Furilazole; Inert Ingredient Tolerances, 57489-57492 [E7-19829]
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Federal Register / Vol. 72, No. 195 / Wednesday, October 10, 2007 / Rules and Regulations
2. Amend the following sections of the
Mailing Standards of the United States
Postal Service, Domestic Mail Manual
(DMM) set forth below:
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500
Additional Mailing Services
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507
Mailer Services
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2.0
Forwarding
2.1
Change-of-Address Order
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2.1.3 Temporary Forwarding
[Revise paragraph in 2.1.3 as follows:]
A customer temporarily moving away
may have mail forwarded for a specific
period of time, not to exceed 12 months
(364 total consecutive days). The Postal
Service provides temporary forwarding
service for a period of two weeks to six
months (15 to 185 days) in response to
an initial temporary change-of-address
order. Customers may extend the
temporary forwarding period up to a
maximum of 12 months (364 days), by
filing a second change-of-address order
to begin on the first day of the second
six-month period (the 186th day) and
expiring on the desired date, up to and
including the last day of the second sixmonth period (364th day). Every
temporary change-of-address order must
specify both beginning and end dates.
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An appropriate amendment to 39 CFR
111.3 will be published to reflect these
changes.
Neva Watson,
Attorney, Legislation.
[FR Doc. E7–19875 Filed 10–9–07; 8:45 am]
BILLING CODE 7710–12–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0557; FRL–8145–2]
Furilazole; Inert Ingredient Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of furilazole (3dichloroacetyl-5-(2-furanyl)-2, 2dimethyloxazolidine; (CAS Reg. No.
121776–33–8) under 40 CFR 180.471
when used as a pesticide inert
ingredient safener on the sorghum
commodities forage, grain, and stover at
0.01 parts per million (ppm). The
Monsanto Company submitted a
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petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection
Act of 1996 (FQPA), requesting an
exemption from the requirement of a
tolerance.
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–2007–0557. 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
web site 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 either in the electronic docket
at https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Karen Angulo, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 306–0404; e-mail address:
angulo.karen@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:
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57489
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at 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 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 the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2007–0557 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before 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
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without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2007–0557, 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 Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Background and Statutory Findings
In the Federal Register of June 1, 2005
(70 FR 31459) (FRL–7715–7), EPA
issued a notice pursuant to section 408
of the Federal Food, Drug, and Cosmetic
Act (FFDCA), 21 U.S.C. 346a, as
amended by the Food Quality Protection
Act (FQPA), announcing the filing of a
pesticide petition (PP 5E6919) by the
Monsanto Company. The petition
requested that 40 CFR 180.471 be
amended by the addition of tolerances
for residues of furilazole (3dichloroacetyl-5-(2-furanyl)-2, 2dimethyloxazolidine; (CAS Reg. No.
121776–33–8) on the sorghum
commodities bran, flour, forage, grain,
and stover at 0.01 parts per million
(ppm). That notice included a summary
of the petition prepared by the
petitioner. No comments were received
in response to the notice of filing.
Section 408(b)(2)(A)(i) of the 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(c)(2)(A)(ii) of the 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 the 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
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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 the FFDCA by
the Food Quality Protection Act (FQPA)
of 1996.
III. Risk Characterization and
Conclusions
Consistent with section 408(b)(2)(D)
of the FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
action and considered its validity,
completeness and reliability and the
relationship of this information 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
nature of the toxic effects caused by
furilazole is discussed in this unit. EPA
has sufficient data to assess the hazards
of and make a determination on
aggregate exposure for the chemical.
The following provides a brief summary
of the risk assessment and conclusions
for the Agency’s review of furilazole.
The full decision document for this
action is available on EPA’s Electronic
Docket at https://www.regulations.gov/
under docket number EPA–HQ–OPP–
2007–0557.
A. Human Health
The Agency reviewed the available
information on furilazole submitted by
the petitioner and determined that the
toxicity database is sufficient. The
toxicity studies used here were
submitted for the establishment of
tolerances of furilazole on corn
commodities (Federal Register of April
3, 2002 (67 FR 15727) (FRL–6828–4).
