Nicosulfuron; Pesticide Tolerances, 17573-17579 [2010-7745]
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Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: March 26, 2010.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.361, revise the
introductory text and the entry for
Alfalfa, forage in the table in paragraph
(a) to read as follows:
■
§ 180.361 Pendimethalin; tolerances for
residues.
(a) General. Tolerances are
established for residues of the herbicide
pendimethalin, including its
metabolites and degradates, in or on the
commodities. Compliance with the
tolerance levels specified in the
following table below is to be
determined by measuring only
pendimethalin, [N- (1-ethylpropyl)-3,4dimethyl-2,6-dinitrobenzenamine], and
its metabolite, 4-[(1-ethylpropyl)amino]2-methyl-3,5-dinitrobenzyl alcohol,
calculated as the stoichiometric
equivalent of pendimethalin, in or on
the following commodities:
Commodity
Parts per million
Alfalfa, forage ...................................................................................................................................................
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*
*
*
*
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*
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[FR Doc. 2010–7740 Filed 4–6–10; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
WReier-Aviles on DSKGBLS3C1PROD with RULES
[EPA–HQ–OPP–2009–0057; FRL–8818–4]
Nicosulfuron; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes
tolerances for residues of nicosulfuron
in or on cattle, fat; cattle, meat; cattle,
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meat byproducts; goat, fat; goat, meat;
goat, meat byproducts; grass, forage;
grass, hay; horse, fat; horse, meat; horse,
meat byproducts; milk; sheep, fat;
sheep, meat; and sheep, meat
byproducts. E. I. du Pont de Nemours
and Company requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA). This
regulation also removes the existing
tolerance for residues of nicosulfuron on
corn, forage.
DATES: This regulation is effective April
7, 2010. Objections and requests for
hearings must be received on or before
June 7, 2010, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
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3.5
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2009–0057. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
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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:
Mindy Ondish, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 605-0723; e-mail address:
ondish.mindy@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
WReier-Aviles on DSKGBLS3C1PROD with RULES
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Electronic Access to
Other Related Information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.gpoaccess.gov/ecfr.
You may also access the OPPTS
harmonized test guidelines referenced
in this document electronically at
https://www.epa.gov/oppts and select
‘‘Test Methods and Guideline.’’
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
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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–2009–0057 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 June 7, 2010.
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–2009–0057, 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
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of April 8,
2009 (74 FR 15971) (FRL–8407–4), 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 8F7501) by E. I.
du Pont de Nemours and Company, P.O.
Box 80038, Wilmington, DE 19880–
0038. The petition requested that 40
CFR 180.454 be amended by
establishing tolerances for residues of
the herbicide nicosulfuron, 3Pyridinecarboxamide, 2-[[[[(4,6dimethoxy-2-pyrimidinyl)amino]
carbonyl]amino]sulfonyl]-N,Ndimethyl-, in or on grass, forage at 9.0
parts per million (ppm); grass, hay at
25.0 ppm; fat (of cattle, goat, hog, horse,
and sheep) at 0.05 ppm; meat (of cattle,
goat, hog, horse, and sheep) at 0.05
ppm; meat byproducts (of cattle, goat,
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hog, horse, and sheep) at 0.05 ppm; milk
at 0.05 ppm; and milk, fat at 0.02 ppm.
That notice referenced a summary of the
petition prepared by E. I. du Pont de
Nemours and Company, 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 review of the data
supporting the petition, EPA is not
establishing the proposed tolerances for
hog, fat; hog, meat; hog, meat
byproducts; and milk, fat. The proposed
tolerance levels for cattle, fat; cattle,
meat; goat, fat; goat, meat; horse, fat;
horse, meat; milk; sheep, fat; and sheep,
meat are being established at 0.01 ppm,
not 0.05 ppm. The reasons for these
changes are explained in Unit IV.C.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue.’’
Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
section 408(b)(2)(D) of FFDCA, EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for the petitioned-for
tolerances for residues of nicosulfuron
and its metabolites and degradates in or
on cattle, fat at 0.01 ppm; cattle, meat
at 0.01 ppm; cattle, meat byproducts at
0.05 ppm; goat, fat at 0.01 ppm; goat,
meat at 0.01 ppm; goat, meat byproducts
at 0.05 ppm; grass, forage at 9.0 ppm;
grass, hay at 25.0 ppm; horse, fat at 0.01
ppm; horse, meat at 0.01 ppm; horse,
meat byproducts at 0.05 ppm; milk at
0.01 ppm; sheep, fat at 0.01 ppm; sheep,
meat at 0.01 ppm; and sheep, meat
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byproducts at 0.05 ppm. EPA’s
assessment of exposures and risks
associated with establishing tolerances
follows.
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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. Specific
information on the studies received and
the nature of the adverse effects caused
by nicosulfuron as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at https://
www.regulations.gov in document
‘‘Nicosulfuron Human Health Risk
Assessment for the Proposed Use on
Grasses,’’ p. 30 in docket ID number
EPA–HQ–OPP–2009–0057.
