Document ID: EPA-HQ-OPP-2007-0876-0002
Agency: epa
Document Type: Rule
Title: Spinetoram; Pesticide Tolerance
Posted Date: 2007-10-10T04:00Z

[Federal Register: October 10, 2007 (Volume 72, Number 195)]
[Rules and Regulations]               
[Page 57492-57500]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10oc07-7]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0876; FRL-8149-9]

 
Spinetoram; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for the combined 
residues of the insecticide spinetoram, in or on acerola; almond, 
hulls; amaranth grain, grain; apple, wet pomace; artichoke, globe; 
asparagus; atemoya; avocado; banana; beet, sugar, molasses; biriba; 
brassica, head and stem, subgroup 5A; brassica, leafy greens, subgroup 
5B; bushberry, subgroup 13B; caneberry, subgroup 13A; canistel; cattle, 
fat; cattle, liver; cattle, meat; cattle, meat byproducts (except 
liver); cherimoya; citrus, dried pulp; citrus, oil; corn, sweet, kernel 
plus cob with husks removed; cotton, gin byproducts; cotton, undelinted 
seed; cranberry; custard apple; egg; feijoa; fig; fruit, citrus, group 
10; fruit, pome, group 11; fruit, stone, group 12; goat, fat; goat, 
liver; goat, meat; goat, meat byproducts (except liver); grain, 
aspirated fractions; grain, cereal, group 15, except rice, sorghum, 
pearl millet and proso millet; grain, cereal, group 16, forage; grain, 
cereal, group 16, hay; grain, cereal, group 16, stover; grain, cereal, 
straw, group 16, except rice; grape; grape, raisin; guava; herb, dried, 
subgroup 19A; herb, fresh, subgroup 19A; hog, fat; hog, meat; hog, meat 
byproducts; horse, fat; horse, liver; horse, meat; horse, meat 
byproducts (except liver); llama; jaboticaba; juneberry; lingonberry; 
longan; lychee; mango; milk; milk, fat; millet, pearl, grain; millet, 
proso, grain; nut, tree, group 14; okra; onion, green; papaya; 
passionfruit; pea and bean, dried shelled, except soybean, subgroup 6C; 
pea and bean, succulent shelled, subgroup 6B; peanut; peanut, hay; 
peppermint, tops; pistachio; poultry, fat; poultry, meat; poultry, meat 
byproducts; pulasan; rambutan; salal; sapodilla; sapote, black; sapote, 
mamey; sapote, white; sheep, fat; sheep, liver; sheep, meat; sheep, 
meat byproducts (except liver); sorghum, grain, grain; soursop; 
soybean, seed; spanish lime; spearmint, tops; star apple; star fruit; 
strawberry; sugar apple; ti, leaves; vegetable, bulb, group 3, except 
green onion; vegetable, cucurbit, group 9; vegetable, foliage of 
legume, group 7; vegetable, fruiting, group 8; vegetable, leafy, except 
brassica, group 4; vegetable, leaves of root and tuber, group 2; 
vegetable, legume, edible podded, subgroup 6A; vegetable, root and 
tuber, group 1; watercress; and wax jambu. Dow AgroSciences, LLC 
requested this tolerance under the Federal Food, Drug and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective October 10, 2007. Objections and 
requests for hearings must be received on or before December 10, 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-2007-0876. 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 
Room S-4400, One Potomac Yard (South Bldg.), 2777 South Crystal Dr., 
Arlington, VA 22202-3503. 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: Bonaventure Akinlosotu, Registration 
Division, Office of Pesticide Programs, Environmental Protection 
Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001; 
telephone number: (703) 605-0653; e-mail address: 
akinlosotu.bonaventure@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:

[[Page 57493]]

