48402 Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Rules and Regulations 

* * * * * 

[FR Doc. E9–22915 Filed 9–22–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0810; FRL–8434–2] 

Spinosad; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of spinosad in or 

on date and pomegranate, and 

additionally increases established 

tolerances in or on almond hulls; tree 

nut, group 14; and pistachio. 

Interregional Research Project Number 4 

(IR-4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

September 23, 2009. Objections and 

requests for hearings must be received 

on or before November 23, 2009, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION ). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0810. 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: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; e-mail address: 

nollen.laura@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 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gov/opptsfrs/home/ 

guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0810 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 November 23, 2009. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0810, 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 December 3, 

2008 (73 FR 73648) (FRL–8391–3), 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 8E7445) by IR-4, 

500 College Rd. East, Suite 201 W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.495 be 

amended by establishing tolerances for 

residues of the insecticide, spinosad, a 

fermentation product of 

Saccharopolyspora spinosa, consisting 

of two related active ingredients: 

Spinosyn A (Factor A; CAS#131929-60- 

7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-a-Lmanno-pyranosyl)oxy]-13-[[5- 

(dimethylamino)-tetrahydro-6-methyl2H-pyran-2-yl]oxy]-9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16btetradecahydro-14-methyl-1H-asIndaceno[3,2-d]oxacyclododecin-7,15- 

dione; and Spinosyn D (Factor D; 

CAS#131929-63-0) or 2-[(6-deoxy-2,3,4- 

tri-O-methyl-a-L-manno-pyranosyl)oxy]- 

13-[[5-(dimethyl-amino)-tetrahydro-6- 

methyl-2H-pyran-2-yl]oxy]-9-ethylmstockstill on DSKH9S0YB1PROD with RULES

Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Rules and Regulations 48403 

2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16btetradecahydro-4,14-methyl-1H-asIndaceno[3,2-d]oxacyclododecin-7,15- 

dione, in or on pomegranate at 0.3 parts 

per million (ppm) and date at 0.1 ppm. 

The petition additionally requested an 

increase in the existing tolerances for 

residues of spinosad in or on tree nut, 

group 14 and pistachio from 0.02 to 0.08 

ppm; and almond, hulls from 2.0 to 9.0 

ppm. That notice referenced a summary 

of the petition prepared on behalf of IR4 by Dow AgroSciences, LLC, the 

registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerance levels for 

almond hulls; tree nut, group 14; and 

pistachio. The reason for these changes 

is explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue.’’ 

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

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for residues of spinosad on 

almond, hulls at 19 ppm; tree nut, group 

14 at 0.10 ppm; pistachio at 0.10 ppm; 

date at 0.10 ppm; and pomegranate at 

0.30 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. 

The existing spinosad data indicate 

that it possesses low acute toxicity via 

the oral, dermal, and inhalation routes 

of exposure. It is not a dermal irritant, 

dermal sensitizer or eye irritant. No 

dermal toxicity was seen at the limit 

dose in a 21–day dermal toxicity study 

in rabbits. 

In mice, rats, and dogs, the target 

organs appeared to be the liver, kidney, 

spleen, heart, thyroid, and bone marrow 

(anemia). In the mouse subchronic 

toxicity study, increased vacuolation of 

cells was noted in the lymphoid organs, 

liver, kidney, stomach, female 

reproductive tract and epididymis. A 

similar effect was seen in the heart, 

lung, pancreas, adrenal cortex, bone 

marrow, tongue, pituitary gland, and 

anemia but to a less severe degree. The 

rat subchronic toxicity study showed 

evidence of thyroid follicle epithelial 

cell vacuolation, anemia, multifocal 

hepatocellular granuloma, 

cardiomyopathy, and splenic 

histiocytosis. Microscopic changes in a 

variety of tissues, anemia and possible 

liver damage were seen in the dog 

subchronic toxicity study. Additionally, 

long-term dietary administration of 

spinosad resulted in increases in serum 

alanine aminotransferase, aspartate 

aminotransferase and triglyceride levels. 

