13168 Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Rules and Regulations 

IV. Will this Notification be Subject to 

the Congressional Review Act? 

No. This action is not a rule for 

purposes of the Congressional Review 

Act (CRA), 5 U.S.C. 804(3), and will not 

be submitted to Congress and the 

Comptroller General. EPA will submit 

the final rule to Congress and the 

Comptroller General as required by the 

CRA. 

List of Subjects in 40 CFR Part 158 

Environmental protection, 

Confidential business information, 

Pesticides and pests, Reporting and 

recordkeeping requirements. 

Dated: January 30, 2007. 

James Jones, 

Director, Office of Pesticide Programs. 

[FR Doc. E7–5162 Filed 3–20–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0579; FRL–8114–4] 

Spinosad; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

and amends tolerances for residues of 

spinosad in or on certain commodities. 

The Interregional Research Project 

Number 4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA). 

DATES: This regulation is effective 

March 21, 2007. Objections and requests 

for hearings must be received on or 

before May 21, 2007, 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–2006–0579. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

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: 

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; e-mail 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. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111), 

e.g., agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

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 an electronic 

copy of this Federal Register document 

through the electronic docket 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 pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, as 

amended by FQPA, any person may file 

an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2006–0579 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 

on or before May 21, 2007. 

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 your 

copies, identified by docket ID number 

EPA–HQ–OPP–2006–0579, 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’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 


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Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Rules and Regulations 13169 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket telephone number is (703) 305–

5805. 

II. Background and Statutory Findings 

In the Federal Register of July 14, 

2006 (71 FR 40105) (FRL–8077–3), EPA 

issued a notice pursuant to section 

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

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

pesticide petitions (PP 6E7068 and 

3E6802) by the IR-4, 500 College Rd. 

East, Suite 201 W, Princeton, NJ 08540. 

The petition requested that 40 CFR 

180.495 be amended by establishing a 

tolerance for residues of the insecticide 

spinosad, in or on hops at 22 parts per 

million (ppm) (under PP 6E7068) and 

amaranth, grain, stover at 10 ppm; 

cattle, meat at 2 ppm; sheep, meat at 2 

ppm; goat, meat at 2 ppm; horse, meat 

at 2 ppm; poultry, meat at 0.1 ppm; 

cattle, fat at 50 ppm; sheep, fat at 50 

ppm; goat, fat at 50 ppm; horse, fat at 

50 ppm; poultry, fat at 1.3 ppm; milk at 

7.0 ppm; milk, fat at 85 ppm; and egg 

at 0.3 ppm (under PP 3E6802). 

Additionally, existing tolerances for 

meat byproducts which are currently 

based on residues in liver will be 

amended to establish separate liver 

tolerances and lower the meat 

byproducts tolerances which will now 

be based on residues in the kidney as 

follows: Cattle, meat byproducts, except 

liver at 5 ppm; sheep, meat byproducts, 

except liver at 5 ppm; goat, meat 

byproducts, except liver at 5 ppm; 

horse, meat byproducts, except liver at 

5 ppm; poultry meat byproducts 

tolerance raised from 0.03 ppm and set 

at 0.1 ppm; cattle, liver at 10 ppm; 

sheep, liver at 10 ppm; goat, liver at 10 

ppm; and horse, liver at 10 ppm (under 

PP 3E6802). That notice referenced a 

summary of the petition prepared by 

Dow AgroScience, the registrant, that is 

available in the docket for this 

rulemaking. There were no comments 

received in response to the notice of 

filing. 