Laboratory studies in rodents show that
exposure to furilazole may cause effects
to the liver. In a 90–day oral toxicity
study on rodents, the no observed
effects level (NOAEL) was 7 milligrams/
kilograms/day (mg/kg/day) and the
lowest observed effects level (LOAEL)
was 34/38 mg/kg/day (male/female),
and in a chronic toxicity study on the
rat the NOAEL was 0.26 mg/kg/day and
the LOAEL was 5.05 mg/kg/day.
Evidence of carcinogenicity was
observed in rodents. For developmental
toxicity, effects (increased number of resorptions; NOAEL was 10 mg/kg/day
and the LOAEL was 75 mg/kg/day) were
observed at maternally toxic doses. In
the final rule, the Agency concluded
‘‘no qualitative or quantitative evidence
of increased susceptibility in the rat or
rabbit fetuses following in-utero
exposure in the developmental toxicity
studies nor to the offspring following
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prenatal/postnatal exposure in the 2–
generation reproduction study.’’ The
Agency further concluded ‘‘taking into
account the lack of increased
susceptibility and the completeness of
the data on toxicity and exposure, EPA
determined that the 10X safety factor to
protect infants and children should be
removed.’’ There are no residual
uncertainties regarding prenatal and/or
postnatal toxicity.
B. Exposure Assessment
The potential for exposure to residues
of furilazole is adequately characterized
based on the results of modeling and the
crop residue studies. The results of the
Dietary Exposure Evaluation Model
(DEEM) model developed when
tolerances for furilazole were first
established on corn estimated that the
amount of the dietary chronic
population adjusted dose (cPAD) for the
U.S. population was 1.4%, and the
highest amount of the cPAD was 3.4%
for all infants less than 1 year old.
Estimates for potential cancer risks were
also very low.
Residue studies (crop field trials and
processed) show that residues of
furilazole on sorghum commodities
were non-quantifiable (less than the
Limit of Quantitation (LOQ) of 0.010
ppm) in all samples of sorghum forage,
grain, and stover.
Considering the results of the residue
studies for furilazole on sorghum
commodities and exposure modeling,
the Agency concludes that dietary (food
and drinking water) exposures of
concern are not anticipated from the
inert ingredient use of furilazole on the
sorghum commodities forage, grain, and
stover. Residential exposure is not
expected because applications are
limited to the agricultural crop
sorghum. EPA is not aware of nonpesticide uses of furilazole, therefore, no
further aggregate assessment is
necessary.
C. Safety Factor for Infants and Children
Section 408 of the FFDCA provides
that EPA shall apply an additional
tenfold margin of safety for infants and
children in the case of threshold effects
to account for prenatal and postnatal
toxicity and the completeness of the
database on toxicity and exposure
unless EPA determines that a different
margin of safety will be safe for infants
and children. Margins of safety are
incorporated into EPA risk assessments
either directly through use of a margin
of exposure analysis or through using
uncertainty (safety) factors in
calculating a dose level that poses no
appreciable risk to humans. The toxicity
database is sufficient for furilazole and
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potential exposure is adequately
characterized based on results of the
residue studies for furilazole on
sorghum commodities and exposure
modeling. In terms of hazard, there are
low concerns and no residual
uncertainties regarding prenatal and/or
postnatal toxicity. Taking into account
the lack of increased susceptibility and
the completeness of the data on toxicity
and exposure, EPA determined that the
10X safety factor to protect infants and
children should be removed.
D. Cumulative Exposure
Section 408(b)(2)(D)(v) of the FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’ Unlike other
pesticides for which EPA has followed
a cumulative risk approach based on a
common mechanism of toxicity, EPA
has not made a common mechanism of
toxicity finding as to furilazole and any
other substances, and the chemical 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
furilazole 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.
