Spinetoram; Pesticide Tolerance, 57492-57500 [E7-19947]
Download as PDF
57492
Federal Register / Vol. 72, No. 195 / Wednesday, October 10, 2007 / Rules and Regulations
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
V. Congressional Review Act
rmajette on PROD1PC64 with RULES
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).
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0876; FRL–8149–9]
Spinetoram; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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,
List of Subjects in 40 CFR Part 180
liver; cattle, meat; cattle, meat
Environmental protection,
byproducts (except liver); cherimoya;
Administrative practice and procedure,
citrus, dried pulp; citrus, oil; corn,
Agricultural commodities, Pesticides
sweet, kernel plus cob with husks
and pests, Reporting and recordkeeping removed; cotton, gin byproducts; cotton,
requirements.
undelinted seed; cranberry; custard
Dated: September 27, 2007.
apple; egg; feijoa; fig; fruit, citrus, group
Lois Rossi,
10; fruit, pome, group 11; fruit, stone,
group 12; goat, fat; goat, liver; goat,
Director, Registration Division, Office of
Pesticide Programs.
meat; goat, meat byproducts (except
liver); grain, aspirated fractions; grain,
I Therefore, 40 CFR chapter I is
cereal, group 15, except rice, sorghum,
amended as follows:
pearl millet and proso millet; grain,
cereal, group 16, forage; grain, cereal,
PART 180—AMENDED
group 16, hay; grain, cereal, group 16,
I 1. The authority citation for part 180
stover; grain, cereal, straw, group 16,
continues to read as follows:
except rice; grape; grape, raisin; guava;
herb, dried, subgroup 19A; herb, fresh,
Authority: 21 U.S.C. 321(q), 346a and 371.
subgroup 19A; hog, fat; hog, meat; hog,
I 2. In §180.471, paragraph (a) is
meat byproducts; horse, fat; horse, liver;
amended by revising the introductory
horse, meat; horse, meat byproducts
text and by alphabetically adding
(except liver); llama; jaboticaba;
commodities to the table to read as
juneberry; lingonberry; longan; lychee;
follows:
mango; milk; milk, fat; millet, pearl,
grain; millet, proso, grain; nut, tree,
§ 180.471 Furilazole; tolerances for
group 14; okra; onion, green; papaya;
residues.
passionfruit; pea and bean, dried
(a) General. Tolerances are
shelled, except soybean, subgroup 6C;
established for residues of furilazole; 3pea and bean, succulent shelled,
dichloroacetyl-5-(2-furanyl)-2, 2subgroup 6B; peanut; peanut, hay;
dimethyloxazolidine (CAS Reg. No.
peppermint, tops; pistachio; poultry, fat;
121776–33–8) when used as an inert
poultry, meat; poultry, meat byproducts;
ingredient (safener) in pesticide
pulasan; rambutan; salal; sapodilla;
formulations in or on the following raw
sapote, black; sapote, mamey; sapote,
agricultural commodities:
white; sheep, fat; sheep, liver; sheep,
meat; sheep, meat byproducts (except
Parts per
Commodity
liver); sorghum, grain, grain; soursop;
million
soybean, seed; spanish lime; spearmint,
tops; star apple; star fruit; strawberry;
*
*
*
*
*
Sorghum, forage .......................
0.01 sugar apple; ti, leaves; vegetable, bulb,
Sorghum, grain .........................
0.01 group 3, except green onion; vegetable,
Sorghum, stover .......................
0.01 cucurbit, group 9; vegetable, foliage of
legume, group 7; vegetable, fruiting,
*
*
*
*
*
group 8; vegetable, leafy, except
[FR Doc. E7–19829 Filed 10–9–07; 8:45 am]
brassica, group 4; vegetable, leaves of
BILLING CODE 6560–50–S
root and tuber, group 2; vegetable,
VerDate Aug<31>2005
15:16 Oct 09, 2007
Jkt 214001
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
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 https://
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
https://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:
E:\FR\FM\10OCR1.SGM
10OCR1
Federal Register / Vol. 72, No. 195 / Wednesday, October 10, 2007 / Rules and Regulations
• 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.
rmajette on PROD1PC64 with RULES
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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://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
VerDate Aug<31>2005
15:16 Oct 09, 2007
Jkt 214001
57493
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;
II. Petition for Tolerance
hog, fat at 1 ppm; hog, meat byproducts
at 0.5 ppm; hog, meat at 0.1 ppm; horse,
In the Federal Register of August 22,
fat at 2 ppm; horse, meat byproducts at
2007 (72 FR 47008) (FRL–8154–1), EPA
1 ppm; horse, meat at 0.1 ppm; ilama at
issued a notice pursuant to section
0.3 ppm; jaboticaba at 0.3 ppm;
408(d)(3) of FFDCA, 21 U.S.C.