Spinosad is classified as ‘‘not likely to 

be carcinogenic to humans’’ based on 

the lack of evidence for carcinogenicity 

in mice and rats. No evidence of 

neurotoxicity was seen in any of the 

submitted studies, including the acute 

and subchronic neurotoxicity studies in 

rats. Spinosad is negative for 

mutagenicity in various mutagenicity 

assays. 

No developmental effects were seen 

in the rat and rabbit developmental 

toxicity studies. In a 2–generation 

reproduction study in rats, decreased 

litter size, survival and body weights 

were observed in the presence of 

maternal toxicity (deaths) at the highest 

dose tested (HDT). In addition, male rats 

exhibited chronic active inflammation 

of the prostate gland. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by spinosad as well as the 

no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in the document 

‘‘Spinosad and Spinetoram. HumanHealth Risk Assessment for Application 

of Spinosad to Date and Pomegranate 

and Spinetoram to Pineapple, Date, 

Pomegranate, Hops, and Spices (Crop 

Subgroup 19B, except black pepper)’’ at 

pages 44-48 in docket ID number EPA– 

HQ–OPP–2008–0810. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

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. 

The Agency has concluded that 

spinosad should be considered 

toxicologically identical to another 

pesticide, spinetoram. This conclusion 

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48404 Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Rules and Regulations 

is based on the following: (1) 

Spinetoram and spinosad are large 

molecules with nearly identical 

structures; and (2) the toxicological 

profiles for each are similar (generalized 

systemic toxicity) with similar doses 

and endpoints chosen for human health 

risk assessment. Spinosad and 

spinetoram should be considered 

toxicologically identical in the same 

manner that metabolites are generally 

considered toxicologically identical to 

the parent. 

Although, as stated above, the doses 

and endpoints for spinosad and 

spinetoram are similar, they are not 

identical due to variations in dosing 

levels used in the spinetoram and 

spinosad toxicological studies. EPA 

compared the spinosad and spinetoram 

doses and endpoints for each exposure 

scenario and selected the lower of the 

two doses for use in human risk 

assessment. 

A summary of the toxicological 

endpoints for spinosad and spinetoram 

used for human risk assessment can be 

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

the document ‘‘Spinosad and 

Spinetoram. Human-Health Risk 

Assessment for Application of Spinosad 

to Date and Pomegranate and 

Spinetoram to Pineapple, Date, 

Pomegranate, Hops, and Spices (Crop 

Subgroup 19B, except black pepper)’’ at 

pages 8 and 21 in docket ID number 

EPA–HQ–OPP–2008–0810. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to spinosad and spinetoram, 

EPA considered exposure under the 

petitioned-for tolerances as well as all 

existing spinosad and spinetoram 

tolerances in 40 CFR 180.495 and 

180.635, respectively. EPA assessed 

dietary exposures from spinosad and 

spinetoram 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 spinosad and spinetoram; therefore, 

a quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. Spinosad and 

spinetoram are considered to be 

toxicologically equivalent. However, as 

both products control the same pest 

species, EPA concluded that it would 

overstate exposure to assume that 

residues of both chemicals would 

appear on the same crop. Therefore, the 

Agency aggregated exposure from 

residues of spinosad and spinetoram by 

assuming that spinosad residues would 

be present in all commodities, because 

side-by-side spinosad and spinetoram 

residue data indicated that spinetoram 

residues were less than or equal to 

spinosad residues. 

In conducting the chronic dietary 

exposure assessment EPA used the food 

consumption data from the U.S. 

Department of Agriculture (USDA) 

1994–1996 and 1998 Continuing Survey 

of Food Intake by Individuals (CSFII). 