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E. Other Considerations
1. Analytical methods. Adequate
enforcement methodology (capillary gas
chromotography using electron capture
detection) is available to enforce the
tolerance exemption expression. The
method may be requested from: Chief,
Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905; email address: residuemethods@epa.gov.
2. International tolerances. The
Agency is not aware of any country
requiring a tolerance for furilazole nor
have any CODEX Maximum Residue
Levels (MRLs) been established for any
food crops at this time.
F. Determination of Safety and
Conclusions
The petitioner requested tolerances
for sorghum flour and bran,
nevertheless, these tolerances are not
being established. The Agency has
determined that tolerances for these
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processed commodities are not
necessary because the residue data
showed that residues of furilazole were
non-quantifiable (less than 0.010 ppm)
in all samples of grain (RAC) and
processed fractions.
Laboratory studies in show that
exposure to furilazole may cause effects
to the liver and evidence of
carcinogenicity was observed.
Developmental effects were observed at
maternally toxic doses and there was no
qualitative or quantitative evidence of
increased susceptibility in the rat or
rabbit fetuses. Therefore, the 10X safety
factor to protect infants and children is
removed.
The results of the DEEM model that
was developed when tolerances for
furilazole were first established
estimated the amount of the dietary
cPAD for the U.S. population was 1.4%,
and the highest amount of the cPAD was
3.4% for all infants less than 1 year old.
Estimates for potential cancer risks were
also very low. Residue studies (crop
field trials and processed) on sorghum
commodities show that residues of
furilazole were non-quantifiable (less
than the LOQ of 0.010 ppm).
Considering the results of the residue
studies and the conservative exposure
modeling, the Agency concludes that
dietary (food and drinking water)
exposures of concern are not anticipated
from the inert ingredient use of
furilazole on sorghum commodities.
Residential exposure is not expected
because applications are limited to the
agricultural crop sorghum. The Agency
is not aware of any non-pesticide uses
of furilazole, therefore, no further
exposure assessment is necessary.
Based on the information in this
preamble, EPA concludes that there is a
reasonable certainty of no harm to the
general population, including infants
and children, from aggregate exposure
to residues of furilazole. Accordingly,
EPA finds that establishing tolerances
for furilazole will be safe. EPA is
establishing tolerances under 40 CFR
180.471 for residues of furilazole in or
on the sorghum commodities forage,
grain, and stover at 0.01 ppm when it is
used as an inert ingredient safener.
In addition, the annual application
rate limitation found in 40 CFR 180.471
is being removed because it is
unnecessary. The establishment of
tolerance levels provides adequate
regulation under FFDCA.
IV. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
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57491
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
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Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
V. Congressional Review Act
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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;
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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,
*
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*
*
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,
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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
Agencies
[Federal Register Volume 72, Number 195 (Wednesday, October 10, 2007)]
[Rules and Regulations]
[Pages 57489-57492]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19829]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0557; FRL-8145-2]
Furilazole; Inert Ingredient Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
furilazole (3-dichloroacetyl-5-(2-furanyl)-2, 2-dimethyloxazolidine;
(CAS Reg. No. 121776-33-8) under 40 CFR 180.471 when used as a
pesticide inert ingredient safener on the sorghum commodities forage,
grain, and stover at 0.01 parts per million (ppm). The Monsanto Company
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food Quality Protection Act of 1996
(FQPA), requesting an exemption from the requirement of a tolerance.
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-2007-0557. 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 web site 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 either in the electronic docket at https://
www.regulations.gov, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Karen Angulo, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 306-0404; e-mail address: angulo.karen@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at 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 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 the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2007-0557 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before 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
[[Page 57490]]
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-0557, 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
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of June 1, 2005 (70 FR 31459) (FRL-7715-7),
EPA issued a notice pursuant to section 408 of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food
Quality Protection Act (FQPA), announcing the filing of a pesticide
petition (PP 5E6919) by the Monsanto Company. The petition requested
that 40 CFR 180.471 be amended by the addition of tolerances for
residues of furilazole (3-dichloroacetyl-5-(2-furanyl)-2, 2-
dimethyloxazolidine; (CAS Reg. No. 121776-33-8) on the sorghum
commodities bran, flour, forage, grain, and stover at 0.01 parts per
million (ppm). That notice included a summary of the petition prepared
by the petitioner. No comments were received in response to the notice
of filing.