Nicosulfuron has low acute toxicity
by oral, dermal, and inhalation routes of
exposure. It is a moderate eye irritant
and is not a dermal sensitizer. No
adverse effects were observed following
subchronic or chronic dietary
administrations of doses exceeding the
limit dose in rats and mice. Chronic
dietary administration to dogs produced
mild effects (decreased body weight
gains in males, increased relative liver
and kidney weights) at the limit dose.
No findings were reported in dogs
following subchronic dosing at
comparable dietary levels.
There was no evidence of potential
immunotoxicity or neurotoxicity in the
submitted studies.
Nicosulfuron was classified by EPA as
a ‘‘not likely’’ human carcinogen based
on the lack of evidence of
carcinogenicity in studies conducted in
rats and mice and in the in vitro and in
vivo genotoxicity studies.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological point of departure
(POD) is identified as the basis for
derivation of reference values for risk
assessment. The POD may be defined as
the highest dose at which no adverse
effects are observed (the NOAEL) in the
toxicology study identified as
appropriate for use in risk assessment.
However, if a NOAEL cannot be
determined, the lowest dose at which
adverse effects of concern are identified
(the LOAEL) or a benchmark dose
(BMD) approach is sometimes used for
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risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction
with the POD to take into account
uncertainties inherent in the
extrapolation from laboratory animal
data to humans and in the variations in
sensitivity among members of the
human population as well as other
unknowns. Safety is assessed for acute
and chronic dietary risks by comparing
aggregate food and water exposure to
the pesticide to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The
aPAD and cPAD are calculated by
dividing the POD by all applicable UFs.
Aggregate short-, intermediate-, and
chronic-term risks are evaluated by
comparing food, water, and residential
exposure to the POD to ensure that the
margin of exposure (MOE) called for by
the product of all applicable UFs is not
exceeded. This latter value is referred to
as the level of concern (LOC).
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk. Thus,
the Agency estimates risk in terms of the
probability of an occurrence of the
adverse effect greater than that expected
in a lifetime. For more information on
the general principles EPA uses in risk
characterization and a complete
description of the risk assessment
process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for nicosulfuron used for
human risk assessment can be found at
https://www.regulations.gov in document
‘‘Nicosulfuron Human Health Risk
Assessment for the Proposed Use on
Grasses,’’ p. 15 in docket ID number
EPA–HQ–OPP–2009–0057.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to nicosulfuron, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing nicosulfuron tolerances in 40
CFR 180.454. EPA assessed dietary
exposures from nicosulfuron in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1–day or single
exposure.
No such effects were identified in the
toxicological studies for nicosulfuron;
therefore, a quantitative acute dietary
exposure assessment is unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
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17575
from the USDA 1994–1996 and 1998
CSFII. As to residue levels in food, EPA
assumed tolerance-level residues and
100 percent crop treated (PCT) for all
existing (corn) and new uses (meat and
milk commodities) of nicosulfuron.
iii. Cancer. Based on the lack of
evidence of carcinogenicity observed in
the 2–year rat and 18–month mouse
carcinogenicity studies and a lack of
evidence of mutagenicity in the in vitro
and in vivo genotoxicity studies, EPA
does not expect nicosulfuron to pose a
cancer risk to humans. Therefore, an
exposure assessment for evaluating
cancer risk is not needed for this
chemical.
iv. Anticipated residue and PCT
information. EPA did not use
anticipated residue and/or PCT
information in the dietary assessment
for nicosulfuron. Tolerance level
residues and/or 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for nicosulfuron in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
nicosulfuron. 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 drinking
water concentrations (EDWCs) of
nicosulfuron for chronic exposures for
non-cancer assessments are estimated to
be 0.685 ppb for surface water and 0.056
ppb for ground water. EDWCs of
nicosulfuron for acute exposures and
chronic exposures for cancer
assessments are not relevant to this
dietary exposure assessment as
explained in unit III.C.1.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
chronic dietary risk assessment, the
water concentration of value 0.685 ppb
was used to assess the contribution to
drinking water. The surface water value
was used in the chronic, non-cancer
dietary risk assessment since it was
higher than the ground water value and,
therefore, more protective.
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).
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Nicosulfuron is not registered for any
specific use patterns that would result
in residential exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found nicosulfuron to
share a common mechanism of toxicity
with any other substances, and
nicosulfuron does not appear to produce
a toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that nicosulfuron does not
have a common mechanism of toxicity
with other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA SF. In applying this provision,
EPA either retains the default value of
10X, or uses a different additional safety
factor when reliable data available to
EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity.
In the developmental toxicity in rats, no
developmental toxicity was seen at the
highest dose tested (6,000 mg/kg/day).