     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 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 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 EPA's tolerance regulations at 
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, 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-2007-0876 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 December 10, 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 this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0876, 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 
Avenue, NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Room S-4400, One Potomac Yard (South 
Bldg.), 2777 South Crystal Dr., Arlington, VA 22202-4503. Deliveries 
are only accepted during the Docket'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 August 22, 2007 (72 FR 47008) (FRL-8154-
1), 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 
5F7006) by Dow AgroSciences, LLC, 9330 Zionsville Road, Indianapolis, 
IN 46268-1053. The petition requested the establishment of a tolerance 
for the combined residues of the insecticide XDE-175, expressed as a 
combination of XDE-175-J: 1-H-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-methyl-2H-pyran-2-yl]oxy]-9-
ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro1 14-
methyl-, (2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR) and 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-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-, 
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS), in or on acerola at 1.5 parts 
per million (ppm); almond, hulls at 2 ppm; amaranth grain, grain at 1 
ppm; apple pomace at 0.5 ppm; artichoke, globe at 0.3 ppm; asparagus at 
0.2 ppm; atemoya at 0.3 ppm; avocado at 0.3 ppm; banana at 0.25 ppm; 
barley, hay and straw at 5 ppm; beet, sugar, molasses at 0.75 ppm; 
biriba at 0.3 ppm; brassica, head and stem, subgroup 5A at 2 ppm; 
bushberry, subgroup 13B at 0.25 ppm; caneberry, subgroup 13A at 0.7 
ppm; canistel at 0.3 ppm; cattle, fat at 2 ppm; cattle, meat byproducts 
at 1 ppm; cattle, meat at 0.1 ppm; cherimoya at 0.3 ppm; citrus, dried 
pulp at 0.5 ppm; citrus, oil at 3 ppm; coriander, leaves at 8 ppm; 
corn, forage at 1.5 ppm; corn, hay at 1 ppm; corn, stover at 5 ppm; 
corn, straw at 1 ppm; corn, sweet, forage at 1.5 ppm; corn, sweet, 
kernel plus cob with husks removed at 0.02 ppm; corn, sweet, stover at 
5 ppm; cotton, gin byproducts at 1.5 ppm; cotton, undelinted seed at 
0.02 ppm; cranberry at 0.01 ppm; custard apple at 0.3 ppm; egg at 0.02 
ppm; feijoa at 0.05 ppm; fig at 0.1 ppm; fruit, citrus, group 10 at 0.3 
ppm; fruit, pome, group 11 at 0.3 ppm; fruit, stone, group 12 at 0.2 
ppm; goat, fat at 2 ppm; goat, meat byproducts at 1 ppm; goat, meat at 
0.1 ppm; grain, aspirated fractions at 5 ppm; grain, cereal, group 15 
(except rice) at 0.02 ppm; grape at 0.5 ppm; grape, raisin at 0.7 ppm; 
guava at 0.3 ppm; herb, dried, subgroup at 22 ppm; herb, fresh, 
subgroup at 3 ppm; hog, fat at 1 ppm; hog, meat byproducts at 0.5 ppm; 
hog, meat at 0.1 ppm; horse, fat at 2 ppm; horse, meat byproducts at 1 
ppm; horse, meat at 0.1 ppm; ilama at 0.3 ppm; jaboticaba at 0.3 ppm; 
juneberry at 0.25 ppm; leafy vegetables (except brassica vegetables 
group) at 8 ppm; legume vegetables, dried shelled pea and bean (crop 
subgroup 6C) at 0.02 ppm; legume vegetables, edible podded (crop 
subgroup 6A) at 0.3 ppm; legume vegetables, succulent shelled pea and 
bean (crop subgroup 6B) at 0.02 ppm; lingonberry at 0.25 ppm; longan at 
0.3 ppm; lychee at 0.3 ppm; mango at 0.3 ppm; milk at 0.5 ppm; milk, 
fat at 1 ppm; millet, forage at 1.5 ppm; millet, hay and straw at 5 
ppm; nut, tree, group 14 at 0.02 ppm; oat, forage at 1.5 ppm; oat, hay 
and straw at 5 ppm; okra at 0.4 ppm; onion, dry bulb at 0.1 ppm; onion, 
green at 2 ppm; papaya at 0.3 ppm; passionfruit at 0.3 ppm; peanut at 
0.02 ppm; peanut, hay at 11 ppm; peppermint, tops at 3.5 ppm; pistachio 
at 0.02 ppm; plantain at 0.25 ppm; poultry, fat at 0.1 ppm; poultry, 
meat byproducts at 0.02 ppm; poultry, meat at 0.02 ppm; pulasan at 0.3 
ppm; rambutan at 0.3 ppm; rye, forage at 1.5 ppm; rye, straw at 5 ppm; 
salal at 0.25 ppm; sapodilla at 0.3 ppm; sapote, black at 0.3 ppm; 
sapote, mamey at 0.3 ppm; sapote, white at 0.3 ppm; sheep, fat at 2 
ppm; sheep, meat byproducts at 1 ppm; sheep, meat at 0.1 ppm; sorghum,

