 

citrus, group 10; grape; grape, raisin; 

nut, tree, group 14; onion, bulb, 

subgroup 3-07A; onion, green, subgroup 

3-07B; pistachio; and vegetable, 

cucurbit, group 9. EPA is also revising 

the difenoconazole crop and animal 

tolerance expressions; deleting all 

section 18 difenoconazole tolerances 

that are no longer needed as a result of 

this action; reinstating tolerances for 

wheat forage, wheat grain, and wheat 

straw, which were inadvertently 

removed when previous tolerances were 

established; correcting the existing 

tolerance for beet, sugar; and deleting 

the grape import superscript. Syngenta 

Crop Protection, Inc. requested the new 

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–2009–0162. 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: 

Rosemary Kearns, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5611; e-mail address: 

kearns.rosemary@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 


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