In the developmental study in rabbits,
developmental toxicity (decreased fetal
body weight, post-implantation loss)
occurred at the same dose (500 mg/kg/
day) as the dose (500 mg/kg/day)
resulting in maternal toxicity (abortions,
clinical signs, decreased body weight
gain, post-implantation loss). In the 2generation reproductive toxicity study
in rats, F2a offspring effects (decreased
litter size at birth, decreased pup
weights at postpartum day 14 through
21) also occurred at the same dose (1265
mg/kg/day) as the dose (1265 mg/kg/
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day) resulting in parental toxicity
(decreased body weight gain in F1
females during the last week of
gestation). Consequently, there is no
quantitative or qualitative evidence of
increased susceptibility following preand/or postnatal exposure to
nicosulfuron.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for
nicosulfuron is adequate to assess
potential pre- and/or postnatal toxicity.
In accordance with 40 CFR part 158
Toxicology Data Requirements, an
immunotoxicity study (870.7800), and
acute and subchronic neurotoxicity
studies (870.6200) are required for
nicosulfuron. Despite the absence of
specific immunotoxicity and
neurotoxicity studies, EPA has
evaluated the available toxicity data and
has determined that there is no evidence
that nicosulfuron either causes
neurotoxic effects or targets the immune
system, and, therefore, EPA does not
expect that these studies will result in
a lower NOAEL than the NOAEL
currently used in assessing nicosulfuron
risk.
ii. There is no indication that
nicosulfuron is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. There is no evidence that
nicosulfuron results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2–generation
reproduction study.
iv. There are no significant residual
uncertainties identified in the exposure
databases for nicosulfuron. Additional
storage stability studies are required for
residues of nicosulfuron in grass forage
and hay, and in livestock tissues.
However, as explained in this Unit, EPA
does not expect these studies to have a
measurable impact on exposure
estimates for nicosulfuron.
a. Data must be submitted on the
stability of nicosulfuron and its
metabolite in grass forage and hay
stored frozen for intervals of up to 9.6
and 12.4 months, respectively. Interim
data are available showing that residues
of nicosulfuron in grass hay and forage
are stable when stored frozen up to 3
months. Additionally, storage stability
data are available for corn, a related
crop, which indicate that nicosulfuron
residues are stable when stored frozen
up to 12 months. Based on these data,
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EPA expects nicosulfuron to be stable in
grass forage and hay stored frozen for
the required 9.6 and 12.4 month
intervals but is requiring submission of
the final study reports as confirmation.
b. Data must also be submitted on the
stability of nicosulfuron and its
metabolite in livestock tissues stored
frozen up to 9.4 months. Despite the
absence of data, EPA has assumed that
nicosulfuron is stable in frozen livestock
tissues, based on data for similar
sulfonylurea (SU) pesticides, such as
prosulfuron, where studies have shown
residues to be stable for up to 25
months. In addition, EPA notes that
dietary exposure to nicosulfuron is low
(< 1% of the cPAD for all population
subgroups), and that the contribution of
residues in livestock to overall dietary
exposure to nicosulfuron is minor,
accounting for only 2.5% of total
exposure for children 1-2 years old, the
population subgroup with the highest
estimated dietary exposure to
nicosulfuron. Therefore, any
adjustments in livestock residue
estimates that might be necessary
following submission of the required
storage stability data would have little
impact on overall dietary exposure
estimates.
The dietary food exposure
assessments were performed based on
100 PCT and tolerance-level residues.
EPA made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to nicosulfuron in drinking water. There
are no residential uses for nicosulfuron;
therefore, residential exposure is not
expected. These assessments will not
underestimate the exposure and risks
posed by nicosulfuron.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic pesticide exposures are safe by
comparing aggregate exposure estimates
to the aPAD and cPAD. The aPAD and
cPAD represent the highest safe
exposures, taking into account all
appropriate SFs. EPA calculates the
aPAD and cPAD by dividing the POD by
all applicable UFs. For linear cancer
risks, EPA calculates the probability of
additional cancer cases given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the POD to
ensure that the MOE called for by the
product of all applicable UFs is not
exceeded.
1. Acute risk. An acute aggregate risk
assessment takes into account exposure
estimates from acute dietary
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WReier-Aviles on DSKGBLS3C1PROD with RULES
consumption of food and drinking
water. No adverse effect resulting from
a single-oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, nicosulfuron is not
expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to nicosulfuron
from food and water will utilize <1% of
the cPAD for the general population and
all population subgroups, including
children 1-2 years old, the population
group receiving the greatest exposure.
There are no residential uses for
nicosulfuron.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level).
Nicosulfuron is not registered for any
use patterns that would result in
residential exposure. Therefore, the
short-term aggregate risk is the sum of
the risk from exposure to nicosulfuron
through food and water and will not be
greater than the chronic aggregate risk.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Nicosulfuron is not registered for any
use patterns that would result in
intermediate-term residential exposure.
Therefore, the intermediate-term
aggregate risk is the sum of the risk from
exposure to nicosulfuron through food
and water, which has already been
addressed, and will not be greater than
the chronic aggregate risk.
