Thifensulfuron methyl; Pesticide Tolerances, 19272-19277 [2010-8135]
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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 in accordance with
sections 408(e) and 408(l)(6) 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).
VIII. 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
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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: April 1, 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 180.614 is amended by
revising paragraph (b) to read as follows:
■
§ 180.614 Kasugamycin; tolerances for
residues.
*
*
*
*
*
(b) Section 18 emergency exemptions.
Time-limited tolerances specified in the
following table are established for
residues of kasugamycin, 3-O-[2-amino4-[(carboxyiminomethyl)amino]-2,3,4,6tetradeoxy-a-D-arabino-hexopyranosyl]D-chiro-inositol 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.
Commodity
Apple
*
Parts per million
0.05
*
*
*
Expiration/
revocation
date
12/31/12
*
[FR Doc. 2010–8133 Filed 4–13–10; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0134; FRL–8818-9]
Thifensulfuron methyl; Pesticide
Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes a
tolerance for residues of thifensulfuron
methyl in or on safflower, seed.
Interregional Research Project Number 4
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(IR-4) requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective April
14, 2010. Objections and requests for
hearings must be received on or before
June 14, 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–2009–0134. 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
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:
Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–6463; e-mail address:
madden.barbara@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
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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.
To access the OPPTS harmonized test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/oppts and select ‘‘Test
Methods and Guidelines.’’
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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–2009–0134 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before June 14, 2010. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
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–2009-0134, 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.
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• 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 9F7523) by IR-4,
500 College Rd. East, Suite 201 W,
Princeton, NJ 08540. The petition
requested that 40 CFR 180.439 be
amended by establishing a tolerance for
residues of the herbicide thifensulfuron
methyl, (methyl-3-[[[[(4-methoxy-6methyl-1,3,5-triazin-2-yl) amino]
carbonyl] amino] sulfonyl]-2thiophenecarboxylate), in or on
safflower, seed at 0.05 parts per million
(ppm). That notice referenced a
summary of the petition prepared on
behalf of IR-4 by E.I. DuPont de
Nemours, 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.
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
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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
tolerance for residues of thifensulfuron
methyl on safflower seed at 0.05ppm.
EPA’s assessment of exposures and risks
associated with thifensulfuron methyl
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.
Thifensulfuron methyl has mild to
low acute toxicity when administered
via the oral, inhalation and dermal
routes of exposure. It has moderate to
low toxicity with respect to eye and skin
irritation and is not a dermal sensitizer.
Most findings in the submitted studies
related to decreases in body weights,
body weight gains, or organ weights (a
reflection of the lower body weights
compared with control weights). There
were increased liver weights in male
dogs and increased thyroid/parathyroid
weights in female dogs. There were no
gross or histopathological changes
reported in any of the studies.
In the rat developmental study, there
were no maternal effects at the highest
dose tested (HDT). The rabbit
developmental study showed a decrease
in maternal body weights at the HDT.
There were no developmental effects at
the HDT. In the 2-generation rat
reproduction study there were no
parental, reproductive or offspring
effects. There was an increase in
quantitative susceptibility in the rat
developmental study, based on
decreased mean fetal body weights, and
an increase in the incidence of small
renal papillae (only at the highest dose
level).
Thifensulfuron methyl is classified as
‘‘not likely to be carcinogenic to
humans,’’ based on acceptable chronic/
carcinogenicity studies in rats and mice
at doses that are considered to be
adequate, and not excessive for the
determination of carcinogenic potential.
The available mutagenicity studies in
vivo and in vitro show that
thifensulfuron methyl is neither
mutagenic nor clastogenic.
Neurotoxicity was not observed in the
submitted guideline studies. There were
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no acute or subchronic neurotoxicity
studies available for review. There were
also no immunotoxicity studies
submitted for review. Immunotoxicity
was observed as a decrease in spleen
weight in the subchronic rat study.
However, this effect was only noted in
males, and only at the mid-level dose of
177 mg/kg. The lack of response at the
high-level dose, the occurrence in a
single sex, the availability of a clear
NOAEL, and the absence of
immunotoxic effects in the remainder of
the database reduce EPA’s concern for
immunotoxicity.
