Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Rules and Regulations 40753 

K. Petitions for Judicial Review 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by October 13, 2009. 

Filing a petition for reconsideration by 

the Administrator of this final rule does 

not affect the finality of this rule for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. Parties with 

objections to this direct final rule are 

encouraged to file a comment in 

response to the parallel notice of 

proposed rulemaking for this action 

published in the proposed rules section 

of today’s Federal Register, rather than 

file an immediate petition for judicial 

review of this direct final rule, so that 

EPA can withdraw this direct final rule 

and address the comment in the 

proposed rulemaking. This action may 

not be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Particulate matter, Reporting and 

recordkeeping requirements. 

Dated: May 12, 2009. 

Laura Yoshii, 

Acting Regional Administrator, Region IX. 

■ Part 52, Chapter I, Title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for Part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart F—California 

■ 2. Section 52.220 is amended by 

adding paragraphs (c) (244)(i)(C)(2), 

(335)(i)(E), and (350)(i)(A)(2) to read as 

follows: 

§ 52.220 Identification of plan. 

* * * * * 

(c) * * * 

(244) * * * 

(i) * * * 

(C) * * * 

(2) Rule 403.1, ‘‘Fugitive Dust Control 

for the Searles Valley Planning Area’’, 

adopted on June 22, 1994 and amended 

on November 25, 1996. 

* * * * * 

(335) * * * 

(i) * * * 

(E) Kern County Air Pollution Control 

District 

(1) Rule 402, ‘‘Fugitive Dust’’, adopted 

on November 29, 1993 and amended on 

November 3, 2004. 

* * * * * 

(350) * * * 

(i) * * * 

(A) * * * 

(2) Rule 401, ‘‘Fugitive Dust’’, adopted 

on September 5, 1974 and amended on 

December 04, 2006. 

* * * * * 

[FR Doc. E9–19338 Filed 8–12–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0805; FRL–8426–9] 

Spinetoram; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

tolerances for the combined residues of 

spinetoram in or on almond, hulls; nut, 

tree, group 14; and pistachio and 

establishes tolerances for date; 

pomegranate; pineapple; pineapple, 

processed residue; spice, subgroup 19B, 

except black pepper; and hop, dried 

cones. The Interregional Research 

Project Number 4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 13, 2009. Objections and 

requests for hearings must be received 

on or before October 13, 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–2008–0805. 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: 

Samantha Hulkower, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 603–0683; e-mail address: 

hulkower.samantha@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:// 


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40754 Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Rules and Regulations 

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–2008–0805 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 October 13, 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–2008–0805, 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 8E7450) by IR-4, 

Rutgers, The State University of New 

Jersey, 500 College Road East, Suite 201 

W., Princeton, NJ 08540. The petition 

requested that 40 CFR 180.635 be 

amended by establishing tolerances for 

residues of the insecticide spinetoram, 

expressed as a combination of: 

XDE-175-J: 1-H-as-indaceno[3,2-d]

oxacyclododecin-7,15-dione,2 2-[(6- 

deoxy-3-O-ethyl-2,4-di-O-methyl-a-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5- 

(dimethylamino)tetrahydro-6-methyl-2H

-pyran-2-yl]oxy]-9-ethyl2,3,3a,4,5,5a,5b,6,9,

10,11,12,13,14,16a,16b-hexadecahydro 

14-methyl-,(2R,3aR,5aR,5bS,9S,13S,14R,

16aS,16bR); 

XDE-175-L: 1H-as-indaceno[3,2- 

d]oxacyclododecin-7,15-dione, 2-[(6- 

deoxy-3-O-ethyl-2,4-di-O-methyl-a-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5- 

(dimethylamino)tetrahydro-6-methyl2H-pyran-2-yl]oxy]-9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16btetradecahydro-4,14-dimethyl-, 

(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS); 