5. Aggregate cancer risk for U.S.
population. Based on a lack of evidence
for carcinogenicity in mice and rats
following long-term dietary
administration and lack of evidence for
mutagenicity in a battery of genotoxicity
studies, nicosulfuron is not expected to
pose a cancer risk.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population or to infants and children
from aggregate exposure to nicosulfuron
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(high performance liquid
chromatography with tandem mass
spectrometric (HPLC/MS/MS) detection
method) is available to enforce the
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15:15 Apr 06, 2010
Jkt 220001
tolerance expression. The method may
be requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are currently no established
Codex or Mexican maximum residue
limits (MRLs) for residues of
nicosulfuron. Canadian MRLs are
established on blueberries and corn, and
are expressed in terms of nicosulfuron.
There are no Canadian MRLs
established on the grass and livestock
commodities associated with this
petition.
C. Revisions to Petitioned-For
Tolerances
EPA is not establishing the proposed
tolerances for hog, fat; hog, meat; and
hog, meat byproducts because there are
no swine feed items associated with the
proposed use on grasses, and the dietary
burden to swine resulting from
registered use on corn is low enough
that there is no reasonable expectation
of finite residues in hog commodities.
The proposed tolerance for milk fat is
not being established because residues
did not concentrate in cream and thus
the tolerance for milk will be sufficient
to cover residues in milk fat from legal
uses of nicosulfuron. The proposed
tolerances for cattle, fat; cattle, meat;
goat, fat; goat, meat; horse, fat; horse,
meat; milk; sheep, fat; and sheep, meat
were lowered from 0.05 ppm to the level
of quantitation (LOQ) at 0.01 ppm, since
the maximum adjusted residue for meat
and fat was at 0.008 ppm.
EPA has also revised the tolerance
expression for all existing and new
nicosulfuron tolerances. The revised
tolerance expression makes clear that
the tolerances cover ‘‘residues of
nicosulfuron, including its metabolites
and degradates’’ and that compliance
with the tolerance levels will be
determined by measuring only
nicosulfuron, 3-Pyridinecarboxamide, 2[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]
carbonyl]amino]sulfonyl]-N,N-dimethyl. EPA has determined that it is
reasonable to make this change in the
tolerance expression final without prior
proposal and opportunity for comment,
because public comment is not
necessary, in that the change has no
substantive effect on the tolerance, but
rather is merely intended to clarify the
existing tolerance expression.
Finally, EPA is removing the
redundant and obsolete tolerance for
residues of nicosulfuron on ‘‘corn,
forage’’ at 0.1 ppm. ‘‘Corn, forage’’ is an
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17577
obsolete commodity term that has been
replaced by the terms ‘‘corn, field,
forage’’ and ‘‘corn, sweet, forage.’’ Since
there are existing tolerances for residues
of nicosulfuron on ‘‘corn, field, forage’’
and ‘‘corn, sweet, forage’’ at 0.1 ppm, the
tolerance on ‘‘corn, forage’’ at the same
level is unnecessary. EPA is making this
change final without prior proposal and
opportunity for comment because it
merely corrects a redundancy in the
nicosulfuron tolerances and has no
substantive effect on them.
V. Conclusion
Therefore, tolerances are established
for residues of nicosulfuron, including
its metabolites and degradates, in or on
cattle, fat at 0.01 ppm; cattle, meat at
0.01 ppm; cattle, meat byproducts at
0.05 ppm; goat, fat at 0.01 ppm; goat,
meat at 0.01 ppm; goat, meat byproducts
at 0.05 ppm; grass, forage at 9.0 ppm;
grass, hay at 25.0 ppm; horse, fat at 0.01
ppm; horse, meat at 0.01 ppm; horse,
meat byproducts at 0.05 ppm; milk at
0.01 ppm; sheep, fat at 0.01 ppm; sheep,
meat at 0.01 ppm; and sheep, meat
byproducts at 0.05 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
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Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
WReier-Aviles on DSKGBLS3C1PROD with RULES
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.
VerDate Nov<24>2008
15:15 Apr 06, 2010
Jkt 220001
Dated: March 26, 2010.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Commodity
Parts per million
Corn,
sweet,
kernel
plus cob
with
husks
removed
0.1
Corn,
sweet,
stover
0.1
2. Section 180.454 is revised to read
as follows:
Goat, fat
0.01
§ 180.454
residues.
Goat,
meat
0.01
Goat,
meat
byproducts
0.05
Grass, forage
9.0
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
■
Nicosulfuron; tolerances for
(a) General. Tolerances are
established for residues of the herbicide
nicosulfuron, including its metabolites
and degradates, in or on the
commodities in the following table
[below]. Compliance with the tolerance
levels specified in the following table
[below] is to be determined by
measuring only nicosulfuron, 3Pyridinecarboxamide, 2-[[[[(4,6dimethoxy-2-pyrimidinyl)amino]
carbonyl]amino]sulfonyl]-N,Ndimethyl-.