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....’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of FFDCA 

and a complete description of the risk 

assessment process, see http:// 

www.epa.gov/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm and 

http://www.epa.gov/fedrgstr/EPA-PEST/ 

2003/July/Day-30/p19357.htm. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with 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, 

consistent with section 408(b)(2) of 

FFDCA, for tolerances for residues of 

spinosad in or on hop, dried cones at 22 

ppm; amaranth, grain, stover at 10 ppm; 

cattle, meat at 2.0 ppm; sheep, meat at 

2.0 ppm; goat, meat at 2.0 ppm; horse, 

meat at 2.0 ppm; poultry, meat at 0.10 

ppm; cattle, fat at 50 ppm; sheep, fat at 

50 ppm; goat, fat at 50 ppm; horse, fat 

at 50 ppm; poultry, fat at 1.30 ppm; milk 

at 7.0 ppm; milk, fat at 85 ppm; and egg 

at 0.30 ppm. Additionally, existing 

tolerances for meat byproducts which 

are based on residues in liver will be 

amended to establish separate liver 

tolerances and lower the meat 

byproducts tolerances which will now 

be based on residues in the kidney as 

follows: Cattle, meat byproducts, except 

liver at 5.0 ppm; sheep, meat 

byproducts, except liver at 5.0 ppm; 

goat, meat byproducts, except liver at 

5.0 ppm; horse, meat byproducts, except 

liver at 5.0 ppm; poultry meat 

byproducts tolerance raised from 0.03 

ppm and set at 0.10 ppm; cattle, liver at 

10 ppm; sheep, liver at 10 ppm; goat, 

liver at 10 ppm; and horse, liver at 10 

ppm. EPA’s assessment of exposures 

and risks associated with establishing 

these tolerances 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. Specific 

information on the studies received and 

the nature of the toxic effects caused by 

spinosad as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies are 

discussed in the Federal Register of 

September 27, 2002 (67 FR 60923) 

(FRL–7199–5). 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the dose at which the NOAEL from 

the toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which the LOAEL is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect 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. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

cancer risk, estimates risk in terms of 

the probability of occurrence of 

additional cancer cases. More 

information can be found on the general 

principles EPA uses in risk 

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

pesticides/health/human.htm. 

A summary of the toxicological 

endpoints for spinosad used for human 

risk assessment can be found at http:// 

www.regulations.gov in the following 

indices: 

1. Docket ID number EPA–HQ–OPP–

2006–0579, entitled Application of 

Spinosad to Hops and as a Mosquito 

Larvicide. Human Health Risk 

Assessment, dated August 2, 2006. 

2. Docket ID number EPA–HQ–OPP–

2005–0510, entitled PPs 3E6699, 

3E6780, and 4E6811. Application of 

Spinosad to Mint; Banana; Plantain; 

Peanut; Bulb Vegetables; Legume 

Vegetables; Forage, Fodder, and Straw 

of Cereal Grains (crop group 16); Grass 

Forage, Fodder, and Hay (crop group 

17); and Nongrass Animal Feeds (crop 

group 18) and Application of Spinosad 

for Control of Fruit Flies. HED Risk 

Assessment, dated September 15, 2005. 


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C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.495) for the 

residues of spinosad, in or on a variety 

of raw agricultural commodities. Risk 

assessments were conducted by EPA to 

assess dietary exposures from spinosad 

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. 

The Agency did not select a dose and 

endpoint for an acute dietary risk 

assessment due to the lack of 

toxicological effects of concern 

attributable to a single exposure (dose) 

in studies available in the database 

including oral developmental toxicity 

studies in rats and rabbits. In the acute 

neurotoxicity study, the NOAEL was 

2,000 milligrams/kilograms/day (mg/kg/ 

day), highest dose tested. An acute 

dietary exposure assessment is not 

required. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the Dietary 

Exposure Evaluation Model software 

with the Food Commodity Intake 

Database (DEEM-FCIDTM) version 2.03 

(acute and cancer endpoints were not 

identified), which incorporates food 

consumption data as reported by 

respondents in the U.S. Department of 

Agriculture (USDA) 1994–1996 and 

1998 Nationwide Continuing Surveys of 

Food Intake by Individuals (CSFII), and 

accumulated exposure to the chemical 

for each commodity. The chronic 

dietary analyses assumed average/ 

projected percent crop treated (PPCT) 

estimates; projected percent head 

treated resulting from the dermal and 

premise treatments to ruminants, 

average field trial residues, and 

experimentally determined processing 

factors; and anticipated livestock 

residues. The chronic analysis assumed 

tolerance level residues for all crop, 

poultry, and egg commodities and 

anticipated residues for ruminant and 

milk commodities. 

iii. Cancer. Spinosad has been 

classified as not likely to be 

carcinogenic in humans based on the 

results of a carcinogenicity study in 

mice and the combined chronic toxicity 

and carcinogenicity study in rats. 