ND-J:(2R,3aR,5aR,5bS,9S,13S, 

14R,16aS,16bR)-9-ethyl-14-methyl-13- 

[[(2S,5S,6R)-6-methyl-5- 

(methylamino)tetrahydro-2H-pyran-2- 

yl]oxy]-7,15-dioxo2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,

14,15,16a,16b-octadecahydro-1H-asindaceno[3,2-d]oxacyclododecin-2-yl 6- 

deoxy-3-O-ethyl-2,4-di-O-methyl-alphaL-mannopyranoside; and 

NF-J: (2R,3S,6S)-6-([(2R,3aR,5aR,

5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy3-O-ethyl-2,4-di-O-methyl-alpha-Lmannopyranosyl)o oxy]-9-ethyl-14- 

methyl-7,15-dioxo2,3,3a,4,5,5a,5b,6,7,9,10,

11,12,13,14,15,16a,16b-octadecahydro1H-as-indaceno[3,2-d]oxacyclododecin13-yl]oxy)-2-methyltetrahydro-2H-pyran

-3-yl(methyl)formamide 

in or on the raw agricultural 

commodities pineapple at 0.02 parts per 

million (ppm); pomegranate at 0.3 ppm; 

date at 0.1 ppm; spice, subgroup 19B, 

except black pepper at 1.7 ppm; hop, 

dried cones at 22 ppm; and pineapple, 

process residue at 0.08 ppm. 

Additionally, the petition proposed to 

increase the levels of existing tolerances 

for nut, tree, group 14 and pistachio 

from 0.04 to 0.08 ppm and almond, 

hulls from 2.0 ppm to 9.0 ppm. That 

notice referenced a summary of the 

petition prepared on behalf of IR-4 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 

tolerances to higher levels than 

proposed for almond, hulls; nut, tree, 

group 14; pistachio; pineapple; and 

pineapple, process residue. The reason 

for these changes are explained in Unit 

IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’ 

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

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for combined residues of 

spinetoram on almond, hulls at 19 ppm; 

nut, tree, group 14 at 0.10 ppm; 

pistachio at 0.10 ppm; date at 0.10 ppm; 

pomegranate at 0.30 ppm; pineapple at 

0.04 ppm; pineapple, processed residue 

at 0.15 ppm; spice, subgroup 19B, 

except black pepper at 1.7 ppm; and 

hop, dried cones at 22 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. 

Spinetoram has low acute toxicity via 

the oral, dermal and inhalation routes of 

exposure. It is a dermal sensitizer but 

not an eye or dermal irritant. In 

subchronic toxicity studies conducted 

in rats, mice and dogs, spinetoram 

produces multi-organ toxicity. 

Treatment had no adverse effects on 


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Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Rules and Regulations 40755 

survival but decreases in body weight, 

body weight gain and/or food 

consumption were observed in all three 

species. Treatment-related findings 

included the presence of a mild anemia, 

alterations in clinical chemistry 

parameters, increased liver weights, 

presence of histiocytic aggregates of 

macrophages in various organs and 

tissues, and degeneration with 

regeneration of the kidney tubules. Dogs 

appear to be the most sensitive species. 

In the subchronic study with dogs, 

lower thymus weights, atrophy of the 

thymic cortex, arteritis and/or 

perivascular inflammation in numerous 

organs with necrosis of the bone marrow 

leading to regenerative anemia was 

seen. In the chronic study with dogs, 

there were no treatment-related effects 

on survival, body weight, hematology, 

clinical chemistry or gross pathology. 

Treatment-related changes were limited 

to arteritis and necrosis of the arterial 

walls of the epididymides in males and 

thymus, thyroid, larynx, and urinary 

bladder in females. It is postulated that 

chronic treatment exacerbated the 

spontaneous arteritis in genetically 

predisposed Beagle dogs (it is called the 

‘‘Beagle Pain Syndrome’’). In 

developmental toxicity studies, there is 

no evidence of increased susceptibility 

following in utero exposures in rats and 

rabbits. In the 2-generation reproduction 

study, no adverse effects were observed 

on the offspring at dose levels that 

produced parental toxicity. EPA has 

concluded that spinetoram is 

toxicologically identical to another 

pesticide, spinosad. Based on the 

structural similarity of spinetoram and 

spinosad and the similarity of the 

toxicological database for the currently 

available studies, spinetoram is 

classified as ‘‘not likely to be 

carcinogenic to humans’’ based on lack 

of evidence for carcinogenicity of 

spinosad in mice and rats. No indication 

of neurotoxicity was observed in the 

acute neurotoxicity screening battery in 

rats, or in the subchronic and chronic 

toxicity studies conducted on 

spinetoram. All the mutagenicity 

studies conducted on spinetoram were 

negative. The no-observed-adverseeffect-level (NOAEL) derived from the 

chronic dog study is well characterized, 

and together with the traditional 

uncertainty/safety factors will provide 

adequate protection for effects observed 

in laboratory animals. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by spinetoram as well as the NOAEL 