As to residue levels in food, EPA 

assumed 100 percent crop treated (PCT) 

for all food crop commodities; used 

average field trial residues for apple, 

Brassica leafy vegetables, citrus, fruiting 

vegetables, herbs, banana, and 

strawberry; used tolerance-level 

residues for the remaining food crop 

commodities; and used Dietary 

Exposure Evaluation Model (DEEM) 

default processing factors for all 

commodities excluding orange juice, 

field corn (meal, starch, flour, and oil), 

grape juice and wheat (flour and germ), 

where the results from processing 

studies were used. Residues in livestock 

were refined through the incorporation 

of a refined dietary burden (average feed 

crop residues and combined spinosad 

and spinetoram PCT estimates) and 

through the incorporation of average 

residues from the feeding and dermal 

magnitude of the residue studies. 

iii. Cancer. Based on the lack of 

evidence of carcinogenicity in rats and 

mice, EPA has classified spinosad 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. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

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. 

EPA assumed 100 PCT for all food 

crop commodities. For certain feed crop 

commodities, the Agency used 

combined spinosad and spinetoram 

projected PCT (PPCT) information to 

calculate beef and dairy cattle burdens 

as follows: 

Sweet corn forage (39%); leaves of 

root and tuber vegetables (50%); 

sorghum grain (5%); and soybean seed 

meal (5%). 

Spinetoram is a recently registered 

pesticide. EPA estimates an upper 

bound of PPCT for a new pesticide use 

by assuming that its actual PCT during 

the initial 5 years of use on a specific 

use site will not exceed the recent PCT 

of the market leader (i.e., the one with 

the greatest PCT) on that site. EPA calls 

this the market leader PPCT estimate. In 

this specific case, the new use to be 

estimated is the combined use of 

spinosad together with that of 

spinetoram, since most new uses of 

spinetoram will likely replace a 

previous use of spinosad. An average 

market leader PCT, based on three 

recent surveys of pesticide usage, if 

available, is used for chronic risk 

assessment. The average market leader 

PCT may be based on one or two survey 

years if three are not available. Also, 

with limited availability of data, the 

average market leader PCT may be based 

on a cross-section of state PCTs. 

Comparisons are only made among 

pesticides of the same pesticide type 

(i.e., the leading insecticide on the use 

site is selected for comparison with the 

new insecticide), or, for refined 

estimates, among pesticides targeting 

the same pests. The market leader PCTs 

are used to determine the average for the 

same pesticide or for different pesticides 

for any year since the same or different 

pesticides may dominate for each year. 

Typically, EPA uses U.S. Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS) as the 

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Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Rules and Regulations 48405 

source for raw PCT data because it is 

publicly available. When a specific use 

site is not surveyed by USDA/NASS, 

EPA uses other sources including 

proprietary data. 

An estimated PPCT, based on the 

average PCT of the market leaders, is 

appropriate for use in chronic dietary 

risk assessment. This method of 

estimating PPCT for a new use of a 

registered pesticide or a new pesticide 

produces a high-end estimate that is 

unlikely, in most cases, to be exceeded 

during the initial 5 years of actual use. 

Predominant factors that bear on 

whether the PPCT could be exceeded 

may include PCTs of similar 

chemistries, pests controlled by 

alternatives, pest prevalence in the 

market and other factors. All relevant 

information currently available for 

predominant factors has been 

considered for the combined use of 

spinetoram and spinosad on each of 

these several crops. It is the Agency’s 

opinion that it is unlikely that actual 

combined PCTs for spinetoram and 

spinosad will exceed the corresponding 

estimated PPCTs during the next 5 

years. 

The Agency believes that the three 

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

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions B and C, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which spinosad may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for spinosad and spinetoram in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of spinosad and 

spinetoram. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST) and Screening 

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

water concentrations (EDWCs) of 

spinosad for surface water are estimated 

to be 34.5 parts per billion (ppb) for 

acute exposures, and 10.5 ppb for 

chronic exposures. For ground water, 

the estimated drinking water 

concentration is 1.1 ppb. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. As 

explained above, an acute dietary risk 

assessment was not conducted for 

spinosad and spinetoram. For chronic 

dietary risk assessment, the water 

concentration of value 10.5 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 Agency has concluded that 

spinosad and spinetoram are 

toxicologically equivalent; therefore, 

residential exposure to both spinosad 

and spinetoram was evaluated. 