Therefore, a quantitative cancer 

exposure assessment was not 

performed. 

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 chemicals that have 

been measured in food. If EPA relies on 

such information, EPA must pursuant to 

FFDCA section 408(f)(1) require 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. Following the initial data 

submission, EPA is authorized to 

require similar data on a time frame it 

deems appropriate. For the present 

action, EPA will issue such data call-ins 

for information relating to anticipated 

residues as are required by FFDCA 

section 408(b)(2)(E) and authorized 

under FFDCA section 408(f)(1). Such 

data call-ins will be required to be 

submitted no later than 5 years from the 

date of issuance of this tolerance. 

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 the 

Agency can make the following 

findings: Condition 1, that 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 such pesticide residue; 

Condition 2, that the exposure estimate 

does not underestimate exposure for any 

significant subpopulation group; and 

Condition 3, if 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 

section 408(b)(2)(F) of FFDCA, EPA may 

require registrants to submit data on 

PCT. 

The Agency used PCT information as 

follows: Almond 5%; apple 30%; 

apricot 10%; avocado 5%; broccoli 

40%; brussel sprout 15%; cabbage 30%; 

cantaloupes 10%; cauliflower 45%; 

celery 50%; cherry 25%; citrus 5%, 

excluding lemon, tangerine, and orange; 

collards 25%; corn, sweet 1%; cotton 

5%; cucumber 20%; eggplant 15%; 

green, mustard 15%; green, turnip 5%; 

kale 30%; lemon 10%; lettuce 50%; 

nectarine 30%; orange 10%; peach 5%; 

pear 10%; pepper 35%; potato 5%; 

prune and plum 10%; spinach 30%; 

squash 10%; strawberry 35%; tangerine 

10%; tomato 20%; and watermelon 5%. 

Exposure analysis also incorporated 

projected percent ruminant head treated 

resulting from the registered dermal and 

premise use (dairy cattle 23% and beef 

cattle 31%, actual data are not available 

despite this being a registered use) and 

projected PCT for alfalfa of 1%. 

EPA uses an average PCT for chronic 

dietary risk analysis. The average PCT 

figure for each existing use is derived by 

combining available Federal, State, and 

private market survey data for that use, 

averaging by year, averaging across all 

years, and rounding up to the nearest 

multiple of five except for those 

situations in which the average PCT is 

less than one. In those cases assumed 

not less than 1%, is used as the average 

and 2.5% is used the maximum. EPA 

uses a maximum PCT for acute dietary 

risk analysis. The maximum PCT figure 

is the single maximum value reported 

overall from available Federal, State, 

and private market survey data on the 

existing use, across all years, and 

rounded up to the nearest multiple of 

five. In most cases, EPA uses available 

data from USDA/National Agricultural 

Statistics Service (USDA/NASS), 

Proprietary Market Surveys, and the 

National Center for Food and 

Agriculture Policy (NCFAP) for the most 

recent 6 years. 

EPA estimates PPCT for a new 

pesticide Use for use in chronic dietary 

risk assessment by assuming that the 

PCT during the pesticide’s initial 5 

years of use on a specific use site will 

not exceed the average PCT of the 

dominant pesticide (i.e., the market 

leader pesticide with the greatest PCT) 

on that site over the three most recent 

pesticide usage surveys. Comparisons 

are only made among pesticides of the 

same pesticide types (i.e., the dominant 

insecticide on the use site is selected for 

comparison with the new insecticide). 

The PCTs included in the average may 

be each for the same pesticide or for 

different pesticides since the same or 

different pesticides may dominate for 

each year selected. Typically, EPA uses 

data from the USDA/NASS as the source 

for the PCT data because they are 

publicly available. When a specific use 

site is not surveyed by USDA/NASS, 

EPA uses other data which may include 

proprietary data. 