juneberry at 0.25 ppm; leafy vegetables
346a(d)(3), announcing the filing of a
(except brassica vegetables group) at 8
pesticide petition (PP 5F7006) by Dow
ppm; legume vegetables, dried shelled
AgroSciences, LLC, 9330 Zionsville
Road, Indianapolis, IN 46268–1053. The pea and bean (crop subgroup 6C) at 0.02
ppm; legume vegetables, edible podded
petition requested the establishment of
a tolerance for the combined residues of (crop subgroup 6A) at 0.3 ppm; legume
vegetables, succulent shelled pea and
the insecticide XDE-175, expressed as a
bean (crop subgroup 6B) at 0.02 ppm;
combination of XDE-175-J: 1-H-asIndaceno[3,2-d]o oxacyclododecin-7,15- lingonberry at 0.25 ppm; longan at 0.3
ppm; lychee at 0.3 ppm; mango at 0.3
dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-Oppm; milk at 0.5 ppm; milk, fat at 1
methyl-a-Lmannopyranosyl)oxy]-13ppm; millet, forage at 1.5 ppm; millet,
[[(2R,5S,6R)-5-(dimethylamino)
tetrahydro-6-methyl-2H-pyran-2-yl]oxy]- hay and straw at 5 ppm; nut, tree, group
14 at 0.02 ppm; oat, forage at 1.5 ppm;
9-ethyl-2,3,3a,4,5,5a,5b,6,9,
10,11,12,13,14,16a,16b-hexadecahydro1 oat, hay and straw at 5 ppm; okra at 0.4
ppm; onion, dry bulb at 0.1 ppm; onion,
14-methyl-,
(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR) green at 2 ppm; papaya at 0.3 ppm;
passionfruit at 0.3 ppm; peanut at 0.02
and XDE–175–L: 1H-as-Indaceno[3,2ppm; peanut, hay at 11 ppm;
d]oxacyclododecin-7,15-dione, 2-[(6peppermint, tops at 3.5 ppm; pistachio
deoxy-3-O-ethyl-2,4-di-O-methyl-aLmannopyranosyl)oxy]-13-[[(2R,5S,6R)- at 0.02 ppm; plantain at 0.25 ppm;
poultry, fat at 0.1 ppm; poultry, meat
5-(dimethylamino)tetrahydro-6-methylbyproducts at 0.02 ppm; poultry, meat
2H-pyran-2-yl]oxy]-9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b- at 0.02 ppm; pulasan at 0.3 ppm;
rambutan at 0.3 ppm; rye, forage at 1.5
tetradecahydro-4,14-dimethyl-,
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS), ppm; rye, straw at 5 ppm; salal at 0.25
ppm; sapodilla at 0.3 ppm; sapote, black
in or on acerola at 1.5 parts per million
at 0.3 ppm; sapote, mamey at 0.3 ppm;
(ppm); almond, hulls at 2 ppm;
sapote, white at 0.3 ppm; sheep, fat at
amaranth grain, grain at 1 ppm; apple
2 ppm; sheep, meat byproducts at 1
pomace at 0.5 ppm; artichoke, globe at
0.3 ppm; asparagus at 0.2 ppm; atemoya ppm; sheep, meat at 0.1 ppm; sorghum,
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: https://
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.
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
E:\FR\FM\10OCR1.SGM
10OCR1
rmajette on PROD1PC64 with RULES
57494
Federal Register / Vol. 72, No. 195 / Wednesday, October 10, 2007 / Rules and Regulations
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, https://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,
VerDate Aug<31>2005
15:16 Oct 09, 2007
Jkt 214001
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
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
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-effectlevel (NOAEL) and the lowest-observedadverse-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 https://www.regulations.gov.
The referenced document is available in
the docket established by this action,
which is described under ADDRESSES,
E:\FR\FM\10OCR1.SGM
10OCR1
Federal Register / Vol. 72, No. 195 / Wednesday, October 10, 2007 / Rules and Regulations
rmajette on PROD1PC64 with RULES
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 https://
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 https://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
VerDate Aug<31>2005
15:16 Oct 09, 2007
Jkt 214001
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
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
57495
upon average field-trial residues for
apple, leafy vegetables (except Brassica),
citrus and fruiting vegetables; tolerancelevel 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,
E:\FR\FM\10OCR1.SGM
10OCR1
rmajette on PROD1PC64 with RULES
57496
Federal Register / Vol. 72, No. 195 / Wednesday, October 10, 2007 / Rules and Regulations
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
VerDate Aug<31>2005
15:16 Oct 09, 2007
Jkt 214001
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 https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the First Index Reservoir
Screening Tool (FIRST) and Screening
Concentration in Ground Water (SCIGROW) models, the estimated
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
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
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 nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides and
flea and tick control on pets).