Spinosad is currently registered for 

homeowner application to turf grass and 

ornamentals and spinetoram is 

registered for homeowner applications 

to gardens, lawns/ornamentals and turf 

grass. 

There is potential for residential 

handler and postapplication exposures 

to both spinosad and spinetoram. Since 

spinosad and spinetoram control the 

same pests, EPA concluded that these 

products will not be used in 

combination with each other and 

combining the residential exposures is 

unnecessary. Short-term residential 

inhalation risks were estimated for adult 

residential handlers, as well as shortterm postapplication incidental oral 

risks (hand-to-mouth, object-to-mouth 

and soil ingestion) for toddlers, based 

on applications to home lawns, home 

gardens and ornamentals. Dermal 

exposures were not assessed, since no 

dermal endpoints of concern were 

identified in the toxicology studies for 

spinosad and spinetoram. 

In addition, a registered fruit fly bait 

application scenario permits application 

to non-crop vegetation, which may 

result in residential exposures to 

spinosad. Based on the application 

rates, EPA concluded that residential 

exposure resulting from this scenario 

would be insignificant when compared 

to the residential exposure resulting 

from the turf/ornamental application 

scenarios; therefore, a quantitative 

analysis of residential exposure 

resulting from the fruit fly bait 

application scenario is unnecessary and 

was not performed. 

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 spinosad and 

spinetoram to share a common 

mechanism of toxicity with any other 

substances, and spinosad and 

spinetoram do not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that spinosad and spinetoram 

do not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

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

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The following acceptable studies are 

available for both spinosad and 

spinoteram: Developmental toxicity 

studies in rats and rabbits and a 2– 

generation reproduction study in rats. 

There is no evidence of increased 

susceptibility of rat or rabbit fetuses to 

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48406 Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Rules and Regulations 

in utero exposure to spinosad or 

spinetoram. In the spinosad and 

spinetoram rat and rabbit 

developmental toxicity studies, no 

developmental toxicity was observed at 

dose levels that induced maternal 

toxicity. In the spinosad 2–generation 

rat reproduction study, maternal and 

offspring toxicity were equally severe, 

indicating no evidence of increased 

susceptibility. In the spinetoram 2- 

generation rat reproduction study, no 

adverse effects were observed in the 

offspring at dose levels that produced 

parental toxicity. Therefore, there is no 

evidence of increased susceptibility and 

there are no concerns or residual 

uncertainties for prenatal and/or 

postnatal toxicity. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for spinosad 

is complete, except for immunotoxicity 

testing. Recent changes to 40 CFR part 

158 make immunotoxicity testing 

(OPPTS Guideline 870.7800) required 

for pesticide registration; however, the 

existing data are sufficient for endpoint 

selection for exposure/risk assessment 

scenarios, and for evaluation of the 

requirements under the FQPA. 

There was some evidence of adverse 

effects on the organs of the immune 

system at the LOAEL in three short-term 

studies with spinosad or spinetoram. In 

these studies, anemia was observed in 

multiple species (rats, mice and dogs) 

with the presence of histiocytic 

aggregates of macrophages in various 

organs and tissues (lymph nodes, 

spleen, thymus, and bone marrow). 

Aggregation of macrophages was 

indicative of immune stimulation in 

response to insults of the chemical 

exposure and was considered secondary 

effects of the toxic effect to the 

hematopoetic system. Therefore, these 

effects are not considered to be 

indicative of frank immunotoxicity. In 

the spinetoram chronic toxicity study in 

dogs, areteritis and necrosis of the 

areterial walls of the thymus was seen 

in one female dog at the HDT. This 

finding is attributed to the exacerbation 

of the spontaneous arteritis present in 

genetically predisposed Beagle dogs 

(‘‘Beagle Pain Syndrome’’), not 

immunotoxicity. Further, a clear 

NOAEL was attained in each of these 

studies, and the observed 

histopathologies were generally 

observed in the presence of other organ 

toxicity. In addition, spinosad and 

spinetoram do not belong to a class of 

chemicals (e.g., the organotins, heavy 

metals, or halogenated aromatic 

hydrocarbons) that would be expected 

to be immunotoxic. 