Specific information on the studies
received and the nature of the adverse
effects caused by thifensulfuron methyl
as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL)
from the toxicity studies can be found
at https://www.regulations.gov in
document ‘‘Thifensulfuron Methyl.
Human Health Risk Assessment for the
Proposed Food/Feed Use of the
Herbicide (Associated with Regional
Section 3 Registration) on Safflower,’’
pp. 9-10 in docket ID number EPA–HQ–
OPP–2009–0134.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level – generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD) – and a safe margin
of exposure (MOE). 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
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 thifensulfuron methyl
used for human risk assessment is
shown in the table of this unit.
TABLE —SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THIFENSULFURON METHYL FOR USE IN HUMAN RISK
ASSESSMENT
Point of Departure and Uncertainty/
Safety Factors
RfD, PAD, LOC for Risk Assessment
Study and Toxicological Effects
Acute dietary
(Females 13 - 50 years of
age)
NOAEL = 159 milligrams/kilograms/
day (mg/kg/day)
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 1.59 mg/kg/day
aPAD = 1.59 mg/kg/day
Developmental Oral Toxicity-Rat.
LOAEL = 725 mg/kg/day based on decreased mean body weight and increased incidence of small renal
papillae
Acute dietary
(General population including
infants and children)
Not applicable.
Chronic dietary
(All populations)
NOAEL= 4.3 mg/kg/day
UFA =10x
UFH = 10x
FQPA SF 1x
Exposure/Scenario
Cancer (Oral)
There were no single dose effects appropriate for acute exposure assessment for the general population.
Chronic RfD = 0.043 mg/kg/
day
cPAD = 0.043mg/kg/day
Carcinogenicity oral toxicity in mice.
LOAEL = 128 mg/kg/day based on decreased body weight and body
weight gain.
Not likely to be a human carcinogen, based on the lack of evidence of carcinogenicity in rats and mice.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population
(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose
(a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to thifensulfuron methyl, EPA
considered exposure under the
petitioned-for tolerance as well as all
existing thifensulfuron methyl
tolerances in 40 CFR 180.439. EPA
assessed dietary exposures from
thifensulfuron methyl 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
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occurring as a result of a 1–day or single
exposure. No such effect was identified
for thifensulfuron methyl for the general
population. However, EPA identified
potential acute effects (decreased mean
body weight, and increased incidence of
small renal papillae) from pre-natal
exposure and thus is assessing exposure
and risk for the population subgroup,
females 13 – 49 years old.
In estimating acute dietary exposure,
EPA used food consumption
information from the United States
Department of Agriculture (USDA)
1994–1996 and 1998 Nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels
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in food, EPA used tolerance-level
residues, DEEM default processing
factors for all processed commodities
and assumed 100 percent crop treated
(PCT) for all commodities covered by
existing or proposed tolerances.
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
used tolerance-level residues, DEEM
default processing factors for all
processed commodities and assumed
100 PCT for all commodities covered by
existing or proposed tolerances.
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iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
classified thifensulfuron methyl as ‘‘not
likely to be carcinogenic to humans’’.
Therefore, a quantitative exposure
assessment to evaluate cancer risk is
unnecessary.
iv. Anticipated residue and PCT
information. EPA did not use
anticipated residue or PCT information
in the dietary assessment for
thifensulfuron methyl. Tolerance level
residues and 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 thifensulfuron methyl in drinking
water. These simulation models take
into account data on the physical,
chemical, and fate/transport
characteristics of thifensulfuron methyl.
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
thifensulfuron methyl for acute
exposures are estimated to be 4.429
parts per billion (ppb) for surface water
and 0.0972 ppb for ground water and for
chronic exposures for non-cancer
assessments are estimated to be 1.5 ppb
for surface water and .0972 ppb for
ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 4.429 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 1.5 ppb was used to assess the
contribution to drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Thifensulfuron methyl 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
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pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found thifensulfuron
methyl to share a common mechanism
of toxicity with any other substances,
and thifensulfuron methyl does not
appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that
thifensulfuron methyl 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 Safety Factor (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.