The estimated PPCT, equivalent to the 

average PCT of the market leader is 

appropriate for use in the chronic 

dietary risk assessment. This method of 

estimating a PPCT for a new use of a 

registered pesticide produces a high-end 

estimate that is unlikely, in most cases, 

to be exceeded during the initial 5 years 

of actual use. 

The predominant factors that bear on 

whether the estimated PPCT could be 

exceeded are whether the new pesticide 

use is more efficacious or controls a 

broader spectrum of pests than the 

dominant pesticides, whether there are 


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concerns with pest pressure as indicated 

in emergency exemption requests or 

other readily available information, and/ 

or other factors based on analysis of 

additional information. All information 

readily available has been considered 

for spinosad on dairy cattle, beef cattle 

and alfalfa, and it is the opinion of the 

Agency that it is unlikely that actual 

PCTs for spinosad on these sites will 

exceed the corresponding estimated 

PPCTs during the next 5 years. For 

cattle, the estimated PPCTs likely would 

not be exceeded because spinosad 

generally is more expensive than the 

leading alternative insecticides although 

it has efficacy on the same order for the 

targeted pests. For alfalfa, its estimated 

PPCT likely also would not be exceeded 

because it is considerably more 

expensive than the leading alternative, 

and treatments for the targeted pest, 

armyworms, have been relatively small 

on average over the past 8 years. 

The Agency believes that the three 

conditions listed in Unit III.C.1.iv. have 

been met. With respect to Condition 1, 

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 2 and 3, 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 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 lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

spinosad in drinking water. Because the 

Agency does not have comprehensive 

monitoring data, drinking water 

concentration estimates are made by 

reliance on simulation or modeling 

taking into account data on the physical 

characteristics of spinosad. 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. 

Typically, EPA evaluates the potential 

for human exposure to pesticides in 

drinking water through an assessment of 

available surface water and ground 

water monitoring data and modeling. 

For spinosad, no monitoring data were 

available for use in this drinking water 

assessment. Therefore, potential human 

exposures to spinosad were evaluated 

through modeling. Estimated exposure 

concentrations (EECs) in surface water 

were calculated using Pesticide Root 

Zone Model/Exposure Analyses 

Modeling System (PRZM/EXAMS). 

Ground water concentrations were 

modeled using Screening Concentration 

in Ground Water (SCI-GROW) (version 

2.3). Drinking water residues were then 

incorporated into the DEEM-FCIDTM

into the food categories ‘‘water, direct, 

all sources’’ and ‘‘water, indirect, all 

sources.’’

Available environmental fate data 

indicate that the spinosad 

transformation products maintain the 

basic ring structure of spinosad and that 

combined spinosad and its 

transformation products are stable. 

Therefore, the Agency concluded that a 

total residue method should be used 

when estimating spinsad residues in 

water, and that spinosad and its 

transformation products are stable 

under the aqueous photolysis, aerobic 

soil metabolism, and anaerobic aquatic 

metabolism conditions. 

Based on modeling results from 

surface water FQPA Index Reservoir 

Screening Tool (FIRST) and ground 

water SCI-GROW drinking water 

concentrations from application of 

spinosad to turf (4 x 0.4 pound active 

ingredient/acre (lb ai/acre); re-entry 

interval (RTI) = 7 days; highest 

registered/proposed rate excluding the 

mosquito larvicide use): The EECs of 

spinosad for acute exposures are 34.5 

parts per billion (ppb), 10.5 ppb for 

chronic exposures, and 1.1 ppb for 

ground water. The dietary exposure 

assessment assumed a water 

concentration of 10.5 ppb for all water 

sources (direct and indirect). Modeled 

estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model (DEEMFCIDTM). 

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). 