Commodity
Cattle, fat
0.01
Cattle,
meat
0.01
Cattle,
meat
byproducts
0.05
Corn,
field,
forage
0.1
Corn,
field,
grain
0.1
Corn,
field,
stover
0.1
Corn, pop,
grain
0.1
Corn, pop,
stover
0.1
Corn,
sweet,
forage
25.0
Horse, fat
0.01
Horse,
meat
0.01
Horse,
meat
byproducts
0.05
Milk
0.01
Sheep, fat
Parts per million
Grass,
hay
0.01
Sheep,
meat
0.01
Sheep,
meat
byproducts
0.05
0.1
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(b) Section 18 emergency exemptions.
Time-limited tolerances specified in the
following table [below] are established
for residues of the herbicide
nicosulfuron, 3-Pyridinecarboxamide, 2[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]
carbonyl]amino]sulfonyl]-N,N-dimethyl, in or on the specified agricultural
commodities, resulting from use of the
pesticide pursuant to FFIFRA section 18
emergency exemptions. The tolerances
expire and are revoked on the date
specified in the table.
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Parts per
million
Commodity
Expiration/
Revokation
Date
Bermuda
grass, forage
10
12/31/11
Bermuda
grass, hay
25
12/31/11
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. 2010–7745 Filed 4–6–10; 8:45 am]
I. General Information
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0141; FRL–8808–9]
Aminopyralid; Pesticide Tolerances
WReier-Aviles on DSKGBLS3C1PROD with RULES
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes
tolerances for residues of aminopyralid,
including its metabolites and
degradates, in or on corn, field, forage;
corn, field, grain; and corn, field, stover.
Dow AgroSciences requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April
7, 2010. Objections and requests for
hearings must be received on or before
June 7, 2010, 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–2009–0141. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
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
VerDate Nov<24>2008
15:15 Apr 06, 2010
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:
Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5218; e-mail address:
stanton.susan@epa.gov.
SUPPLEMENTARY INFORMATION:
Jkt 220001
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Electronic Access to
Other Related Information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
To access the OPPTS harmonized test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/oppts and select ‘‘Test
Methods & Guidelines’’ on the left-side
navigation menu.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
PO 00000
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17579
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–2009–0141 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 June 7, 2010.
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–2009–0141, 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
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of May 6, 2009
(74 FR 20947) (FRL–8412–7), 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 8F7455) by Dow
AgroSciences, 9330 Zionsville Rd.,
Indianapolis, IN 46268. The petition
requested that 40 CFR 180.610 be
amended by establishing tolerances for
combined residues of the herbicide
aminopyralid, 4-amino-3,6-dichloro-2pyridinecarboxylic acid, and its glucose
conjugate, expressed as total parent, in
or on corn, forage at 0.30 parts per
million (ppm); corn, grain at 0.20 ppm;
and corn, stover at 0.20 ppm. That
notice referenced a summary of the
petition prepared by Dow AgroSciences,
the registrant, which is available to the
public in the docket, https://
www.regulations.gov. Comments were
E:\FR\FM\07APR1.SGM
07APR1
Agencies
[Federal Register Volume 75, Number 66 (Wednesday, April 7, 2010)]
[Rules and Regulations]
[Pages 17573-17579]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7745]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0057; FRL-8818-4]
Nicosulfuron; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
nicosulfuron in or on cattle, fat; cattle, meat; cattle, meat
byproducts; goat, fat; goat, meat; goat, meat byproducts; grass,
forage; grass, hay; horse, fat; horse, meat; horse, meat byproducts;
milk; sheep, fat; sheep, meat; and sheep, meat byproducts. E. I. du
Pont de Nemours and Company requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation also
removes the existing tolerance for residues of nicosulfuron on corn,
forage.
DATES: This regulation is effective April 7, 2010. Objections and
requests for hearings must be received on or before June 7, 2010, 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-2009-0057. All documents in the
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-
[[Page 17574]]
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: Mindy Ondish, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 605-0723; e-mail address: ondish.mindy@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Electronic Access to Other Related Information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.gpoaccess.gov/ecfr. You may
also access the OPPTS harmonized test guidelines referenced in this
document electronically at https://www.epa.gov/oppts and select ``Test
Methods and Guideline.''
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0057 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 June 7, 2010.