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

can be found at http:// 

www.regulations.gov in document 

Human Health Risk Assessment for 

Application of spinosad to date and 

pomegranate and spinetoram to 

pineapple, date, pomegranate, hopes, 

and spices (crop subgroup 19B, except 

black pepper) on page 4 and attachment 

3 pages 49–54 in docket ID number 

EPA–HQ–OPP–2008–0805. 

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 

is based on the following: Spinetoram 

and spinosad are large molecules with 

nearly identical structures; and 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 spinetoram/spinosad used 

for human risk assessment can be found 

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

document Human Health Risk 

Assessment for Application of spinosad 

to date and pomegranate and 

spinetoram to pineapple, date, 

pomegranate, hopes, and spices (crop 

subgroup 19B, except black pepper) on 

page 8 in docket ID number EPA–HQ– 

OPP–2008–0805. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to spinetoram/spinosad, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing spinetoram/spinosad tolerances 

in 40 CFR 180.635. EPA assessed dietary 

exposures from spinetoram/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. 

No such effects were identified in the 

toxicological studies for spinetoram/ 

spinosad; therefore, a quantitative acute 

dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. Spinosad is 

registered for application to all of the 

same crops as spinetoram, with similar 

pre-harvest and retreatment intervals, 

and application rates greater than or 

equal to spinetoram. Further, both 

products control the same pest species. 

For this reason, EPA has concluded it 

would overstate exposure to assume that 

residues of both spinosad and 

spinetoram would appear on the same 

food. Rather, EPA aggregated exposure 

by either assuming that all commodities 

contain spinosad residues (because sideVerDate Nov<24>2008 16:28 Aug 12, 2009 Jkt 217001 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 E:\FR\FM\13AUR1.SGM 13AUR1

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40756 Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Rules and Regulations 

by-side spinetoram and spinosad 

residue data indicated that spinetoram 

residues were less than or equal to 

spinosad residues) or summing the 

percentage of a crop that would be 

treated with spinosad and the 

percentage that would be treated with 

spinetoram. 

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 

Surveys of Food Intakes by Individuals 

(CSFII). As to residue levels in food, the 

chronic analysis assumed 100% crop 

treated for all food crop commodities; 

average field-trial residues for apple, 

Brassica leafy vegetables, citrus, fruiting 

vegetables, herbs, banana, and 

strawberry; tolerance-level residues for 

the remaining food crop commodities; 

DEEMtm (ver. 7.81) 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 spinosad 

processing factors were assumed. 

Residues in livestock were refined 

through the incorporation of a refined 

dietary burden (average feed-crop 

residues and percent crop treated 

estimates) and through the 

incorporation of average residues from 

the feeding and dermal magnitude of the 

residue studies. 

iii. Cancer. Spinetoram is considered 

to be ‘‘not likely to be a carcinogen to 

humans’’ based on its similarity to 

another spynosin pesticide, spinosad. 

Preliminary results of a carcinogenicity 

study in mice indicate that spinetoram 

is not carcinogenic to mice at doses up 

to 37.5 milligram/kilogram/day (mg/kg/ 

day). Consequently, a quantitative 

cancer exposure and risk assessment is 

not appropriate for spinetoram. 

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. 

The EPA assumed 100% crop treated 

for all food crop commodities; however, 

in calculating beef and dairy cattle 

dietary burdens, the Agency used 

combined spinosad and spinetoram 

projected percent crop treated (PPCT) 

information as follows: 

39% sweet corn forage. 

50% leaves of root and tuber 

vegetables. 

5% sorghum grain. 

5% soybean seed meal. 

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 average 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 use of 

spinetoram will likely replace 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 crosssection 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 used to determine 

the average may consist of PCTs 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 USDA/National 

Agricultural Statistics Service (USDA/ 

NASS) as the 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 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. Of greatest 

relevance here is that both spinosad and 

spinetoram control a relatively narrow 

range of pests compared to the market 

leaders. Based on this analysis, EPA 

believes 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 spinetoram may be applied in a 

particular area. 