[[Page 57494]]

forage at 1.5 ppm; sorghum, hay at 5 ppm; sorghum, stover at 5 ppm; 
soursop at 0.3 ppm; soybean at 0.02 ppm; spanish lime at 0.3 ppm; 
spearmint, tops at 3.5 ppm; star apple at 0.3 ppm; star fruit at 0.3 
ppm; strawberry at 1 ppm; sugar apple at 0.3 ppm; teosinte, forage at 
1.5 ppm; ti, leaves at 10 ppm; triticale, forage at 1.5 ppm; triticale, 
hay at 5 ppm; vegetable, brassica, leafy, group 5 at 10 ppm; vegetable, 
bulb, group 3 (except green onion) at 0.1 ppm; vegetable, cucurbit 
(cucumber, melon, squashes), group 9 at 0.3 ppm; vegetable, foliage of 
legume, group 7 at 8 ppm; vegetable, fruiting, group 8 at 0.4 ppm; 
vegetable, leaves of root and tuber, group 2 at 10 ppm; vegetable, root 
and tuber, group 1 at 0.1 ppm; watercress at 8 ppm; wax jambu at 0.3 
ppm; wheat, forage at 1.5 ppm; and wheat, hay and straw at 5 ppm. That 
notice referenced a summary of the petition prepared 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 EPA's review of the residue chemistry data submitted in 
support of the petition, the Agency has revised commodity definitions 
and/or some of the proposed tolerances and concludes that the 
establishment of the following tolerance is appropriate for the 
insecticide spinetoram as follows: Acerola at 0.30 ppm; almond, hulls 
at 2.0 ppm; amaranth grain, grain at 1.0 ppm; apple, wet pomace at 0.50 
ppm; artichoke, globe at 0.30 ppm; asparagus at 0.04 ppm; atemoya at 
0.30 ppm; avocado at 0.30 ppm; banana at 0.25 ppm; beet, sugar, 
molasses at 0.75 ppm; biriba at 0.30 ppm; brassica, head and stem, 
subgroup 5A at 2.0 ppm; brassica, leafy greens, subgroup 5B at 10 ppm; 
bushberry, subgroup 13B at 0.25 ppm; caneberry, subgroup 13A at 0.70 
ppm; canistel at 0.30 ppm; cattle, fat at 5.5 ppm; cattle, liver at 
0.85 ppm; cattle, meat at 0.20 ppm; cattle, meat byproducts (except 
liver) at 0.60 ppm; cherimoya at 0.30 ppm; citrus, dried pulp at 0.50 
ppm; citrus, oil at 3.0 ppm; corn, sweet, kernel plus cob with husks 
removed at 0.04 ppm; cotton, gin byproducts at 1.5 ppm; cotton, 
undelinted seed at 0.04 ppm; cranberry at 0.04 ppm; custard apple at 
0.30 ppm; egg at 0.04 ppm; feijoa at 0.30 ppm; fig at 0.10 ppm; fruit, 
citrus, group 10 at 0.30 ppm; fruit, pome, group 11 at 0.20 ppm; fruit, 
stone, group 12 at 0.20 ppm; goat, fat at 5.5 ppm; goat, liver at 0.85 
ppm; goat, meat at 0.20 ppm; goat, meat byproducts (except liver) at 
0.60 ppm; grain, aspirated fractions at 20 ppm; grain, cereal, group 
15, except rice, sorghum, pearl millet and proso millet at 0.04 ppm; 
grain, cereal, group 16, forage at 3.5 ppm; grain, cereal, group 16, 
hay at 10 ppm; grain, cereal, group 16, stover at 10 ppm; grain, 
cereal, straw, group 16, except rice at 1.0 ppm; grape at 0.50 ppm; 
grape, raisin at 0.70 ppm; guava at 0.30 ppm; herb, dried, subgroup 19A 
at 22 ppm; herb, fresh, subgroup 19A at 3.0 ppm; hog, fat at 0.40 ppm; 
hog, meat at 0.04 ppm; hog, meat byproducts at 0.04 ppm; horse, fat at 
5.5 ppm; horse, liver at 0.85 ppm; horse, meat at 0.20 ppm; horse, meat 
byproducts (except liver) at 0.60 ppm; llama at 0.30 ppm; jaboticaba at 
0.30 ppm; juneberry at 0.25 ppm; lingonberry at 0.25 ppm; longan at 
0.30 ppm; lychee at 0.30 ppm; mango at 0.30 ppm; milk at 0.30 ppm; 
milk, fat at 7.5 ppm; millet, pearl, grain at 1.0 ppm; millet, proso, 
grain at 1.0 ppm; nut, tree, group 14 at 0.04 ppm; okra at 0.40 ppm; 
onion, green at 2.0 ppm; papaya at 0.30 ppm; passionfruit at 0.30 ppm; 
pea and bean, dried shelled, except soybean, subgroup 6C at 0.04 ppm; 
pea and bean, succulent shelled, subgroup 6B at 0.04 ppm; peanut at 
0.04 ppm; peanut, hay at 11 ppm; peppermint, tops at 3.5 ppm; pistachio 
at 0.04 ppm; poultry, fat at 0.10 ppm; poultry, meat at 0.04 ppm; 
poultry, meat byproducts at 0.04 ppm; pulasan at 0.30 ppm; rambutan at 
0.30 ppm; salal at 0.25 ppm; sapodilla at 0.30 ppm; sapote, black at 
0.30 ppm; sapote, mamey at 0.30 ppm; sapote, white at 0.30 ppm; sheep, 
fat at 5.5 ppm; sheep, liver at 0.85 ppm; sheep, meat at 0.20 ppm; 
sheep, meat byproducts (except liver) at 0.60 ppm; sorghum, grain, 
grain at 1.0 ppm; soursop at 0.30 ppm; soybean, seed at 0.04 ppm; 
spanish lime at 0.30 ppm; spearmint, tops at 3.5 ppm; star apple at 
0.30 ppm; star fruit at 0.30 ppm; strawberry at 1.0 ppm; sugar apple at 
0.30 ppm; ti, leaves at 10 ppm; vegetable, bulb, group 3, except green 
onion at 0.10 ppm; vegetable, cucurbit, group 9 at 0.30 ppm; vegetable, 
foliage of legume, group 7 at 8.0 ppm; vegetable, fruiting, group 8 at 
0.40 ppm; vegetable, leafy, except brassica, group 4 at 8.0 ppm; 
vegetable, leaves of root and tuber, group 2 at 10 ppm; vegetable, 
legume, edible podded, subgroup 6A at 0.30 ppm; vegetable, root and 
tuber, group 1 at 0.10 ppm; watercress at 8.0 ppm; and wax jambu at 
0.30 ppm.