Spinosad is currently registered for 

use on numerous crops with tolerances 

for combined residues of spinosad 

ranging from 0.01 to 200 ppm, as well 

as residential, non-dietary sites 

including turf and ornamentals to 

control a variety of worms, moths, flies, 

beetles, midges, thrips, leafminers, and 

fire ants. Granular (homeowner) and EC 

(commercial applicators) formulations 

are registered. No dermal endpoints 

were identified and based on the 

granular formulation and low-vapor 

pressure for spinosad, residential 

handler/applicator and post-application 

dermal/inhalation exposure assessments 

were not conducted. The Agency 

concluded that there is a potential for 

toddler short-term, non-dietary, oral 

exposures (hand-to-mouth, object-tomouth, ingestion of granulars, and soil 

ingestion). Since EPA did not identify 

an acute dietary endpoint, episodic 

ingestion of granulars was not assessed. 

The Agency notes that the registered 

fruit fly bait application scenario 

permits application to non-crop 

vegetation and this use may result in 

residential exposures. Based on the 

application rates (fruit fly bait—0.0003 

lb ai/acre and turf/ornamental—0.41 lbs 

ai/acre), EPA concludes that residential 

exposure resulting from the fruit fly 

application will be insignificant when 

compared to the exposure resulting from 

the turf/ornamental application. 

Therefore, quantitative analysis of the 

residential exposure resulting from the 

fruit fly bait application 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.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

spinosad and any other substances and 

spinosad does not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has not 

assumed that spinosad has 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 the policy statements released by 


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EPA’s Office of Pesticide Programs 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism on 

EPA’s website at http://www.epa.gov/ 

pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold 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. Margins of safety are 

incorporated into EPA risk assessments 

either directly through use of a MOE 

analysis or through using uncertainty 

(safety) factors in calculating a dose 

level that poses no appreciable risk to 

humans. In applying this provision, 

EPA either retains the default value of 

10X when reliable data do not support 

the choice of a different factor, or, if 

reliable data are available, EPA uses a 

different additional safety factor value 

based on the use of traditional 

uncertainty factors and/or special FQPA 

safety factors, as appropriate. 

2. Prenatal and postnatal sensitivity. 

There is no indication of increased 

susceptibility of rat and rabbit fetuses to 

in utero and/or postnatal exposure to 

spinosad. 

3. Conclusion. EPA has determined 

that reliable data show that it would be 

safe for infants and children to reduce 

the FQPA safety factor to 1X. That 

decision is based on the following 

findings: 

i. The toxicological database for 

spinosad is complete for FQPA 

assessment. 

ii. There is no evidence of increased 

susceptibility of rat or rabbit fetuses 

following in utero exposure in the 

developmental studies with spinosad, 

and there is no evidence of increased 

susceptibility of young rats in the 

reproduction study with spinosad. 

iii. There are no residual uncertainties 

identified in the exposure databases; the 

dietary food exposure assessment 

(chronic only; no acute endpoint was 

identified) is refined using anticipated 

residues calculated from field trial data 

and available PCT information. 

iv. EPA has indicated that the dietary 

drinking water exposure is based on 

conservative modeling estimates. 

v. EPA Residential Standard 

Operational Procedures (SOPs) were 

used to assess post-application exposure 

to children as well as incidental oral 

exposure of toddlers, so these 

assessments do not underestimate the 

exposure and risks posed by spinosad. 

E. Aggregate Risks and Determination of 

Safety 

Safety is assessed for acute and 

chronic risks by comparing aggregate 

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 LOC by all 

applicable uncertainty/safety factors. 

For linear cancer risks, EPA calculates 

the probability of additional cancer 

cases given aggregate exposure. Short-, 

intermediate-, and long-term risks are 

evaluated by comparing aggregate 

exposure to the LOC to ensure that the 

MOE called for by the product of all 

applicable uncertainty/safety factors is 

not exceeded. 

1. Acute risk. As there were no toxic 

effects attributable to a single dose, an 

endpoint of concern was not identified 

for the general population or to the 

subpopulation females 13–50 years old. 