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2. Dietary exposure from drinking 

water.The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for spinetoram/spinosad in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of spinetoram/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. 

Based on the First Index Reservoir 

Screening Tool (FIRST) and Screening 

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

water concentrations (EDWCs) of 

spinetoram for acute exposures are 

estimated to be 14.419 parts per billion 

(ppb) for surface water and 0.072 ppb 

for ground water. For chronic exposures 

for non-cancer assessments are 

estimated to be 6.171 ppb for surface 

water and 0.072 ppb for ground water. 

EDWCs for spinosad for acute exposures 

are estimated to be 34.5 ppb for surface 

water and 1.1 ppb for ground water. For 

chronic exposures for non-cancer 

assessments are estimated to be 10.5 

ppb for surface water and 1.1 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 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. Spinetoram is registered 

for homeowner applications to gardens, 

lawns/ornamentals and turf grass. No 

dermal endpoints for either spinetoram 

or spinosad were identified. Therefore, 

only short-term incidental oral 

exposures to toddlers were evaluated for 

the registered turf and ornamental 

application scenarios for spinosad and 

spinetoram and short-term inhalation 

exposure to handler/applicators for the 

registered home garden, turf, and 

ornamental application scenarios. 

There is potential for residential 

handler and post-application exposures 

to both spinosad and spinetoram. Since 

spinosad and spinetoram control the 

same pests, EPA concludes that these 

products will not be used for the same 

uses in combination with each other 

and thus combining spinosad and 

spinetoram residential exposures would 

overstate exposure. Short-term 

residential inhalation risks were 

estimated for adult residential handlers, 

as well as short-term post-application 

incidental oral risks for toddlers, based 

on applications to home lawns, home 

gardens and ornamentals. 

EPA notes that for spinosad the 

registered fruit fly bait application 

scenario permits application to noncrop vegetation and this use may result 

in residential exposures. Based on the 

application rates (fruit fly bait - 0.0003 

lb ai/acre; 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 

homeowner uses on the turf/ 

ornamentals. 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.’’ 

EPA has not found spinetoram/ 

spinosad to share a common mechanism 

of toxicity with any other substances, 

and spinetoram/spinosad does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

spinetoram/spinosad does not have a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

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

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA 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. 

There is no evidence of increased 

susceptibility of rat and rabbit fetuses to 

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 did not induce maternal 

toxicity. In the spinosad 2-generation 

reproduction studies, maternal and 

offspring toxicity were equally severe, 

indicating no evidence of increased 

susceptibility. In the spinetoram 2- 

generation reproduction study, no 

adverse effects were observed on 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 pre-natal 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 spinetoram 

is complete, except for immunotoxicity 

testing. Recent changes to 40 CFR part 

158 make immunotoxicity testing 

(OPPTS Harmonized 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 chronic study with dogs, areteritis 

and necrosis of the areterial walls of the 


pwalker on DSK8KYBLC1PROD with RULES
40758 Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Rules and Regulations 

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 870.7800 immunotoxicity 

study will result in a POD less than the 

NOAEL of 2.49 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 

spinetoram/spinosad is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

spinetoram/spinosad results in 

increased susceptibility in in utero rats 

or rabbits in the prenatal developmental 

studies or in young rats in the 2– 

generation reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

utilized 100 PCT and tolerance-level 

residues, and DEEMTM default 

processing factors for all registered and 

proposed commodities and refined 

livestock estimates. These refinements 

are based on reliable data. The EPA 

used PPCT information when 

calculating livestock dietary burdens for 

sweet corn forage, leaves of root and 

tuber vegetables, sorghum grain, and 

soybean seed meal. EPA believes that 

the PPCT estimates used are 

conservative estimates. EPA made 

conservative (protective) assumptions in 

the ground water and surface water 

modeling used to assess exposure to 

spinetoram/spinosad in drinking water. 

EPA used similarly conservative 

assumptions to assess post-application 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by spinetoram/spinosad. 

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, spinetoram/ 

spinosad is not expected to pose an 

acute risk. 

