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Spinetoram; Pesticide Tolerance


[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 (59 FR 22951, 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.

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

[[Page 57499]]

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 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

 
 


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