No acute risk is expected from exposure 

to spinosad. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to spinosad from food and 

water will utilize 37% of the cPAD for 

the U.S. population, 32% of the cPAD 

for all infants less than a year old, and 

86% of the cPAD for children 1–2 years 

old. Based on the use pattern, chronic 

residential exposure to residues of 

spinosad is not expected. Therefore, 

EPA does not expect the aggregate 

exposure to exceed 100% of the cPAD. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Spinosad is currently registered for 

uses (turf and ornamental application) 

that could result in short-term 

residential exposures (incidental oral 

exposures to toddlers). This incidental 

oral exposure is combined with chronic 

dietary (food and water) exposure for 

determination of aggregate short-term 

exposure. The Agency uses chronic 

dietary exposure when conducting 

short-term aggregate assessments as it 

has been determined this will more 

accurately reflect exposure from food 

than will acute exposure. 

Upon analyses of all available data, 

resulting aggregate MOEs are greater 

than or equal to 160. Therefore, the 

Agency concludes that short-term 

aggregate exposure to spinosad from 

food and residential uses is below the 

LOC. 

4. Aggregate cancer risk for U.S. 

population. Spinosad has been 

classified as ‘‘not likely to be 

carcinogenic in humans’’ based on the 

results of a carcinogenicity study in 

mice and the combined chronic toxicity 

and carcinogenicity study in rats. 

Therefore, spinosad is not expected to 

pose a cancer risk to humans. 

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, and to infants and children 

from aggregate exposure to spinosad 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

There is a practical method; liquid 

chromatography mass spectroscopyaccelerated climate prediction initiative 

(LCMS-ACPI) for detecting and 

measuring levels of spinosad in or on 

food with a limit of detection (0.002 

ppm) that allows monitoring of food 

with residues at or above the level set 

for these tolerances. The method has 

undergone successful EPA laboratory 

validation. 

Adequate enforcement methodology 

using high pressure liquid 

chromatography with ultraviolet 

detector (HPLC/UV) is available to 

enforce the tolerances in plants. 

Adequate livestock methods are 

available for tolerance enforcement. 

Method RES 94094 (GRM 95.03) is an 

HPLC/UV method suitable for 

determination of spinosad residues in 

ruminant commodities. Method GRM 

95.03 has undergone successful 

independent laboratory validation (ILV) 

and EPA laboratory validation, and has 

been forwarded to the Food and Drug 

Administration (FDA) for inclusion in 

PAM Volume II. Method GRM 95.15 is 

another HPLC/UV method suitable for 

determination of spinosad residues in 

poultry commodities. This method has 

been forwarded to FDA for inclusion in 

PAM Volume II. Method RES 95114, an 

immunoassay method for determination 

of spinosad residues in ruminant 

commodities, underwent a successful 

ILV and EPA laboratory validation. It 

has been submitted to FDA for inclusion 

in PAM Volume II. The methods may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Road, Fort 

Meade, MD 20755–5350; telephone 

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

residuemethods@epa.gov. 


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Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Rules and Regulations 13173 

B. International Residue Limits 

No Codex, Canadian, or Mexican 

maximum residue limits (MRLs) have 

been established for residues of 

spinosad on the raw agricultural 

commodities associated with this 

action. 

V. Conclusion 

Therefore, tolerances are established 

for residues of spinosad. Spinosad is a 

fermentation product of 

Saccharopolyspora spinosa. The 

product consist of two selected active 

ingredients: Spinosyn A (Factor A: 

CAS# 131929–60–7) or 2-[(6-deoxy2,3,4-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-Omethyl-aL-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 hop, dried cones at 22 

ppm and amaranth, grain, stover at 10 

ppm; cattle, meat at 2.0 ppm; sheep, 

meat at 2.0 ppm; goat, meat at 2.0 ppm; 

horse, meat at 2.0 ppm; poultry, meat at 

0.10 ppm; cattle, fat at 50 ppm; sheep, 

fat at 50 ppm; goat, fat at 50 ppm; horse, 

fat at 50 ppm; poultry, fat at 1.3 ppm; 

milk at 7.0 ppm; milk, fat at 85 ppm; egg 

at 0.30 ppm; cattle, meat byproducts, 

except liver at 5.0 ppm; sheep, meat 

byproducts, except liver at 5.0 ppm; 

goat, meat byproducts, except liver at 

5.0 ppm; horse, meat byproducts, except 

liver at 5.0 ppm; poultry meat 

byproducts tolerance raised from 0.03 

ppm and set at 0.10 ppm; cattle, liver at 

10 ppm; sheep, liver at 10 ppm; goat, 

liver at 10 ppm; and horse, liver at 10 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to petitions 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 due to its lack of 

significance, this final rule is not subject 

to Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). 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., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