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. . . 
.'' These provisions were added to FFDCA by the Food Quality Protection 
Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for the petitioned-for tolerances 
for the combined residues of the insecticide spinetoram. EPA's 
assessment of exposures and risks associated with establishing the 
tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The toxicity database is incomplete for spinetoram; however, 
the database for spinetoram taken together with a similar spinosyn 
insecticide, spinosad, is adequate for risk assessment evaluations and 
determination of FQPA. All studies evaluated on spinetoram were deemed 
acceptable and met guideline criteria.
    More detailed information on the studies received and the nature of 
the adverse effects caused by spinetoram as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found in the document 
entitled, ``Spinetoram: Human Health Risk Assessment for Numerous 
Proposed Application Scenarios,'' dated September 20, 2007, by going to 
http://www.regulations.gov. The referenced document is available in the 

docket established by this action, which is described under ADDRESSES,

[[Page 57495]]

and is identified as EPA-HQ-OPP-2007-0876-0003 in that docket. Locate 
and click on the hyperlink for docket ID number EPA-HQ-OPP-2007-0876. 
Double-click on the document to view the referenced information on 
pages 53-59 of 97.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from 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) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC 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 
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 UFs. Short-term, intermediate-term and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for spinetoram used for 
human risk assessment can be found in the document entitled, 
``Spinetoram: Human Health Risk Assessment for Numerous Proposed 
Application Scenarios,'' dated September 20, 2007, by going to http://www.regulations.gov.
 The referenced document is available in the docket 