2. Chronic risk. Since there are no 

registered/proposed uses which result 

in chronic residential exposures, the 

chronic aggregate exposure assessment 

consists of exposure from food and 

water. Using the exposure assumptions 

described in this unit for chronic 

exposure, EPA has concluded that 

chronic exposure to spinetoram/ 

spinosad from food and water will 

utilize 95% of the cPAD for children 1– 

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). 

Spinetoram/spinosad is currently 

registered for uses that could result in 

short-term residential exposure and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

spinetoram/spinosad. 

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 ≥160. Short-term 

aggregate risk does not exceed the LOC 

for EPA (MOE of <100). 

4. Intermediate-term risk. Spinetoram/ 

spinosad is 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 spinetoram/spinosad 

through food and water, which has 

already been addressed, and will not be 

greater than the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. The Agency considers 

spinetoram to be ‘‘Not Likely to be 

Carcinogenic to Humans.’’ See Unit 

III.C.iii. for more detailed information. 

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 spinetoram/ 

spinosad residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

FDA Multiresidue Methods (MRMs): 

XDE-175-J, XDE-175-L, ND-J, NF-J, NDL, and NF-L were screened through the 

Food and Drug Administration Pesticide 

Analytical Methods Volume I (PAM I) 

MRMs. None of the test substances were 

found to be fluorescent using 

procedures outlined in Protocol A. All 

test substances were subjected to 

Protocol C, modules DG1, DG5, DG13, 

DG17, and DG18. Test substances were 

determined to be nonchromatographable by the chosen gas 

chromatography modules described in 

Protocol C. Due to the poor sensitivity 

of the test substances to detection by 

methods described in Protocol C, no 

further analyses were performed by 

Protocols D, E, or F. Since the test 

substances are not acids, phenols, or 

substituted ureas, analyses were not 

performed using Protocols B or G. The 

test substances were not detectable 

through FDA PAM I Protocols A and C; 

therefore, these methods are unsuitable 

for enforcement. The MRM results were 

forwarded to the FDA. 

Adequate enforcement methodology. 

Plants: Method GRM 05.03 (HPLC/MS/ 

MS). Livestock: Method GRM 05.15 

HPLC/mass spectrometry (MS) is 

available to enforce the tolerance 

expression. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

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

residuemethods@epa.gov. 

B. International Residue Limits 

There are currently no established 

Codex, Canadian, or Mexican MRLs for 

residues of spinetoram on the requested 

crops. 

C. Revisions to Petitioned-For 

Tolerances 

The tolerance expression for 

spinetoram includes residues of XDEVerDate Nov<24>2008 16:28 Aug 12, 2009 Jkt 217001 PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 E:\FR\FM\13AUR1.SGM 13AUR1

pwalker on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Rules and Regulations 40759 

175-J, XDE-175-L, ND-J, and NF-J. EPA 

is establishing tolerances for the 

following commodities at levels higher 

than proposed: nut, tree, group 14 and 

pistachio raised to 0.10 ppm; almond, 

hulls raised to 19 ppm; pineapple to 

0.04 ppm; and pineapple, processed 

residue 0.15 ppm. These changes are 

based on the residue field trial data and 

the North American Free Trade 

Agreement (NAFTA) MRL Spreadsheet. 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of spinetoram, 

expressed as a combination of: 

XDE-175-J: 1-H-as-indaceno[3,2-d]

oxacyclododecin-7,15-dione,2 2-[(6- 

deoxy-3-O-ethyl-2,4-di-O-methyl-a-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5- 

(dimethylamino)tetrahydro-6-methyl2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,4,5,

5a,5b,6,9,10,11,12,13,14,16a,16bhexadecahydro14-methyl-, 

(2R,3aR,5aR,5bS,9S,13S,

14R,16aS,16bR); 

XDE-175-L: 1H-as-indaceno[3,2- 

d]oxacyclododecin-7,15-dione, 2-[(6- 

deoxy-3-O-ethyl-2,4-di-O-methyl-a-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5- 

(dimethylamino)tetrahydro-6-methyl2H-pyran-2-yl]oxy]-9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16btetradecahydro-4,14-dimethyl-,

(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS); 