The prenatal and postnatal toxicology
database for thifensulfuron methyl
includes rat and rabbit prenatal
developmental toxicity studies and a 2–
generation reproduction toxicity study
in rats. There was evidence of increased
quantitative susceptibility in the rat
developmental toxicity study. At the
HDT, decreased mean fetal weights, and
an increase in incidence of small renal
papillae were observed in the absence of
maternal toxicity. There was no
indication of pre- or post-natal
susceptibility in the rabbit
developmental or rat reproduction
studies.
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
thifensulfuron methyl is complete
except for immunotoxicity, acute
neurotoxicity and subchronic
neurotoxicity testing. Recent changes to
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40 CFR part 158 make acute and
subchronic neurotoxicity testing
(OPPTS Guideline 870.6200) and
immunotoxicity testing (OPPTS
Guideline 870.7800) required for
pesticide registration; however, the
existing data are sufficient for endpoint
selection for exposure/risk assessment
scenarios, and for evaluation of the
requirements under the FQPA.
Neurotoxicity was not observed in
any of the studies up to the HDT, nor
is there any expectation of neurotoxicity
based on the mechanism of action.
Furthermore, the toxicity database for
thifensulfuron methyl does not indicate
that the immune system is the primary
target organ. Immunotoxicity was
observed as a decrease in spleen weight
in the subchronic rat study. However,
this effect was only noted in males, and
only at the mid-level dose of 177 mg/kg.
The lack of response in the high-level
dose, the occurrence in a single sex, the
availability of a clear NOAEL, and the
absence of immunotoxic effects in the
remainder of the database reduces EPA’s
concern for immunotoxicity. The overall
weight of evidence suggests that
thifensulfuron methyl does not directly
target the immune system, and this
finding (decrease in spleen weight) may
be due to secondary effects of a primary
toxicity. Therefore, the Agency does not
believe that conducting the acute and
subchronic neurotoxicity, and the
immunotoxicity studies will result in a
lower point of departure than the
currently selected endpoints for overall
risk assessment, and therefore, a
database uncertainty factor is not
needed to account for the lack of these
studies.
ii. There is no indication that
thifensulfuron methyl is a neurotoxic
chemical and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. There is evidence that
thifensulfuron methyl results in
increased susceptibility in in utero rats
in the prenatal developmental studies
and in young rats in the 2–generation
reproduction study; therefore, a degree
of concern analysis was performed to
determine the level of concern for the
effects observed when considered in the
context of all available toxicity data and
to identify any residual concerns after
establishing toxicity endpoints and
traditional UF’s to be used in the
thifensulfuron methyl risk assessment.
In considering the overall toxicity
profile and the endpoints and doses
selected for the thifensulfuron methyl
risk assessment, EPA characterized the
degree of concern for the susceptibility
observed in the rat developmental and
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2-generation reproductive studies as low
and determined that there are no
residual uncertainties for prenatal and/
or postnatal toxicity because:
a. The only missing toxicity data for
thifensulfuron methyl are the newly
required neurotoxicity and
immunotoxicity studies; however, no
additional UF is needed in the absence
of these studies because there is no
evidence to indicate that thifensulfuron
methyl targets the nervous system or the
immune system. Further, EPA has
concluded a developmental
neurotoxicity study is not required.
b. There are clear NOAELs and
LOAELs for the developmental and
offspring effects noted in the rat
developmental toxicity and in the 2–
generation reproduction toxicity studies
and the doses and endpoints have been
selected from these studies for risk
assessment for the relevant exposed
populations, ie., pregnant females and
children.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on conservative
assumptions, including 100 PCT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to
thifensulfuron methyl in drinking water.
These assessments will not
underestimate the exposure and risks
posed by thifensulfuron methyl.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer 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 appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
thifensulfuron methyl will occupy less
than 1% of the aPAD for females (ages
13 – 49), the population subgroup
receiving the greatest exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to thifensulfuron
methyl from food and water will utilize
1% of the cPAD for children (ages 3 –
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5), the population subgroup receiving
the greatest exposure. There are no
residential uses for thifensulfuron
methyl.