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). 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. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism(64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers, and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this final 

rule does not have any ‘‘tribal 

implications’’ as described in Executive 

Order 13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

6, 2000). Executive Order 13175, 

requires EPA to develop an accountable 

process to ensure ‘‘meaningful and 

timely input by tribal officials in the 

development of regulatory policies that 

have tribal implications.’’ ‘‘Policies that 

have tribal implications’’ is defined in 

the Executive order to include 

regulations that have ‘‘substantial direct 

effects on one or more Indian tribes, on 

the relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

final rule will not have substantial 

direct effects on tribal governments, on 

the relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this final rule. 

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 5, 2007. 

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: 


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13174 Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Rules and Regulations 

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

■ 2. The table in paragraph (a) of 

§ 180.495 is amended by: 

■ i. Alphabetically adding amaranth, 

grain, stover; cattle, liver; goat, liver; 

hop, dried cones; horse, liver; and 

sheep, liver. 

■ ii. Revising the remainder of the 

entries listed. 

The additions and revisions to the 

table in paragraph (a) read as follows: 

§ 180.495 Spinosad; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million Expiration/Revocation Date 

*****

Amaranth, grain, stover ............................................................................................................................... 10 None 

*****

Cattle, fat ..................................................................................................................................................... 50 None 

Cattle, liver ................................................................................................................................................... 10 None 

Cattle, meat ................................................................................................................................................. 2.0 None 

Cattle, meat byproducts, except liver .......................................................................................................... 5.0 None 

*****

Egg ............................................................................................................................................................... 0.30 None 

*****

Goat, fat ....................................................................................................................................................... 50 None 

Goat, liver .................................................................................................................................................... 10 None 

Goat, meat ................................................................................................................................................... 2.0 None 

Goat, meat byproducts, except liver ............................................................................................................ 5.0 None 

*****

Hop, dried cones ......................................................................................................................................... 22 None 

Horse, fat ..................................................................................................................................................... 50 None 

Horse, liver ................................................................................................................................................... 10 None 

Horse, meat ................................................................................................................................................. 2.0 None 

Horse, meat byproducts, except liver .......................................................................................................... 5.0 None 

*****

Milk ............................................................................................................................................................... 7.0 None 

Milk, fat ........................................................................................................................................................ 85 None 

*****

Poultry, fat .................................................................................................................................................... 1.3 None 

Poultry, meat ................................................................................................................................................ 0.10 None 

Poultry, meat byproducts ............................................................................................................................. 0.10 None 

*****

Sheep, fat .................................................................................................................................................... 50 None 

Sheep, liver .................................................................................................................................................. 10 None 

Sheep, meat ................................................................................................................................................ 2.0 None 

Sheep, meat byproducts, except liver ......................................................................................................... 5.0 None 

*****

* * * * * 

[FR Doc. E7–4760 Filed 3–20–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0325; FRL–8117–9] 

6-Benzyladenine; Exemption from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the biochemical 

pesticide, 6-benzyladenine (6–BA), in or 

on pear when applied/used as a plant 

regulator. Valent BioSciences 

Corporation (Valent) submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA), requesting an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 6- 

benzyladenine. 

DATES: This regulation is effective 

March 21, 2007. Objections and requests 

for hearings must be received on or 

before May 21, 2007, 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–2006–0325. All documents in the 

docket are listed in the index for the 

docket. 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 

telephone number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Denise Greenway, Biopesticides and 

Pollution Prevention Division (7511P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8263; e-mail address: 

greenway.denise@epa.gov. 

SUPPLEMENTARY INFORMATION: 


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