ND-J:(2R,3aR,5aR,5bS,9S,13S,14R,

16aS,16bR)-9-ethyl-14-methyl-13- 

[[(2S,5S,6R)-6-methyl-5- 

(methylamino)tetrahydro-2H-pyran-2- 

yl]oxy]-7,15-dioxo2,3,3a,4,5,5a,5b,6,7,9,10,11,

12,13,14,15,16a,16b-octadecahydro-1Has-indaceno[3,2-d]oxacyclododecin-2-yl 

6-deoxy-3-O-ethyl-2,4-di-O-methylalpha-L-mannopyranoside; and 

NF-J: (2R,3S,6S)-6- 

([(2R,3aR,5aR,5bS,9S,13S,

14R,16aS,16bR)-2-[(6-deoxy-3-O-ethyl2,4-di-O-methyl-alpha-Lmannopyranosyl)o oxy]-9-ethyl-14- 

methyl-7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,

9,10,11,12,13,14,15,16a,16boctadecahydro-1H-as-indaceno[3,2- 

d]oxacyclododecin-13-yl]oxy)-2- 

methyltetrahydro-2H-pyran-3- 

yl(methyl)formamide 

in or on the following commodities is 

increased to almond, hulls at 19 ppm; 

nut, tree, group 14 at 0.10 ppm; 

pistachio at 0.10 ppm; date at 0.10 ppm; 

pomegranate at 0.30 ppm; pineapple 

0.04 ppm; pineapple, processed residue 

at 0.15 ppm; spice, subgroup 19B, 

except black pepper at 1.7 ppm; and 

hop, dried cones at 22 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). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 31, 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 180.635 is amended by 

revising the entries in the table in 

paragraph (a) for almond, hulls; nut, 

tree, group 14; and pistachio and 

alphabetically adding entries for date; 

hop, dried cones; pineapple; pineapple, 

processed residue; pomegranate; and 

spice, subgroup 19b, except black 

pepper, to read as follows: 

§ 180.635 Spinetoram; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

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

* * * * * 

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

* * * * * 

Hop, dried cones .......................... 22 


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40760 Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Rules and Regulations 

1The effective date was subsequently extended to 

September 1, 2006 (71 FR 3786, January 24, 2006). 

Commodity Parts per 

million 

* * * * * 

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

* * * * * 

Pineapple ...................................... 0.04 

Pineapple, processed residue ...... 0.15 

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

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

* * * * * 

Spice, subgroup 19B, except 

black pepper ............................. 1.7 

* * * * * 

* * * * * 

[FR Doc. E9–19195 Filed 8–12–09; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 571 

[Docket No. NHTSA–2009–0145] 

RIN 2127–AK04 

Federal Motor Vehicle Safety 

Standards; Controls, Telltales and 

Indicators 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), 

Department of Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: In an August 2005 final rule, 

we updated our standard regulating 

motor vehicle controls, telltales and 

indicators. The standard specifies 

requirements for the location, 

identification, and illumination of these 

items. In May 2006, we published a 

response to four petitions for 

reconsideration, including one asking us 

to reconsider a requirement for color 

contrast between identifiers and their 

backgrounds. We denied this petition 

for reconsideration. 

In response to another petition for 

reconsideration from the Alliance of 

Automobile Manufacturers (the 

Alliance) of the color contrast 

requirement, specifically for the horn 

control identifier, in this final rule, we 

amend the standard to provide that an 

identifier is not required if the horn 

control is placed in the middle of the 

steering wheel. If the horn control is 

placed elsewhere in the motor vehicle, 

the control would be required to be 

identified by the specified horn symbol 

in a color that stands out clearly against 

the background. 

DATES: Effective Date: The effective date 

for this final rule is February 9, 2010. 

The compliance date for vehicles under 

10,000 pounds GVWR for S5.4.3 

continues to be September 1, 2011. 

Compliance date for the extension of 

the standard’s control, indicator, and 

telltale requirements to vehicles at 

10,000 pounds GVWR or greater over 

continues to be September 1, 2013. 

Optional early compliance is 

permitted as of the date today’s final 

rule is published. 

Petitions for reconsideration: Petitions 

for reconsideration of today’s final rule 

must be received not later than 

September 28, 2009. 