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-2009-0057, 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 Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of April 8, 2009 (74 FR 15971) (FRL-8407-
4), 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
8F7501) by E. I. du Pont de Nemours and Company, P.O. Box 80038,
Wilmington, DE 19880-0038. The petition requested that 40 CFR 180.454
be amended by establishing tolerances for residues of the herbicide
nicosulfuron, 3-Pyridinecarboxamide, 2-[[[[(4,6-dimethoxy-2-
pyrimidinyl)amino] carbonyl]amino]sulfonyl]-N,N- dimethyl-, in or on
grass, forage at 9.0 parts per million (ppm); grass, hay at 25.0 ppm;
fat (of cattle, goat, hog, horse, and sheep) at 0.05 ppm; meat (of
cattle, goat, hog, horse, and sheep) at 0.05 ppm; meat byproducts (of
cattle, goat, hog, horse, and sheep) at 0.05 ppm; milk at 0.05 ppm; and
milk, fat at 0.02 ppm. That notice referenced a summary of the petition
prepared by E. I. du Pont de Nemours and Company, 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 review of the data supporting the petition, EPA is not
establishing the proposed tolerances for hog, fat; hog, meat; hog, meat
byproducts; and milk, fat. The proposed tolerance levels for cattle,
fat; cattle, meat; goat, fat; goat, meat; horse, fat; horse, meat;
milk; sheep, fat; and sheep, meat are being established at 0.01 ppm,
not 0.05 ppm. The reasons for these changes are explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue.''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for residues of nicosulfuron and its metabolites and
degradates in or on cattle, fat at 0.01 ppm; cattle, meat at 0.01 ppm;
cattle, meat byproducts at 0.05 ppm; goat, fat at 0.01 ppm; goat, meat
at 0.01 ppm; goat, meat byproducts at 0.05 ppm; grass, forage at 9.0
ppm; grass, hay at 25.0 ppm; horse, fat at 0.01 ppm; horse, meat at
0.01 ppm; horse, meat byproducts at 0.05 ppm; milk at 0.01 ppm; sheep,
fat at 0.01 ppm; sheep, meat at 0.01 ppm; and sheep, meat
[[Page 17575]]
byproducts at 0.05 ppm. EPA's assessment of exposures and risks
associated with establishing tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by nicosulfuron 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 at https://www.regulations.gov in document ``Nicosulfuron Human Health Risk
Assessment for the Proposed Use on Grasses,'' p. 30 in docket ID number
EPA-HQ-OPP-2009-0057.
Nicosulfuron has low acute toxicity by oral, dermal, and inhalation
routes of exposure. It is a moderate eye irritant and is not a dermal
sensitizer. No adverse effects were observed following subchronic or
chronic dietary administrations of doses exceeding the limit dose in
rats and mice. Chronic dietary administration to dogs produced mild
effects (decreased body weight gains in males, increased relative liver
and kidney weights) at the limit dose. No findings were reported in
dogs following subchronic dosing at comparable dietary levels.
There was no evidence of potential immunotoxicity or neurotoxicity
in the submitted studies.
Nicosulfuron was classified by EPA as a ``not likely'' human
carcinogen based on the lack of evidence of carcinogenicity in studies
conducted in rats and mice and in the in vitro and in vivo genotoxicity
studies.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a benchmark dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the level of concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for nicosulfuron used for
human risk assessment can be found at https://www.regulations.gov in
document ``Nicosulfuron Human Health Risk Assessment for the Proposed
Use on Grasses,'' p. 15 in docket ID number EPA-HQ-OPP-2009-0057.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to nicosulfuron, EPA considered exposure under the petitioned-
for tolerances as well as all existing nicosulfuron tolerances in 40
CFR 180.454. EPA assessed dietary exposures from nicosulfuron in food
as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
No such effects were identified in the toxicological studies for
nicosulfuron; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance-
level residues and 100 percent crop treated (PCT) for all existing
(corn) and new uses (meat and milk commodities) of nicosulfuron.
iii. Cancer. Based on the lack of evidence of carcinogenicity
observed in the 2-year rat and 18-month mouse carcinogenicity studies
and a lack of evidence of mutagenicity in the in vitro and in vivo
genotoxicity studies, EPA does not expect nicosulfuron to pose a cancer
risk to humans. Therefore, an exposure assessment for evaluating cancer
risk is not needed for this chemical.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for nicosulfuron. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for nicosulfuron in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of nicosulfuron. 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 drinking water concentrations (EDWCs) of nicosulfuron for
chronic exposures for non-cancer assessments are estimated to be 0.685
ppb for surface water and 0.056 ppb for ground water. EDWCs of
nicosulfuron for acute exposures and chronic exposures for cancer
assessments are not relevant to this dietary exposure assessment as
explained in unit III.C.1.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 0.685 ppb was used to
assess the contribution to drinking water. The surface water value was
used in the chronic, non-cancer dietary risk assessment since it was
higher than the ground water value and, therefore, more protective.
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).
[[Page 17576]]
Nicosulfuron is not registered for any specific use patterns that
would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found nicosulfuron to share a common mechanism of
toxicity with any other substances, and nicosulfuron does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
nicosulfuron does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. In the developmental
toxicity in rats, no developmental toxicity was seen at the highest
dose tested (6,000 mg/kg/day). In the developmental study in rabbits,
developmental toxicity (decreased fetal body weight, post-implantation
loss) occurred at the same dose (500 mg/kg/day) as the dose (500 mg/kg/
day) resulting in maternal toxicity (abortions, clinical signs,
decreased body weight gain, post-implantation loss). In the 2-
generation reproductive toxicity study in rats, F2a offspring effects
(decreased litter size at birth, decreased pup weights at postpartum
day 14 through 21) also occurred at the same dose (1265 mg/kg/day) as
the dose (1265 mg/kg/day) resulting in parental toxicity (decreased
body weight gain in F1 females during the last week of gestation).