3. Short and intermediate-term risk.
Short and intermediate-term aggregate
exposure takes into account residential
exposure plus chronic exposure to food
and water (considered to be a
background exposure level).
A short and intermediate-term
adverse effect was identified; however,
thifensulfuron methyl is not registered
for any use patterns that would result in
short or intermediate-term residential
exposure. Short and intermediate-term
risk is assessed based on short and
intermediate-term residential exposure
plus chronic dietary exposure. Because
there is no short or intermediate-term
residential exposure and chronic dietary
exposure has already been assessed
under the appropriately protective
cPAD (which is at least as protective as
the point of departure used to assess
short and intermediate-term risk), no
further assessment of short or
intermediate-term risk is necessary, and
EPA relies on the chronic dietary risk
assessment for evaluating short and
intermediate-term risk for
thifensulfuron methyl.
4. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
thifensulfuron methyl is not expected to
pose a cancer risk to humans.
5. 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
thifensulfuron methyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The following adequate enforcement
methodology is available to enforce the
tolerance expression: Two High
Pressure Liquid Chromatography
(HPLC) photo-conductivity detection
methods. The methods 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 no CODEX, Canadian or
Mexican maximum residue limits
(MRLs) established for residues of
thifensulfuron methyl on safflower.
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C. Revisions to Petitioned-For
Tolerances
EPA revised the tolerance expression
in paragraph (a) to clarify:
1. That, as provided in FFDCA section
408(a)(3), the tolerance covers
metabolites and degradates of
thifensulfuron methyl not specifically
mentioned; and
2. That compliance with the specified
tolerance levels is to be determined by
measuring only the specific compounds
mentioned in the tolerance expression.
V. Conclusion
Therefore, a tolerance is established
for residues of thifensulfuron methyl
(methyl-3-[[[[(4-methoxy-6-methyl-1,3,5triazin-2-yl) amino] carbonyl] amino]
sulfonyl]-2-thiophenecarboxylate), in or
on safflower, seed 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
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
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Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations
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).
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.439, revise paragraph (a)
introductory text and paragraph (c) to
read as follows:
■
§ 180.439 Thifensulfuron methyl;
tolerances for residues.
(a) General. Tolerances are
established for residues of
thifensulfuron methyl, including its
metabolites and degradates, in or on the
commodities listed in the following
table [below]. Compliance with the
tolerance levels specified in the
following table [below] is to be
determined by measuring only
thifensulfuron methyl (methyl 3-[[[[(4methoxy-6-methyl-1,3,5-triazin-2yl)amino]carbonyl]amino] sulfonyl]-2thiophenecarboxylate).
*
*
*
*
*
(c) Tolerances with regional
registrations. Tolerances are established
for residues of thifensulfuron methyl,
including its metabolites and
degradates, in or on the commodities
listed in the following table [below].
Compliance with the tolerance levels
specified in the following table [below]
is to be determined by measuring only
thifensulfuron methyl (methyl 3-[[[[(4methoxy-6-methyl-1,3,5-triazin-2yl)amino]carbonyl]amino] sulfonyl]-2thiophenecarboxylate).
Commodity
Parts per million
Safflower, seed ...............
*
*
*
*
0.05
*
[FR Doc. 2010–8135 Filed 4–13–10; 8:45 am]
BILLING CODE 6560–50–S
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Parts 2, 90, and 95
[WP Docket No. 07–100, FCC 10–36]
List of Subjects in 40 CFR Part 180
PLMR Licensing; Frequency
Coordination and Eligibility Issues
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
AGENCY: Federal Communications
Commission.
ACTION: Final rule.
jlentini on DSKJ8SOYB1PROD with RULES
Dated: April 1, 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:
■
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16:13 Apr 13, 2010
Jkt 220001
SUMMARY: In this document, the Federal
Communications Commission
(Commission) considers rule changes to
certain of its rules that were addressed
in a previous decision in this
proceeding. In that decision, the
Commission proposed various changes
to its rules regarding PLMR licensing,
including frequency coordination and
eligibility issues. This proceeding is part
of our continuing effort to provide clear
and concise rules that facilitate new
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19277
wireless technologies, devices and
services, and are easy for the public to
understand.