The Agency has concluded that
spinosad and spinetoram are
toxicologically equivalent; therefore,
residential exposure to both spinosad
and spinetoram was evaluated.
Spinosad is currently registered for 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 shortterm 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
E:\FR\FM\10OCR1.SGM
10OCR1
Federal Register / Vol. 72, No. 195 / Wednesday, October 10, 2007 / Rules and Regulations
rmajette on PROD1PC64 with RULES
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 https://
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
VerDate Aug<31>2005
15:16 Oct 09, 2007
Jkt 214001
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
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
57497
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 shortterm 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 shortterm 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
E:\FR\FM\10OCR1.SGM
10OCR1
57498
Federal Register / Vol. 72, No. 195 / Wednesday, October 10, 2007 / Rules and Regulations
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.
rmajette on PROD1PC64 with RULES
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 EPArecommended tolerance).
VerDate Aug<31>2005
15:16 Oct 09, 2007
Jkt 214001
relationships or distribution of power
Therefore, the tolerance is established and responsibilities established by
Congress in the preemption provisions
for the combined residues of the
of section 408(n)(4) of FFDCA. As such,
insecticide spinetoram, expressed as a
the Agency has determined that this
combination of XDE-175-J: 1-H-asIndaceno[3,2-d]o oxacyclododecin-7,15- action will not have a substantial direct
effect on States or tribal governments on
dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-Othe relationship between the national
methyl-a-Lmannopyranosyl)oxy]-13government and the States or tribal
[[(2R,5S,6R)-5-(dimethylamino)
tetrahydro-6-methyl-2H-pyran-2-yl]oxy]- governments, or on the distribution of
power and responsibilities among the
9-ethylvarious levels of government or between
2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,
the Federal Government and Indian
16a,16b-hexadecahydro1 14-methyl-,
(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR) tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
and XDE–175–L: 1H-as-Indaceno[3,2d]oxacyclododecin-7,15-dione,2 2-[(6Federalism (64 FR 43255, August 10,
deoxy-3-O-ethyl-2,4-di-O-methyl-a1999) and Executive Order 13175,
Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)- entitled Consultation and Coordination
5-(dimethylamino)tetrahydro-6-methyl- with Indian Tribal Governments (65 FR
2H-pyran-2-yl]oxy]-9-ethyl67249, November 6, 2000) do not apply
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b- to this rule. In addition, this rule does
tetradecahydro-4,14-dimethyl-,
not impose any enforceable duty or
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS). contain any unfunded mandate as
described under Title II of the Unfunded
VI. Statutory and Executive Order
Mandates Reform Act of 1995 (UMRA)
Reviews
(Public Law 104–4).
This final rule establishes a tolerance
This action does not involve any
under section 408(d) of FFDCA in
technical standards that would require
response to a petition submitted to the
Agency consideration of voluntary
Agency. The Office of Management and
Budget (OMB) has exempted these types consensus standards pursuant to section
12(d) of the National Technology
of actions from review under Executive
Transfer and Advancement Act of 1995
Order 12866, entitled Regulatory
(NTTAA), Public Law 104–113, section
Planning and Review (58 FR 51735,
12(d) (15 U.S.C. 272 note).
October 4, 1993). Because this rule has
been exempted from review under
VII. Congressional Review Act
Executive Order 12866, this rule is not
subject to Executive Order 13211,
The Congressional Review Act, 5
Actions Concerning Regulations That
U.S.C. 801 et seq., generally provides
Significantly Affect Energy Supply,
that before a rule may take effect, the
Distribution or Use (66 FR 28355, May
agency promulgating the rule must
22, 2001) or Executive Order 13045,
submit a rule report to each House of
entitled Protection of Children from
the Congress and to the Comptroller
Environmental Health Risks and Safety
General of the United States. EPA will
Risks (62 FR 19885, April 23, 1997).
submit a report containing this rule and
This final rule does not contain any
other required information to the U.S.
information collections subject to OMB
Senate, the U.S. House of
approval under the Paperwork
Representatives and the Comptroller
Reduction Act (PRA), 44 U.S.C. 3501 et
General of the United States prior to
seq., nor does it require any special
publication of this final rule in the
considerations under Executive Order
Federal Register. This final rule is not
12898, entitled Federal Actions to
a ‘‘major rule’’ as defined by 5 U.S.C.
Address Environmental Justice in
804(2).