Consequently, there is no quantitative or qualitative evidence of
increased susceptibility following pre- and/or postnatal exposure to
nicosulfuron.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for nicosulfuron is adequate to assess
potential pre- and/or postnatal toxicity. In accordance with 40 CFR
part 158 Toxicology Data Requirements, an immunotoxicity study
(870.7800), and acute and subchronic neurotoxicity studies (870.6200)
are required for nicosulfuron. Despite the absence of specific
immunotoxicity and neurotoxicity studies, EPA has evaluated the
available toxicity data and has determined that there is no evidence
that nicosulfuron either causes neurotoxic effects or targets the
immune system, and, therefore, EPA does not expect that these studies
will result in a lower NOAEL than the NOAEL currently used in assessing
nicosulfuron risk.
ii. There is no indication that nicosulfuron is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that nicosulfuron results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no significant residual uncertainties identified in
the exposure databases for nicosulfuron. Additional storage stability
studies are required for residues of nicosulfuron in grass forage and
hay, and in livestock tissues. However, as explained in this Unit, EPA
does not expect these studies to have a measurable impact on exposure
estimates for nicosulfuron.
a. Data must be submitted on the stability of nicosulfuron and its
metabolite in grass forage and hay stored frozen for intervals of up to
9.6 and 12.4 months, respectively. Interim data are available showing
that residues of nicosulfuron in grass hay and forage are stable when
stored frozen up to 3 months. Additionally, storage stability data are
available for corn, a related crop, which indicate that nicosulfuron
residues are stable when stored frozen up to 12 months. Based on these
data, EPA expects nicosulfuron to be stable in grass forage and hay
stored frozen for the required 9.6 and 12.4 month intervals but is
requiring submission of the final study reports as confirmation.
b. Data must also be submitted on the stability of nicosulfuron and
its metabolite in livestock tissues stored frozen up to 9.4 months.
Despite the absence of data, EPA has assumed that nicosulfuron is
stable in frozen livestock tissues, based on data for similar
sulfonylurea (SU) pesticides, such as prosulfuron, where studies have
shown residues to be stable for up to 25 months. In addition, EPA notes
that dietary exposure to nicosulfuron is low (< 1% of the cPAD for all
population subgroups), and that the contribution of residues in
livestock to overall dietary exposure to nicosulfuron is minor,
accounting for only 2.5% of total exposure for children 1-2 years old,
the population subgroup with the highest estimated dietary exposure to
nicosulfuron. Therefore, any adjustments in livestock residue estimates
that might be necessary following submission of the required storage
stability data would have little impact on overall dietary exposure
estimates.
The dietary food exposure assessments were performed based on 100
PCT and tolerance-level residues. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to nicosulfuron in drinking water. There are no residential
uses for nicosulfuron; therefore, residential exposure is not expected.
These assessments will not underestimate the exposure and risks posed
by nicosulfuron.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary
[[Page 17577]]
consumption of food and drinking water. No adverse effect resulting
from a single-oral exposure was identified and no acute dietary
endpoint was selected. Therefore, nicosulfuron is not expected to pose
an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
nicosulfuron from food and water will utilize <1% of the cPAD for the
general population and all population subgroups, including children 1-2
years old, the population group receiving the greatest exposure. There
are no residential uses for nicosulfuron.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Nicosulfuron is not registered for any use patterns that would
result in residential exposure. Therefore, the short-term aggregate
risk is the sum of the risk from exposure to nicosulfuron through food
and water and will not be greater than the chronic aggregate risk.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Nicosulfuron is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to nicosulfuron through food and water, which has already been
addressed, and will not be greater than the chronic aggregate risk.
5. Aggregate cancer risk for U.S. population. Based on a lack of
evidence for carcinogenicity in mice and rats following long-term
dietary administration and lack of evidence for mutagenicity in a
battery of genotoxicity studies, nicosulfuron is not expected to pose a
cancer risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to nicosulfuron residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high performance liquid
chromatography with tandem mass spectrometric (HPLC/MS/MS) detection
method) is available to enforce the tolerance expression. The method
may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are currently no established Codex or Mexican maximum residue
limits (MRLs) for residues of nicosulfuron. Canadian MRLs are
established on blueberries and corn, and are expressed in terms of
nicosulfuron. There are no Canadian MRLs established on the grass and
livestock commodities associated with this petition.
C. Revisions to Petitioned-For Tolerances
EPA is not establishing the proposed tolerances for hog, fat; hog,
meat; and hog, meat byproducts because there are no swine feed items
associated with the proposed use on grasses, and the dietary burden to
swine resulting from registered use on corn is low enough that there is
no reasonable expectation of finite residues in hog commodities. The
proposed tolerance for milk fat is not being established because
residues did not concentrate in cream and thus the tolerance for milk
will be sufficient to cover residues in milk fat from legal uses of
nicosulfuron. The proposed tolerances for cattle, fat; cattle, meat;
goat, fat; goat, meat; horse, fat; horse, meat; milk; sheep, fat; and
sheep, meat were lowered from 0.05 ppm to the level of quantitation
(LOQ) at 0.01 ppm, since the maximum adjusted residue for meat and fat
was at 0.008 ppm.