Based on the above considerations, 

EPA does not believe that conducting a 

special series OPPTS Guideline 

870.7800 immunotoxicity study will 

result in a POD less than the NOAEL of 

2.49 miligrams/kilograms/day (mg/kg/ 

day) already set for spinosad and 

spinetoram. Consequently, an additional 

database uncertainty factor does not 

need to be applied. 

ii. There is no indication that 

spinosad and spinetoram are neurotoxic 

chemicals and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that spinosad 

and spinetoram result 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 tolerance-level 

residues or reliable data from field trial 

studies and 100 PCT for all registered 

and proposed commodities except 

certain feed crop commodities. The 

PPCT estimates used to refine certain 

feed crop estimates provide 

conservative, high-end estimates 

developed using the market leader 

approach that are unlikely to be 

exceeded. Conservative ground and 

surface water modeling estimates were 

used to assess exposure to spinosad and 

spinetoram in drinking water. 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 spinosad and spinetoram. 

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, spinosad and 

spinetoram are not expected to pose an 

acute risk. 

2. Chronic risk. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

spinosad and spinetoram are not 

expected; therefore, the chronic 

aggregate exposure assessment consists 

of exposures from food and water only. 

Using the exposure assumptions 

described in this unit for chronic 

exposure, EPA has concluded that 

chronic exposure to spinosad and 

spinetoram from food and water will 

utilize 95% of the cPAD for children 1 

to 2 years old, the population group 

receiving the greatest exposure. 

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). 

Spinosad and spinetoram are 

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 

spinosad and spinetoram. Using the 

exposure assumptions described in this 

unit for short-term exposures, EPA has 

concluded the combined short-term 

food, water, and residential exposures 

aggregated result in aggregate MOEs of 

greater than or equal to 160 for all 

population subgroups. As the aggregate 

MOEs are greater than 100 for all 

population subgroups, including infants 

and children, short-term aggregate 

exposure to spinosad and spinetoram is 

not of concern to EPA. 

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). 

Spinosad and spinetoram are not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Therefore, the 

intermediate-term aggregate risk is the 

sum of the risk from exposure to 

spinosad and spinetoram through food 

and water, which has already been 

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Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Rules and Regulations 48407 

addressed, and will not be greater than 

the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in mice and 

rats at doses that were judged to be 

adequate to assess the carcinogenic 

potential, spinosad and spinetoram 

were classified as ‘‘not likely to be 

carcinogenic to humans,’’ and are not 

expected to pose a cancer risk to 

humans. 

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 spinosad and 

spinetoram residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Method RES 94025, GRM 94.02 (a 

high performance liquid 

chromatography method with 

ultraviolet absorption detection (HPLC/ 

UV)) has been adequately validated and 

determined to be acceptable to enforce 

the tolerance expression in plant 

commodities. In addition, the following 

additional methods (which are 

essentially similar to GRM 94.02) have 

been submitted for other crop matrices: 

GRM 95.17 for leafy vegetables; GRM 

96.09 for citrus; GRM 96.14 for tree 

nuts; GRM 95.04 for fruiting vegetables; 

and GRM 94.02.S1 for cotton gin 

byproducts. These methods have been 

forwarded to the Food and Drug 

Administration (FDA) for inclusion in 

Pesticide Analytical Methods Volume II 

(PAM II). These methods may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are currently no Canadian 

maximum residue limits (MRLs) 

established for residues of spinosad in 

or on the crops associated with this 

review. Codex MRLs exist for spinosad 

on almond hull (2 ppm) and almond 

nutmeat (0.01 ppm). These MRLs are 

based on field trial data which 

employed a 14–day pre-harvest interval 

(PHI), while the U.S. almond hull (19 

ppm) and tree nut (0.10 ppm) tolerances 

are based on a 1–day PHI. Since the U.S. 

and Codex tolerances are based on 

different application scenarios and since 

the U.S. tolerances are significantly 

greater (10x) than those currently 

established by Codex, harmonization is 

not possible. 

C. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

supporting the petition, EPA revised 

tolerances for certain proposed 

commodities as follows: almond, hulls 

from 9.0 ppm to 19 ppm; nut, tree, 

group 14 from 0.08 ppm to 0.10 ppm; 

and pistachio from 0.08 ppm to 0.10 

ppm. EPA revised the tolerance levels 

based on analysis of the residue field 

trial data using the Agency’s Tolerance 

Spreadsheet in accordance with the 

Agency’s Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data. 

V. Conclusion 

Therefore, tolerances are established 

for residues of spinosad, consisting of 

two related active ingredients: Spinosyn 

A (Factor A; CAS#131929-60-7) or 2-[(6- 

deoxy-2,3,4-tri-O-methyl-a-L-mannopyranosyl)oxy]-13-[[5-(dimethylamino)- 

tetrahydro-6-methyl-2H-pyran-2-yl]oxy]- 

9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16btetradecahydro-14-methyl-1H-asIndaceno[3,2-d]oxacyclododecin-7,15- 

dione; and Spinosyn D (Factor D; 

CAS#131929-63-0) or 2-[(6-deoxy-2,3,4- 

tri-O-methyl-a-L-manno-pyranosyl)oxy]- 

13-[[5-(dimethyl-amino)-tetrahydro-6- 

methyl-2H-pyran-2-yl]oxy]-9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16btetradecahydro-4,14-methyl-1H-asIndaceno[3,2-d]oxacyclododecin-7,15- 

dione, in or on almond, hulls at 19 ppm; 

nut, tree, group 14 at 0.10 ppm; 

pistachio at 0.10 ppm; date at 0.10 ppm; 

and pomegranate at 0.30 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 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

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48408 Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Rules and Regulations 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 8, 2009. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.495 is amended in 

paragraph (a) by revising the entries in 

the table for ‘‘Almond, hulls’’; ‘‘Nut, 

tree, group 14’’ and ‘‘Pistachio’’; and by 

alphabetically adding entries for ‘‘Date’’ 

and ‘‘Pomegranate’’ to the table to read 

as follows: 

180.495 Spinosad; tolerances for residues. 

(a) * * * 

Commodity Parts per million 

*** * *

Almond, hulls ........................................................................................................... 19 

*** * *

Date ......................................................................................................................... 0.10 

*** * *

Nut, tree, group 14 .................................................................................................. 0.10 

*** * *

Pistachio .................................................................................................................. 0.10

Pomegranate ........................................................................................................... 0.30 

*** * *

* * * * * 

[FR Doc. E9–22534 Filed 9–22–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0239; FRL–8438–9] 

Metolachlor, S-Metolachlor, Bifenazate, 

Buprofezin, and 2,4-D; Tolerance 

Actions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is modifying, 

establishing and revoking certain 

tolerances for the herbicides 

metolachlor and S-metolachlor and 

correcting the tolerance for guava (from 

guave) on bifenazate and buprofezin and 

2,4-D on cranberry. The regulatory 

actions finalized in this document are in 

follow-up to the Agency’s reregistration 

program under the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA), and tolerance reassessment 

program under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), section 

408(q). 

DATES: This regulation is effective 

September 23, 2009. Objections and 

requests for hearings must be received 

on or before November 23, 2009, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0239. 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 either 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 

hours of operation of this Docket 

Facility are 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: Jane 

Smith, Pesticide Re-evaluation Division 

(7508P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–0048; e-mail address: 

smith.jane-scott@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

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