established by this action, which is described under ADDRESSES, and is 
identified as EPA-HQ-OPP-2007-0876-0003 in that docket. Locate and 
click on the hyperlink for docket ID number EPA-HQ-OPP-2007-0876. 
Double-click on the document to view the referenced information on 
pages 29-30 of 97.
    Briefly, EPA has concluded that spinetoram is toxicologically 
identical to another pesticide, spinosad. As a result, EPA picked the 
lowest of the spinosad and spinetoram endpoints for each exposure 
scenario.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to spinetoram, EPA considered exposure under the petitioned-
for tolerances for spinetoram. Spinosad and spinetoram are 
toxicologically equivalent and this fact was taken into account in 
assessing aggregate exposure.
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for spinosad and spinetoram; 
therefore, a quantitative acute dietary exposure assessment is 
unnecessary.
    ii. Chronic exposure. As previously stated, spinosad and spinetoram 
are toxicologically equivalent; however, EPA has concluded it would 
overstate exposure to assume that residues of both spinosad and 
spinetoram would appear on the same food because both products control 
the same pest species, and thus it is unlikely that spinosad and 
spinetoram will be applied to the same crop. Rather, EPA aggregated 
exposure by either assuming that all commodities contain spinosad 
(because side-by-side spinosad and spinetoram 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. The approach 
of assuming 100 percent crop treated (PCT) was used for all food 
commodities and the approach of summing the percent of commodities 
projected to be treated with spinosad and spinetoram for feed 
commodities.
    The chronic dietary exposure assessment was conducted using the 
Dietary Exposure Evaluation Model - Food Consumption Intake Database, 
Version 2.03 (DEEMTM-FCID) which incorporates the United 
States Department of Agriculture (USDA) 1994-1996 and 1998 Continuing 
Surveys of Food Intakes by Individuals (CSFII). In addition to the PCT 
assumptions described above, EPA, in estimating chronic exposure, 
relied upon average field-trial residues for apple, leafy vegetables 
(except Brassica), citrus and fruiting vegetables; tolerance-level 
residues for the remaining food crop commodities; average feed crop 
residues for feed commodities from the following crops - sweet corn 
forage, leaves of root and tuber vegetables and aspirated grain 
fractions; average residues from animal feeding and dermal magnitude of 
residue studies; DEEMTM (Version 7.81) default processing 
factors for all commodities excluding field corn (meal, starch, flour 
and oil), grape juice and wheat (flour and germ), where the results 
from the processing studies were assumed and modeled drinking water 
estimates.
    iii. Cancer. Spinetoram is considered to be ``Not likely to be 
Carcinogenic 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). As a result, cancer 
exposure assessment is not required for spinetoram.
    iv. Anticipated residue and 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 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. 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 this tolerance.
    For the chronic dietary exposure assessment, EPA assumed: 100 PCT 
for all food crop commodities along with summing the percent of 
commodities projected to be treated with spinosad and spinetoram for 
feed commodities; average field-trial residues for apple, leafy 
vegetables (except Brassica), citrus and fruiting vegetables; 
tolerance-level residues for the remaining food crop commodities; 
average feed crop residues for feed commodities from the following 
crops: Sweet corn forage, leaves of root and tuber vegetables and 
aspirated grain fractions; average residues from animal feeding and 
dermal magnitude of residue studies; DEEMTM (Version 7.81) 
default processing factors for all commodities excluding field corn 
(meal,

[[Page 57496]]

starch, flour and oil), grape juice and wheat (flour and germ), where 
the results from the processing studies were assumed and modeled 
drinking water estimates.
    EPA estimates an upper bound of projected percent crop treated 
(PPCT) for a new pesticide use by assuming that its actual PCT during 
the initial 5 years of use on a specific use site will not exceed the 
recent PCT of the market leader (i.e., the one with the greatest PCT) 
on that site. EPA calls this the market leader PPCT estimate. In this 
specific case, the new use to be estimated is the combined use of 
spinosad together with that of spinetoram since most new use of 
spinetoram will likely replace previous use of spinosad. An average 
market leader PCT, based on 3 recent surveys of pesticide usage, if 
available, is used for chronic risk assessment. The average market 
leader PCT may be based on 1 or 2 survey years if 3 are not available. 
Also, with limited availability of data, the average market leader PCT 
may be based on a cross-section of state PCTs. Comparisons are only 
made among pesticides of the same pesticide type (i.e., the leading 
insecticide on the use site is selected for comparison with the new 
insecticide), or, refined estimates, among pesticides targeting the 
same pests. The market leader PCTs used to determine the average may be 
each 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 
(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 a high-end estimate that is unlikely, in most cases, 
to be exceeded during the initial 5 years of actual use. Predominant 
factors that bear on whether the PPCT could be exceeded may include 
PCTs of similar chemistries, pests controlled by alternatives, pest 
prevalence in the market and other factors. All relevant information 
currently available for predominant factors has been considered for the 
combined use of spinetoram and spinosad on each of these several crops. 
It is the Agency's opinion that it is unlikely that actual combined 
PCTs for spinetoram and spinosad will exceed the corresponding 
estimated PPCTs during the next five years.
    The PPCTs for the combined use of spinosad and spinetoram for 
chronic risk assessment were determined using the market leader 
approach for the feed commodities of sweet corn, grain sorghum, 
soybeans and turnip greens. For turnip greens, the PCTs of market 
leaders were averaged over states rather than years because only 1-year 
of data was available.
    The Agency believes that the 3 conditions listed in this Unit 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 spinetoram may 
be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for spinetoram 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 environmental fate characteristics of 
spinetoram. Further information regarding EPA drinking water models 
used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm
.