DATES: Effective May 14, 2010.
FOR FURTHER INFORMATION CONTACT:
Rodney P. Conway, at
Rodney.Conway@FCC.gov, Wireless
Telecommunications Bureau, (202) 418–
2904, or TTY (202) 418–7233.
This is a
summary of the Commission’s Second
Report and Order (‘‘Second R&O’’) in
WP Docket No. 07–100, FCC 10–36,
adopted on March 3, 2010, and released
March 10, 2010. In a Notice of Proposed
Rulemaking and Order (NPRM and
Order) published at 72 FR 32582, June
13, 2007, in this proceeding, the
Commission proposed various changes
to its rules regarding PLMR licensing,
including frequency coordination and
eligibility issues. The full text of this
document is available for inspection
and copying during normal business
hours in the FCC Reference Center, 445
12th Street, SW., Washington, DC
20554. The complete text may be
purchased from the Commission’s copy
contractor, Best Copy and Printing, Inc.,
445 12th Street, SW., Room CY–B402,
Washington, DC 20554. The full text
may also be downloaded at: https://
www.fcc.gov. Alternative formats are
available to persons with disabilities by
sending an e-mail to fcc504@fcc.gov or
by calling the Consumer &
Governmental Affairs Bureau at 202–
418–0530 (voice), 202–418–0432 (tty).
1. Part 90 contains the rules for both
the Private Land Mobile Radio (PLMR)
Services and certain Commercial Mobile
Radio Services (CMRS). PLMR licensees
generally do not provide for-profit
communications services. Some
examples of PLMR licensees are public
safety agencies, businesses that use
radio only for their internal operations,
utilities, transportation entities, and
medical service providers. CMRS
licensees, by comparison, do provide
for-profit communications services,
such as paging and Specialized Mobile
Radio services that offer customers
communications that are interconnected
to the public switched network.
2. Frequency Coordination and
Related Matters. Applications for new
and modified part 90 stations generally
require frequency coordination before
the application is submitted to the
Commission, but certain types of
applications are exempt from the
frequency coordination requirement
because they do not ‘‘have an impact on
near-term frequency selections.’’ The
NPRM sought comment on whether to
permit licensees to forgo frequency
SUPPLEMENTARY INFORMATION:
E:\FR\FM\14APR1.SGM
14APR1
Agencies
[Federal Register Volume 75, Number 71 (Wednesday, April 14, 2010)]
[Rules and Regulations]
[Pages 19272-19277]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-8135]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0134; FRL-8818-9]
Thifensulfuron methyl; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
thifensulfuron methyl in or on safflower, seed. Interregional Research
Project Number 4 (IR-4) requested this tolerance under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April 14, 2010. Objections and
requests for hearings must be received on or before June 14, 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-2009-0134. 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 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: Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6463; e-mail address: madden.barbara@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
[[Page 19273]]
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. To
access the OPPTS harmonized test guidelines referenced in this document
electronically, please go to https://www.epa.gov/oppts and select ``Test
Methods and Guidelines.''
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-2009-0134 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
June 14, 2010. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
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-2009-0134, 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
9F7523) by IR-4, 500 College Rd. East, Suite 201 W, Princeton, NJ
08540. The petition requested that 40 CFR 180.439 be amended by
establishing a tolerance for residues of the herbicide thifensulfuron
methyl, (methyl-3-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl) amino]
carbonyl] amino] sulfonyl]-2-thiophenecarboxylate), in or on safflower,
seed at 0.05 parts per million (ppm). That notice referenced a summary
of the petition prepared on behalf of IR-4 by E.I. DuPont de Nemours,
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.
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
tolerance for residues of thifensulfuron methyl on safflower seed at
0.05ppm. EPA's assessment of exposures and risks associated with
thifensulfuron methyl 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.