Section 408(b)(2)(A)(i) of the 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(c)(2)(A)(ii) of the 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 the 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 the FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
III. Risk Characterization and Conclusions
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness and
reliability and the relationship of this information 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 nature of the toxic effects caused
by furilazole is discussed in this unit. EPA has sufficient data to
assess the hazards of and make a determination on aggregate exposure
for the chemical. The following provides a brief summary of the risk
assessment and conclusions for the Agency's review of furilazole. The
full decision document for this action is available on EPA's Electronic
Docket at https://www.regulations.gov/ under docket number EPA-HQ-OPP-
2007-0557.
A. Human Health
The Agency reviewed the available information on furilazole
submitted by the petitioner and determined that the toxicity database
is sufficient. The toxicity studies used here were submitted for the
establishment of tolerances of furilazole on corn commodities (Federal
Register of April 3, 2002 (67 FR 15727) (FRL-6828-4). Laboratory
studies in rodents show that exposure to furilazole may cause effects
to the liver. In a 90-day oral toxicity study on rodents, the no
observed effects level (NOAEL) was 7 milligrams/kilograms/day (mg/kg/
day) and the lowest observed effects level (LOAEL) was 34/38 mg/kg/day
(male/female), and in a chronic toxicity study on the rat the NOAEL was
0.26 mg/kg/day and the LOAEL was 5.05 mg/kg/day. Evidence of
carcinogenicity was observed in rodents. For developmental toxicity,
effects (increased number of re-sorptions; NOAEL was 10 mg/kg/day and
the LOAEL was 75 mg/kg/day) were observed at maternally toxic doses. In
the final rule, the Agency concluded ``no qualitative or quantitative
evidence of increased susceptibility in the rat or rabbit fetuses
following in-utero exposure in the developmental toxicity studies nor
to the offspring following prenatal/postnatal exposure in the 2-
generation reproduction study.'' The Agency further concluded ``taking
into account the lack of increased susceptibility and the completeness
of the data on toxicity and exposure, EPA determined that the 10X
safety factor to protect infants and children should be removed.''
There are no residual uncertainties regarding prenatal and/or postnatal
toxicity.
B. Exposure Assessment
The potential for exposure to residues of furilazole is adequately
characterized based on the results of modeling and the crop residue
studies. The results of the Dietary Exposure Evaluation Model (DEEM)
model developed when tolerances for furilazole were first established
on corn estimated that the amount of the dietary chronic population
adjusted dose (cPAD) for the U.S. population was 1.4%, and the highest
amount of the cPAD was 3.4% for all infants less than 1 year old.
Estimates for potential cancer risks were also very low.
Residue studies (crop field trials and processed) show that
residues of furilazole on sorghum commodities were non-quantifiable
(less than the Limit of Quantitation (LOQ) of 0.010 ppm) in all samples
of sorghum forage, grain, and stover.
Considering the results of the residue studies for furilazole on
sorghum commodities and exposure modeling, the Agency concludes that
dietary (food and drinking water) exposures of concern are not
anticipated from the inert ingredient use of furilazole on the sorghum
commodities forage, grain, and stover. Residential exposure is not
expected because applications are limited to the agricultural crop
sorghum. EPA is not aware of non-pesticide uses of furilazole,
therefore, no further aggregate assessment is necessary.
C. Safety Factor for Infants and Children
Section 408 of the FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
analysis or through using uncertainty (safety) factors in calculating a
dose level that poses no appreciable risk to humans. The toxicity
database is sufficient for furilazole and
[[Page 57491]]
potential exposure is adequately characterized based on results of the
residue studies for furilazole on sorghum commodities and exposure
modeling. In terms of hazard, there are low concerns and no residual
uncertainties regarding prenatal and/or postnatal toxicity. Taking into
account the lack of increased susceptibility and the completeness of
the data on toxicity and exposure, EPA determined that the 10X safety
factor to protect infants and children should be removed.