    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated environmental concentrations (EECs) 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. The EECs for chronic 
exposures are estimated to be 6.171 ppb for surface water and 0.072 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 14.419 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration value of 6.171 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 non-occupational, 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 the following residential non-dietary sites: Homeowner application 
to turf grass and ornamentals to control a variety of worms, moths, 
flies, beetles, midges, thrips, leafminers and fire ants (granular 
formulation). Spinetoram is proposed for homeowner applications to 
gardens, lawns/ornamentals and turf grass for control of lepidopterous 
larvae (worms or caterpillars), dipterous leafminers, thrips, sawfly 
larvae, certain psyllids and leaf-feeding beetles and red imported fire 
ants.
    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 in combination with each other and combining the 
residential exposures is unnecessary. Short-term residential inhalation 
risks were estimated for adult residential handlers, as well as short-
term post-application incidental oral risks for toddlers, based on 
applications to home lawns, home gardens and ornamentals.
    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

[[Page 57497]]

toxicity, EPA has not made a common mechanism of toxicity finding as to 
spinetoram and any other substances and spinetoram 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 
spinetoram 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 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 (``10x'') ten-fold margin of safety for infants and 
children in the case of threshold effects to account for pre- and/or 
post-natal 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. 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 FQPA safety factor value based on the use of 
traditional UFs and/or special FQPA safety factors, as appropriate.
    2. Pre-natal and post-natal sensitivity. There is no evidence of 
increased susceptibility of rat and rabbit fetuses to in utero exposure 
to spinetoram. In the developmental toxicity study in rats, no 
developmental effects were observed at dose levels that induced 
maternal toxicity. In the developmental study in rabbits, no 
developmental toxicity was seen at dose levels that induced maternal 
toxicity. In the 2-generation reproduction study, no offspring toxicity 
occurred. Parental/systemic toxicity was observed at a lower dose than 
the dose at which offspring showed no effects.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the 10x FQPA safety 
factor to 1x. That decision is based on the following findings:
    i. The toxicity database for spinetoram is adequate for this risk 
assessment despite the lack of a chronic toxicity study in rats. The 
preliminary review of a mouse carcinogenicity study provides evidence 
that the chronic toxicity of spinosad and spinetoram is comparable 
since spinetoram chronic toxicity produced similar toxicity at the 
similar doses as seen previously with spinosad. Therefore, it is 
expected that the ongoing spinetoram chronic carcinogenicity study in 
rats would produce similar chronic toxicity at a similar dose as was 
seen in the chronic toxicity study in rats with spinosad.
    ii. There is no indication that spinetoram is a neurotoxic chemical 
and there is no need for a DNT study or additional UFs to account for 
neurotoxicity.
    iii. There is no evidence that spinetoram results in increased 
susceptibility in in utero rats or rabbits in the pre-natal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-term, intermediate-term 
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 UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, no acute risks were identified in the 
toxicological studies for spinosad and spinetoram; therefore, a 
quantitative acute dietary exposure assessment is not required for 
spinetoram.
    2. Chronic risk. Since there are no registered/proposed uses which 
result in chronic residential exposures, the chronic aggregate exposure 
assessment is concerned only with exposure from food and water. Using 
the exposure assumptions described in this unit for chronic dietary 
exposure, EPA has concluded that exposure to spinosad and spinetoram 
from food and water will utilize < =72% of the cPAD for the population 
group children 1-2 years old, the most highly exposed population.
    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).
    Spinetoram 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 food and water and short-term 
exposures for spinetoram.
    Short-term incidental oral exposures to toddlers are anticipated 
from the registered turf and ornamental application scenarios for 
spinosad and spinetoram and short-term inhalation exposure to handler/
applicators is anticipated for the proposed home garden, turf and 
ornamental application scenarios for spinetoram; however, no handler/
applicator exposure to spinosad is anticipated. Since spinosad and 
spinetoram control the same pests, EPA concludes that these products 
will not be used in combination with each other and incidental oral 
exposure from spinosad and spinetoram do not need to be added together. 
For aggregate short-term assessment, EPA selected the incidental oral 
exposure resulting from application of spinosad as this was higher than 
the incidental exposure resulting from application of spinetoram.
    The incidental oral or inhalation exposures were combined with 
chronic dietary (food and water) exposure for determination of 
aggregate short-term exposure. EPA uses chronic dietary exposure when 
conducting short-term aggregate assessments as it has been determined 
that this will more accurately reflect exposure from food over the 
Agency's defined short-term interval (1-30 days) than will acute 
exposure. Since the short-term inhalation and incidental oral endpoints 
are based on the same study and since the level of concern for 
incidental oral and inhalation assessments are both 100, chronic 
dietary exposure may be added to short-term inhalation or short-term 
incidental oral exposure and this total exposure can then be compared 
to the selected endpoints for aggregate risk assessment. The aggregate 
MOEs are >=190; therefore, short-term aggregate exposure to spinosad 
and spinetoram are not of concern to EPA.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Though residential exposure could occur, no toxicological effects 
have been identified for intermediate-term toxicity. Therefore, the 
aggregate risk is the sum of the risk from food and water.
    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 the risk assessment, EPA 
concludes that there is a reasonable certainty that no