EPA has also revised the tolerance expression for all existing and
new nicosulfuron tolerances. The revised tolerance expression makes
clear that the tolerances cover ``residues of nicosulfuron, including
its metabolites and degradates'' and that compliance with the tolerance
levels will be determined by measuring only nicosulfuron, 3-
Pyridinecarboxamide, 2-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]
carbonyl]amino]sulfonyl]-N,N-dimethyl-. EPA has determined that it is
reasonable to make this change in the tolerance expression final
without prior proposal and opportunity for comment, because public
comment is not necessary, in that the change has no substantive effect
on the tolerance, but rather is merely intended to clarify the existing
tolerance expression.
Finally, EPA is removing the redundant and obsolete tolerance for
residues of nicosulfuron on ``corn, forage'' at 0.1 ppm. ``Corn,
forage'' is an obsolete commodity term that has been replaced by the
terms ``corn, field, forage'' and ``corn, sweet, forage.'' Since there
are existing tolerances for residues of nicosulfuron on ``corn, field,
forage'' and ``corn, sweet, forage'' at 0.1 ppm, the tolerance on
``corn, forage'' at the same level is unnecessary. EPA is making this
change final without prior proposal and opportunity for comment because
it merely corrects a redundancy in the nicosulfuron tolerances and has
no substantive effect on them.
V. Conclusion
Therefore, tolerances are established for residues of nicosulfuron,
including its metabolites and degradates, in or on cattle, fat at 0.01
ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts at 0.05 ppm;
goat, fat at 0.01 ppm; goat, meat at 0.01 ppm; goat, meat byproducts at
0.05 ppm; grass, forage at 9.0 ppm; grass, hay at 25.0 ppm; horse, fat
at 0.01 ppm; horse, meat at 0.01 ppm; horse, meat byproducts at 0.05
ppm; milk at 0.01 ppm; sheep, fat at 0.01 ppm; sheep, meat at 0.01 ppm;
and sheep, meat byproducts at 0.05 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory
[[Page 17578]]
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 26, 2010.
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. Section 180.454 is revised to read as follows:
Sec. 180.454 Nicosulfuron; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide nicosulfuron, including its metabolites and degradates, in or
on the commodities in the following table [below]. Compliance with the
tolerance levels specified in the following table [below] is to be
determined by measuring only nicosulfuron, 3-Pyridinecarboxamide, 2-
[[[[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyl]amino]sulfonyl]-N,N-
dimethyl-.
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cattle, fat 0.01
------------------------------------------------------------------------
Cattle, meat 0.01
------------------------------------------------------------------------
Cattle, meat byproducts 0.05
------------------------------------------------------------------------
Corn, field, forage 0.1
------------------------------------------------------------------------
Corn, field, grain 0.1
------------------------------------------------------------------------
Corn, field, stover 0.1
------------------------------------------------------------------------
Corn, pop, grain 0.1
------------------------------------------------------------------------
Corn, pop, stover 0.1
------------------------------------------------------------------------
Corn, sweet, forage 0.1
------------------------------------------------------------------------
Corn, sweet, kernel plus cob with husks 0.1
removed
------------------------------------------------------------------------
Corn, sweet, stover 0.1
------------------------------------------------------------------------
Goat, fat 0.01
------------------------------------------------------------------------
Goat, meat 0.01
------------------------------------------------------------------------
Goat, meat byproducts 0.05
------------------------------------------------------------------------
Grass, forage 9.0
------------------------------------------------------------------------
Grass, hay 25.0
------------------------------------------------------------------------
Horse, fat 0.01
------------------------------------------------------------------------
Horse, meat 0.01
------------------------------------------------------------------------
Horse, meat byproducts 0.05
------------------------------------------------------------------------
Milk 0.01
------------------------------------------------------------------------
Sheep, fat 0.01
------------------------------------------------------------------------
Sheep, meat 0.01
------------------------------------------------------------------------
Sheep, meat byproducts 0.05
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table [below] are established for residues
of the herbicide nicosulfuron, 3-Pyridinecarboxamide, 2-[[[[(4,6-
dimethoxy-2-pyrimidinyl)amino] carbonyl]amino]sulfonyl]-N,N-dimethyl-,
in or on the specified agricultural commodities, resulting from use of
the pesticide pursuant to FFIFRA section 18 emergency exemptions. The
tolerances expire and are revoked on the date specified in the table.
[[Page 17579]]
------------------------------------------------------------------------
Expiration/
Commodity Parts per Revokation
million Date
------------------------------------------------------------------------
Bermuda grass, forage 10 12/31/11
------------------------------------------------------------------------
Bermuda grass, hay 25 12/31/11
------------------------------------------------------------------------
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2010-7745 Filed 4-6-10; 8:45 am]
BILLING CODE 6560-50-S