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
List of Subjects in 40 CFR Part 180
1994).
Since tolerances and exemptions that
Environmental protection,
are established on the basis of a petition Administrative practice and procedure,
under section 408(d) of FFDCA, such as Agricultural commodities, Pesticides
the tolerance in this final rule, do not
and pests, Reporting and recordkeeping
require the issuance of a proposed rule,
requirements.
the requirements of the Regulatory
Dated: September 27, 2007.
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
Debra Edwards,
This final rule directly regulates
Director, Office of Pesticide Programs.
growers, food processors, food handlers
I Therefore, 40 CFR chapter I is
and food retailers, not States or tribes,
nor does this action alter the
amended as follows:
V. Conclusion
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
E:\FR\FM\10OCR1.SGM
10OCR1
Federal Register / Vol. 72, No. 195 / Wednesday, October 10, 2007 / Rules and Regulations
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.635 is added to read as
follows:
I
§ 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-asIndaceno[3,2-d]o oxacyclododecin-7,15dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-Omethyl-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-[(6deoxy-3-O-ethyl-2,4-di-O-methyl-aLmannopyranosyl)oxy]-13-[[(2R,5S,6R)5-(dimethylamino)tetrahydro-6-methyl2H-pyran-2-yl]oxy]-9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16btetradecahydro-4,14-dimethyl-,
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS),
in or on the following raw agricultural
commodities:
rmajette on PROD1PC64 with RULES
Commodity
Parts per million
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) ........................................................................................
Ilama ............................................................................................................................................
Jaboticaba ....................................................................................................................................
Juneberry .....................................................................................................................................
Lingonberry ..................................................................................................................................
VerDate Aug<31>2005
15:16 Oct 09, 2007
Jkt 214001
PO 00000
57499
Frm 00015
Fmt 4700
Sfmt 4700
E:\FR\FM\10OCR1.SGM
0.30
2.0
1.0
0.50
0.30
0.04
0.30
0.30
0.25
0.75
0.30
2.0
10
0.25
0.70
0.30
5.5
0.85
0.20
0.60
0.30
0.50
3.0
0.04
1.5
0.04
0.04
0.30
0.04
0.30
0.10
0.30
0.20
0.20
5.5
0.85
0.20
0.60
20
0.04
3.5
10
10
1.0
0.50
0.70
0.30
22
3.0
0.40
0.04
0.04
5.5
0.85
0.20
0.60
0.30
0.30
0.25
0.25
10OCR1
57500
Federal Register / Vol. 72, No. 195 / Wednesday, October 10, 2007 / Rules and Regulations
Commodity
Parts per million
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 products (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 ...................................................................................................................................
Wax jambu ...................................................................................................................................
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registration. [Reserved]
(d) Indirect and invertent residues.
[Reserved]
DEPARTMENT OF COMMERCE
[FR Doc. E7–19947 Filed 10–9–07; 8:45 am]
[Docket No. 061020273–7001–03]
rmajette on PROD1PC64 with RULES
BILLING CODE 6560–50–S
National Oceanic and Atmospheric
Administration
50 CFR Part 648
RIN 0648–XC92
Fisheries of the Northeastern United
States; Summer Flounder Fishery;
Rescission of Commercial Closure for
Connecticut
National Marine Fisheries
Service (NMFS), National Oceanic and
AGENCY:
VerDate Aug<31>2005
15:16 Oct 09, 2007
Jkt 214001
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
0.30
0.30
0.30
0.30
7.5
1.0
1.0
0.04
0.40
2.0
0.30
0.30
0.04
0.04
0.04
11
3.5
0.04
0.10
0.04
0.04
0.30
0.30
0.25
0.30
0.30
0.30
0.30
5.5
0.85
0.20
0.60
1.0
0.30
0.04
0.30
3.5
0.30
0.30
1.0
0.30
10
0.10
0.30
8.0
0.40
8.0
10
0.30
0.10
8.0
0.30
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; rescission of
closure.
SUMMARY: NMFS announces rescission
of the closure previously issued for the
State of Connecticut. This notification is
consistent with Connecticut’s
announcement to reopen the
commercial summer flounder fishery
within State waters, effective September
24, 2007. The rescission of this closure
is due to catch accounting corrections
that have reduced previously reported
landings in Connecticut. The public is
advised that landings are allowed for
E:\FR\FM\10OCR1.SGM
10OCR1
Agencies
[Federal Register Volume 72, Number 195 (Wednesday, October 10, 2007)]
[Rules and Regulations]
[Pages 57492-57500]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19947]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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 https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://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 https://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: https://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, https://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
https://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 https://
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 https://
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 https://
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 https://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 6