ADDRESSES: Petitions for reconsideration 

of the final rule must refer to the docket 

number set forth above and be 

submitted to the Administrator, 

National Highway Traffic Safety 

Administration, 1200 New Jersey 

Avenue, SE., Washington, DC 20590. 

FOR FURTHER INFORMATION CONTACT: For 

non-legal issues you may call Ms. Gayle 

Dalrymple, Office of Crash Avoidance 

Standards at (202) 366–5559. Her FAX 

number is (202) 366–7002. For legal 

issues, you may call Ms. Dorothy 

Nakama, Office of the Chief Counsel at 

(202) 366–2992. Her FAX number is 

(202) 366–3820. You may send mail to 

both of these officials at National 

Highway Traffic Safety Administration, 

1200 New Jersey Avenue, SE., 

Washington, DC 20590. 

SUPPLEMENTARY INFORMATION: 

I. Background 

NHTSA issued Federal Motor Vehicle 

Safety Standard (FMVSS) No. 101, 

Controls and Displays, in 1967 (32 FR 

2408) as one of the initial FMVSSs. The 

standard applies to passenger cars, 

multipurpose passenger vehicles 

(MPVs), trucks, and buses. The purpose 

of FMVSS No. 101 is to assure the 

accessibility and visibility of motor 

vehicle controls and displays under 

daylight and nighttime conditions, in 

order to reduce the safety hazards 

caused by the diversion of the driver’s 

attention from the driving task, and by 

mistakes in selecting controls. 

At present, FMVSS No. 101 specifies 

requirements for the location (S5.1), 

identification (S5.2), and illumination 

(S5.3) of various controls and displays. 

It specifies that those controls and 

displays must be accessible and visible 

to a driver properly seated wearing his 

or her safety belt. Table 1, ‘‘Controls, 

Telltales and Indicators with 

Illumination or Color Requirements,’’ 

and Table 2, ‘‘Identifiers for Controls, 

Telltales and Indicators with No Color 

or Illumination Requirements,’’ indicate 

which controls and displays are subject 

to the identification requirements, and 

how they are to be identified, colored, 

and illuminated. For the horn control, 

Table 2 specifies the horn symbol in 

Column 2, and the word ‘‘Horn’’ in 

Column 3. 

II. 2005 and 2006 Final Rules 

In a final rule published in the 

Federal Register (70 FR 48295) on 

August 17, 2005, NHTSA amended 

FMVSS No. 101 by extending the 

standard’s telltale and indicator 

requirements to vehicles of Gross 

Vehicle Weight Rating (GVWR) 4,536 

kilograms (10,000 pounds) and over, 

updating the standard’s requirements 

for multi-function controls and multitask displays to make the requirements 

appropriate for advanced systems, and 

reorganizing the standard to make it 

easier to read. Table 1 and Table 2 

continue to include only those symbols 

and words previously specified in the 

controls and displays standard or in 

another applicable FMVSS. 

The final rule specified an effective 

date of February 13, 2006 for 

requirements applicable to passenger 

cars, multipurpose passenger vehicles, 

trucks and buses under 4,536 kg GVWR 

(10,000 pounds).1

NHTSA received petitions for 

reconsideration of the August 17, 2005 

final rule, including one from the 

Alliance. In the August 17, 2005 final 

rule, the requirement that the identifier 

for each telltale must be in a color that 

stands out clearly against the 

background was extended to identifiers 

for controls and indicators (see S5.4.3). 

The Alliance asked for reconsideration 

of this requirement, stating that not all 

identifiers are in a color that stands out 

clearly against the background. The 

Alliance further stated that it is not 

needed, citing as an example the horn 

identifier. 

Most vehicle models use the horn 

symbol as the identifier, which is 

molded into the air bag cover, without 

a color ‘‘that stands out clearly against 

the background’’ filled in. The Alliance 

commented that: ‘‘The symbol is the 

same color as the background, but it can 

still be recognized because the 

embossment stands out against the 

background.’’ The Alliance petitioned 

for the regulatory text at S5.4.3 to be 

changed to: ‘‘The identification required 

by Table 1 or Table 2 for a telltale, 

control or indicator shall contrast with 

the background.’’ 

In the May 15, 2006 final rule, 

response to petitions for reconsideration 

(71 FR 27964), we noted that over the 

years, the agency had received 

numerous complaints regarding the 


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