D. Cumulative Exposure
Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' Unlike other pesticides for
which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, EPA has not made a common mechanism of toxicity
finding as to furilazole and any other substances, and the chemical
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 furilazole 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.
E. Other Considerations
1. Analytical methods. Adequate enforcement methodology (capillary
gas chromotography using electron capture detection) is available to
enforce the tolerance exemption expression. The method may be requested
from: Chief, Analytical Chemistry Branch, Environmental Science Center,
701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-
2905; e-mail address: residuemethods@epa.gov.
2. International tolerances. The Agency is not aware of any country
requiring a tolerance for furilazole nor have any CODEX Maximum Residue
Levels (MRLs) been established for any food crops at this time.
F. Determination of Safety and Conclusions
The petitioner requested tolerances for sorghum flour and bran,
nevertheless, these tolerances are not being established. The Agency
has determined that tolerances for these processed commodities are not
necessary because the residue data showed that residues of furilazole
were non-quantifiable (less than 0.010 ppm) in all samples of grain
(RAC) and processed fractions.
Laboratory studies in show that exposure to furilazole may cause
effects to the liver and evidence of carcinogenicity was observed.
Developmental effects were observed at maternally toxic doses and there
was no qualitative or quantitative evidence of increased susceptibility
in the rat or rabbit fetuses. Therefore, the 10X safety factor to
protect infants and children is removed.
The results of the DEEM model that was developed when tolerances
for furilazole were first established estimated the amount of the
dietary cPAD for the U.S. population was 1.4%, and the highest amount
of the cPAD was 3.4% for all infants less than 1 year old. Estimates
for potential cancer risks were also very low. Residue studies (crop
field trials and processed) on sorghum commodities show that residues
of furilazole were non-quantifiable (less than the LOQ of 0.010 ppm).
Considering the results of the residue studies and the conservative
exposure modeling, the Agency concludes that dietary (food and drinking
water) exposures of concern are not anticipated from the inert
ingredient use of furilazole on sorghum commodities. Residential
exposure is not expected because applications are limited to the
agricultural crop sorghum. The Agency is not aware of any non-pesticide
uses of furilazole, therefore, no further exposure assessment is
necessary.
Based on the information in this preamble, EPA concludes that there
is a reasonable certainty of no harm to the general population,
including infants and children, from aggregate exposure to residues of
furilazole. Accordingly, EPA finds that establishing tolerances for
furilazole will be safe. EPA is establishing tolerances under 40 CFR
180.471 for residues of furilazole in or on the sorghum commodities
forage, grain, and stover at 0.01 ppm when it is used as an inert
ingredient safener.
In addition, the annual application rate limitation found in 40 CFR
180.471 is being removed because it is unnecessary. The establishment
of tolerance levels provides adequate regulation under FFDCA.
IV. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this 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
[[Page 57492]]
Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113,
section 12(d) (15 U.S.C. 272 note).
V. 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.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
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. In Sec. 180.471, paragraph (a) is amended by revising the
introductory text and by alphabetically adding commodities to the table
to read as follows:
Sec. 180.471 Furilazole; tolerances for residues.
(a) General. Tolerances are established for residues of furilazole;
3-dichloroacetyl-5-(2-furanyl)-2, 2-dimethyloxazolidine (CAS Reg. No.
121776-33-8) when used as an inert ingredient (safener) in pesticide
formulations in or on the following raw agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Sorghum, forage............................................ 0.01
Sorghum, grain............................................. 0.01
Sorghum, stover............................................ 0.01
------------------------------------------------------------------------
* * * * *
[FR Doc. E7-19829 Filed 10-9-07; 8:45 am]
BILLING CODE 6560-50-S