Thifensulfuron methyl has mild to low acute toxicity when
administered via the oral, inhalation and dermal routes of exposure. It
has moderate to low toxicity with respect to eye and skin irritation
and is not a dermal sensitizer. Most findings in the submitted studies
related to decreases in body weights, body weight gains, or organ
weights (a reflection of the lower body weights compared with control
weights). There were increased liver weights in male dogs and increased
thyroid/parathyroid weights in female dogs. There were no gross or
histopathological changes reported in any of the studies.
In the rat developmental study, there were no maternal effects at
the highest dose tested (HDT). The rabbit developmental study showed a
decrease in maternal body weights at the HDT. There were no
developmental effects at the HDT. In the 2-generation rat reproduction
study there were no parental, reproductive or offspring effects. There
was an increase in quantitative susceptibility in the rat developmental
study, based on decreased mean fetal body weights, and an increase in
the incidence of small renal papillae (only at the highest dose level).
Thifensulfuron methyl is classified as ``not likely to be
carcinogenic to humans,'' based on acceptable chronic/carcinogenicity
studies in rats and mice at doses that are considered to be adequate,
and not excessive for the determination of carcinogenic potential. The
available mutagenicity studies in vivo and in vitro show that
thifensulfuron methyl is neither mutagenic nor clastogenic.
Neurotoxicity was not observed in the submitted guideline studies.
There were
[[Page 19274]]
no acute or subchronic neurotoxicity studies available for review.
There were also no immunotoxicity studies submitted for review.
Immunotoxicity was observed as a decrease in spleen weight in the
subchronic rat study. However, this effect was only noted in males, and
only at the mid-level dose of 177 mg/kg. The lack of response at the
high-level dose, the occurrence in a single sex, the availability of a
clear NOAEL, and the absence of immunotoxic effects in the remainder of
the database reduce EPA's concern for immunotoxicity.
Specific information on the studies received and the nature of the
adverse effects caused by thifensulfuron methyl 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 ``Thifensulfuron Methyl. Human Health
Risk Assessment for the Proposed Food/Feed Use of the Herbicide
(Associated with Regional Section 3 Registration) on Safflower,'' pp.
9-10 in docket ID number EPA-HQ-OPP-2009-0134.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level - generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD) - and a safe
margin of exposure (MOE). 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 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 thifensulfuron methyl
used for human risk assessment is shown in the table of this unit.
Table --Summary of Toxicological Doses and Endpoints for Thifensulfuron methyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of Departure and
Exposure/Scenario Uncertainty/Safety RfD, PAD, LOC for Risk Study and Toxicological
Factors Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary NOAEL = 159 milligrams/ Acute RfD = 1.59 mg/kg/ Developmental Oral
(Females 13 - 50 years of age)...... kilograms/day (mg/kg/ day Toxicity-Rat.
day) aPAD = 1.59 mg/kg/day.. LOAEL = 725 mg/kg/day
UFA = 10x.............. based on decreased
UFH = 10x.............. mean body weight and
FQPA SF = 1x........... increased incidence of
small renal papillae
----------------------------------------------------------------------------------------------------------------
Acute dietary Not applicable. There were no single
(General population including infants dose effects
and children). appropriate for acute
exposure assessment
for the general
population.
----------------------------------------------------------------------------------------------------------------
Chronic dietary NOAEL= 4.3 mg/kg/day Chronic RfD = 0.043 mg/ Carcinogenicity oral
(All populations).................... UFA =10x............... kg/day toxicity in mice.
UFH = 10x.............. cPAD = 0.043mg/kg/day.. LOAEL = 128 mg/kg/day
FQPA SF 1x............. based on decreased
body weight and body
weight gain.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral) Not likely to be a human carcinogen, based on the lack of evidence of
carcinogenicity in rats and mice.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
reference dose. MOE = margin of exposure. LOC = level of concern.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to thifensulfuron methyl, EPA considered exposure under the
petitioned-for tolerance as well as all existing thifensulfuron methyl
tolerances in 40 CFR 180.439. EPA assessed dietary exposures from
thifensulfuron methyl 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 effect was
identified for thifensulfuron methyl for the general population.
However, EPA identified potential acute effects (decreased mean body
weight, and increased incidence of small renal papillae) from pre-natal
exposure and thus is assessing exposure and risk for the population
subgroup, females 13 - 49 years old.