[[Page 57498]]

harm will result to the general population or to infants and children 
from aggregate exposure to spinetoram residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    EPA review of the proposed enforcement method, without laboratory 
trial, indicates that the registrant's methods for plant and animal 
commodities appear to meet the Agency's residue chemical guidelines for 
acceptable tolerance enforcement methods. EPA recommends that a 
laboratory validation is not necessary for spinetoram based on the 
following reasons:
     The methods appear well-written and include detailed 
instructions.
     The methods appear quick and efficient.
     The recovery data are acceptable for all tested 
commodities; and
     The independent laboratory validation (ILV) data submitted 
are acceptable and indicate that method performance is acceptable. The 
method 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.

B. International Residue Limits

    There are currently no established CODEX, Canadian or Mexican 
maximum residue limits (MRLs) for residues of spinetoram in/on various 
plant and livestock commodities. The Agency notes that spinetoram is 
being evaluated as part of a joint review with Health Canada's Pest 
Management Regulatory Agency (PMRA) and the plant tolerances 
recommended in Unit V. are based on translation of spinosad residue 
data (i.e., translation of the spinosad tolerances). The majority of 
the spinosad plant tolerances were established prior to the use of the 
tolerance spreadsheet calculator and the procedure used by EPA and PMRA 
to establish these tolerances were different; therefore, many of the 
plant tolerances are not harmonized with the Canadian MRLs although 
they are based on the same residue data. Since the EPA and PMRA 
spinetoram tolerances are based on the same residue data, trade issues 
are not expected to be an issue. EPA harmonized the livestock 
tolerances with the Canadian MRLs when possible (i.e., when the PMRA-
recommended tolerance was greater than the EPA-recommended tolerance).

V. Conclusion

    Therefore, the tolerance is established for the combined 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-[(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-ethyl-
2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro1 14-methyl-, 
(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR) and 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-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-, 
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS).

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been 
exempted from review under Executive Order 12866, this 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) 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 6, 
2000) do not apply to this rule. In addition, this 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: September 27, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

[[Page 57499]]

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.635 is added to read as follows:

Sec.  180.635  Spinetoram; tolerances for residues.

    (a) General. Tolerances are established for the combined 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-[(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-ethyl-
2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro1 14-methyl-, 
(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR) and 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-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-, 
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS), in or on the following raw 
agricultural commodities:

----------------------------------------------------------------------------------------------------------------
                            Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Acerola..........................................................                                           0.30
Almond, hulls....................................................                                            2.0
Amaranth grain, grain............................................                                            1.0
Apple, wet pomace................................................                                           0.50
Artichoke, globe.................................................                                           0.30
Asparagus........................................................                                           0.04
Atemoya..........................................................                                           0.30
Avocado..........................................................                                           0.30
Banana...........................................................                                           0.25
Beet, sugar, molasses............................................                                           0.75
Biriba...........................................................                                           0.30
Brassica, head and stem, subgroup 5A.............................                                            2.0
Brassica, leafy greens, subgroup 5B..............................                                             10
Bushberry, subgroup 13B..........................................                                           0.25
Caneberry, subgroup 13A..........................................                                           0.70
Canistel.........................................................                                           0.30
Cattle, fat......................................................                                            5.5
Cattle, liver....................................................                                           0.85
Cattle, meat.....................................................                                           0.20
Cattle, meat byproducts (except liver)...........................                                           0.60
Cherimoya........................................................                                           0.30
Citrus, dried pulp...............................................                                           0.50
Citrus, oil......................................................                                            3.0
Corn, sweet, kernel plus cob with husks removed..................                                           0.04
Cotton, gin byproducts...........................................                                            1.5
Cotton, undelinted seed..........................................                                           0.04
Cranberry........................................................                                           0.04
Custard apple....................................................                                           0.30
Egg..............................................................                                           0.04
Feijoa...........................................................                                           0.30
Fig..............................................................                                           0.10
Fruit, citrus, group 10..........................................                                           0.30
Fruit, pome, group 11............................................                                           0.20
Fruit, stone, group 12...........................................                                           0.20
Goat, fat........................................................                                            5.5
Goat, liver......................................................                                           0.85
Goat, meat.......................................................                                           0.20
Goat, meat byproducts (except liver).............................                                           0.60
Grain, aspirated fractions.......................................                                             20
Grain, cereal, group 15, except rice, sorghum, pearl millet and                                             0.04
 proso millet....................................................
Grain, cereal, group 16, forage..................................                                            3.5
Grain, cereal, group 16, hay.....................................                                             10
Grain, cereal, group 16, stover..................................                                             10
Grain, cereal, straw, group 16, except rice......................                                            1.0
Grape............................................................                                           0.50
Grape, raisin....................................................                                           0.70
Guava............................................................                                           0.30
Herb, dried, subgroup 19A........................................                                             22
Herb, fresh, subgroup 19A........................................                                            3.0
Hog, fat.........................................................                                           0.40
Hog, meat........................................................                                           0.04
Hog, meat byproducts.............................................                                           0.04
Horse, fat.......................................................                                            5.5
Horse, liver.....................................................                                           0.85
Horse, meat......................................................                                           0.20
Horse, meat byproducts (except liver)............................                                           0.60
Ilama............................................................                                           0.30
Jaboticaba.......................................................                                           0.30
Juneberry........................................................                                           0.25
Lingonberry......................................................                                           0.25

[[Page 57500]]

Longan...........................................................                                           0.30
Lychee...........................................................                                           0.30
Mango............................................................                                           0.30
Milk.............................................................                                           0.30
Milk, fat........................................................                                            7.5
Millet, pearl, grain.............................................                                            1.0
Millet, proso, grain.............................................                                            1.0
Nut, tree, group 14..............................................                                           0.04
Okra.............................................................                                           0.40
Onion, green.....................................................                                            2.0
Papaya...........................................................                                           0.30
Passionfruit.....................................................                                           0.30
Pea and bean, dried shelled, except soybean, subgroup 6C.........                                           0.04
Pea and bean, succulent shelled, subgroup 6B.....................                                           0.04
Peanut...........................................................                                           0.04
Peanut, hay......................................................                                             11
Peppermint, tops.................................................                                            3.5
Pistachio........................................................                                           0.04
Poultry, fat.....................................................                                           0.10
Poultry, meat....................................................                                           0.04
Poultry, meat byproducts.........................................                                           0.04
Pulasan..........................................................                                           0.30
Rambutan.........................................................                                           0.30
Salal............................................................                                           0.25
Sapodilla........................................................                                           0.30
Sapote, black....................................................                                           0.30
Sapote, mamey....................................................                                           0.30
Sapote, white....................................................                                           0.30
Sheep, fat.......................................................                                            5.5
Sheep, liver.....................................................                                           0.85
Sheep, meat......................................................                                           0.20
Sheep, meat products (except liver)..............................                                           0.60
Sorghum, grain, grain............................................                                            1.0
Soursop..........................................................                                           0.30
Soybean, seed....................................................                                           0.04
Spanish lime.....................................................                                           0.30
Spearmint, tops..................................................                                            3.5
Star apple.......................................................                                           0.30
Star fruit.......................................................                                           0.30
Strawberry.......................................................                                            1.0
Sugar apple......................................................                                           0.30
Ti, leaves.......................................................                                             10
Vegetable, bulb, group 3, except green onion.....................                                           0.10
Vegetable, cucurbit, group 9.....................................                                           0.30
Vegetable, foliage of legume, group 7............................                                            8.0
Vegetable, fruiting, group 8.....................................                                           0.40
Vegetable, leafy, except Brassica, group 4.......................                                            8.0
Vegetable, leaves of root and tuber, group 2.....................                                             10
Vegetable, legume, edible podded, subgroup 6A....................                                           0.30
Vegetable, root and tuber, group 1...............................                                           0.10
Watercress.......................................................                                            8.0
Wax jambu........................................................                                           0.30
----------------------------------------------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registration. [Reserved]
    (d) Indirect and invertent residues. [Reserved]
[FR Doc. E7-19947 Filed 10-9-07; 8:45 am]

BILLING CODE 6560-50-S