In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA used tolerance-
level residues, DEEM default processing factors for all processed
commodities and assumed 100 percent crop treated (PCT) for all
commodities covered by existing or proposed tolerances.
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 used tolerance-level
residues, DEEM default processing factors for all processed commodities
and assumed 100 PCT for all commodities covered by existing or proposed
tolerances.
[[Page 19275]]
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
classified thifensulfuron methyl as ``not likely to be carcinogenic to
humans''. Therefore, a quantitative exposure assessment to evaluate
cancer risk is unnecessary.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
thifensulfuron methyl. Tolerance level residues and 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 thifensulfuron methyl in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of thifensulfuron methyl. 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 thifensulfuron
methyl for acute exposures are estimated to be 4.429 parts per billion
(ppb) for surface water and 0.0972 ppb for ground water and for chronic
exposures for non-cancer assessments are estimated to be 1.5 ppb for
surface water and .0972 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 4.429 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 1.5 ppb was used to assess
the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Thifensulfuron methyl
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 thifensulfuron methyl to share a common mechanism
of toxicity with any other substances, and thifensulfuron methyl does
not appear to produce a toxic metabolite produced by other substances.
For the purposes of this tolerance action, therefore, EPA has assumed
that thifensulfuron methyl 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 Safety
Factor (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. The prenatal and postnatal
toxicology database for thifensulfuron methyl includes rat and rabbit
prenatal developmental toxicity studies and a 2-generation reproduction
toxicity study in rats. There was evidence of increased quantitative
susceptibility in the rat developmental toxicity study. At the HDT,
decreased mean fetal weights, and an increase in incidence of small
renal papillae were observed in the absence of maternal toxicity. There
was no indication of pre- or post-natal susceptibility in the rabbit
developmental or rat reproduction studies.
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 thifensulfuron methyl is complete
except for immunotoxicity, acute neurotoxicity and subchronic
neurotoxicity testing. Recent changes to 40 CFR part 158 make acute and
subchronic neurotoxicity testing (OPPTS Guideline 870.6200) and
immunotoxicity testing (OPPTS Guideline 870.7800) required for
pesticide registration; however, the existing data are sufficient for
endpoint selection for exposure/risk assessment scenarios, and for
evaluation of the requirements under the FQPA.
Neurotoxicity was not observed in any of the studies up to the HDT,
nor is there any expectation of neurotoxicity based on the mechanism of
action. Furthermore, the toxicity database for thifensulfuron methyl
does not indicate that the immune system is the primary target organ.
Immunotoxicity was observed as a decrease in spleen weight in the
subchronic rat study. However, this effect was only noted in males, and
only at the mid-level dose of 177 mg/kg. The lack of response in the
high-level dose, the occurrence in a single sex, the availability of a
clear NOAEL, and the absence of immunotoxic effects in the remainder of
the database reduces EPA's concern for immunotoxicity. The overall
weight of evidence suggests that thifensulfuron methyl does not
directly target the immune system, and this finding (decrease in spleen
weight) may be due to secondary effects of a primary toxicity.
Therefore, the Agency does not believe that conducting the acute and
subchronic neurotoxicity, and the immunotoxicity studies will result in
a lower point of departure than the currently selected endpoints for
overall risk assessment, and therefore, a database uncertainty factor
is not needed to account for the lack of these studies.
ii. There is no indication that thifensulfuron methyl is a
neurotoxic chemical and there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is evidence that thifensulfuron methyl results in
increased susceptibility in in utero rats in the prenatal developmental
studies and in young rats in the 2-generation reproduction study;
therefore, a degree of concern analysis was performed to determine the
level of concern for the effects observed when considered in the
context of all available toxicity data and to identify any residual
concerns after establishing toxicity endpoints and traditional UF's to
be used in the thifensulfuron methyl risk assessment. In considering
the overall toxicity profile and the endpoints and doses selected for
the thifensulfuron methyl risk assessment, EPA characterized the degree
of concern for the susceptibility observed in the rat developmental and
[[Page 19276]]
2-generation reproductive studies as low and determined that there are
no residual uncertainties for prenatal and/or postnatal toxicity
because:
a. The only missing toxicity data for thifensulfuron methyl are the
newly required neurotoxicity and immunotoxicity studies; however, no
additional UF is needed in the absence of these studies because there
is no evidence to indicate that thifensulfuron methyl targets the
nervous system or the immune system. Further, EPA has concluded a
developmental neurotoxicity study is not required.
b. There are clear NOAELs and LOAELs for the developmental and
offspring effects noted in the rat developmental toxicity and in the 2-
generation reproduction toxicity studies and the doses and endpoints
have been selected from these studies for risk assessment for the
relevant exposed populations, ie., pregnant females and children.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on conservative assumptions, including 100 PCT and tolerance-level
residues. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to thifensulfuron
methyl in drinking water. These assessments will not underestimate the
exposure and risks posed by thifensulfuron methyl.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to thifensulfuron methyl will occupy less than 1% of the aPAD for
females (ages 13 - 49), the population subgroup receiving the greatest
exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
thifensulfuron methyl from food and water will utilize 1% of the cPAD
for children (ages 3 - 5), the population subgroup receiving the
greatest exposure. There are no residential uses for thifensulfuron
methyl.
3. Short and intermediate-term risk. Short and intermediate-term
aggregate exposure takes into account residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
A short and intermediate-term adverse effect was identified;
however, thifensulfuron methyl is not registered for any use patterns
that would result in short or intermediate-term residential exposure.
Short and intermediate-term risk is assessed based on short and
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no short or intermediate-term residential exposure and
chronic dietary exposure has already been assessed under the
appropriately protective cPAD (which is at least as protective as the
point of departure used to assess short and intermediate-term risk), no
further assessment of short or intermediate-term risk is necessary, and
EPA relies on the chronic dietary risk assessment for evaluating short
and intermediate-term risk for thifensulfuron methyl.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, thifensulfuron methyl is not expected to pose a cancer risk to
humans.
5. 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 thifensulfuron methyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The following adequate enforcement methodology is available to
enforce the tolerance expression: Two High Pressure Liquid
Chromatography (HPLC) photo-conductivity detection methods. The methods
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 no CODEX, Canadian or Mexican maximum residue limits
(MRLs) established for residues of thifensulfuron methyl on safflower.
C. Revisions to Petitioned-For Tolerances
EPA revised the tolerance expression in paragraph (a) to clarify:
1. That, as provided in FFDCA section 408(a)(3), the tolerance
covers metabolites and degradates of thifensulfuron methyl not
specifically mentioned; and
2. That compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.
V. Conclusion
Therefore, a tolerance is established for residues of
thifensulfuron methyl (methyl-3-[[[[(4-methoxy-6-methyl-1,3,5-triazin-
2-yl) amino] carbonyl] amino] sulfonyl]-2-thiophenecarboxylate), in or
on safflower, seed 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 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
[[Page 19277]]
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: April 1, 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. In Sec. 180.439, revise paragraph (a) introductory text and
paragraph (c) to read as follows:
Sec. 180.439 Thifensulfuron methyl; tolerances for residues.
(a) General. Tolerances are established for residues of
thifensulfuron methyl, including its metabolites and degradates, in or
on the commodities listed in the following table [below]. Compliance
with the tolerance levels specified in the following table [below] is
to be determined by measuring only thifensulfuron methyl (methyl 3-
[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]
sulfonyl]-2-thiophenecarboxylate).
* * * * *
(c) Tolerances with regional registrations. Tolerances are
established for residues of thifensulfuron methyl, including its
metabolites and degradates, in or on the commodities listed in the
following table [below]. Compliance with the tolerance levels specified
in the following table [below] is to be determined by measuring only
thifensulfuron methyl (methyl 3-[[[[(4-methoxy-6-methyl-1,3,5-triazin-
2-yl)amino]carbonyl]amino] sulfonyl]-2-thiophenecarboxylate).
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Safflower, seed...................................... 0.05
------------------------------------------------------------------------
* * * * *
[FR Doc. 2010-8135 Filed 4-13-10; 8:45 am]
BILLING CODE 6560-50-S